[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mindfulness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mindfulness":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,46,79,106,140,168,207,236,266,277,306,338,362,393,422,450,476,504,539,565,584,612,635,669,695],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054326","dose-response-effects-of-a-brief-audio-guided-mindfulness-intervention-for-acute-pain-100054326",false,"NCT07562412","Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain","Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain While Awaiting Orthopedic Care","Inclusion Criteria:\n\n* Receiving treatment at Tallahassee Orthopedic Center\n* Understanding English instructions fluently\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Unable to consent because of physical or mental incapacity.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.",[27,28,29,30,31,32],"Pain","Pain Management","Mindfulness","Orthopedic","Acute Pain","Chronic Pain","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2026-04-29",{"date":41,"type":21},"2027-04-30",{"name":43,"class":44},"Florida State University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100641340","effect-of-mandala-coloring-on-menopausal-attitude-perceived-stress-and-mindfulness-100641340","NCT07657429","Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness","The Effect of Mandala Coloring on Menopausal Attitudes, Perceived Stress, and Mindfulness in Women During Menopause: A Randomized Controlled Trial","MANDALA-MENO","* Inclusion Criteria:\n\n  * Women aged 45-55 years\n  * Being in the menopausal period (absence of menstruation for at least 12 months)\n  * Ability to read and understand Turkish\n  * Voluntary agreement to participate in the study\n* Exclusion Criteria:\n\n  * Diagnosed psychiatric or cognitive disorders\n  * Communication problems preventing participation\n  * Visual impairment or fine motor limitations preventing mandala coloring\n  * Use of hormone replacement therapy\n  * Regular participation in mandala coloring, mindfulness, or similar mind-body practices","FEMALE","45 Years","55 Years",{"count":58,"type":21},140,[24],"Menopause is a natural life stage associated with hormonal changes that may affect women physically and psychologically. During this period, women may experience increased stress levels, negative attitudes toward menopause, and decreased mindfulness. Mandala coloring is a structured art-based intervention that may promote relaxation and improve psychological well-being. This randomized controlled trial aims to evaluate the effect of mandala coloring on attitudes toward menopause, perceived stress, and mindfulness levels among menopausal women.",[62,63,29],"Menopause","Psychological Stress",[65,62,66,29,67,68],"Mandala Coloring","Perceived Stress","Women Health","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-24",{"date":72,"type":37},"2026-06-29",{"date":74,"type":21},"2026-05-30",{"date":76,"type":21},"2026-09-30",{"name":78,"class":44},"Ondokuz Mayıs University",{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100590813","phase-1-mindfulness-meditation-for-insomnia-100590813","NCT06972303","Mindfulness Meditation for Insomnia","A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder","Inclusion Criteria:\n\n* Age 18 years and older;\n* Chronic insomnia (≥ 3 nights\u002Fweek, for ≥ 3 months), defined by DSM-V or ICSD-3;\n* Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency \\>20 min;\n* Insomnia Severity Index score ≥ 15;\n* Speak and understand English;\n* Have a smart device (phone or tablet) for mobile app installation\n\nExclusion Criteria:\n\n* Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);\n* Shift worker or routine night shifts;\n* Women with pregnancy or breastfeeding;\n* Regular (defined as twice a week or more) practice of mind-body interventions;\n* Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);\n* Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;\n* Currently under medications with sleep changing effects (e.g., anxiolytics\u002Fbenzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);\n* Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.",{"count":87,"type":21},30,[89,90],"PHASE1","PHASE2","The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.",[93,94,95,29,96],"Sleep Initiation and Maintenance Disorders","Insomnia","Insomnia Chronic","Telemedicine","2026-06-21",{"date":99,"type":37},"2026-06-23",{"date":101,"type":37},"2026-03-31",{"date":103,"type":21},"2028-12-29",{"name":105,"class":44},"Brigham and Women's Hospital",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":45},"100607998","mindful-breath-for-people-with-copd-100607998","NCT07195838","Mindful-Breath for People With COPD","Effects of a Hybrid, Personalised Mindfulness-optimised Pulmonary Rehabilitation (Mindful-Breath) Programme for Active Living for People With Chronic Obstructive Pulmonary Disease: A Pilot Randomised Controlled Trial","Inclusion Criteria:\n\n* Age: 50-80 years\n* Sex: Male or female\n* Education level: Primary or above\n* Diagnosis: COPD (Baseline FEV1 \\\u003C80% and FEV1\u002FFVC \\\u003C70% of predicted normal values)\n* Severity of COPD: Stage I to IV\n* Group of COPD: Group B, or E, based on 2024 GOLD guideline (36)\n* Clinical stability: No acute exacerbation in the past 4 weeks. Patients with recent acute exacerbation in the past 4 weeks will be screened again in subsequent follow-up.\n* Moderate stress: PSS score ≥14 (28)\n* Access to a mobile device (e.g., a smartphone, tablet, or laptop) with internet connectivity\n* Ability to read, communicate, and provide written consent in Chinese.\n\nExclusion Criteria:\n\n* Engaging in \\>60 minutes\u002Fweek of moderate PA based on American Lung Association guidelines\n* Recent or ongoing receipt of other pharmacological\u002Fbehavioral trials within the past 3 months\n* Contraindications or severe comorbidities that may limit full participation (mental diseases, deafness, limb activity disorder, coronary heart disease, arterial aneurysm, uncontrolled hypertension, pregnancy, etc)\n* Co-existing respiratory diseases (Asthma\u002Finterstitial lung disease\u002Fbronchiectasis) or active malignancies\n* Very severe COPD requiring long-term oxygen therapy or home non-invasive ventilation","50 Years","80 Years",{"count":116,"type":21},60,[24],"Individuals living with chronic obstructive pulmonary disease (COPD) often suffer from stress and behavioral risks such as physical inactivity. In an attempt to promote healthy behaviors and overall wellbeing among this particular population, this study aims to develop and evaluate a personalized Mindful-Breath intervention combining telehealth technology and mindfulness for COPD patients. This is an assessor-blinded, two-arm exploratory randomized controlled trial with a sequential mixed-method design. A total of 60 participants will be recruited and randomly assigned to either intervention or control group using 1:1 ratio. Intervention group will go through 8 weekly 60-min hybrid group sessions, combining mindfulness-based pulmonary rehabilitation and lifestyle modification. Personalized mindfulness-based lifestyle counselling through instant messages with chat-based support throughout the 8-week intervention period will also be provided. Control group will receive a single in-person 60-min group session on general education on pulmonary rehabilitation and lifestyle modification and will only receive reminder messages for follow-ups. Variables such as time spent on physical activity, lung function, perceived stress, symptom burden and health-related quality of life will be collected at three time-points (T0: baseline, prior to randomization; T1: immediate post-intervention; T2: 3-month post-intervention).",[29,120,121],"Pulmonary Rehabilitation","Chronic Obstructive Pulmonary Disease (COPD)",[123,124,125,126,127,128,129,130],"mindfulness","pulmonary rehabilitation","chronic obstructive pulmonary disease","RCT","lifestyle modification","mHealth","EMI","physical inactivity","2026-06-15",{"date":133,"type":37},"2026-06-16",{"date":135,"type":37},"2025-09-30",{"date":137,"type":21},"2027-06-30",{"name":139,"class":44},"The University of Hong Kong",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":158,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":45},"100579202","dyadic-mindfulness-for-people-with-parkinsons-disease-and-their-caregivers-100579202","NCT06821230","Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers","Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: A Randomized Controlled Trial in People With Parkinson's Disease and Their Caregivers","Inclusion Criteria of PwPD:\n\n* Chinese patients with idiopathic mild-moderate PD (as indicated by the Hoehn and Yahr Scale stages I-III: those with unilateral\u002Fbilateral symptoms, with\u002Fwithout postural instability who are able to walk\u002Fstand unassisted)\n* Aged ≥18 years\n\nInclusion Criteria of caregivers of PwPD:\n\n\\- Self-identified as the primary caregivers of their patient\n\nEither patient or caregiver needs to experience at least mild negative emotions (as indicated by the 21-item Depression, Anxiety and Stress Scale \\[DASS21\\] score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15)\n\nBoth need to be able to communicate in Cantonese and provide written consent.\n\nExclusion Criteria:\n\n* Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (\\>2 times per week)\n* Have a pre-existing acute psychotic disease\n* Currently participating in any other behavioral or pharmacological trial\n* Have significant cognitive impairment, as indicated by an Abbreviated Mental Test score≤ 6\n* Have other contraindications that may limit their full participation (e.g., severe hearing\u002Fvision impairment)",{"count":148,"type":21},200,[24],"The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness\u002Fineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.",[29,152,153,154,155,156,157],"Caregivers","Movement Disorders","Neurodegenerative Disease","Dyadic Intervention","Psychosocial Health","Parkinsons Disease",[159,29,160],"Parkinsons disease","dyadic care","2026-05-28",{"date":163,"type":37},"2026-06-01",{"date":165,"type":37},"2025-02-11",{"date":137,"type":21},{"name":139,"class":44},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":175,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":188,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":45},"100634675","choice-and-autonomy-in-learning-mindfulness-for-pediatric-residents-100634675","NCT07542769","Choice and Autonomy in Learning Mindfulness for Pediatric Residents","CALM-PR","Inclusion Criteria:\n\n* Current categorical pediatrics residents at Northwestern University.\n* Preliminary pediatrics residents who intend to continue in pediatrics.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n\\- None; all pediatric residents meeting inclusion criteria are eligible.",true,{"count":177,"type":21},42,[24],"This study is a pilot clinical trial designed to evaluate a flexible, online mindfulness program for pediatric residents. Medical training can be stressful, and although mindfulness programs are often offered to support well-being, many are either in-person or follow a fixed format that may not fit individual schedules or preferences. This study will test a digital mindfulness program called Wakeful, which allows participants to complete the course at their own pace. Participants will be randomly assigned to one of two groups: one group will be able to choose the length of their mindfulness program (3, 5, or 7 weeks), while the other group will be assigned a program length without a choice. The goal is to understand whether giving participants a choice improves how often they use the program, how satisfied they are with it, and whether they complete it. The main outcomes of this study focus on how participants interact with the program, including how many sessions they complete, how often they practice mindfulness on their own, and how useful and relevant they find the program. The study will also look at overall satisfaction and how many participants drop out before finishing. In addition, the study will explore whether participants report changes in mindfulness and compassion for others, although it is not designed to determine clinical improvements in mental health. By understanding how pediatric residents engage with different program formats, this study aims to inform the design of more flexible and user-centered digital wellness programs that better fit into demanding medical training environments.",[181,182,29,183,184,185,186,187],"Program Engagement","Treatment Adherence and Compliance","Self-Compassion","Physician Burnout","Psychological Well-Being","Meditation","Meditation Training",[29,186,189,190,191,192,193,182,194,181,195,196,183,197],"Digital Health Intervention","Internet-Based Intervention","Physician Well-Being","Graduate Medical Education","Pediatric Residency","Patient Acceptance of Health Care","User Engagement","Pilot Projects","Compassion","2026-05-21",{"date":200,"type":37},"2026-05-26",{"date":202,"type":37},"2026-04-13",{"date":204,"type":21},"2027-05-01",{"name":206,"class":44},"Northwestern University",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":175,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":45},"100596088","mindfulness-to-enhance-cognitive-health-in-latino-older-adults-100596088","NCT07040904","Mindfulness to Enhance Cognitive Health in Latino Older Adults","Mindfulness to Enhance Cognitive Health in Latinx Older Adults","MLX","Inclusion Criteria:\n\n* Hispanic\u002FLatino\n* Age 65 and older\n* Male, female, or non-binary\n* Community living\n* Medically stable and willing to undergo the study procedures\n* No extensive mindfulness training experience\n\nExclusion Criteria:\n\n* Clinically unstable psychiatric disorder that requires immediate treatment (e.g., ECT)\n* Medical conditions suggesting significantly shortened lifespan (e.g., metastatic cancer) or prohibiting safe participation in the interventions\u002Fassessments (e.g., Parkinson's disease, musculoskeletal conditions)\n* Sensory impairment (hearing, vision) preventing participation\n* Current alcohol or substance abuse\n* Current\u002Fconcurrent cognitive training known to affect neuroplasticity (e.g., brain-training programs), or other interventions expected to affect neuroplasticity significantly (e.g., psychedelics, cholinesterase inhibitors, high-dose sedatives).","65 Years",{"count":116,"type":21},[24],"The primary objective of the proposed research is to investigate the promise and underlying mechanisms of mindfulness training as a preventative lifestyle intervention to enhance cognitive health in Latino older adults, thereby mitigating risk of Alzheimer's Disease (AD) in a population that may be particularly vulnerable.",[29,220],"Alzheimer's Disease Related Dementia",[222,223,224,225,29,226],"AD Biomarkers","Alzheimer's Disease","Alzheimer's disease and related dementias","cognitive behavioral intervention","Mindfulness Training","2026-05-05",{"date":229,"type":37},"2026-05-11",{"date":231,"type":37},"2024-12-10",{"date":233,"type":21},"2026-07-31",{"name":235,"class":44},"Washington University School of Medicine",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":45},"100635750","soma-validation-rct-testing-structural-equivalence-and-mechanistic-orthogonality-of-an-open-source-mindfulness-stimulus-library-100635750","NCT07556744","SOMA Validation RCT: Testing Structural Equivalence and Mechanistic Orthogonality of an Open-Source Mindfulness Stimulus Library","The Standardized Open-source Mindfulness Architecture (SOMA): A Modular, Equity-Engineered Stimulus Library for Mechanistic Mindfulness Research","SOMA-VAL","Inclusion Criteria:\n\nAged 18 years or older (or the legal age of majority in the participant's country of residence, whichever is higher)\n\nFluent in English (English as first language or self-reported fluent language)\n\nAble to listen to a 12-minute audio recording with headphones, earphones, or device speaker\n\nAccess to a device capable of completing an online survey\n\nExclusion Criteria:\n\nCurrent diagnosis of a mental health condition\n\nCurrently receiving or waiting for treatment for mental health symptoms (e.g., psychological therapy or psychiatric medication)\n\nRegular yoga or meditation practice in the last six months",{"count":245,"type":21},360,[24],"Background: Mindfulness research faces two structural problems. First, weak active control conditions make it impossible to isolate specific mechanisms from expectancy and non-specific effects. Second, most protocols systematically exclude low-socioeconomic status (SES) populations through design assumptions that presuppose high literacy, quiet private spaces, and familiarity with contemplative practice.\n\nObjective: This study validates the Standardized Open-source Mindfulness Architecture (SOMA), the first modular, open-source stimulus library purpose-built to address both challenges simultaneously. SOMA comprises 88 distinct audio assets organized around 16 sensory practice modules, each paired with a structurally equivalent active control script engineered to induce analytically orthogonal cognitive processing.\n\nDesign: Pre-registered randomized controlled trial using a 2×2 mixed design (Condition \\[Mindfulness vs. Active Control\\] × Measure \\[State Mindfulness Scale vs. Analytical Engagement Scale\\]), with quota sampling to ensure equal representation of participants with and without a university-level degree (n = 180 per SES stratum).\n\nSetting: Online, via Prolific Academic recruitment platform and Qualtrics survey software.\n\nParticipants: N = 360 English-proficient adults aged 18 years and older (or the applicable minimum age of majority in the participant's country of residence) without a current mental health diagnosis or treatment, and without a current meditation practice.\n\nIntervention: Each participant listens to a single 12-minute audio-guided exercise. Participants are randomly assigned to either the Mindfulness condition or the Active Control condition, and within that condition to one of 16 practice scripts. Mindfulness scripts guide bottom-up experiential awareness; Active Control scripts guide top-down analytical processing of the same everyday activities.\n\nPrimary Outcomes: (1) Credibility and expectancy equivalence between conditions (H1: Two One-Sided Tests on Credibility and Expectancy Questionnaire composite, equivalence bounds d = ±0.40); (2) mechanistic double dissociation - higher state mindfulness in the Mindfulness condition and higher analytical engagement in the Active Control condition (H2: 2×2 mixed ANOVA, interaction term as primary criterion).\n\nExploratory Outcome: SES-related differential experiential accessibility (H3: independent-samples t-test plus equivalence test on Semantic Differential composite by SES group).",[29,249],"Healthy Volunteers",[29,251,252,253,254,255,256,257,68],"Active Control","Stimulus Library","Mechanistic Research","Open Science","Socioeconomic Status","Credibility","Expectancy","2026-04-28",{"date":260,"type":37},"2026-05-04",{"date":227,"type":21},{"date":263,"type":21},"2026-05-31",{"name":265,"class":44},"Institute for Human Development and Potential (IHDP), Singapore",{"id":267,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":25,"conditions":270,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":276,"locationsCount":45},"100636186",{"count":20,"type":21},[24],[27,28,29,30,31,32],"2026-04-27",{"date":273,"type":37},"2026-05-01",{"date":273,"type":21},{"date":41,"type":21},{"name":43,"class":44},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":294,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":45},"100635716","effect-of-an-empowerment-based-psychoeducation-program-on-burnout-and-psychological-outcomes-in-nurse-managers-100635716","NCT07556302","Effect of an Empowerment-Based Psychoeducation Program on Burnout and Psychological Outcomes in Nurse Managers","The Effect of an Empowerment-Based Psychoeducation Program on Burnout, Self-Leadership, Psychological Empowerment, and Psychological Resilience in Nurse Managers: A Randomized Controlled Trial","EMPOWER-NM","Inclusion Criteria:\n\n* Nurse managers currently working in healthcare institutions\n* Aged 18 years or older\n* Willing to participate in the study\n* Able to attend all psychoeducation sessions\n* Provide informed consent\n\nExclusion Criteria:\n\n* Participation in a similar psychoeducation or intervention program within the last 6 months\n* Inability to attend scheduled sessions regularly\n* Refusal to provide informed consent",{"count":116,"type":21},[24],"This randomized controlled trial aims to evaluate the effectiveness of an empowerment-based psychoeducation program on burnout, self-leadership, mindfulness, and psychological resilience among nurse managers. The study population consists of nurse managers working in healthcare settings.\n\nThe primary objective of this study is to determine whether the psychoeducation program reduces burnout levels and improves self-leadership, mindfulness, and psychological resilience among nurse managers.\n\nThe main research questions are as follows:\n\nDoes the empowerment-based psychoeducation program reduce burnout levels in nurse managers? Does the program improve self-leadership levels in nurse managers? Does the program increase mindfulness levels in nurse managers? Does the program enhance psychological resilience in nurse managers?\n\nIn this randomized controlled design, participants will be assigned to either an intervention group or a control group. The intervention group will receive a structured empowerment-based psychoeducation program lasting five weeks, while the control group will not receive any intervention.\n\nParticipants will undergo the following procedures:\n\nCompletion of baseline (pre-test) assessments (T1) Participation in the psychoeducation program for the intervention group (5 weeks) No intervention for the control group Completion of post-intervention assessments (T2) Completion of follow-up assessments three months after the intervention (T3)\n\nThe findings of this study are expected to contribute to the development of evidence-based interventions aimed at strengthening managerial competencies and psychological well-being among nurse managers.",[289,290,291,292,29,293],"Burnout","Leadership","Psychological Empowerment Program","Psychological Resilience","Nurse Led Interventions",[295,296,297,292,289],"nurse led interventions","Psychological Empowerment program","Self-leadership","2026-04-24",{"date":39,"type":37},{"date":301,"type":21},"2026-06-05",{"date":303,"type":21},"2026-10-05",{"name":305,"class":44},"Suleyman Demirel University",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":175,"sex":17,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":324,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":336,"locationsCount":45},"100634533","effect-of-mbsr-training-on-childbirth-fear-bonding-and-breastfeeding-in-adolescent-pregnant-women-100634533","NCT07540923","Effect of MBSR Training on Childbirth Fear, Bonding and Breastfeeding in Adolescent Pregnant Women","Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth, Maternal and Paternal Bonding and Breastfeeding Success in Adolescent Pregnant Women and Their Partners","Inclusion Criteria:\n\n1. Being between 15-19 years of age\n2. Being in the third trimester of pregnancy (30-33 weeks of gestation)\n3. Being primiparous\n4. Having no history of miscarriage, abortion or similar obstetric problems during pregnancy\n5. Not having a high-risk pregnancy diagnosis\n6. Being literate\n7. Partner accepting to actively participate in the parenting process\n\nExclusion Criteria:\n\n1. Having a chronic disease\n2. Having physical or psychological health problems\n3. Having a psychiatric diagnosis in the participant or their partner\n4. Having a detected health problem or congenital anomaly in the fetus\n5. Having previously received Mindfulness-Based Stress Reduction (MBSR) training\n6. Not completing the planned training program\n7. Voluntarily withdrawing from the study","15 Years","19 Years",{"count":316,"type":21},54,[24],"This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.",[320,321,322,29,323],"Pregnancy in Adolescence","Fear","Mother-Child Relations","Breastfeeding",[325,326,327,328,329,323],"Adolescent Pregnancy","Fear of Childbirth","Maternal Bonding","Paternal Bonding","Mindfulness-Based Stress Reduction","2026-04-17",{"date":332,"type":37},"2026-04-21",{"date":334,"type":37},"2025-12-01",{"date":74,"type":21},{"name":337,"class":44},"Inonu University",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":45},"100632584","a-mindfulness-based-intervention-for-sexual-assault-survivors-100632584","NCT07515586","A Mindfulness-based Intervention for Sexual Assault Survivors","Leveraging Implementation Science to Develop a Mindfulness-Based Intervention to Reduce Alcohol Misuse and Tobacco Use Among Sexual Violence Survivors","Inclusion Criteria:\n\n* 18-24 years of age\n* currently enrolled as a full-time undergraduate at GSU\n* self-reported lifetime SV victimization\n* self-reported SV victimization in the past 6 months\n* drank alcohol within the last 30 days\n* must own a smartphone\n\nExclusion Criteria:\n\n* not applicable","24 Years",{"count":347,"type":21},120,[24],"The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. As a secondary goal, we aim to learn if intervention 1 reduces alcohol misuse and tobacco use in sexual assault survivors. The main questions it aims to answer are:\n\n* Is intervention 1 feasible to implement?\n* Is intervention 1 an acceptable intervention among the primary population, sexual assault survivors?\n* Does intervention 1 reduce alcohol misuse and tobacco use?\n\nResearchers will compare intervention 1 to an attention-placebo control group (e.g., online resources on healthy eating and nutrition).\n\nParticipants will:\n\n* take online surveys at baseline, 1 month follow-up, and 3-month follow-up\n* answer text-message questions at baseline and post-test\n* view and engage in an educational program",[351,352,29,353],"Alcohol Misuse","Tobacco Use","Stress",{"date":355,"type":37},"2026-04-07",{"date":357,"type":21},"2027-10",{"date":359,"type":21},"2030-08",{"name":361,"class":44},"Georgia State University",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":175,"sex":54,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":382,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":45},"100578015","stress-reactivity-and-mother-infant-cardiovascular-disease-risk-100578015","NCT06805799","Stress Reactivity and Mother-Infant Cardiovascular Disease Risk","Maternal-Infant Stress Reactivity as an Intergenerational Pathway to Cardiovascular Disease Risk","Inclusion Criteria:\n\n* For the parent RCT study: Inclusion criteria: singleton pregnancy, English speaking, \\>18 years old, \\\u003C20 weeks' gestation at enrollment, normotensive at enrollment, and criteria consistent with 'moderate' to 'high' risk for preeclampsia based on American College of Obstetrician and Gynecologist guidelines. For the current research study: Participants will be (n=40) individuals from the parent RCT who have consented to be contacted for future research in the parent study and are not pregnant during the mentored research study procedures.\n\nExclusion Criteria:\n\nFor the parent RCT study: Exclusion criteria: multiple gestations; chronic hypertension; active suicidality or psychosis; ongoing mind-body practice (e.g., yoga, meditation, mindfulness \\> once a week).\n\n\\-","6 Months",{"count":371,"type":21},40,[24],"Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum.\n\nUsing a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.",[375,376,377,378,29,379,380,381],"Maternal Health","Infant Health","Hypertension","Behavioral Medicine","Psychophysiology","Cardiovascular Diseases","Cardiovascular Diseases Risk",[29,379,383,384,385,377],"Coregulation","Maternal-infant Coregulation","Cardiovascular Disease Risk",{"date":387,"type":37},"2026-04-01",{"date":389,"type":21},"2026-04-15",{"date":233,"type":21},{"name":392,"class":44},"Lifespan",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":175,"sex":17,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":45},"100629644","the-behavioral-effects-of-mindfulness-based-technology-use-training-in-preschool-children-100629644","NCT07477353","The Behavioral Effects of Mindfulness-Based Technology Use Training in Preschool Children","The Effect of Mindfulness-Based Technology Use Training Applied to Preschool Children on Media Use, Sleep, Fear, and Close Relationships","Inclusion Criteria:\n\n* Obtaining verbal and written parental consent\n\n  * Being in the 3-6-year-old preschool age range\n  * Agreeing to participate regularly in the mindfulness training program\n  * Being open to communication and group interaction during the training process\n  * Not having previously participated in a similar psychological resilience or emotion regulation program\n\nExclusion Criteria:\n\n* Refusing to participate in the study or withdrawing consent during the process\n\n  * Having a cognitive or physical impairment that would prevent the completion of the questionnaires\n  * Having a level of absenteeism that could affect the implementation of the study","3 Years","6 Years",{"count":403,"type":21},50,[24],"With the rapid advancement of technology, the use of digital devices has become widespread even in early childhood. While the conscious and controlled use of technology in the preschool period can contribute to children's development, prolonged and uncontrolled screen use can lead to various negative consequences such as sleep problems, attention issues, increased anxiety levels, and difficulties in social relationships. In particular, exposure to violent media content can cause children to perceive the world as more frightening and experience anxiety.\n\nMindfulness-based training supports individuals in directing their attention to the present moment, recognizing their emotions, and accepting their experiences without judgment. Such training is known to develop self-regulation, attention, and emotional awareness skills in children.\n\nThe purpose of this study is to examine the effect of mindfulness-based technology use training applied to preschool children on their media usage habits, sleep patterns, fear levels, and parent-child relationship. The study is planned as a randomized controlled trial with an experimental design. The intervention group will receive mindfulness-based technology use training, while the control group will receive no intervention. The study expects that mindfulness-based training will reduce children's screen time, improve sleep quality, decrease fear levels, and strengthen parent-child relationships. This study aims to contribute to the development of intervention programs that support healthy technology use in early childhood.",[407,29,408],"Child","Media Use",[410,411,412,413],"mindfulness-based education","fear reactions","sleep patterns","child","2026-03-17",{"date":416,"type":37},"2026-03-19",{"date":418,"type":21},"2026-03-15",{"date":233,"type":21},{"name":421,"class":44},"Yazgulu Hemedoglu",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":45},"100543863","the-impacts-of-mindfulness-on-psychological-wellbeing-among-nursing-students-100543863","NCT06361394","The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students","The Impacts of Mindfulness on Psychological Wellbeing and Nursing Competencies Among Nursing Students","Inclusion Criteria:\n\n* Nursing students enrolled at the participating university\n* Aged 18 years or older\n* Willing to participate in the study\n* Able to provide written informed consent\n* Enrolled in the elective course \"Mindfulness and Happiness\" for assignment to the experimental group, or not enrolled in the course for assignment to the comparison group\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Unwilling or unable to provide informed consent",{"count":430,"type":21},240,[24],"The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students.",[434,29,435],"Psychological Well-being","Problematic Internet Use",[437,353,438,439,29,440],"Empathy","Anxiety","Nursing students","Problematic internet use","2026-03-16",{"date":443,"type":37},"2026-03-18",{"date":445,"type":37},"2025-02-10",{"date":447,"type":21},"2026-12-31",{"name":449,"class":44},"Chang Gung University of Science and Technology",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":465,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":4},"100614475","yoga-meditation-and-mindful-eating-intervention-in-university-students-100614475","NCT07280078","Yoga, Meditation and Mindful Eating Intervention in University Students","Evaluation of a Yoga, Meditation and Mindful Eating Intervention for the Control of Stress, Anxiety, Depression, and Mindfulness in University Students","Yoga-UDEA","Inclusion Criteria:\n\n* Undergraduate students enrolled in the curso \"Yoga, Meditation, and Mindful Eating\" at the Faculty of Pharmaceutical and Food Sciences (CIFAL), University of Antioquia.\n* Willing to participate voluntarily and complete all study assessments.\n* Able to attend the full program (32 hours over one academic semester).\n\nExclusion Criteria:\n\n* Students currently practicing yoga or meditation regularly.\n* Pregnant women or participants with any medical condition that prevents safe participation in yoga practice.\n* Individuals with severe psychiatric disorders requiring pharmacological treatment.",{"count":116,"type":21},[24],"The aim of this study is to learn whether a program that combines yoga, meditation, and mindful eating can help reduce stress, anxiety, and depression, and improve mindfulness in university students.\n\nThe main questions the study aims to answer are:\n\n* Does participating in yoga, meditation, and mindful eating sessions lower students' levels of stress, anxiety, and depression?\n* Does the program improve students' mindfulness and general well-being?\n\nWhat will happen in the study:\n\nParticipants will:\n\n* Attend weekly sessions of yoga, meditation, and mindful eating for 32 hours total.\n* Practice physical postures (Asanas), breathing exercises (Pranayama), relaxation, and meditation.\n* Receive short lessons about mindful nutrition and healthy lifestyle habits.\n* Complete questionnaires before and after the program to measure stress, anxiety, depression, and mindfulness.",[462,438,463,29,464],"Stress, Psychological","Depression","Well-being",[466],"Yoga, Meditation, Stress, Psychological; Anxiety; Well-being; Mindful Eating; Psychological","2026-02-16",{"date":469,"type":37},"2026-02-18",{"date":471,"type":21},"2026-07",{"date":473,"type":21},"2026-08",{"name":475,"class":44},"Universidad de Antioquia",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":175,"sex":54,"minAge":55,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":491,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":4},"100625583","psychosocial-effects-of-mindfulness-based-exercise-in-postmenopausal-women-100625583","NCT07424521","Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women","The Effects of Mindfulness-Based Exercise on Anxiety, Depression, and Sleep Quality in Postmenopausal Women","Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Being in the early postmenopausal period (no more than 8 years have passed since menopause)\n* Having experienced natural menopause\n* Having had at least one pregnancy\n* Residing in Istanbul or Izmir provinces\n\nExclusion Criteria:\n\n* History of trauma or illness that would prevent exercise\n* Having received hormone replacement therapy\n* Being involved in a different exercise program\n* Presence of a severe cardiopulmonary, orthopedic, or neurological disease\n* Presence of a psychological or psychiatric diagnosis\n* Presence of physical discomforts such as severe dizziness\n* Cooperation problems and incompatibility","60 Years",{"count":485,"type":21},20,[24],"Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality.\n\nContinuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.",[489,29,490],"Psychosocial Functioning","Postmenopausal Symptoms",[123,492,493,494,495],"postmenopausal","depression","sleep quality","anxiety","2026-02-14",{"date":498,"type":37},"2026-02-20",{"date":500,"type":21},"2026-03-01",{"date":163,"type":21},{"name":503,"class":44},"Halic University",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":175,"sex":54,"minAge":511,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":523,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":45},"100619990","mindfulness-and-meditation-based-lactation-education-on-maternal-breastmilk-in-the-neonatal-icu-100619990","NCT07351799","Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU","The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study","Inclusion Criteria:\n\n* Maternal age \\> 20 years of age\n* Read, write and understand English\n* Infant NICU admit\n* Infant birthplace of Rochester, MN (Mayo Clinic)\n* Maternal adherence to pumping ≥ 8 times in 24 hours\n* Mother enrolled within 72 hours of birth\n* Gestational age of neonate at birth of \\\u003C 34 0\u002F7 weeks\n\nExclusion Criteria:\n\n* Maternal extensive existing mindfulness practice\n* Maternal breast\u002Fchest surgery\n* Maternal polycystic ovarian syndrome (PCOS)\n* Maternal current illicit substance abuse\n* Diagnosis of maternal current severe mental health concerns\n* Maternal multiple gestation (twins or higher order) pregnancy and delivery","20 Years",{"count":371,"type":21},[24],"The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.",[516,29,517,518,519,186,520,521,522,438,463],"Lactation","NICU","Breastmilk","Neonatal","Pumping, Breast","Cortisol","Oxytocin",[524,123,517,525,519,526,527,528,529,495,463],"lactation","breastmilk","meditation","pumping, breast","cortisol","oxytocin","2026-01-12",{"date":532,"type":37},"2026-01-20",{"date":534,"type":37},"2025-09-22",{"date":536,"type":21},"2026-11-02",{"name":538,"class":44},"Mayo Clinic",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":45},"100619591","development-of-the-online-mindfulness-based-intervention-mind-space-application-for-thai-university-students-phase-ii-100619591","NCT07346612","Development of the Online Mindfulness-based Intervention (Mind Space Application) for Thai-university Students: Phase II","Inclusion Criteria: the researchers will specifically recruit volunteers who:\n\n1. are current studying in years 1-4 of undergraduate programs\n2. can read, speak, and write in Thai\n3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28))\n4. have no history of learning disorders (ADHD, other specific learning disorders)\n5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders)\n6. have no meditation experience within the past 6 months\n\nExclusion Criteria: the researchers will exclude the volunteers who;\n\n1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations)\n2. uncomfortable or feel distress and cannot participate in each mindfulness-based intervention session","25 Years",{"count":547,"type":21},450,[24],"Development of the online mindfulness-based intervention (MFU-mindful Application for Thai university students: Phase II\n\nObjectives:\n\nPhase I: (October 2025 to September 2026)\n\n1. To develop the mindfulness-based intervention (Mind Space application) for Thai university students.\n2. To test the feasibility of the mindfulness-based intervention (Mind space Application) for Thai university students.\n3. To determine the effect size of mindfulness-based intervention (Mind space Application) on mental health outcomes for Thai university students: A pilot study. Phase II: (October 2026 to December 2026)\n\n1\\. To examine the effects of mindfulness-base intervention (Mindspace Application) on mental health outcomes for Thai university students For this research project, investigators will develop the mindfulness-based intervention (Mindspace application) based on mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) by encouraging participants to pay attention to their present thoughts, emotions, feelings, and behaviors without judgment. This attention will help them learn the relationship between their thoughts, emotions, and behaviors and their mental health outcomes (mindfulness, stress, anxiety, and depression), though. mindfulness practice (body scan, sitting meditation, and mindful movement) using an online application). Furthermore, investigators will teach participants how to shape their thoughts and manage their wandering minds and negative and irritable thoughts. Finally, participants will learn how to become an individual with reasonable flexibility and positive thoughts.\n\nSettings: the researchers plan to conduct the program in three universities in Northern Thailand.\n\nPopulation and sample:\n\nPopulation: Thai university students who are between years 1 and 4 (undergraduate).\n\nSample:\n\nPhase I: Mae Fah Luang University, Phayao University, and Utraradit University students who are studying during the Fall semester, year 2026. Investigators will specifically recruit volunteers who:\n\nInclusion criteria:\n\n1. are current studying in years 1-4 of undergraduate programs\n2. can read, speak, and write in Thai\n3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28)\n4. have no history of learning disorders (ADHD, other specific learning disorders)\n5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders)\n6. have no meditation experience within the past 6 months\n\nExclusion criteria:\n\n1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations)\n2. They may feel uncomfortable or distressed and may not be able to participate in each mindfulness-based intervention session.\n\nConceptual frameworks. For this research project, the investigators will develop and refine an online mindfulness-based intervention, the Mind Space Application, grounded in the principles of Mindfulness-Based Stress Reduction (MBSR; Kabat-Zinn, 2003) and Mindfulness-Based Cognitive Therapy (MBCT; Segal et al., 2002). The program is designed to cultivate nonjudgmental awareness of thoughts, feelings, emotions, and behaviors among university students (Kabat-Zinn, 2003). In addition, it aims to enhance participants' understanding of the interrelationships among cognitions, emotions, affective experiences, and behaviors that contribute to psychological distress, including stress, anxiety, and depressive symptoms.\n\nThe intervention incorporates core mindfulness practices delivered via an online application, including body scan exercises, sitting meditation, and mindfulness-based movement for relaxation. Furthermore, participants will be guided to develop cognitive awareness and adaptive responses to internal and external stressors, with particular emphasis on recognizing and managing automatic thoughts (wandering mind), negative thoughts, and irrational or maladaptive cognitions. Through this process, participants are encouraged to cultivate more rational, flexible, and positive thinking patterns.\n\nThe researchers anticipate that this program will enhance mindfulness skills and, in turn, contribute to reductions in stress, anxiety, and depressive symptoms among the study participants.\n\nThe effectiveness of the Mind Space application will be examined across both short-term and long-term periods. Short-term effects will be assessed at baseline and immediately post-intervention (8 weeks), while long-term effectiveness will be evaluated at a 6-month follow-up. Outcomes in the intervention group will be compared with those in a control group. The primary outcome variables include mental health indicators-stress, anxiety, and depressive symptoms-as well as levels of mindfulness among Thai university students. Data will be analyzed using a one-way repeated-measures multivariate analysis of variance (MANOVA).",[551,552,29],"University Students","Psychological Well Being",[554,493,555],"university students","psychological well being","2026-01-07",{"date":558,"type":37},"2026-01-16",{"date":560,"type":21},"2026-02-01",{"date":562,"type":21},"2027-09-30",{"name":564,"class":44},"Mae Fah Luang University",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":582,"locationsCount":45},"100526974","feasibility-of-a-mindfulness-intervention-for-endometriosis-surgery-100526974","NCT06141720","Feasibility of a Mindfulness Intervention for Endometriosis Surgery","Inclusion Criteria:\n\n1. age 18 years or older\n2. diagnosis or probable diagnosis of endometriosis\n3. candidate for surgical procedure for endometriosis\n4. English speaking\n5. have access to wifi and email\n\nExclusion Criteria:\n\n1. prior formal mindfulness training\n2. Unable to consent",{"count":485,"type":21},[24],"Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.",[575,27,29],"Endometriosis","2025-12-09",{"date":578,"type":37},"2025-12-17",{"date":580,"type":37},"2024-05-30",{"date":76,"type":21},{"name":583,"class":44},"Milton S. Hershey Medical Center",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":592,"enrollmentInfo":593,"targetDuration":4,"studyType":22,"phases":595,"briefSummary":596,"conditions":597,"keywords":600,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":45},"100614927","mindfulness-walking-intervention-to-enhance-resilience-iwalk-100614927","NCT07285954","Mindfulness Walking Intervention to Enhance Resilience (iWalk)","A Randomized Controlled Trial of a Walking Meditation Intervention (iWalk) to Enhance Resilience in Adults","iWalk","Inclusion Criteria:\n\n1. 18 years or older,\n2. clinical diagnosis of a neurodegenerative disease such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, stroke, etc.,\n3. have not practiced meditation regularly (e.g., 10 mins per day) and have never attended any meditation classes or community programs,\n4. never received meditation training via coaching\u002Fcertification\u002Flife coaching,\n5. have internet access,\n6. with no severe cognitive impairment, i.e., have a score of ≥ 21 on Modified Telephonic Interview for Cognitive Status (TICS-M),\n7. be able to walk with or without an assistive device (Patient determined Disease Steps score ranged from 0-6),\n8. are willing to be randomized to an intervention or a control group,\n9. are willing to wear Fitbit (a wrist smart watch) for eight weeks,\n10. are individuals who are right-handed according to the Edinburgh Handedness Questionnaire,\n11. are willing to participate in all assessments, including in-person testing using electroencephalography (EEG) and cognitive tests, online survey\u002Fquestionnaires, and online interviews or focus group discussions,\n12. are willing to wear a Hexoskin t-shirt, which is a heart rate variability monitor, while doing the assessments in person.\n\nExclusion Criteria:\n\nParticipants who cannot speak, read, write, or listen in English.","110 Years",{"count":594,"type":21},90,[24],"This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS).\n\nThe objectives are to evaluate:\n\n1. Recruitment capability and retention rates,\n2. Acceptability and adherence to the intervention,\n3. Feasibility of assessment procedures, and\n4. Preliminary effects on psychological, physiological, and behavioral outcomes.",[154,598,29,599],"EEG","Adults",[601,602,598],"Walking meditation","Emotional regulation","2025-12-02",{"date":605,"type":37},"2025-12-16",{"date":607,"type":37},"2025-06-01",{"date":609,"type":21},"2029-12-31",{"name":611,"class":44},"University of Illinois at Urbana-Champaign",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":623,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":4},"100400582","mindfulness-in-high-risk-pregnancies-100400582","NCT04496115","Mindfulness in High Risk Pregnancies","The Impact of Mindfulness on Prenatal Depression, Anxiety and Stress in Mothers at Risk of Preterm Delivery","Inclusion Criteria:\n\n* Pregnant mothers admitted to the antepartum ward at the Lois Hole Hospital for risk of preterm delivery (\\\u003C 34 weeks GA) are eligible for the study.\n* if they speak, read and write English,\n* if their inpatient stay is anticipated to be at least 4 weeks following recruitment\n* if they are willing and able to attend the mindfulness sessions.\n\nExclusion Criteria:\n\n* if they are experiencing current mental illness issues\n* if they are experiencing current or prior substance abuse",{"count":116,"type":21},[24],"Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child.\n\nAlthough pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group.\n\nMindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies.\n\nTo date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress.\n\nThis study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.",[353,438,463,29],[29,624,625],"Antepartum","High Risk Pregnancy","2025-11-14",{"date":628,"type":37},"2025-11-18",{"date":630,"type":21},"2026-09-01",{"date":632,"type":21},"2027-06",{"name":634,"class":44},"University of Alberta",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":652,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":45},"100603964","mind-body-resilience-program-for-cardiac-arrest-survivors-and-their-caregivers-recovering-together-after-cardiac-arrest-100603964","NCT07143357","Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest","Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).","RT-CA","Inclusion Criteria:\n\n1. Out-of-hospital or in-hospital CA survivor (must have new diagnosis of \"cardiac arrest\" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)\n2. survivor must score \\>5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation\n3. ability and willingness to participate in a hybrid in-person\u002Flive video intervention\n4. English speaking adults (18 year or older)\n5. at least one member of the dyad endorses clinically significant emotional distress during screening (\\>7 on either of the Hospital Anxiety and Depression Scale subscales).\n\nExclusion Criteria:\n\n1. active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care\n2. any other psychiatric or neurological condition that would preclude meaningful participation\n3. the caregiver must not be a cardiac arrest survivor",{"count":644,"type":21},84,[24],"The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.",[648,649,438,463,152,650,651,29],"Emotional Distress","Cardiac Arrest (CA)","Survivorship","Resilience",[653,654,655,656,657,123,658,659,495,493],"emotional distress","cardiac arrest","cardiac arrest survivorship","caregivers","resilience","mind-body","behavioral interventions","2025-10-21",{"date":662,"type":37},"2025-10-23",{"date":664,"type":37},"2025-10-17",{"date":666,"type":21},"2028-07",{"name":668,"class":44},"Massachusetts General Hospital",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":175,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":22,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":694},"100607243","effects-of-mindfulness-or-brain-stimulation-intervention-for-late-life-adults-in-taiwan-urban-and-rural-areas-100607243","NCT07186023","Effects of Mindfulness or Brain Stimulation Intervention for Late-life Adults in Taiwan Urban and Rural Areas","Intervention Evaluation for Late-life Depression in Taiwan Urban and Rural Areas: Long-term Tracking and Prediction of Non-pharmaceutical Interventions by Smart AI Technologies","PredictNPI","Inclusion Criteria for individuals participating in mindfulness-based Interventions:\n\n* Literate or have received an education above the elementary level.\n* Have normal or corrected vision and hearing, able to communicate and understand explanations.\n* Right-handed individuals as assessed by the Edinburgh Handedness Inventory.\n\nExclusion Criteria for individuals participating in mindfulness-based Interventions:\n\n* Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.\n* Individuals with neurological system disorders.\n* Individuals with alcohol or drug dependence.\n* Individuals with other major physical illnesses, such as diabetes, heart failure, or endocrine abnormalities, or those who have experienced an acute myocardial infarction within the past three months.\n* Individuals with metal objects in the body that cannot undergo magnetic resonance imaging (MRI), such as cardiac pacemakers, vascular clips, hearing aids, artificial joints, steel pins, etc.\n* Individuals with Claustrophobia.\n* Individuals in pregnancy or possibility of pregnancy.\n\nInclusion Criteria for individuals participating in brain stimulation Intervention:\n\n* Individuals diagnosed with major depressive disorder by psychiatrists according to the Diagnostic and Statistical Manual, and who can cooperate with the psychiatric outpatient clinic regulations.\n* Literate or have received an education above the elementary level.\n* Have normal or corrected vision and hearing, able to communicate and understand explanations.\n* Right-handed individuals as assessed by the Edinburgh Handedness Inventory.\n* Individuals are prescribed brain stimulation therapy by clinical physicians.\n\nExclusion Criteria for individuals participating in brain stimulation Intervention:\n\n* Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.\n* Individuals with neurological system disorders.\n* Individuals with alcohol or drug dependence.\n* Individuals with other major physical illnesses, such as diabetes, heart failure, or endocrine abnormalities, or those who have experienced an acute myocardial infarction within the past three months.\n* Individuals with metal objects in the body that cannot undergo magnetic resonance imaging (MRI), such as cardiac pacemakers, vascular clips, hearing aids, artificial joints, steel pins, etc.\n* Individuals with Claustrophobia.\n* Individuals in pregnancy or possibility of pregnancy.",{"count":678,"type":21},124,[24],"This randomized controlled trial will examine the effects of mindfulness-based interventions and brain stimulation interventions on cognitive function and psychological well-being in older adults. The study will employ a comprehensive assessment approach incorporating psychological evaluations, behavioral assessments, psychophysiological measurements, and neuroimaging analyses to characterize the outcome of nonpharmaceutical interventions in improving geriatric well-being or reducing depression severity.",[682,683,684,29,685],"Late-Life Adults","Late-Life Prodromal Depression","Late-Life Depression","Brain Stimulation Intervention","2025-09-15",{"date":534,"type":37},{"date":689,"type":37},"2025-08-01",{"date":691,"type":21},"2028-12",{"name":693,"class":44},"National Health Research Institutes, Taiwan",2,{"id":696,"slug":697,"hasResults":12,"nctId":698,"briefTitle":699,"officialTitle":699,"acronym":4,"eligibilityCriteria":700,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":701,"targetDuration":4,"studyType":22,"phases":703,"briefSummary":704,"conditions":705,"keywords":708,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":717,"locationsCount":45},"100565438","phase-1-combined-guanfacine-and-mindfulness-meditation-as-an-adjunct-to-buprenorphine-maintenance-in-opioid-use-disorder-100565438","NCT06642181","Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder","Inclusion Criteria:\n\nN=224 individuals with a history of SCID-5 OUD, and maintained on BUP for at least 4 weeks (N=80 in the R61 phase and N=144 in the R33 phase). These individuals must be:\n\n* aged 18 to 55 years and have a body mass index (BMI) of 18-35;\n* have a positive urine toxicology screen for non-prescription opioids\n* be in good health as verified by screening examination\n* able to read English and provide informed consent.\n\nExclusion Criteria:\n\n* Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (although mild use will be permitted)\n* Use of medications in the last 6 months that may affect cerebral function with the exception of BUP and individuals stabilized on SSRIs\n* psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)\n* hypotensive individuals with sitting blood pressure below 100\u002F50 mmHG\n* Women who are pregnant, nursing or refuse to use a reliable form of birth control\n* EKG evidence at baseline screening of any clinically significant conduction abnormalities (Bazett's QTc of \\>450 msec for men and QTc\\>470 msec for women)\n* R33 phase will additionally include failure to satisfy fMRI safety protocols.",{"count":702,"type":21},224,[89],"The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication\u002Fbehavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.",[29,706,707],"Guanfacine","Opioid Use Disorder",[709,710,706],"Opioid","MIndfulness","2025-08-04",{"date":713,"type":37},"2025-08-08",{"date":715,"type":37},"2025-07-15",{"date":76,"type":21},{"name":718,"class":44},"Rutgers, The State University of New Jersey"]