[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"emotional-distress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:emotional-distress":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,44,69,94,119,145,189,214,250,279,308,334,367,418,440,458,478,498],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643870","mindfulness-intervention-for-emotional-distress-mied-in-patients-with-gerd-100643870",false,"NCT07667894","Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD","Effects of an Online Mindfulness-Based Emotion Intervention on Symptoms and Emotional Distress in Patients With Gastroesophageal Reflux Disease: A Multicenter Randomized Waitlist-Controlled Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Aged 18 to 65 years.\n2. GERD-Q score of 8 or higher.\n3. Willingness to maintain a relatively stable usual treatment regimen during the study unless medically indicated changes are required.\n4. Ability to use a smartphone, computer, or tablet to participate in the online program and complete online questionnaires.\n5. Willingness to comply with course training and follow-up assessments.\n6. Ability to understand the study and provide written or electronic informed consent.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Alarm symptoms or high suspicion of serious organic disease, including but not limited to progressive dysphagia, hematemesis, melena, unexplained weight loss, anemia, recurrent vomiting, or persistent chest pain without exclusion of cardiovascular risk.\n2. Current or previous severe esophageal organic disease or gastrointestinal malignancy.\n3. History of anti-reflux surgery, partial gastrectomy, or other upper gastrointestinal surgery that may substantially affect reflux symptom assessment.\n4. GERD-Q score greater than 15, or symptoms judged by the study physician to be extremely severe and requiring priority medical evaluation or intensified treatment.\n5. Current uncontrolled severe mental disorder, such as schizophrenia, manic episode of bipolar disorder, acute severe depressive episode, or severe substance use disorder.\n6. Current suicide risk, operationalized as a score greater than 1 on item 9 of the PHQ-9.\n7. Previous systematic participation in MIED, mindfulness-based stress reduction, mindfulness-based cognitive therapy, or another structured mindfulness program.","ALL","18 Years","65 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this multicenter randomized waitlist-controlled clinical trial is to evaluate whether an online Mindfulness-Based Intervention for Emotional Distress (MIED) can reduce emotional distress and reflux-related symptoms in adults with gastroesophageal reflux disease (GERD). GERD is a common chronic gastrointestinal condition that is frequently accompanied by anxiety, depressive symptoms, stress, and impaired quality of life.\n\nThe main questions this study aims to answer are:\n\nCan online MIED reduce emotional distress in patients with GERD?\n\nCan online MIED reduce reflux-related symptoms and improve reflux-related quality of life?\n\nAre changes in psychological processes, such as distress tolerance, cognitive flexibility, experiential avoidance, emotional behaviors, and life engagement, associated with improvements in emotional distress and reflux symptoms?\n\nResearchers will compare participants receiving online MIED with participants in a waitlist control group receiving usual medical care and health management to determine whether online MIED leads to greater improvement over time.\n\nParticipants will:\n\ncomplete screening and baseline assessments;\n\nbe randomly assigned to either the online MIED intervention group or the waitlist control group;\n\nif assigned to the intervention group, complete an 8-week online MIED program with one session per week;\n\ncontinue necessary usual medical care during the study, while keeping medication use stable when possible;\n\ncomplete online questionnaires at baseline, during the intervention, after the intervention, and at 3, 6, 12, and 24 months after the intervention;\n\nreport information on reflux symptoms, emotional distress, quality of life, sleep, stress, resilience, life satisfaction, healthcare use, intervention adherence, and adverse events.",[27,28],"Gastroesophageal Reflux Disease","Emotional Distress",[28,27,30],"Mindfulness Intervention for Emotional Distress","NOT_YET_RECRUITING","2026-06-19",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":21},"2026-07-01",{"date":39,"type":21},"2028-05-15",{"name":41,"class":42},"Xinghua Liu","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100644416","emotional-distress-and-pathologic-response-in-locally-advanced-gastricgej-adenocarcinoma-100644416","NCT07662070","Emotional Distress and Pathologic Response in Locally Advanced Gastric\u002FGEJ Adenocarcinoma","A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing to participate in this study.\n2. Age \\>18 years; both sexes are eligible.\n3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n4. Resectable locally advanced disease as assessed by imaging and\u002For multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.\n5. Planned to receive neoadjuvant therapy followed by curative-intent surgery.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. No prior systemic antitumor treatment for the current tumor at baseline.\n8. Able to understand and complete questionnaire assessments.\n9. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.\n4. Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.\n5. Any other condition judged by the investigator to make the participant unsuitable for enrollment.",{"count":52,"type":21},120,"3 Years","OBSERVATIONAL","This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.",[57,58,28,59],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Pathologic Response","2026-06-17",{"date":62,"type":35},"2026-06-23",{"date":64,"type":21},"2026-06-26",{"date":66,"type":21},"2028-12-31",{"name":68,"class":42},"West China Second University Hospital",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100594584","auricular-acupuncture-on-emotional-distress-in-service-members-and-veterans-with-ptsd-100594584","NCT07021352","Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD","Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Active duty service member and veterans\n* A score of 14 or above on the abbreviated PCL 6-item\n* A score of 24 or above on the EDS\n* Agrees to participate in mindfulness therapy\n* Able to provide informed consent\n\nExclusion Criteria:\n\n\\- Has had mindfulness therapy received from a healthcare provider in the past month",{"count":77,"type":21},66,[24],"Emotional distress (ED) refers to a state of mental suffering that significantly impairs an individual's ability to cope, often leading to a decline in overall well-being. In military contexts, ED is a prevalent concern due to the unique and demanding challenges faced by military personnel both in combat zones and during peacetime. The primary objective of this study is to assess the efficacy of integrating ear acupuncture with mindfulness therapy in mitigating ED and alleviating post-traumatic stress disorder (PTSD) symptoms among military personnel. The study will examine the effects of auricular acupuncture (AA) and mindfulness therapy (MT) on ED in military personnel with PTSD. The NADA ear acupuncture protocol will be administered using acupuncture semi-permanent (ASP), sterile needles placed in the bilateral ears, which will remain in place until they naturally fall out. Mindfulness therapy will incorporate relaxation techniques, such as yoga and controlled breathing exercises, specifically designed to alleviate ED. A mixed-methods approach, integrating both quantitative and qualitative methods, will be employed concurrently to evaluate the interventions' effectiveness and to explore the participants' perceived benefits. Specific Aim 1: To evaluate the effectiveness and perceived benefits of the National Acupuncture Detoxification Association (NADA) ear acupuncture protocol as an adjunct therapy to brief mindfulness therapy for reducing emotional distress in service members and veterans with PTSD. Specific Aim 2: To examine the effectiveness of NADA as an adjunct therapy to brief mindfulness therapy in improving sleep disturbances, alcohol use, and pain in service members and veterans with PTSD.",[81,28],"PTSD and Substance Use Disorder","RECRUITING","2026-04-21",{"date":85,"type":35},"2026-04-24",{"date":87,"type":35},"2026-03-02",{"date":89,"type":21},"2028-06",{"name":91,"class":92},"United States Naval Medical Center, San Diego","FED",2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100633466","emerging-technologies-and-teen-mental-health-100633466","NCT07527052","Emerging Technologies and Teen Mental Health","Inclusion Criteria:\n\n* Adolescents must (A) be between ages 12 and 17 years\n* (B) have a positive screen for suicide risk (i.e. endorsement of suicidal ideation via self-report or parent-report)\n* (C) have access to a personal social media account\n* (D) be fluent in English\n* (E) have available a parent who is fluent in English or Spanish.\n\nExclusion Criteria:\n\n* Adolescents must not (A) have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)\n* (B) show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services.","12 Years","17 Years",{"count":103,"type":21},200,[24],"This study will recruit teens who are experiencing subacute suicidal ideation to test the effect of a brief psychoeducational intervention focused on social media use wherein youth learn about active and prosocial use of social media platforms.",[107,28,108],"Social Functioning","Suicidal Ideation","2026-04-08",{"date":111,"type":35},"2026-04-14",{"date":113,"type":35},"2026-03-20",{"date":115,"type":21},"2028-12",{"name":117,"class":42},"Florida International University",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":126,"maxAge":101,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":118},"100586949","a-novel-auditory-application-for-distraction-in-pediatric-patients-100586949","NCT06922032","A Novel Auditory Application for Distraction in Pediatric Patients","A Novel Auditory Application for Distraction in Pediatric Patients: A Pilot Feasibility and Acceptability Study","Inclusion Criteria:\n\n* Between 4-17 years\n* English speaking participants\n\nExclusion Criteria:\n\n* Legal guardian not present to obtain consent\n* Child with hearing impairment\n* Child with a significant neurological condition, or major developmental disability\n* Child with facial abnormalities or injuries prohibiting use of headsets\n* Nausea at the time of recruitment,\n* A history of severe motion sickness,\n* A history of seizures","4 Years",{"count":128,"type":21},20,[24],"This mixed-methods study seeks to evaluate the feasibility of Mystic Pets software and hardware within the pediatric population. This study will take place at Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA).",[28],[133,134,135],"Game engagement","Awe","Procedural Distraction","2026-03-19",{"date":138,"type":35},"2026-03-23",{"date":140,"type":21},"2026-05-01",{"date":142,"type":21},"2027-04-30",{"name":144,"class":42},"Stanford University",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":172,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":118},"100493968","neurostimulation-versus-therapy-for-problems-with-emotions-100493968","NCT05712057","Neurostimulation Versus Therapy for Problems With Emotions","Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis","Inclusion Criteria:\n\n* age 18 to 55\n* elevated overall score on Difficulties with Emotion Regulation Scale (DERS total score \\>=90)\n* has been in the same type of psychotherapy (including none) for the last 4 weeks\u002F1mo (\\*except for current CBT) and is willing to stay on the same regimen throughout the study.\n* low self-reported use of cognitive restructuring (ERQ restructuring subscale average score \\\u003C 4.7)\n* meets criteria for at least one mood (including Bipolar II w\u002Fo current hypomania), anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (except exclusionary diagnoses such as severe anorexia). Note: Both current or partial remission of the disorder will be ok for inclusion into the study.\n* verbal agreement to maintain dose of prescribed psychotropic medication (if any) constant throughout the study, provided they are stable on it for the past 4 weeks (except exclusion medication and except if there is a medical emergency requiring changes in medication).\n* Naïve to rTMS\n\nExclusion Criteria:\n\n* current hypomania (Note: Bipolar II w\u002Fo current hypomanic episode is ok for inclusion)\n* meets diagnostic criteria for current or history of psychotic disorder, or psychotic features,\n* meets diagnostic criteria for Bipolar I disorder\n* meets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorder\n* unable to read, blind, or deaf, or unwilling to give consent\n* non-English speaker,\n* verbal IQ \\\u003C 90 on the North American Adult Reading Test (NART).\n* current uncontrolled anorexia or other condition requiring hospitalization\n* high risk for suicide defined as either having attempted suicide in past 6 months or reporting current suicidal ideation that includes a method, plan, or intent to die\n* current serious medical illness, including current severe migraine headaches\n* started\u002Fchanged psychotropic medications in the prior 4 weeks, or plans to change medication during the study\n* history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesions that are contraindications for TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), have left elbow\u002Fhand\u002Fwrist tendonitis\n* conditions associated with increased intracranial pressure, space occupying brain lesion (considered significant and unsafe for TMS by the study MD), transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis\n* Wellbutrin \\>300mg per day or on daily stimulant\u002FADHD medications above the recommended FDA daily recommendations\n* use of investigational drug or devices within 4 weeks of screening\n* cochlear implants\n* Pregnancy\n* metal in body that would exclude them from the MRI scan; severe claustrophobia\n* is a prisoner or in police custody at time of screening, or has pending court case jeopardizing the participation in the study\n* has had TMS in their lifetime\n* has had CBT in the past 4 weeks or plans to start therapy during the study\n* weighs over 300 pounds (could not fit in MRI scanner)","55 Years",{"count":154,"type":21},240,[24],"The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training.\n\nParticipants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.",[158,159,160,161,162,163,164,165,166,28,167,168,169,170,171],"Emotion Regulation","Mood Disorders","Stress Disorder","Anxiety Disorders","OCD","Impulse Control Disorder","Eating Disorders","Emotional Dysfunction","Emotional Instability","Emotional Maladjustment","Emotional Impulsivity","Obsessive-Compulsive Disorder","Emotion Dysregulation","Borderline Personality Disorder",[170,173,174,175,176,177,178,179,180],"Distress Intolerance","Neuromodulation","Neurostimulation","TMS","cognitive restructuring","regulation skills","neuroimaging","Emotion regulation",{"date":182,"type":35},"2026-03-04",{"date":184,"type":35},"2023-05-15",{"date":186,"type":21},"2027-12-01",{"name":188,"class":42},"Duke University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":198,"studyType":54,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":118},"100626531","impact-of-emotional-status-on-prognosis-of-patients-with-bclc-stage-bc-hepatocellular-carcinoma-undergoing-hepatic-arterial-infusion-chemotherapy-combined-with-targeted-and-immunotherapy-100626531","NCT07436845","Impact of Emotional Status on Prognosis of Patients With BCLC Stage B\u002FC Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy","Impact of Emotional Status on Prognosis of Patients With BCLC Stage B\u002FC Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy: A Multicenter, Prospective, Observational Clinical Study","Inclusion Criteria:\n\n* 1: All patients provided voluntary, written informed consent prior to any study procedures.\n\n  2: Aged 18 years or older, both male and female.\n\n  3: Patients with clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C hepatocellular carcinoma, who are deemed eligible for hepatic arterial infusion chemotherapy (HAIC) combined with targeted and immunotherapy as assessed by the clinician.\n\n  4: No prior systemic antitumor therapy.\n\n  5: At least one intrahepatic evaluable lesion is present, with the intrahepatic lesion constituting the primary tumor burden. (According to RECIST v1.1 criteria, the measurable lesion must have a long diameter \\>= 10 mm on spiral CT scan, or enlarged lymph nodes must have a short diameter \\>= 15 mm.);\n\n  6: Child-Pugh score \\\u003C= 7 (Rated as Child-Pugh class A or B);\n\n  7: Able to swallow tablets normally;\n\n  8: ECOG performance status: 0-1;\n\n  9: Patients' psychological status and laboratory test indicators can be comprehensively documented at baseline and during the treatment period;\n\n  10: All patients have no history of other psychiatric disorders.\n\nExclusion Criteria:\n\n1\\. Presence of any active autoimmune disease or history of autoimmune diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved in adulthood and requires no intervention may be included; asthma requiring medical intervention with bronchodilators is excluded).\n\n2: Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (at a dose \\>10mg\u002Fday of prednisone or equivalent), continuing within 2 weeks prior to enrollment.\n\n3: Known history of central nervous system metastases or hepatic encephalopathy.\n\n4: Congenital or acquired immunodeficiency (e.g., HIV infection);\n\n5: History or presence of other malignancies within the past 3 years (with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n\n6: Current use of antidepressant or anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic medications.\n\n7: Any other condition deemed by the investigator as likely to affect the study results or lead to premature termination of the study, such as alcohol or drug abuse, other severe co-morbidities (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.\n\n\\-",{"count":197,"type":21},90,"2 Years","This study is a multicenter, prospective, observational clinical trial designed to evaluate the impact of baseline emotional status on the clinical outcomes of patients with BCLC stage B\u002FC hepatocellular carcinoma undergoing HAIC combined with targeted immunotherapy. A total of 90 patients are planned to be enrolled and divided into a depressive mood group and a non-depressive mood group based on a PHQ-9\u002FGAD-7 score of ≥5 points. The primary study endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profile. Dynamic assessments of patients' emotional status, quality of life (EORTC QLQ-C30), and peripheral blood levels of neuroendocrine-immune markers will be conducted at preset time points. The results indicate that emotional status may serve as an important modifiable factor influencing the efficacy of comprehensive therapy in patients with advanced liver cancer, providing an evidence-based basis for the formulation of psychosomatic integrated clinical intervention strategies in the future.",[201,28,202,203,204],"Hepatocellular Carcinoma (HCC)","HAIC(Hepatic Artery Infusion Chemotherapy)","Immunotherapy","Targeted Therapy","2026-02-23",{"date":207,"type":35},"2026-02-27",{"date":209,"type":35},"2025-12-01",{"date":211,"type":21},"2028-01-01",{"name":213,"class":42},"Nanfang Hospital, Southern Medical University",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":232,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100618415","the-coma-family-program-coma-f-a-resilience-program-for-caregivers-of-patients-with-severe-acute-brain-injury-100618415","NCT07331324","The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","COMA-F","Inclusion Criteria:\n\n1. 18 years or older - study population\n2. English fluency and literacy - measures and intervention are in English\n3. Screens positive for emotional distress on either depression or anxiety subscales (\\>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)\n4. Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:\n\n   1. 18 years or older - study population\n   2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population\n   3. Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \\> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population\n   4. Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)\n   5. Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and\u002For percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive\u002Ffunctional recovery from initial coma, but all were severe enough to require trach and\u002For PEG\n   6. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in \"d\"; such caregivers would require different intervention\n   7. Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \\\u003C7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)\n\nExclusion Criteria:\n\n* 1\\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care",{"count":223,"type":21},150,[24],"The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.",[227,28,228,229,230,231],"Caregiver Distress","Caregivers","Resilience","Coma","Brain Injury",[233,234,235,236,237,238,239],"caregivers","emotional distress","caregiver burden","resilience","coma","severe acute brain injury","mindfulness","2026-02-18",{"date":242,"type":35},"2026-02-20",{"date":244,"type":21},"2026-05",{"date":246,"type":21},"2030-12",{"name":248,"class":42},"Massachusetts General Hospital",3,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":257,"sex":16,"minAge":258,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100488388","intervention-to-prevent-behavioral-health-symptoms-among-pandemic-affected-children-100488388","NCT05639465","Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children","Pragmatic RCT of a Multi-level Mechanistically Informed Community Intervention to Prevent the Onset of Behavioral Health Symptoms Among Socioeconomically Disadvantaged Pandemic Affected Children","Inclusion Criteria:\n\n* child experienced the COVID-19 pandemic and an additional large-scale disaster\n* child score is 5 or above on the Strengths and Difficulties Questionnaire\n* child is in 3- 8th grade at enrollment\n* the parent or guardian must complete informed consent and child assent\n* child must speak English or Spanish.\n\nExclusion Criteria:\n\n* child is currently receiving treatment for a diagnosed mental health condition\n* children who are not able to interact with other students in a group work format, regardless of IEP status",true,"8 Years","14 Years",{"count":261,"type":21},800,[24],"Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.",[28,265,266,267,268],"Prosocial Behavior","Pandemic, COVID-19","Coping Skills","Social Support","2026-01-21",{"date":271,"type":35},"2026-01-23",{"date":273,"type":35},"2022-11-15",{"date":275,"type":21},"2027-05-15",{"name":277,"class":42},"University of Illinois at Urbana-Champaign",9,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100615125","promoting-positive-emotions-in-adolescents-using-positive-events-training-an-indicated-approach-100615125","NCT07288541","Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach","Promoting Positive Emotions in Adolescents Using Positive Event Training: An Indicated Approach (iPET)","iPET","Inclusion Criteria:\n\n* 12-16 years (age)\n* moderate level of baseline depressive symptoms Exclusion Criteria: \u002F","16 Years",{"count":289,"type":21},36,[24],"Research shows that high positive emotionality is an essential ingredient in building resilience in youngsters, especially those with a vulnerability to develop depressive symptomatology. It may empower them against actual depression and its various long-term adverse outcomes. One way to achieve positive emotions is via the recollection and anticipation of specific positive events. Therefore, to cultivate positive emotions in young people, a user-friendly group training program was developed, translated from basic research findings: Positive Event Training (PET). Through PET, adolescents learn to solidify positive memories and positive plans for the future. In this project, a comprehensive evaluation of PET's efficacy is conducted using a robust methodology with vulnerable youth.",[28,293],"Anhedonia",[295,296,297,234,298],"positive emotions","anhedonia","positive affect regulation","autobiographical thinking","2025-12-03",{"date":301,"type":35},"2025-12-17",{"date":303,"type":21},"2025-12",{"date":305,"type":21},"2027-01",{"name":307,"class":42},"KU Leuven",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":118},"100590519","resiliency-intervention-for-patients-with-als-and-their-care-partners-100590519","NCT06968468","Resiliency Intervention for Patients With ALS and Their Care-Partners","Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners","RT-ALS","Inclusion Criteria for patient with ALS:\n\n* recent (within \\~2 months) of first appointment at Healey Center for diagnosis of ALS documented in Epic (based on recommendations from neurologists)\n* ability to understand the study and research protocol as determined by a standardized teach-back method of assessment\n* ability to communicate by writing, speaking, or assistive communication device\n\nInclusion Criteria for dyad:\n\n* English speaking adults\n* dyad lives together\n* at least one partner endorses clinically significant emotional distress during screening (\\>7 on either subscale of the HADS)\n\nExclusion Criteria:\n\n* patient with ALS with comorbid terminal diagnosis or severe mental health disorder that limits ability to participate (by self-report, as determined by our clinical team);\n* cognitive disorder that limits ability to participate (per neurologist)\n* inability or unwillingness to use live video technology (will teach any dyads who have low technology literacy how to use live video technology)",{"count":128,"type":21},[24],"The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.",[320,28],"Amyotrophic Lateral Sclerosis (ALS)",[322,323,324,325],"Amyotrophic Lateral Sclerosis","ALS","Caregiving","Coping","2025-11-14",{"date":328,"type":35},"2025-11-17",{"date":330,"type":21},"2026-05-13",{"date":332,"type":21},"2027-02-28",{"name":248,"class":42},{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":352,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":118},"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":343,"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.",[28,347,348,349,228,350,229,351],"Cardiac Arrest (CA)","Anxiety","Depression","Survivorship","Mindfulness",[234,353,354,233,236,239,355,356,357,358],"cardiac arrest","cardiac arrest survivorship","mind-body","behavioral interventions","anxiety","depression","2025-10-21",{"date":361,"type":35},"2025-10-23",{"date":363,"type":35},"2025-10-17",{"date":365,"type":21},"2028-07",{"name":248,"class":42},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":375,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":395,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":118},"100597441","therapeutic-writing-for-adults-suffering-from-chronic-pain-and-comorbid-mental-health-disorders-100597441","NCT07058532","Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders","Therapeutic Writing Intervention in Pain Rehabilitation","TWfCP&MH","Inclusion Criteria:\n\n* Adult women (18 years or older), assigned female at birth and self-identify as women\n* Diagnosed with or experience of chronic, widespread (non-cancer) pain lasting at least two years\n* Diagnosed with or living with one or more mild mental health disorders (e.g., anxiety, mild depression), without current or past severe psychiatric conditions\n* Diagnosed with or experience of nociplastic pain (e.g., fibromyalgia)\n* Not currently using medications that may impair cognitive functioning (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Able to attend approximately 11 in-person visits over a 3-month period\n* Willing and able to participate in a structured therapeutic writing intervention\n* Purposefully selected to reflect a range of lived experiences relevant to the study's aims\n\nExclusion Criteria:\n\n* Presence of severe mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression, or other psychotic conditions)\n* Use of medications known to impair memory, attention, or decision-making (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Participation in other concurrent treatments that may influence study outcomes\n* Cognitive limitations that would hinder meaningful engagement in the writing intervention\n* Individuals not assigned female at birth or who do not identify as women","FEMALE",{"count":377,"type":21},5,[24],"The goal of this observational study is to understand the effects and experiences of therapeutic writing interventions in adult women with chronic pain and co-occurring mental health conditions. The main questions it aims to answer are:\n\nCan therapeutic writing help relieve chronic pain and emotional distress?\n\nHow does writing support emotional processing, regulation, and meaning-making during rehabilitation?\n\nParticipants will take part in a two-part writing intervention involving:\n\nGuided writing exercises that focus on emotional processing, emotion regulation, and creating meaning.\n\nIndividual interviews after the writing sessions to explore their experiences.\n\nThe study uses qualitative analysis methods-phenomenology and logotherapy-to better understand how these writing interventions may support recovery, improve well-being, and offer non-pharmacological tools for managing chronic pain and mental health challenges.",[381,382,383,384,385,386,28,158,387,388,389,390,391,161,392,393,394],"Chronic Pain","Mental Health Disorder","Psychiatric &Amp;Amp;or Mood Disorder","Psychiatric Comorbidities","Psychiatric Diagnosis","Emotional Pain","Emotional Processing","Meaning of Life","Meaning Made","Meaning of Life and Life Satisfaction","Depressive Disorder","Sleep Disorder","Comorbid Depression","Process, Acceptance",[396,397,398,399,180,400,401,402,403,404,405,406,407,408],"Therapeutic writing","Chronic pain","Mental health disorders","Psychiatric disorders","Emotional processing","Meaning-making","Non-pharmacological intervention","Logotherapy","Phenomenological analysis","Psychosocial rehabilitation","Pain management","Pain coping","Creative writing","2025-06-30",{"date":411,"type":35},"2025-07-10",{"date":413,"type":21},"2025-08",{"date":415,"type":21},"2026-04",{"name":417,"class":42},"Toni Salikka",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":4},"100586748","temporal-dynamics-of-mindfulness-intervention-for-emotional-distress-daily-interventions-and-assessments-100586748","NCT06919406","Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments","Inclusion Criteria:\n\n* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.\n\nExclusion Criteria:\n\n* Subjects who could not access the Internet.\n* Subjects with insufficient Chinese ability.\n* Subjects who have participated in mindfulness-based projects for more than 6 weeks before, and \u002F or the current frequency of meditation practice is more than once a week.\n* Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder.\n* Subjects at risk of suicide.","60 Years",{"count":426,"type":21},100,[24],"This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.",[28,430],"Depression, Anxiety","2025-04-02",{"date":433,"type":35},"2025-04-09",{"date":435,"type":21},"2025-04-05",{"date":437,"type":21},"2025-09-10",{"name":439,"class":42},"Peking University",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":257,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":4},"100576435","mindfulness-interventions-and-emotional-distress-a-daily-study-100576435","NCT06785259","Mindfulness Interventions and Emotional Distress: A Daily Study","Complex Systems Analysis of the Impact of Mindfulness Intervention on Emotional Distress: A Study of Daily Interventions and Daily Diary",{"count":52,"type":21},[24],"This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress",[28],"2025-01-17",{"date":452,"type":35},"2025-01-21",{"date":454,"type":21},"2025-01-18",{"date":456,"type":21},"2025-05-20",{"name":439,"class":42},{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":257,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":4},"100571616","mechanisms-of-mindfulness-interventionrumination-behavioral-experiments-100571616","NCT06722573","Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments","Mechanism of Rumination in the Alleviation of Emotional Distress by Mindfulness-Based Interventions: Evidence from Behavioral Experiments","Inclusion Criteria:\n\n* \\- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.\n* \\- Aged 18-55 years old.\n\nExclusion Criteria:\n\n* \\- Subjects who could not access the Internet;\n* \\- Subjects with insufficient Chinese ability;\n* \\- Subjects who have participated in mindfulness based projects for more than 6 weeks before, and \u002F or the current frequency of meditation practice is more than once a week;\n* \\- Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;\n* \\- Subjects with high risk of suicide.",{"count":466,"type":21},160,[24],"This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress",[28],"2024-12-04",{"date":472,"type":35},"2024-12-09",{"date":474,"type":21},"2024-12-10",{"date":476,"type":21},"2025-06-10",{"name":439,"class":42},{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":257,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":118},"100563896","mechanisms-of-mindfulness-intervention-cognitive-flexibility-dose-manipulation-100563896","NCT06622122","Mechanisms of Mindfulness Intervention: Cognitive Flexibility Dose Manipulation","Exploring the Mechanism of Mindfulness Intervention: Manipulating the Dose of Cognitive Flexibility Intervention","Inclusion Criteria:\n\n* \\- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.\n* \\- Aged 18-65 years old.\n\nExclusion Criteria:\n\n* \\- Subjects who could not access the Internet;\n* \\- Subjects with insufficient Chinese ability;\n* \\- Subjects who have participated in mindfulness based projects for more than 6 weeks before, and \u002F or the current frequency of meditation practice is more than once a week;\n* \\- Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;\n* \\- Subjects with high risk of suicide.",{"count":486,"type":21},300,[24],"This study hopes to:\n\n1. explore whether an increase in the dosage of cognitive flexibility intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress.\n2. explore whether cognitive flexibility mediates the effects of mindfulness intervention on alleviating emotional distress.",[28],"2024-09-28",{"date":492,"type":35},"2024-10-01",{"date":494,"type":21},"2024-10-11",{"date":496,"type":21},"2025-05-11",{"name":439,"class":42},{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":505,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100431114","the-opera-study-evaluating-qol-after-rectal-cancer-surgery-100431114","NCT04893876","The OPERa Study: Evaluating QoL After Rectal Cancer Surgery","The OPERa Study: A Multicenter Observational Prospective Cohort Study to Evaluate Determinants of Long-Term Quality of Life Following Restorative Proctectomy for Rectal Cancer Treatment","Inclusion Criteria:\n\n* Patients \\>18 years with histopathologically confirmed adenocarcinoma of the rectum, defined as tumor ≤15cm from the anal verge who are planned for RP ± neoadjuvant treatment or WW (CRT alone without surgery).\n\nExclusion Criteria:\n\n* Metastatic disease at diagnosis;\n* Planned for abdominoperineal resection (APR), low Hartmann's or pelvic exenteration (PE);\n* Cannot be contacted by telephone;\n* Unable to read and comprehend English or French;\n* Unable to give clear and informed consent.",{"count":506,"type":21},1200,"Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap.\n\nThe main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional\u002Ffinancial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP.\n\nThis multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \\& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.\n\nThe main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.",[509,510,511,512,513,28,514],"Rectal Cancer","Quality of Life","Bowel Dysfunction","Sexual Dysfunction","Urinary Dysfunction","Surgery","2022-08-17",{"date":517,"type":35},"2022-08-18",{"date":519,"type":21},"2023-01-01",{"date":521,"type":21},"2029-09-30",{"name":523,"class":42},"Jewish General Hospital"]