[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distress-emotional\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distress-emotional":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,50,79,116,144,178,209,238,257,282,309,342,371,401,425,454,479,502,522,553],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100491071","training-in-evidence-based-treatments-in-psycho-oncology-100491071",false,"NCT05674357","Training in Evidence-based Treatments in Psycho-Oncology","Patient Inclusion Criteria:\n\n* Adults \\> 18 years of age.\n* Currently receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance.\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3.\n* Reports distress or presenting problem is related to patients' illness and\u002For treatment (e.g., cancer treatment).\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.\n* Located in the state of Massachusetts for the duration of sessions.\n\nCaregiver Inclusion criteria:\n\n* Adults \\> 18 years of age\n* Currently caring for someone receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3\n* Reports distress or presenting problem is related to caregiving\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion\n* Located in the state of Massachusetts for the duration of sessions\n\nPatient Exclusion Criteria:\n\n* Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n* Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).\n* Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.\n* Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n\nTherapist Inclusion criteria:\n\n-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.\n\nTherapist Exclusion criteria:\n\n-Obtained licensure as a clinical psychologist in any state.","ALL","18 Years",{"count":18,"type":19},115,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.\n\nThe intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.\n\n* Cognitive Behavioral Therapy (CBT)\n* Acceptance Commitment Therapy (ACT)\n* Mindfulness-Based Cognitive Therapy (MBCT)\n* Mindfulness-Based Stress Reduction (MBSR)\n* Meaning-Centered Psychotherapy (MCP)\n* Cognitive Behavioral Therapy for Insomnia (CBT-I)\n* CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.\n\nParticipation in this research study is expected to last about 26 weeks.\n\nIt is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.",[25,26,27,28,29],"Distress, Emotional","Depression, Anxiety","Fatigue","Pain","Insomnia",[31,32,33,34,35,36],"CBT","Cognitive-Behavioral Therapies","Emotional Distress","Anxiety","Depression","Symptom-Related Distress","RECRUITING","2026-06-11",{"date":40,"type":41},"2026-06-15","ACTUAL",{"date":43,"type":41},"2023-01-09",{"date":45,"type":19},"2029-01-01",{"name":47,"class":48},"Massachusetts General Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100551568","exploring-physical-and-psychological-needs-and-quality-of-life-in-patients-with-advanced-cancer-receiving-immunotherapy-100551568","NCT06461780","Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy","Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events","Inclusion Criteria:\n\n* (1) Patients diagnose cancer and are informed\n* (2) Aged ≥18 years old\n* (3) Conscious clear and able to communicate",{"count":58,"type":19},200,"1 Year","OBSERVATIONAL","During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.",[63,64,65,25,66,67,68],"Cancer","Immunotherapy","IrAE","Care Need","Financial Toxicity","Quality of Life","2026-04-24",{"date":71,"type":41},"2026-04-30",{"date":73,"type":41},"2024-03-18",{"date":75,"type":19},"2028-08-01",{"name":77,"class":78},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":87,"maxAge":16,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":90,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":49},"100636006","a-scalable-trans-diagnostic-intervention-targeting-adolescent-agency-supported-by-conversational-ai-agencia-100636006","NCT07560072","A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)","A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI","AGENCIA","Inclusion Criteria:\n\n* Adolescents aged 12 to 18 years at enrollment.\n* Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).\n* Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.\n* Ability to use digital materials through a personal device and basic reading skills in Spanish.\n* Availability to attend assessments and participate in the intervention and follow-up schedule.\n* Informed consent from caregivers and assent from the adolescent.\n\nExclusion Criteria:\n\n* Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).\n* Score of \"Severe\" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying\u002Fsocial problems).\n* Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive\u002Fexpressive language difficulties, motor limitations preventing device use).\n* Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.\n* Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.","12 Years",{"count":89,"type":19},465,[22],"The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.\n\nParticipants will be randomly assigned to one of three groups:\n\nAGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.\n\nDigital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.\n\nThe main research questions are:\n\nDoes AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?\n\nParticipants will:\n\n* Complete three structured sessions depending on their assigned group.\n* Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.\n* Receive brief phone calls during follow-ups to support questionnaire completion.\n\nA total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.",[93,94,95,96,25,97],"Irritability","Neurodevelopmental Disorders","Impulsivity","Emotional Dysregulation","Distress, Psychological",[99,100,101,102,103,104,105,106],"Adolescents","Randomized controlled trial","Personal Agency","Digital health intervention","Neurodevelopmental disorders","Family accommodation","Conversational AI","Trans diagnostic interventions","NOT_YET_RECRUITING","2026-04-23",{"date":71,"type":41},{"date":111,"type":19},"2026-04-01",{"date":113,"type":19},"2028-12-31",{"name":115,"class":48},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":49},"100629724","readiness-and-progress-in-emotion-regulation-therapy-100629724","NCT07478393","Readiness and Progress in Emotion Regulation Therapy","Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* Fluent in English (and therefore able to provide consent)\n* Currently living in New York State\n* Access to at least one device with internet and video-conferencing capabilities\n* High self-reported worry, rumination, and\u002For self-criticism\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder\n\nExclusion Criteria:\n\n* Active suicidal ideation or intent\n* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder\n* Currently in therapy or receiving any type of psychosocial treatment\n* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months\n* Current students at Teachers College, Columbia University","65 Years",{"count":124,"type":19},36,[22],"This study is an open trial designed to examine individual changes that occur before, during, and after 6 modules of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.",[128,129,130,34,35,25],"Rumination","Worry","Self-Criticism",[129,128,130,132,133,134],"Emotion Regulation Therapy","Emotion Regulation","Treatment Mechanisms","2026-03-12",{"date":137,"type":41},"2026-03-17",{"date":139,"type":41},"2025-10-24",{"date":141,"type":19},"2028-09-01",{"name":143,"class":48},"Teachers College, Columbia University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":161,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":49},"100547238","behavioral-approaches-to-reduce-diabetes-distress-in-adults-with-type-1-diabetes-a-pragmatic-smart-100547238","NCT06405373","Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART","Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care","ChargeUp","Inclusion Criteria:\n\n* Adults 30 years and older\n* Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes\n* Elevated diabetes distress, defined as a score \\>= 2.0 on the T1-DDAS core scale\n* English speaking\n\nExclusion Criteria:\n\n* Does not receive diabetes care at UNC Endocrinology at Eastowne\n* Cannot commit to the pre-scheduled weekly, virtual sessions\n* Diagnosis of any major medical or psychiatric condition that would preclude participation\n* Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment\n* Visual or auditory impairment that would interfere with participation in a group intervention\n* Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment","30 Years",{"count":58,"type":19},[22],"This study is designed to compare two behavioral approaches to reduce diabetes distress (\"the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes\") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the \"Primary\" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be \"non-responders\" (i.e., the Primary intervention was not effective) will be re-randomized to one of two \"Supplementary\" interventions, which will include individualized sessions to learn and\u002For practice strategies related to either the psychological or problem-solving approach.",[157,158,159,160,25],"Diabetes type1","Diabetes Mellitus, Type 1","Diabetes, Autoimmune","Diabetes Mellitus",[162,163,164,165,166,167,168],"Diabetes","Type 1 diabetes","Diabetes distress","T1D","Emotional distress","Telehealth","SMART design","2025-10-28",{"date":171,"type":41},"2025-10-29",{"date":173,"type":41},"2024-10-01",{"date":175,"type":19},"2027-09-15",{"name":177,"class":48},"University of North Carolina, Chapel Hill",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":20,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":49},"100609034","who-psychological-interventions-for-mental-health-outcomes-in-migrants-resettled-in-italy-the-advance-trial-100609034","NCT07209306","WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial","Testing the Effectiveness and Implementability of WHO Psychological Intervention Strategies for Improving Mental Health Outcomes in Migrant Populations Resettled in Italy: the ADVANCE Randomized Controlled Trial","ADVANCE-IT","Inclusion Criteria:\n\n* 18 years or older\n* Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants;\n* Having elevated levels of psychological distress (K10 \\>15.9);\n* Sufficient mastery (written and spoken) of one of the languages the SH+\u002FDWM intervention is being delivered in (i.e., English and\u002For Italian);\n* Oral and written informed consent before entering the study.\n\nExclusion Criteria:\n\n* Planning to permanently move back to their home country before the last follow-up assessment (at six months after randomization);\n\n  * Having acute medical conditions (requiring hospitalization);\n  * Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up based on screening tool and clinical judgement;\n  * Having a severe mental disorder (e.g., psychotic disorders, substance-dependence) based on clinical judgement;\n  * Having severe cognitive impairment based on clinical judgement (e.g., severe intellectual disability or dementia);\n  * Currently receiving specialized psychological treatment (e.g., Cognitive Behavioral treatment (CBT), Eye Movement Desensitizing and Reprocessing (EMDR));\n  * In case of current psychotropic medication use: being on an unstable dose for at least two months.",{"count":187,"type":19},237,[22],"Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their lives during and after migration. The World Health Organization has developed scalable psychological interventions, including Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM), which are designed for delivery by non-professional helpers and adaptable to various cultures and mental health issues. While initial randomized controlled trials (RCTs) show these interventions are effective, their medium to long-term efficacy, implementability and scalability have not been thoroughly evaluated.\n\nObjectives: This study aims to examine the efficacy of SH+ and DWM versus a psychological placebo in reducing anxiety and depression symptoms among migrants experiencing elevated psychological distress. Additionally, it seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions.\n\nStudy design: We will conduct a hybrid three-arm efficacy-implementation randomized controlled trial.\n\nStudy population Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 \\>15.9) (n=237).\n\nIntervention : All participants (in the three comparison groups) will receive Psychological First Aid (PFA) and enhanced care as usual (ECAU). In addition to PFA and ECAU, the intervention group 1 will receive SH+ complemented with an online booster session (delivered 4 weeks after SH+), the intervention group 2 will receive DWM complemented with an online booster session (delivered 4 weeks after DWM), and the intervention group 3 will receive psychological placebo (PsychP) complemented with an online session with neutral contents of the same duration of groups 1 and 2 (delivered 4 weeks after PsychP).\n\nMain study parameters\u002Fendpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, in-person or through (video) calls. For all participants, online assessments will take place at baseline, at 4\u002F6 weeks after having received DWM (which corresponds to 1 week after the booster session, and 3 months after randomization), and at 6 months after randomization. The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to three-month after randomization, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen's d effect size of 0.3 in the SH+ and DWM groups at 3 months after randomization. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), functional impairment (WHODAS), wellbeing (WHO-5), quality of life (EQ-5D-5L), and cost of care (CSRI). Implementation outcomes will be measured with the Adoption of Information, Technology measure, Measure of Disseminability and Levels of Institutionalization tool, adverse events, and WHO fidelity forms. Additional study parameters include demographic data and dropouts.",[97,25],[192,193,194,195,196,197,198,199],"Migrant populations","Psychological distress","Psychological wellbeing","WHO psychological interventions","Effectiveness","Implementation","Self-Help Plus","Doing What Matters in Times of Stress","2025-10-02",{"date":202,"type":41},"2025-10-06",{"date":204,"type":41},"2025-04-09",{"date":206,"type":19},"2027-04-30",{"name":208,"class":48},"Universita di Verona",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":218,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":49},"100523748","ascent-intervention-for-brain-tumor-patients-100523748","NCT06099743","ASCENT Intervention for Brain Tumor Patients","An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors","Inclusion Criteria:\n\n* Age ≥ 18\n* Massachusetts General Hospital Cancer Center Patient\n* Within 6 months of diagnosis of malignant primary Central Nervous System (CNS) tumor\n* English speaking\n\nExclusion Criteria:\n\n* Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment\u002Fdementia)\n* Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension subscale \\\u003C 8)\n* Current or imminent hospice enrollment",{"count":217,"type":19},100,[22],"The goal of this study is to refine and test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.",[221,222,223,25],"Malignant Brain Tumor","Glioma","Coping Skills",[225,226,227,228,229],"glioma","supportive care","brain tumor","psychological distress","support","2025-07-10",{"date":232,"type":41},"2025-07-14",{"date":234,"type":41},"2025-05-15",{"date":236,"type":19},"2029-07-31",{"name":47,"class":48},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":20,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":49},"100559935","targeting-components-of-distress-tolerance-100559935","NCT06570603","Targeting Components of Distress Tolerance","Inclusion Criteria:\n\n* Fluent in English\n* Uses Android or iPhone smartphone\n* Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher\n* Distress Intolerance Index (DII) scores of 3 or higher\n\nExclusion Criteria:\n\n* Work or School that does not allow consistent access to phone (or is unsafe)\n* No internet access for completing follow-up surveys",{"count":245,"type":19},240,[22],"The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.\n\nThe main questions it aims to answer are:\n\nHow are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?\n\nDoes targeting willingness to feel upset and\u002For self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?\n\nAre improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?\n\nParticipants will:\n\nAnswer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app\n\nUndergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab\n\nBe prompted to use the intervention skill via the cell phone app during the second week, after the intervention\n\nComplete weekly reports of mental health symptoms",[25],"2025-07-07",{"date":230,"type":41},{"date":252,"type":41},"2024-10-03",{"date":254,"type":19},"2027-04",{"name":256,"class":48},"University of Arkansas, Fayetteville",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":15,"minAge":265,"maxAge":87,"enrollmentInfo":266,"targetDuration":4,"studyType":20,"phases":268,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":49},"100468723","phase-3-anxiolysis-for-laceration-repair-in-children-100468723","NCT05383495","Anxiolysis for Laceration Repair in Children","Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial","ALICE","Inclusion Criteria:\n\ni) Age 2-12.99 years \\[highest incidence of laceration repair\\] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designate (trainee) iv) Child or caregiver desires anxiolysis for laceration repair \\[justification: incorporates family preferences based on their prior experiences or beliefs about child's response\\] vii) Local anesthesia planned to involve topical anesthetic (LET), infiltrated lidocaine, ring, or thenar block\n\nExclusion Criteria:\n\ni) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist \\\u003C 24 hours prior to interventions (may compound sedative effect and increase the SAE risk). 24-hours encompasses the duration of sedation of most agents.\n\nii) Hypersensitivity to any intervention iii) Occlusion of \\> 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug absorption) iv) Hemodynamic abnormalities: bradycardia or hypotension \\\u003C 2 SD of age-related normal value v) IND contraindications: Pre-existing renal insufficiency, uncorrected mineralocorticoid deficiency, pulmonary hypertension, uncorrected cyanotic heart disease, cardiac conduction disorder, pulmonary hypertension, pulmonary edema, vitamin B12 or folate disorder, phenylketonuria, or psychosis vi) Sedation contraindications: Impaired level of consciousness or respiratory instability vii) N2O contraindications: Conditions associated with potential accumulation of gas within body spaces viii) Suspected or confirmed pregnancy (as reported by patient) ix) Inability to vocalize pain due to motor deficits (unable to apply the OSBD-R) x) Caregiver unable to complete study tasks due to insufficient comprehension of either English or French in the absence of a native language interpreter xi) Weight \\>= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or II (controlled mild to moderate disease) xii) No concomitant fracture or dislocation requiring orthopedic manipulation","2 Years",{"count":267,"type":19},300,[269],"PHASE3","This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).",[272,25],"Laceration of Skin","2025-04-29",{"date":275,"type":41},"2025-04-30",{"date":277,"type":41},"2023-12-19",{"date":279,"type":19},"2026-12-31",{"name":281,"class":48},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":289,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":20,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":49},"100584346","stress-management-for-college-students-100584346","NCT06888141","Stress Management for College Students","Virtual Intervention Targeting Distress in College Students: A Pilot Study","Inclusion Criteria:\n\n* 18 years of age or older\n* college student\n\nExclusion Criteria:\n\n* Younger than 18 years of age",true,{"count":291,"type":19},500,[22],"The goal of this clinical trial is to learn if a virtual task can reduce distress in college students. The main questions it aims to answer are:\n\n1. Will those who complete the virtual task have less distress?\n2. Will men and women both benefit equally from the virtual task?\n\nResearchers will compare the virtual task to a control task (another virtual task that we expect will not impact distress) to see if distress differs.\n\nParticipants will spend 20 minutes engaging in the virtual task (or the control task) on 3 different days all within one week. They will complete a survey about their well-being before starting the first virtual task and again \\~6 weeks afterward.",[25],[296,297,298,299],"virtual intervention","men\u002Fmale","college students","emotional distress","2025-03-14",{"date":302,"type":41},"2025-03-21",{"date":304,"type":41},"2025-02-18",{"date":306,"type":19},"2026-02-18",{"name":308,"class":48},"Boise State University",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":20,"phases":318,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":49},"100582462","the-effect-of-immersive-virtual-reality-and-relaxing-videos-on-lung-cancer-patients-100582462","NCT06863623","The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients","The Effect of Immersive Virtual Reality and Relaxing Videos on Symptom Severity, Distress and Quality of Life in Patients With Lung Cancer Undergoing Chemotherapy","Inclusion Criteria:\n\n* are over 18 years old,\n* diagnosed with lung cancer,\n* will receive chemotherapy for the first time,\n* will receive at least 2 cycles of chemotherapy treatment\n* agree to participate in the study,\n\nExclusion Criteria:\n\n* Having a cognitive and psychiatric disorder and diagnosis,\n* Having brain metastasis or chronic disease related to the head-brain region,\n* Having vision-hearing problems,\n* Having epilepsy, vertigo, chronic severe headache, dizziness problems,\n* Having a history of virtual reality, simulator or motion sickness,\n* Having\u002Fdeclaring that he\u002Fshe has open area, underwater, specific animal phobia,\n* Do not agree to participate in the study",{"count":317,"type":19},90,[22],"Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is the virtual reality applications. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive\u002Fimersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and dryg type. During the chemotherapy treatment, the patients will take interactive\u002Fimmersibe virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycles, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.",[321,322,25,323],"Lung Cancer","Chemotherapy Effect","Quality of Life (QOL)",[325,326,327,328,329,330,331,332],"cancer","chemotherapy","immersive","virtual reality","lung cancer","quality of life","symptom","side-effect","2025-03-10",{"date":335,"type":41},"2025-03-13",{"date":337,"type":41},"2024-09-01",{"date":339,"type":19},"2025-12-31",{"name":341,"class":48},"Hacettepe University",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100499449","digital-voice-analysis-as-a-measure-of-frailty-and-distress-100499449","NCT05783401","Digital Voice Analysis as a Measure of Frailty and Distress","Digital Voice Analysis as a Measure of Frailty and Distress. A Feasibility Study (DIVAN)","DIVAN","Inclusion Criteria:\n\n* Active cancer or haemato-oncological malignancy\n* Adults (≥ 18 years)\n* Ability to understand, speak and read German language fluently\n* Ability to provide written consent\n* Sufficient or corrected vision to see the images\n* Sufficient auditory comprehension for participation in the study based on the therapist's clinical opinion\n* Ability to concentrate for 20-30 minutes based on the investigator's clinical opinion\n* Signed informed consent to the study\n\nExclusion Criteria:\n\n* Aphonia, dysphonia or other obvious voice alterations of patient's voice\n* Life-expectancy shorter ≤ 14 days as judged by a physician or nurse via \"surprise question\"\n* Breathlessness whilst speaking\n* Cognitive impairment as judged by physician or Mini-Cog in the G8 screening tool\n* Severe physical, emotional or existential suffering because of which the enrollment and participation in the study would result in patient burden, as judged by the treating physicians and their multiprofessional team members",{"count":217,"type":19},"This study evaluates if it is possible to identify quantitative parameters from audio signals to describe the changes in patient's state in relation to frailty and distress.",[353,25],"Frailty",[355,356,357,358,359,360],"Frailty monitoring","Distress monitoring","Digital voice analysis (DVA)","Machine learning","Distress Thermometer","G8 geriatric screening tool","2025-01-16",{"date":363,"type":41},"2025-01-17",{"date":365,"type":41},"2022-11-19",{"date":367,"type":19},"2025-11",{"name":369,"class":48},"University Hospital, Basel, Switzerland",2,{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":289,"sex":15,"minAge":87,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":20,"phases":382,"briefSummary":383,"conditions":384,"keywords":385,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":49},"100550049","universally-delivered-interventions-for-young-people-100550049","NCT06442007","Universally Delivered Interventions for Young People","A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan","Mindset-PK","Young persons (YP)\n\nInclusion Criteria:\n\n* Youth is between the age 12-15 years (inclusive) at the time of study enrollment.\n* Youth has one parent or legal guardian to give consent.\n* Youth speaks Urdu well enough to complete the paper based intervention.\n\nExclusion Criteria:\n\n* Intellectual disability, as this may undermine comprehension of intervention material.\n* Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and\u002For psychiatric treatment needs (if identified with any acute medical and\u002For psychiatric problem, they would be referred to appropriate health services through parents).\n\nSchools Inclusion Criteria\n\nSchools in the study areas are eligible to participate if they meet all the following criteria:\n\n1. the school authority agrees to participate;\n2. the schools shall be non-specialist public schools;\n3. school contains at least 80 students; Exclusion criteria\n\nIf the school meet the following exclusion criteria, they are ineligible to participate:\n\n1. the school authority refuses to participate;\n2. a specialist and\u002For independent or private school;","15 Years",{"count":381,"type":19},564,[22],"Mental health problems are amongst the major contributors to disease burden globally.\n\nAccording to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.\n\nExisting evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.\n\nOne approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.\n\nThis study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.",[25],[386,387,388,389,390,391],"adolescents","anxiety","depression","single session interventions","growth mindset","Pakistan","2024-12-05",{"date":394,"type":41},"2024-12-10",{"date":396,"type":19},"2025-05-01",{"date":398,"type":19},"2025-12-30",{"name":400,"class":48},"Pakistan Institute of Living and Learning",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":122,"enrollmentInfo":408,"targetDuration":4,"studyType":20,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":49},"100499169","brief-interventions-for-coping-with-distress-100499169","NCT05779761","Brief Interventions for Coping with Distress","A Randomized Controlled Trial of Brief Interventions for Coping with Distress","Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* Fluent in English (and therefore able to provide consent)\n* Currently living in New York City\n* Access to a smartphone and the internet\n* High self-reported worry, rumination, and\u002For self-criticism\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder\n\nExclusion Criteria:\n\n* Active suicidal ideation or intent\n* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder\n* Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period\n* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months\n* Current students at Teachers College, Columbia University\n* Individuals with cardiac conditions, diagnosed hyperhidrosis, and traumatic brain injuries or other neurological conditions (e.g., dementia, Parkinson's, epilepsy)",{"count":409,"type":19},180,[22],"This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.",[25,413,34,35],"Emotional Dysfunction",[133,415,34,35,129,128,130,416],"Distress Disorders","Skills Training","2024-11-18",{"date":419,"type":41},"2024-11-21",{"date":421,"type":41},"2023-05-12",{"date":423,"type":19},"2025-12",{"name":143,"class":48},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":432,"minAge":16,"maxAge":122,"enrollmentInfo":433,"targetDuration":4,"studyType":20,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":49},"100559654","the-effectiveness-of-e-health-intervention-in-improving-mental-health-outcomes-among-breast-cancer-patients-100559654","NCT06566937","The Effectiveness of E-health Intervention in Improving Mental Health Outcomes Among Breast Cancer Patients","The Development and Effectiveness of E-health Videos in Improving Mental Help-seeking Intention and Behaviour Among Breast Cancer Patients","Inclusion Criteria:\n\n* Breast cancer patients from all stages of the disease who are currently undergoing treatment at Institut Kanser Negara (IKN)\n* Age 18 years and above\n* Patients willing to participate\n* Patients understand either Malay or English language\n\nExclusion Criteria:\n\n* Patients with breast cancer and metastasis to the brain\n* Patients who are diagnosed with mental illness\n* Patients with performance status 3 and above (based on The Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status)","FEMALE",{"count":434,"type":19},114,[22],"Study Purpose: The study aims to assess how effective e-health interventions are at improving mental health help-seeking intentions and behaviours among breast cancer patients.\n\nIntervention: E-health interventions will be utilized to encourage patients to seek mental health support. These interventions are designed to be accessible and convenient, offering support and information through digital platforms.\n\nParticipants: The study will involve breast cancer patients between the ages of 18 and 65.\n\nKey Objectives:\n\nPrimary Goal: To measure any changes in patients' intentions and actions to seek mental health support before and after using e-health interventions.\n\nSecondary Goals: To explore how these interventions impact mental health literacy, reduce self-stigma, and identify barriers and facilitators to seeking help.\n\nComparison: The study will compare outcomes for patients using e-health tools against those receiving traditional care without digital interventions.\n\nExpected Outcomes: Researchers anticipate that e-health interventions will improve mental health help-seeking behaviours, enhance understanding of mental health issues, and reduce the stigma associated with seeking support.\n\nSignificance: This study could demonstrate the potential of digital health tools to support mental well-being among breast cancer patients, providing new ways to access care and overcome traditional barriers to seeking mental health support.",[438,439,26,25],"Breast Cancer","Breast Neoplasms",[441,442,443,444],"telemedicine","e-health","help-seeking intention","behaviour","2024-08-19",{"date":447,"type":41},"2024-08-22",{"date":449,"type":41},"2024-08-09",{"date":451,"type":19},"2026-09-30",{"name":453,"class":48},"National University of Malaysia",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":20,"phases":462,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":370},"100420385","phase-1-psilocybin-for-psychological-and-existential-distress-in-palliative-care-psyched-pal-100420385","NCT04754061","PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)","PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I\u002FII Proof-of-concept, Dose-finding, and Feasibility Clinical Trial","Inclusion Criteria:\n\n1. Patients \\>\u002F=18 years of age\n2. Advanced illness under palliative care management, defined as having 1 to \\\u003C12 months life expectancy (in the judgment of the palliative care provider)\n3. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System\n4. Ability to understand and communicate in English or French\n\nExclusion Criteria:\n\n1. Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder\n2. Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those considering or being assessed for MAiD will still be eligible)\n3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution\n4. Documented moderate or severe dementia diagnosis\n5. Inability to provide first-person informed consent\n6. Severe or unstable physical symptoms based on the judgment of the palliative care provider\n7. Palliative Performance Scale \\\u003C30%\n8. Cancer with known central nervous system (CNS) involvement or other CNS disease\n9. Use of high-dose psychedelic substances in the past year\n10. Taking lithium at any dose\n11. Taking tramadol at any dose\n12. Taking any monoamine oxidase inhibitor at any dose \\[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\\]\n13. Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) (patients can be included if their atypical antipsychotic is either stopped, or if appropriate, substituted with haloperidol 48 hours prior to the start and for the duration of the intervention period and follow-up)\n14. Inability to ingest oral capsule\n15. Pregnancy or lactation\n\nFor participants taking either an SSRI or an antipsychotic medication, there are several conditions for participation: (1) the PC provider must approve their participation in the study; (2) the SSRI\u002Fanti-psychotic medication dose cannot change for the duration of the intervention trial and follow-up, and; (3) the patient must not be taking more than the maximum allowable trial dose for each SSRI.\n\nAll trial participants must agree to not take any other psychedelic substance for the duration of the clinical trial and follow-up, and to notify the investigative team of any medication changes during intervention or follow-up. Participants must also agree not to take their benzodiazepine or antipsychotic medication, if applicable, within 12 hours (6 hours pre and 6 hours post) of taking their psilocybin dose (participants will be given detailed instructions about this in their Instruction Leaflet). Participants must also agree not to drive or operate any heavy machinery on any treatment day for the duration of the 4-week intervention.",{"count":5,"type":19},[463,464],"PHASE1","PHASE2","The goal of this multi-centre phase I\u002FII open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured.",[26,25],[468,228,469,470],"existential distress","psilocybin","microdosing","2024-08-06",{"date":449,"type":41},{"date":474,"type":41},"2024-01-08",{"date":476,"type":19},"2025-06",{"name":478,"class":48},"Ottawa Hospital Research Institute",{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":289,"sex":15,"minAge":152,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":20,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":500,"locationsCount":49},"100549529","impact-of-subgingival-instrumentation-on-psychological-distress-and-mental-health-status-in-bruxers-with-periodontitis-100549529","NCT06435208","Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis","Inclusion Criteria:\n\n* Systemically healthy patients\n* Patient having periodontitis with bruxism\n* Age between 30-50 years\n\nExclusion Criteria:\n\n* History of mental health disorder\n* History of systemic disease\n* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs\n* Pregnant or lactating females","50 Years",{"count":487,"type":19},45,[22],"Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.",[491,492,493,25],"Periodontal Diseases","Bruxism","Periodontitis","2024-07-04",{"date":496,"type":41},"2024-07-08",{"date":494,"type":41},{"date":499,"type":19},"2025-02-01",{"name":501,"class":48},"Postgraduate Institute of Dental Sciences Rohtak",{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":289,"sex":15,"minAge":508,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":20,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":519,"leadSponsor":520,"locationsCount":4},"100549145","indigenous-youth-and-young-adults-with-diabetes-peer-mentorship-program-100549145","NCT06430203","Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program","Inclusion Criteria:\n\nAge 10-29 years old Clinical diagnosis of diabetes or gestational diabetes\n\nExclusion Criteria:\n\nAge \\> 29 years old Not at risk of diabetes","10 Years","29 Years",{"count":511,"type":19},40,[22],"The goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes.\n\n* Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?\n* What is it like for Indigenous youth and young adults to be live with diabetes?\n* Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?\n* Can a peer-mentoring program lead to changes in lifestyle (diet, physical activity, substance use) and diabetes related clinical outcomes among Indigenous youth and young adults with diabetes.\n\nResearchers will compare distress, resilience, lifestyles, and diabetes related clinical outcomes before participating in the peer-mentoring program and at 6 and 12 months into the program. Additionally, participants will be asked to share their journey with diabetes through photos throughout the program\n\nParticipants will:\n\n* Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes\n* Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors\n* Complete questionnaires on distress, resilience, and lifestyle every 6 months.\n* Participate in Photovoice workshops to share their stories through pictures.",[160,25],"2024-05-24",{"date":517,"type":41},"2024-05-29",{"date":337,"type":19},{"date":141,"type":19},{"name":521,"class":48},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":432,"minAge":16,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":20,"phases":532,"briefSummary":533,"conditions":534,"keywords":538,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":4},"100500040","supporting-women-with-breast-cancer-to-practice-dibh-at-home-before-radiation-therapy-100500040","NCT05791084","Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy","Supporting Women With Left Sided Breast Cancer to Practice Deep Inspiration Breath Hold (DIBH) at Home Before Radiation Therapy Treatment","DIBHApp","Inclusion Criteria:\n\nInclusion criteria for the study:\n\n* patients \\> 18 years of age\n* with a left-sided breast cancer diagnosis or DCIS\n* who are to receive RT with DIBH technology\n* with curative intention\n* preparatory CT visit minimum 7 days to a maximum of 4 weeks\n* able to speak and understand good enough Swedish to be able to assimilate content in the mobile app and answer surveys and interview questions\n* have access to a smart mobile phone.\n\nExclusion Criteria:\n\n* patients receiving palliative RT or neoadjuvant chemotherap\n* Planning CT starting \\\u003C 7 days\n* people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.",{"count":531,"type":19},160,[22],"To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.",[535,25,536,537],"Health Literacy","Preparedness","Mobile Application",[539,540,541,542,543],"DIBH","RCT","radiotherapy","mobile application","distress","2023-03-16",{"date":546,"type":41},"2023-03-30",{"date":548,"type":19},"2023-09-01",{"date":550,"type":19},"2029-03-30",{"name":552,"class":48},"Jonkoping University",{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":561,"enrollmentInfo":562,"targetDuration":508,"studyType":60,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":49},"100414888","the-prospective-observational-compraya-cohort-study-100414888","NCT04682470","The Prospective Observational COMPRAYA Cohort Study","COMPRehensive Assessment of Prevalence, Risk Factors and Mechanisms of Impaired Medical and Psychosocial Health Outcomes Among Adolescents and Young Adults With Cancer: the Prospective Observational COMPRAYA Cohort Study","COMPRAYA","Inclusion Criteria:\n\n* Pathological confirmed cancer diagnosis;\n* Age 18 - 39 years at time of first cancer diagnosis;\n* Able to understand the informed consent form;\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Mentally incompetent patients based on the opinion of treating physician .\n* Inability to understand the Dutch language\n* Life expectancy less than 6 months based on the opinion of treating physician .","39 Years",{"count":563,"type":19},4000,"Rationale: Childhood cancer survivorship attracts attention globally, because successes in treatment have led to increasing number of survivors who reach adulthood, in which survivorship issues affecting health-related quality of life (HRQoL) become prominent. Most paediatric patients are treated intensively with irradiation and\u002For chemotherapy, which put them at risk for early and\u002For late adverse medical and psychosocial events. In contrast, much less is known about adolescent and young adult (AYA) cancer patients, diagnosed between 18-39 years, who, with an 80% chance to survive, also have a long life ahead. AYA cancer patients, much more than children, suffer from delay in diagnosis, lack of centralization of care, ageadjusted expertise, and AYA follow-up care. AYAs typically present with a rare tumour: either with a paediatric malignancy (e.g. acute lymphoblastic leukaemia, paediatric brain tumours), a more typical tumour of AYA age (e.g. Hodgkin's disease, germ cell cancer, melanoma, thyroid cancer) or with an adult tumour at unusual young age (e.g. gastrointestinal, lung, breast carcinomas). Next to these differences in epidemiology, the tumour biology, developmental challenges (e.g. forming relationships, becoming financially independent, having children) and treatment regimens differ between AYAs and children, and therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Furthermore, novel treatments with targeted agents or immunotherapy are more likely to be administrated to AYAs compared to children. Finally, a rare group of incurable AYA cancer patients will survive for many years, for whom health outcome and supportive care intervention data are lacking.\n\nGlobally, so far, the identification of AYA cancer patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic, biological, physiological); or combinations of influences for impaired (agespecific) health outcomes, remains largely unknown. Understanding who is at risk and why will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines, in co-creation with AYA cancer patients.\n\nObjective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among a population-based sample of AYA cancer patients.\n\nStudy design: Prospective, observational cohort study Study population: All AYAs diagnosed (18-39 years at primary diagnosis) with cancer (any type) within the first 3 months after diagnosis (eligibility window of 1 month to ensure all eligible AYA cancer patients can be included) in one of the participating centres (or treated in one of these centres) in The Netherlands.\n\nMain study parameters\u002Fendpoints: The main outcomes are medical (e.g. second tumour; survival; fertility) and psychosocial (e.g. distress) health outcomes. Other study parameters (covariates\u002Fmoderators\u002Fmediators) are characteristics of the individual (e.g. age, sex, cultural background, partner status, educational level, occupation, tumour type, disease stage, body composition, comorbid conditions, coping style), characteristics of the environment (e.g. cancer treatment, lifestyle), and genetic and biological factors (e.g. family history of cancer, stress and inflammation markers (e.g. cortisol, IL-6), microbiome).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: On an individual level, patients who participate are asked to complete questionnaires on an annual basis for at least 10 years. All sample collections will take place at three time points: 0-3 months after diagnosis (baseline), 2 and 5 years; except blood for DNA analyses which will only take place at baseline. The collection of blood, hair and faeces at three occasions is minimally invasive and the risks of blood draws, hair and fecal sampling are negligible. All safety measures and procedures will be performed according to local guidelines. Patients will not experience direct benefit from participation in the COMPRAYA study.\n\nBy participating, patients will contribute to a better insight in the prevalence of impaired medical and psychosocial (age-specific) health outcomes in AYA and evidence on factors associated with these health outcomes. This will lead to better and more personalized cancer care and supportive care tools for future AYA cancer patients.",[566,567,568,25,569,570,63],"Second Cancer","Survivorship","Fertility Issues","Lifestyle","Genetic Disease","2022-02-11",{"date":573,"type":41},"2022-03-02",{"date":575,"type":41},"2021-06-18",{"date":577,"type":19},"2035-06",{"name":579,"class":48},"The Netherlands Cancer Institute"]