[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cognitive-behavioral-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cognitive-behavioral-therapy":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,55,92,105,133,166,195,240,265,290,317,345,367,393,422,460,486,513],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[26,27,28,29,30,31,32,33,34,35],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[26,27,37,28,38,34,39,40,41],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-05-10",{"date":50,"type":20},"2027-06",{"name":52,"class":53},"Johns Hopkins University","OTHER",5,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100636769","digitally-enhanced-cognitive-behavioral-therapy-100636769","NCT07569991","Digitally Enhanced Cognitive-Behavioral Therapy","Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity","CBT+","Inclusion Criteria:\n\n* Age 12-17 years\n* Body mass index (BMI) ≥85th percentile for age and sex\n* Elevated depression symptoms, Center for Epidemiologic Studies-Depression Scale (CES-D) ≥21\n\nExclusion Criteria:\n\n* Type 2 diabetes; Fasting glucose ≥126 mg\u002FdL or HbA1c ≥6.5\n* Major developmental (e.g., intellectual developmental disability) or medical or genetic condition (e.g. cancer, Bardet-Biedhl)\n* Pregnancy\u002Fbreastfeeding (females)\n* Bariatric surgery, weight loss medication, or weight loss \\>3% in the past 3 months\n* Active suicidality or self-harm","12 Years","17 Years",{"count":66,"type":20},60,[23],"Adolescent depression is a major public health problem. Depression affects adolescents' emotional well-being now and in the future, and it also affects their physical health, especially the risk for heart disease and other cardiovascular and metabolic health problems. In adolescents with depression and obesity, evidence-based programs for depression, like cognitive-behavioral therapy (CBT), might improve physical health, in part by supporting healthy behaviors such as physical activity, nutritious eating, and getting enough sleep. Our preliminary studies provide support for this overarching hypothesis. If adolescents have access to a digital app to support practicing CBT skills in between program sessions, it might especially help them to learn skills that help to feel better and be healthier in their day-to-day lives. We are tailoring a digital app for this purpose and we will make changes to the app based on feedback from adolescents, their parents, and their doctors. Once the app is well-liked and helpful, and works well as a support for taking part in CBT, we will randomly assign 60 adolescents with depression and overweight\u002Fobesity to either \"CBT+\" - a CBT group program plus the app, or \"CBT-only\" - the CBT group program only. We will pilot test whether this research is feasible, likeable, and credible, learning information that will inform a larger study to test of CBT+ can support emotional well-being, health behavior, and cardiovascular and metabolic health in adolescents.",[70,71,72,73,74],"Depression in Adolescence","Obesity & Overweight","Cognitive-behavioral Therapy","Mobile Health Technology (mHealth)","Health Behavior",[76,77,78,79,80],"cognitive-behavioral therapy","depression","adolescents","cardiometabolic health","mHealth","NOT_YET_RECRUITING","2026-06-03",{"date":84,"type":46},"2026-06-05",{"date":86,"type":20},"2027-01-01",{"date":88,"type":20},"2028-08-01",{"name":90,"class":53},"Colorado State University",1,{"id":93,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":24,"conditions":96,"keywords":97,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":54},"100490200",{"count":19,"type":20},[23],[26,27,28,29,30,31,32,33,34,35],[26,27,37,28,38,34,39,40,41],"2026-05-26",{"date":100,"type":46},"2026-05-28",{"date":48,"type":46},{"date":103,"type":20},"2026-09",{"name":52,"class":53},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":91},"100636470","phase-2-group-pacbt-for-depression-100636470","NCT07566104","Group PACBT for Depression","Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder","Inclusion Criteria:\n\n* Ages 21-60,\n* Fluent in English\n* Able to swallow capsules,\n* Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),\n* Active current depressive symptoms (i.e., scores \\>16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986),\n* Have an identified support person (i.e., trusted adult friend or relative) who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,\n* For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study. Must be willing to take on-site pregnancy tests.\n* Agree to refrain from any psychoactive drug (including alcohol) within 24 hours of each drug session and during the drug sessions. Participants will be allowed to consume their usual amount of caffeine prior to and after the drug sessions.\n* Agree to not take any PRN medications on the mornings of the drug sessions\n* Has been medically cleared for the study by a physician\n* Participants must remain on anti-hypertensive medications if prescribed previously to manage hypertension\n\nExclusion Criteria:\n\n* A personal or family history (first-degree) of psychosis or mania\n* Resting blood pressure above 140 systolic, 90 diastolic or heart rate \\> 90 beats per minute (averaged across four separate measurements)\n* Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),\n* Active suicidality (i.e., HAM-D item 3 score of greater than 3) or other psychiatric disturbance requiring acute treatment\n* Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan), lithium, or efavirenz \\[regardless of whether the drug(s) is\u002Fare prescribed for MDD or other conditions\\]\n* Current use of opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n* Currently receiving cognitive behavioral therapy,\n* Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition\n* QTc interval measurement of \\> 450 ms in males or \\> 460 ms in females as measured by the baseline ECG\n* A history of stroke or Transient Ischemic Attack (TIA)\n* Epilepsy or history of seizures\n* Insulin-dependent diabetes\n* Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months (including for nicotine and cannabis)\n* Positive urine drug screen for illicit substances (not including cannabis)\n* Use of other psychedelics or ketamine within prior 12 months\n* Adverse prior reaction to a 5-HT2A receptor agonist psychedelic agent\n* Pregnant, trying to get pregnant, or nursing","21 Years","60 Years",{"count":115,"type":20},30,[117],"PHASE2","This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.",[120,121,32],"Depression - Major Depressive Disorder","Psilocybin",[123],"group treatment","2026-04-28",{"date":126,"type":46},"2026-05-04",{"date":128,"type":20},"2027-01",{"date":130,"type":20},"2028-12",{"name":132,"class":53},"University of California, Los Angeles",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":140,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":91},"100635247","phase-2-tiaoshen-anti-cancer-protocol-and-cbt-for-insomnia-and-survival-in-ovarian-cancer-100635247","NCT07550205","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive).\n2. Performance status (PS) score of 0-2.\n3. Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.\n4. Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.\n5. Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance \\[nocturnal awakening ≥2 times\\], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).\n6. Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).\n7. Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.\n\nExclusion Criteria:\n\n1. Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.\n2. History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.\n3. Pregnant or lactating women.\n4. Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.\n5. Language barriers that would prevent completion of assessments or therapy.\n6. Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.\n7. Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.\n8. History of chronic alcohol dependence.\n9. Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).\n10. Participation in any other clinical trial within 3 months prior to enrollment.\n11. Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.","FEMALE","80 Years",{"count":19,"type":20},[117,144],"PHASE3","Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.\n\nIntervention \\& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.\n\nParticipants will be randomly assigned to one of two groups for the initial 18-week phase:\n\nExperimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).\n\nControl Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.",[147,148,149,150,32],"Ovarian Neoplasms Malignant","Sleep Initiation and Maintenance Disorders","Medicine, Chinese Traditional","Chinese Herbal Medicine",[152,153,154,40,155,156],"Ovarian Cancer","Cancer-Related Insomnia","Traditional Chinese Medicine","Randomized Controlled Trial","Progression-Free Survival","2026-04-19",{"date":159,"type":46},"2026-04-24",{"date":161,"type":20},"2026-05-01",{"date":163,"type":20},"2029-09-30",{"name":165,"class":53},"Shanghai Municipal Hospital of Traditional Chinese Medicine",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100633889","internet-based-cognitive-behavioural-therapy-icbt-for-anxiety-and-depression-in-singapore-100633889","NCT07532551","Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore","Assessing the Clinical and Cost Effectiveness of Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore","1. Quantitative Study - Patients\n\n   Inclusion Criteria:\n   * Age ≥21 years\n   * Tier 2 - 3 depression and\u002For anxiety based on PHQ-9 and GAD-7 scores\n\n     * PHQ-9 score of 5 to 19\n     * GAD-7 score of 5 to 14\n   * Able to provide informed consent\n\n   Exclusion Criteria:\n   * Unable to read or understand English (Primary 6 level)\n   * Unable to use the internet (e.g. due to lack of internet access or insufficient digital literacy)\n   * Does not possess a mobile device or is not able to access the iCBT application\n   * Actively experiencing psychosis\n   * Suspected with personality disorder\n   * Primary concern is obsessive compulsive disorder (OCD)\n   * Tier 4 patients with severe depression or anxiety\n\n     * PHQ-9 score of 20 and above\n     * GAD-7 score of 15 and above\n   * Any suicidal risk or ideation\n\n     * PHQ-9 Question 9 score of more than 2\n2. Qualitative Study - Service Providers\n\nInclusion Criteria:\n\n* Are currently or previously have been involved in the delivery, supervision, or implementation of the iCBT programme\n* Have had direct experience supporting patients enrolled in the study\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Have no direct involvement in the iCBT programme; or\n* Have had insufficient exposure to the programme, defined as managing fewer than one referred case or less than one month of involvement at the time of recruitment.\n* Conflict of interest or Supervisory Hierarchy Concerns - Individuals whose participation may create perceived coercion or introduce bias\n* Inability to provide informed consent",{"count":174,"type":20},390,[23],"Cognitive-behavioural therapy (CBT) has a robust evidence base for treating anxiety disorders and depression, including transdiagnostic CBT. Internet-based CBT (iCBT) offers a new approach to delivering these therapies. iCBT is a digital adaptation of traditional CBT that leverages digital platforms to deliver similar therapeutic interventions. iCBT encompasses structured programmes that provide users with tools and techniques to manage mental health issues such as depression and anxiety. The digital format ensures timely access to CBT and typically includes interactive modules, videos, self-assessment tools, and virtual therapist support. This study aims to evaluate the effectiveness of iCBT in reducing symptoms of anxiety and depression, as well as its cost-effectiveness and acceptability in local context.\n\nThe main questions it aims to answer are:\n\n1. Do participants receiving iCBT show a reduction in symptoms of anxiety and\u002For depression, and does the effectiveness of iCBT vary based on individual user characteristics?\n2. What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans?\n3. Is iCBT more cost-effective as compared to usual care?\n\nResearchers will compare guided iCBT to usual care (traditional CBT) to assess iCBT's clinical effectiveness, cost-effectiveness, and acceptability in Singapore's primary and community healthcare settings.\n\nParticipants in the intervention group will:\n\n1. Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques\n2. Counsellors will schedule 3 regular check-ins\n3. Questionnaires will be administered at 5 timepoints\n4. Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT\n\nParticipants in the control group will:\n\n1. Continue usual care\n2. Questionnaires will be administered at 5 timepoints\n\nA parallel qualitative study involving service providers is required to contextualise trial findings, identify implementation barriers and enablers and inform national scale-up and policy decisions. It aims to explore service providers' experiences, perceptions and contextual factors influencing the implementation of iCBT within routine primary-care and community mental-health services participating in this trial.",[178,32],"Depression and\u002For Anxiety in the Mild-to-moderate Range",[180,181,182,183,184,77],"internet-delivered cognitive behavioural therapy","cognitive behavioural therapy","CBT","iCBT","anxiety","2026-04-12",{"date":187,"type":46},"2026-04-16",{"date":189,"type":20},"2026-04",{"date":191,"type":20},"2028-03",{"name":193,"class":53},"National University of Singapore",3,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":220,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":91},"100620350","enhancing-mental-and-physical-health-of-women-veterans-30-100620350","NCT07356479","Enhancing Mental and Physical Health of Women Veterans 3.0","Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) 3.0 (QUE 25-015)","EMPOWER","Inclusion Criteria:\n\n* This study is recruiting VA sites - not individual patients.\n* Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and\u002For facility level leadership support for participation.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":5,"type":20},[23],"Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.",[207,208,209,210,211,212,213,214,32,215,216,217,218,219],"Cardiovascular Diseases","Overweight","Obesity","Hypertension","Cholesterol","Diabetes Mellitus","Prediabetic State","Menopause","Primary Health Care","Stress Disorders, Post-Traumatic","Prevention","Implementation Science","Quality Improvement",[221,208,209,210,211,212,213,214,32,215,216,217,222,219,223,224,225,226,227,228,229,74],"Cardiovascular diseases","Implementation science","Women","Veterans","Patient Participation","Patient Satisfaction","Patient Preference","Physicians, Primary Care","Physicians, Women","2026-01-12",{"date":232,"type":46},"2026-01-21",{"date":234,"type":20},"2026-10-01",{"date":236,"type":20},"2031-09-30",{"name":238,"class":239},"VA Office of Research and Development","FED",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":91},"100420943","fear-of-recurrence-and-stopping-immunotherapy-100420943","NCT04761328","Fear of Recurrence and Stopping Immunotherapy","Distress Associated With Stopping Immunotherapy of Cancer Patients","Inclusion Criteria:\n\n* Age 21 years and older\n* Fluent in English\n* Diagnosis of cancer and history of treatment with immunotherapy\n\nExclusion Criteria:\n\n* Active suicidal ideation, delusions or hallucinations",{"count":248,"type":20},100,[23],"The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.",[32],[253,254,28,255],"Fear of recurrence","Quality of life","Anxiety","2025-12-01",{"date":258,"type":46},"2025-12-05",{"date":260,"type":46},"2021-08-02",{"date":262,"type":20},"2028-12-31",{"name":264,"class":53},"University of Pittsburgh",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":91},"100462625","building-an-equitable-and-accessible-system-of-eating-disorder-care-for-va-dod-and-underrepresented-americans-100462625","NCT05304104","Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans","Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans With Eating Disorders (EASED Study)","EASED","Inclusion Criteria:\n\n* Aged 18 and older\n* Presence of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Bulimia Nervosa (BN) or Binge Eating Disorder (BED)\n* Veteran Health Administration (VHA) user\n\nExclusion Criteria:\n\n* Active psychosis or high acute risk for suicide\n* Medical or psychiatric illness, or cognitive deficits, that interfere with providing consent, completing assessments, or engaging in treatment for eating disorders\n* Pregnancy or lactation\n* Patients with suspected Anorexia or Atypical Anorexia will be excluded and referred to other VA care services",{"count":274,"type":20},144,[23],"When untreated, eating disorders present with tremendous burdens to affected active duty Service members and Veterans and their families, and are very costly to the DoD and VA healthcare system. A comparative effectiveness study with state-of-the-art virtual treatment for BN and BED specifically adapted for testing with the Veteran population and other underrepresented eating disorder populations will lead to major improvements in clinical outcomes. The treatment will be integrated with VA's newest telehealth technology to profoundly enhance access to care anywhere, at any time. This trial of therapist-led and self-help CBT treatments, combined with our expert panel methods to inform VA Clinical Practice Guidelines for Eating Disorders and plans for dissemination, will accelerate the pace for the transition of results both for large-scale deployment in the VA system and for real-world impact among diverse and underrepresented eating disorder populations.",[278,279,280,32],"Binge-Eating Disorder","Bulimia Nervosa","Veterans Health","2025-11-19",{"date":283,"type":46},"2025-11-25",{"date":285,"type":46},"2022-04-22",{"date":287,"type":20},"2025-12",{"name":289,"class":239},"VA Connecticut Healthcare System",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":297,"sex":16,"minAge":17,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":91},"100610841","brief-culturally-adapted-cbt-for-ocd-100610841","NCT07232823","Brief Culturally Adapted CBT for OCD","Brief Culturally Adapted Cognitive Behaviour Therapy (CaCBT) for Obsessive-Compulsive Disorder: A Randomised Controlled Trial From Pakistan","Inclusion Criteria:\n\n* Participants aged 18 years or above\n* Participants with at least an elementary level of reading and writing\n* Clinical diagnosis of Obsessive Compulsive Disorder, either alone or comorbid with depression or anxiety\n\nExclusion Criteria:\n\n* Participants with excessive use of alcohol or drugs (using ICD-10 RDC for alcohol or drug abuse or dependence)\n* Those with significant cognitive impairment (for example, intellectual disability or dementia)\n* Or those with OCD comorbid active psychosis",true,"65 Years",{"count":300,"type":20},166,[23],"The purpose aims to assess the efficacy of Brief Culturally Adapted Cognitive Behaviour Therapy (Ca-CBT) for the treatment of Obsessive Compulsive Disorder (OCD).",[304,32],"Obsessive-Compulsive Disorder",[182,306,307],"CaCBT","OCD","2025-11-15",{"date":310,"type":46},"2025-11-18",{"date":312,"type":46},"2024-10-20",{"date":314,"type":20},"2025-12-31",{"name":316,"class":53},"Pakistan Association of Cognitive Therapists",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":91},"100484368","exposure-based-cbt-for-avoidantrestrictive-food-intake-in-functional-dyspepsia-100484368","NCT05587127","Exposure-Based CBT for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","Inclusion Criteria\n\n* Age at least 18 years at screening visit\n* Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)\n* Negative upper endoscopy or upper radiographic GI series to rule out structural\u002Forganic cause for FD\n* Avoidant\u002FRestrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)\n* ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)\n* Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)\n* No previous history of CBT for functional dyspepsia or ARFID\n* Computer\u002Finternet webcam access\n* Fluency in English\n* Stable dose for 30 days if on any medication\n\nExclusion Criteria\n\n* Inability to provide informed consent\n* Presence of other conditions that could explain the patient's symptoms by chart:\n\nPyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer\n\n* Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)\n* History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)\n* History of any serious medical condition (e.g., cancer)\n* Use of narcotic analgesics greater than three days per week\n* Current pregnancy or breastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart\n* Intellectual disability by history\n* Current substance\u002Falcohol use disorder within the past month\n* Current\u002Fhistory of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)\n* Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)\n* Active suicidal ideation (by MINI-Screen)\n* Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))\n* Current enteral or parenteral feeding\n* Plans to initiate another psychotherapy or pregnancy in the concurrent study period",{"count":325,"type":20},50,[23],"Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant\u002Frestrictive food intake disorder (ARFID) with weight loss.",[329,330,331,32,332,333,334,335],"Avoidant\u002FRestrictive Food Intake Disorder","Dyspepsia","Feeding and Eating Disorders","Appetite Regulation","Functional Dyspepsia","Post-prandial Distress Syndrome","Behavioral Medicine","2025-09-22",{"date":338,"type":46},"2025-09-25",{"date":340,"type":46},"2022-11-30",{"date":342,"type":20},"2027-05",{"name":344,"class":53},"Massachusetts General Hospital",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":351,"maxAge":64,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":91},"100486118","cbt-augmentation-to-promote-medication-discontinuation-in-pediatric-ocd-100486118","NCT05609916","CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD","Inclusion Criteria:\n\n* The child is between the ages of 7 to 17 at enrollment with a primary diagnosis of OCD of \\> 6 months duration based on the Kiddie Schedule for Affective Disorders and Schizophrenia Lifetime Version for DSM-5 (KSADS-PL) and have a CY-BOCS ≥ 16.\n* The child is on stable and maximally tolerated SRI medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic. Paroxetine is exclusionary due to safety concerns.\n* Both the child and parent participating in the study are English speaking.\n* Both the child and their parent participating in the study reside in Texas.\n\nExclusion Criteria:\n\n* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and\u002For intellectual disability.\n* The child has severe current suicidal\u002Fhomicidal ideation and\u002For self-injury requiring medical intervention.\n* The child is receiving concurrent psychotherapy for OCD.\n* Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant\u002Fpsychoactive medication less than 2 weeks prior to study enrollment.","7 Years",{"count":353,"type":20},200,[23],"The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.",[32,304,357,358],"Obsessive-Compulsive Disorder in Children","Obsessive-Compulsive Disorder in Adolescence","2025-07-18",{"date":361,"type":46},"2025-07-20",{"date":340,"type":46},{"date":364,"type":20},"2027-08-30",{"name":366,"class":53},"Baylor College of Medicine",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":297,"sex":16,"minAge":375,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":91},"100416301","a-randomized-controlled-evaluation-of-a-compassion-course-for-healthcare-professionals-100416301","NCT04700878","A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals","A Randomized Controlled Evaluation of a Compassion-course With the Aim of Reducing Stress of Conscience and Work-related Stress and Increase Levels of Professional Quality of Life and Self-compassion in Healthcare Professionals","ICOP","Inclusion Criteria:\n\nThe inclusion criteria will be as follows: the participants work directly with patients full-time or part-time, score 45 points or higher on the primary outcome measure Stress of Conscience Questionnaire (SCQ), are proficient in Swedish, have the requisite time to attend a digital course, and accept the course's format.\n\nThe exclusion criteria include being partially or fully on sick leave due to stress.\n\nAll criteria are assessed on the basis of self-assessment forms of the participants, but in case of uncertainty, follow-up questions can be done by phone.","20 Years",{"count":377,"type":20},548,[23],"The aim is to investigate whether an internet-based compassion course of five modules contributes to reducing stress of conscience and work-related stress, increase the experience of professional quality of life and self-compassion in healthcare professionals.",[381,382,383,32],"Psychological Stress","Compassion","Occupational Health","2025-03-14",{"date":386,"type":46},"2025-03-19",{"date":388,"type":46},"2021-02-01",{"date":390,"type":20},"2027-12-31",{"name":392,"class":53},"Linnaeus University",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100490571","longitudinal-neurocognitive-psychosocial-and-health-related-quality-of-life-assessment-in-advanced-cancer-survivors-treated-with-immunotherapy-and-the-efficacy-of-integrative-neurocognitive-remediation-therapy-100490571","NCT05667857","Longitudinal Neurocognitive, Psychosocial and Health-related Quality of Life Assessment in Advanced Cancer Survivors Treated With Immunotherapy and the Efficacy of Integrative Neurocognitive Remediation Therapy","CognIT","Inclusion Criteria:\n\n1. Non-intervention group:\n\n   * Provision of written informed consent\n   * Diagnosed with advanced cancer of any type\n   * Initiated immunotherapy (Anti-PD1, Anti-PDL1, CTLA-4, …) at least one year ago\n   * Have a confirmed normalization on whole-body 18F-FDG PET\n   * English, Dutch or French-speaking\n2. Integrative neurocognitive remediation therapy group:\n\n   * Provision of written informed consent\n   * Objective cognitive impairment and\u002For subjective cognitive complaints\n   * Confirmed normalization on whole-body 18F-FDG PET for patients (cohort 1)\n   * Disease-free (cohort 2) or no active disease for patients with CNS tumors (cohort 3)\n   * Having received a cancer therapy of any kind\n   * Having ended cancer treatment (immunotherapy, chemotherapy, radiotherapy, surgery, …) with an exception of ongoing adjuvant hormone therapy\n   * Dutch or French speaking\n\nExclusion Criteria:\n\n* severe co-morbid non cancer-related psychiatric disorders such as psychosis, obsessive compulsive disorders, eating disorders etc., patients with cognitive impairment related to dementia, and patients that are physically or mentally not able to fill in the questionnaires",{"count":248,"type":20},[23],"Since 2010, the field of immunotherapy has grown substantially, leading to a growing population of long-term cancer survivors treated with immunotherapy. Since cancer survivorship in immunotherapy is an emerging field, to date not much is known about psychosocial and neurocognitive survivorship-related issues in advanced cancer survivors treated with immunotherapy. Preliminary findings indicated significant psychosocial and cognitive problems in survivors of advanced melanoma persist after treatment with immunotherapy. The objective for this project is twofold. First, the investigators want to longitudinally identify survival-related problems in survivors of advanced cancer treated with immunotherapy. The second goal is to identify the efficacy of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program. The investigators will focus on the following outcomes: (1) Psychosocial consequences, such as emotional complaints, fatigue, fear of recurrence, (2) neurocognitive functioning, and (3) health-related quality of life. The INCRT combines personalized computerized cognitive training and neurocognitive strategy training, with group sessions of exercise, mindfulness, Acceptance and Commitment Therapy, and cognitive behavioral therapy.\n\nWe will have three cohorts:\n\n* Cohort 1: advanced cancer survivors treated with immunotherapy\n* Cohort 2: cancer survivors treated with cancer therapy of any kind (excluded immunotherapy), and who have subjective complaints and\u002For objective cognitive impairment\n* Cohort 3: cancer survivors of a central nervous system (CNS) tumor, who do not have active disease in the CNS, and who have subjective complaints and\u002For objective cognitive impairment\n\nIn the first part of the study, survival-related problems will be evaluated in cohort 1, in a longitudinal manner by means of a semi-structured interview at baseline, various questionnaires and a computerized neuropsychological test battery.\n\nIn the second part of the study, patients of cohort 1, 2 and 3 with subjective or objective cognitive dysfunction can follow the INCRT program. The efficacy of the INCRT is evaluated through a pre-INCRT and post-INCRT evaluation. This evaluation consist of several questionnaires and neuropsychological tests. Long-term efficacy will be evaluated by a follow-up evaluation six months after completion of the INCRT program.",[404,405,406,407,32,408,409,410,411],"Cognitive Remediation","Neuropsychology","Quality of Life","Psycho-Oncology","Cancer Survivors","Immunotherapy","Cognitive Dysfunction","Psychological Distress","2025-01-16",{"date":414,"type":46},"2025-01-20",{"date":416,"type":46},"2022-07-13",{"date":418,"type":20},"2033-12",{"name":420,"class":53},"Universitair Ziekenhuis Brussel",2,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":298,"enrollmentInfo":430,"targetDuration":432,"studyType":433,"phases":4,"briefSummary":434,"conditions":435,"keywords":439,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":91},"100486629","precision-medicine-in-the-depression-treatment-100486629","NCT05616559","Precision Medicine in the Depression Treatment","The BrainDrugs-Depression Study: A Prospective Precision Psychiatry Cohort Study in the Treatment of Depression","BDD","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).\n* Referral to a treatment package for single-episode depression.\n\nExclusion Criteria:\n\n* Psychosis or psychotic symptoms\n* History of severe head trauma\n* Somatic disease associated with morphological brain changes (e.g., brain tumour)\n* Insufficient Danish language skills to complete questionnaires and cognitive testing\n\nAdditional exclusion criteria for Cohort II:\n\n* Severe somatic disease\n* Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)\n\nAdditional exclusion criteria for Cohort III:\n\n* Severe somatic disease\n* Contraindications for MRI\n* Exposure to radioactivity \\>10 mSv within the last year\n* Pregnancy or breastfeeding\n* Use of psychotropic drugs",{"count":431,"type":20},800,"18 Months","OBSERVATIONAL","The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.",[436,437,410,32,438],"Depressive Disorder, Major","Treatment Outcome","Antidepressive Agents",[440,441,442,443,444,445,446,447,448,449,450,255],"PET","MRI","fMRI","EEG","Prediction of treatment response","Early life stress","Selective Serotonin Reuptake Inhibitor","Psychometrics","MDD","Cold cognition","Social cognition","2024-10-03",{"date":453,"type":46},"2024-10-08",{"date":455,"type":46},"2021-06-15",{"date":457,"type":20},"2026-12",{"name":459,"class":53},"Rigshospitalet, Denmark",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":91},"100551023","improving-treatment-of-major-depressive-disorder-by-reducing-negative-future-oriented-mental-imagery-100551023","NCT06454695","Improving Treatment of Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery","Improving Treatment of Severe Major Depressive Disorder by Reducing Negative Future-Oriented Mental Imagery","PROFIT","Inclusion Criteria:\n\n* Aged 18 years or older;\n* Meet DSM-5 criteria for major depressive disorder;\n* Presence of 1-3 negative future-oriented mental images, which cause distress;\n* Be able to understand questionnaires and study information letter;\n* In case of medication use: are stable on medication for six weeks or longer.\n\nExclusion Criteria:\n\n* Current or history of psychotic disorder;\n* Current or history of bipolar disorder;\n* Severe cognitive impairment (e.g., mental retardation) as evidenced by educational records, parental report and\u002For clinical impression;\n* Current EMDR or imagery rescripting therapy;\n* Other circumstances that might affect participation (e.g., severe medical disorder, relocation).",{"count":325,"type":20},[23],"Patients with major depressive disorder (MDD) often do not sufficiently benefit from treatment. That is, around 50% of patients with MDD do not respond to treatment and 20-30% only achieve partial remission. Future-oriented negative mental imagery (e.g., mental images of suicide or own funeral) is likely an important maintaining factor of depression and initial studies in depression indicate that targeting mental imagery with 'imagery rescripting' could be a promising therapeutic technique to reduces depressive symptomatology by targeting these images directly that elicits strong affects\u002Femotions and depressive symptomatology.\n\nBefore testing the (cost)effectiveness of future-oriented imagery rescripting to treatment as usual (TAU), a pilot study is needed to examine 1) the acceptability of the intervention, 2) the feasibility of the study, and 3) the variance of effect on reducing depressive symptomatology that can serve as estimate of the sample size for a follow-up randomized controlled trial (RCT).\n\nA multicenter pilot RCT with a mixed factorial design with three time points (i.e., baseline, post-treatment, and follow-up of 3 months) will test 50 patients with MDD who will be randomly allocated to future-oriented imagery rescripting plus TAU or TAU only.\n\nThe sample consists of adult patients of 18 years or older with an MDD diagnosis.\n\nAll patients in this pilot study receive TAU, which involves a combination of pharmacological and psychological interventions. Half of the patients will also receive 3-5 sessions of future-oriented imagery rescripting (ImRes). In each ImRes session, patients identify an image of a autobiographic catastrophic future event (e.g., catastrophic images of future suicide or the loss of work or a loved one). They are subsequently asked to \"rescript\" this image into a more benign one.\n\nThe primary aim of this pilot study is to determine the acceptability of the intervention. The secondary aims are to elucidate factors that may facilitate or hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to estimate the variance of the effect on reduction of depressive symptomatology, which informs the sample size calculation of the follow-up RCT. To study acceptability, the investigators assess depressive symptoms (BDI-II and BADS) and treatment satisfaction (SRS and CSQ-8). To measure feasibility, the investigators will assess recruitment\u002Fadmission ratio, dropout and (serious) adverse events. Finally, to estimate the variance of effects, group effects on the BDI-II will be tested at post-treatment and follow-up (corrected for baseline).\n\nImagery rescripting on negative memories has already proven effective and safe in MDD patients. There is no known major risk associated with study participation. Patient burden comprises an online or phone-based screening interview of maximum 60 minutes and several questionnaires. Participants receive a reimbursement of €25,- after study completion (i.e., after follow-up assessment). The project will contribute to improving the care for patients with MDD. If the results show that the intervention is feasible and acceptable, this pilot study will inform the setup of the main RCT on the (cost)effectiveness of the intervention (ZonMW).",[472,473,32],"Major Depressive Disorder","Mental Imagery",[475,476,28],"Imagery rescripting","Prospective negative mental images","2024-08-22",{"date":479,"type":46},"2024-08-23",{"date":481,"type":46},"2024-06-01",{"date":483,"type":20},"2025-11-01",{"name":485,"class":53},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":297,"sex":140,"minAge":493,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":21,"phases":497,"briefSummary":498,"conditions":499,"keywords":502,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":91},"100556197","effectiveness-of-cbt-in-improving-psycho-neuro-endocrine-factors-in-women-following-in-vitro-fertilization-program-100556197","NCT06521957","Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program","The Effectiveness of Cognitive Behavioral Therapy in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program","Inclusion Criteria:\n\n* Women with primary infertility\n* Aged 25-42 at the start of the study\n* Willing to participate in the study and willing to sign informed consent form\n* Minimum education of high school, able to read, write and understand Bahasa Indonesia\n\nExclusion Criteria:\n\n* Having one or multiple psychotic disorder(s)","25 Years","42 Years",{"count":496,"type":20},75,[23],"The goal of this clinical trial is to learn if Cognitive Behavioral Therapy (CBT) can improve psychological, neurological, and hormonal aspects in women undergoing In Vitro Fertilization (IVF). The main questions it aims to answer are:\n\n* Is CBT effective in improving psychological aspects (anxiety, depression, and coping mechanism) in women undergoing IVF?\n* Is CBT effective in improving neuroendocrine aspects (cortisol levels, neuroepinephrine levels, free trioodothyronine levels) in women underoing IVF?\n\nResearchers will compare CBT to no intervention to see if CBT is effective in improving psychoneuroendocrine aspects.",[32,500,501],"Hormone Disturbance","In Vitro Fertilization",[32,503,501],"Psycho-Neuro-Endocrine","2024-07-23",{"date":506,"type":46},"2024-07-26",{"date":508,"type":46},"2023-07-05",{"date":510,"type":20},"2025-06-01",{"name":512,"class":53},"Fakultas Kedokteran Universitas Indonesia",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":297,"sex":16,"minAge":375,"maxAge":298,"enrollmentInfo":520,"targetDuration":4,"studyType":21,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100517095","effects-of-cognitive-behavioral-therapy-for-insomnia-in-nurses-with-post-covid-19-condition-100517095","NCT06013085","Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition","CBT-I","Inclusion Criteria:\n\n* nurses with post COVID-19 condition\n\nExclusion Criteria:\n\n* history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker",{"count":248,"type":20},[23],"Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.\n\nAim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.\n\nMethods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.\n\nDiscussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.",[32],"2023-08-25",{"date":526,"type":46},"2023-08-28",{"date":528,"type":20},"2023-09-01",{"date":530,"type":20},"2026-07-31",{"name":532,"class":53},"Tri-Service General Hospital"]