[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-anxiety":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,52,77,107,138,163,192,221,251,275,297,321,348,382,414,435,467,486,508,533,564,590,603,624,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100053402","technology-assisted-methods-to-advance-suicide-prevention-among-youth-in-colombia-100053402",false,"NCT06651554","Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia","Harnessing Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombian School Settings","Inclusion Criteria for youth:\n\n* aged 14-19\n* attending a secondary school in Bogota\n* willing to try the digital platform\n\nExclusion Criteria for youth:\n\n* not meeting inclusion criteria",true,"ALL","14 Years","19 Years",{"count":22,"type":23},228,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study will investigate a multi-level approach that applies technology-assisted methods to reduce suicidal thoughts and behaviors (SIB) and promote mental health among Colombian youth: (a) digital platform for youth; (b) digital platform for teachers; and (c) hybrid mental health training diploma program for teachers. This approach will evaluate an open-access digital platform for suicide prevention among Colombian youth. Key features of the digital platform include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements. The digital platform's teacher interface will incorporate psychoeducation, brief suicide-risk screening and decision support tools to enhance teacher capacity to assess risk for suicide and refer youth to the appropriate level of services.\n\nStudy investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota, Colombia. Study aims are to:\n\nAim 1. An initial needs assessment will be conducted with key stakeholders (youth, teachers, caregivers, school administrators) to identify barriers and facilitators to successful implementation of the multi-level approach. User-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype.\n\nAim 2. Investigators will evaluate: (a) feasibility, acceptability, and usability of the digital platform across three schools in Colombia; and (b) the preliminary effects of the digital platform in reducing SIB and improving mood (e.g., anxiety\u002Fdepression) among Colombian youth aged 14-19 attending the three schools. Safety planning skills acquisition (youth-level) and linkages to mental health services (service-level) will be assessed as potential mechanisms of change.\n\nAim 3. The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research, healthcare delivery capacity, and mental health policy. In partnership with Pontificia Javeriana University, experts in suicide prevention, data science, and implementation science will be engaged to build in-country research capacity at the individual and institutional level.",[29,30,31,32],"Suicidal Ideations","Suicidal Behaviors","Depression, Anxiety","Well-being",[34,35,36,37,38],"suicide prevention","adolescent health","mHealth","Colombia","Implementation Science","RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":43},"2025-05-12",{"date":47,"type":23},"2027-01-31",{"name":49,"class":50},"Brown University","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":51},"100531465","phase-2-psilocybin-assisted-psychotherapy-in-patients-with-advanced-cancer-on-maintenance-therapy-100531465","NCT06200155","Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","TRIP - TReatment to Improve Depression and\u002For Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","Inclusion Criteria:\n\n1. Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric\u002FGEJ cancer, cervical, anal, or MSI-high\n2. Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)\n3. No prior grade 3 AEs on current standard of care cancer treatment regimen;\n4. Age ≥ 25 years; as by the age of 25 brain is fully developed.\n5. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM, by a board certified psychiatrist), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder; Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis are determined by a MD Anderson board certified psychiatrist.\n6. At least 6 months life expectancy as per primary medical oncologist.\n7. Have an ECOG performance status of 0, 1, or 2.\n8. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n9. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n10. Agree to abstain from any nicotine products for at least 12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed) as well as on days of salivary sample collection.\n11. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions (except as described above for nicotine and caffeine) and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Participant tested positive for a prescribed substance are eligible. Participant failing on the 2nd test (UDS) will be excluded.\n12. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications and those with primary MOA on serotonergic neurons (e.g., ondansetron) for a minimum of 2 weeks prior to study or 4 weeks for SSRI. Intermittent or PRN use of short-acting anxiolytics may be permitted as defined below in exclusionary criteria).\n13. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n14. Eligible participants will have a responsible individual that will provide transportation home after the psilocybin session is complete.\n15. Fluent in English\n\nExclusion Criteria:\n\n1. History of depression prior to cancer diagnosis.\n2. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior\n3. History of bipolar disorder, psychosis (of any nature), and seizures.\n4. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.\n5. ECG with QTc \\> 450.\n6. Patients with metal implants.\n7. Asymptomatic ALT or AST elevations \\>\u002F= 5X upper limit of normal, symptomatic ALT or AST elevations \\>\u002F= 2X upper limit of normal, or total bilirubin \\>\u002F= 2X upper limit of normal.\n8. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n   Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n   History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n9. persons with first- or second-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder.\n10. Actively progressing disease as defined by the primary oncologist.\n11. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n12. Participants with brain metastases.\n13. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \\>140\u002F90 mmHg and HR\\> 90 bpm.\n14. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n15. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm ii. Epilepsy iii. History of stroke iv. Cerebral aneurysm v. Dementia vi. Delirium\n16. a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>25 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n    i. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\n    ii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\n    iii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    iv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    g. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin h. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\n    i. Have an allergy or intolerance to any of the materials contained in either drug product j. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and\u002For existential distress (e.g., pharmacologic or psychotherapeutic interventions)\n17. Participants who have any of the below niacin contraindications:\n\n    1. Active liver disease or unexplained persistent elevations in hepatic transaminases\n    2. active peptic ulcer disease\n    3. arterial bleeding\n    4. Hypersensitivity to niacin or any component of this medication\n18. BP\\> 200\u002F110 (or malignant hypertension defined as 200\u002F120) would prevent a patient from receiving psilocybin dosing and would prompt calling a physician during blood pressure monitoring for cardiac risk evaluation.","25 Years",{"count":61,"type":23},30,[63],"PHASE2","To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and\u002For anxiety in participants who are being treated for advanced cancer.",[31,66,67],"Psilocybin-Assisted Psychotherapy","Advanced Cancer","2026-06-22",{"date":70,"type":43},"2026-06-24",{"date":72,"type":43},"2024-04-16",{"date":74,"type":23},"2026-12-31",{"name":76,"class":50},"M.D. Anderson Cancer Center",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":51},"100503580","phase-2-efficacy-and-safety-of-magnesium-vitamin-b6-in-first-episode-bipolar-disorder-100503580","NCT05837104","Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder","Inclusion Criteria:\n\n* Persons between the ages of 18 and 50\n* DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years\n* Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.\n* Young Mania Rating Scale (YMRS) scores of less than 15\n* Ability to sign informed consent.\n* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent.\n* Persons weighing over 350lbs.\n* Declines to participate.\n* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.\n* 2 or more manic symptoms that meet DSM-V criteria.\n* Persons of childbearing potential who are not using a medically accepted means of contraception.\n* Persons who are deemed a serious suicide or homicide risk.\n* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.\n* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.\n* Persons meeting criteria for bipolar mixed episode.\n* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.\n* Severe hypomagnesemia (serum magnesium of 0.45 mmol\u002FL).\n* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.\n* Seizure disorder.\n* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.\n* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.\n* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.\n* Have any medical condition that would prevent blood draws.\n* Have a history of significant head injury.\n* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6\n* Patients taking psychostimulant medication","18 Years","50 Years",{"count":87,"type":23},40,[63],"This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.",[91,31,92],"Bipolar I Disorder","Stress",[94,95,96,97,98,92],"First episode Bipolar Disorder","Magnesium vitamin B6","Brain energy metabolism","Depression","Anxiety",{"date":100,"type":43},"2026-06-25",{"date":102,"type":43},"2023-12-13",{"date":104,"type":23},"2026-10",{"name":106,"class":50},"Mclean Hospital",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":20,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":51},"100599263","multidimensional-sleep-health-intervention-to-optimize-concussion-recovery-100599263","NCT07082218","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial","SCORE","Inclusion Criteria:\n\n* Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \\[PCSI\\] score ≥9)\n* Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria\n* 10-19 years of age (aligned with World Health Organization definition of 'adolescent')\n\nExclusion Criteria:\n\n* History of treatment for pre-concussion sleep-related disorders","10 Years",{"count":117,"type":23},54,[26],"Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.",[121,122,123,124,31],"Concussion (Diagnosis)","Concussion, Mild Traumatic Brain Injury","Treatment","Sleep Health",[126,127,128],"intervention","mild traumatic brain injury","sleep quality","2026-06-17",{"date":131,"type":43},"2026-06-18",{"date":133,"type":43},"2025-09-10",{"date":135,"type":23},"2027-06-15",{"name":137,"class":50},"University of Colorado, Denver",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":24,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":51},"100372256","internet-delivered-cognitive-behaviour-therapy-for-public-safety-personnel-100372256","NCT04127032","Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel","Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges","Inclusion Criteria:\n\n* 18 years of age or older\n* residing in a Canadian province or territory in which PSPNET is able to offer services\n* endorsing symptoms of anxiety, depression, or post-traumatic stress\n* able to access a computer and internet service\n* willing to provide a physician as emergency contact unless the participant does not have a physician and the clinician conducting the telephone screening assesses the need for an emergency contact to be low.\n\nExclusion Criteria:\n\n* high suicide risk\n* suicide attempt or hospitalization in the last year\n* primary problems with psychosis, alcohol or drug problems, mania\n* currently receiving regular psychological treatment for anxiety or depression\n* not present in Canada during treatment\n* concerns about ICBT",{"count":146,"type":23},250,[26],"This study evaluates a transdiagnostic Internet-delivered cognitive behavioural therapy (ICBT) recently tailored for Canadian public safety personnel (PSP) reporting symptoms of depression, anxiety, or posttraumatic stress. Outcomes of interest include engagement with the intervention, changes in symptoms and functioning, and strengths and limitations of implementing ICBT with Canadian PSP.",[31,150],"Psychological Trauma",[152,153,154],"Internet","Cognitive Behavioral Therapy","Telemedicine","2026-06-16",{"date":131,"type":43},{"date":158,"type":43},"2019-12-01",{"date":160,"type":23},"2028-03-31",{"name":162,"class":50},"University of Regina",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":51},"100491071","training-in-evidence-based-treatments-in-psycho-oncology-100491071","NCT05674357","Training in Evidence-based Treatments in Psycho-Oncology","Patient Inclusion Criteria:\n\n* Adults \\> 18 years of age.\n* Currently receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance.\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3.\n* Reports distress or presenting problem is related to patients' illness and\u002For treatment (e.g., cancer treatment).\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.\n* Located in the state of Massachusetts for the duration of sessions.\n\nCaregiver Inclusion criteria:\n\n* Adults \\> 18 years of age\n* Currently caring for someone receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3\n* Reports distress or presenting problem is related to caregiving\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion\n* Located in the state of Massachusetts for the duration of sessions\n\nPatient Exclusion Criteria:\n\n* Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n* Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).\n* Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.\n* Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n\nTherapist Inclusion criteria:\n\n-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.\n\nTherapist Exclusion criteria:\n\n-Obtained licensure as a clinical psychologist in any state.",{"count":170,"type":23},115,[26],"The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.\n\nThe intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.\n\n* Cognitive Behavioral Therapy (CBT)\n* Acceptance Commitment Therapy (ACT)\n* Mindfulness-Based Cognitive Therapy (MBCT)\n* Mindfulness-Based Stress Reduction (MBSR)\n* Meaning-Centered Psychotherapy (MCP)\n* Cognitive Behavioral Therapy for Insomnia (CBT-I)\n* CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.\n\nParticipation in this research study is expected to last about 26 weeks.\n\nIt is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.",[174,31,175,176,177],"Distress, Emotional","Fatigue","Pain","Insomnia",[179,180,181,98,97,182],"CBT","Cognitive-Behavioral Therapies","Emotional Distress","Symptom-Related Distress","2026-06-11",{"date":185,"type":43},"2026-06-15",{"date":187,"type":43},"2023-01-09",{"date":189,"type":23},"2029-01-01",{"name":191,"class":50},"Massachusetts General Hospital",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":17,"sex":18,"minAge":59,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":51},"100590062","test-of-target-engagement-of-ambiguity-aversion-100590062","NCT06962527","Test of Target Engagement of Ambiguity Aversion","Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement","Inclusion Criteria:\n\n1. Ages 25 to 60\n2. Right-handed\n3. Ability to read and write English\n4. Capacity to provide informed consent\n5. Intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile)\n\nExclusion Criteria:\n\n1. Personal history of psychosis, mania, or hypomania\n2. Personal history of autism spectrum disorder\n3. IQ \\\u003C 80 as determined by the Wechsler Test of Adult Reading\n4. Head injury with greater than 120 seconds loss of consciousness\n5. Neurological condition (e.g., epilepsy, Parkinson's, cerebral palsy, history of stroke)\n6. Currently pregnant\n7. Use of any implanted electrical device (e.g., pacemaker, spinal stimulator, vagal nerve stimulator, Inspire sleep apnea device, etc.).","60 Years",{"count":201,"type":23},140,[26],"The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.",[205,98,206,31],"Intolerance of Uncertainty","Intolerance of Uncertainty; Anxiety",[208,209,210,211],"Ambiguity aversion","Intolerance of uncertainty","Computational modeling","EEG\u002FERP","2026-05-21",{"date":214,"type":43},"2026-05-26",{"date":216,"type":43},"2025-07-07",{"date":218,"type":23},"2029-12-31",{"name":220,"class":50},"Northwestern University",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100503307","harlem-strong-mental-health-coalition-100503307","NCT05833555","Harlem Strong Mental Health Coalition","Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation","Inclusion Criteria:\n\n* Black and Latino adults between 18 and 65 years\n* Harlem residents from low-income housing developments or receiving primary care services in Harlem\n* PHQ-4 Total Score ≥3, moderate risk for depression\n\nExclusion Criteria:\n\n* Those with risk for depression or anxiety who screen positive for severe mental illness (e.g., psychosis, mania, substance abuse, and high suicide risk) using screening items from the Mini-International Neuropsychiatric Interview will be excluded from the study and referred to MH services at higher levels of care","65 Years",{"count":230,"type":23},700,[26],"Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH\u002Fbehavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral\u002FMH, social services, and other community resources.",[234,31,235],"Stress-related Problem","Mental Health Wellness",[237,238,239,240],"Task-sharing","Implementation research","Collaborative care","Behavior Activation","2026-05-18",{"date":243,"type":43},"2026-05-20",{"date":245,"type":43},"2023-04-05",{"date":247,"type":23},"2026-08-31",{"name":249,"class":50},"City University of New York, School of Public Health",2,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":228,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":51},"100614351","the-comparing-app-support-strategies-study-100614351","NCT07278466","The COMParing App Support Strategies Study","Inclusion Criteria:\n\n* Elevated symptoms of depression and\u002For anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)\n* Proficiency in English\n* Access to a smartphone and internet\n* Ability to receive text messages\n\nExclusion Criteria:\n\n* Non-US citizen or legal resident (green card holder)\n* History of psychosis or mania\n* Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9\n* Individuals who do not provide the information required for GUID generation\n* Previous participation",{"count":258,"type":23},688,[26],"The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.",[31],[263,264,265,266],"HMP app","healthy minds program","Microsupport","meditation","2026-05-14",{"date":241,"type":43},{"date":270,"type":43},"2026-03-13",{"date":272,"type":23},"2029-01-31",{"name":274,"class":50},"University of Wisconsin, Madison",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":51},"100615771","youth-emotional-and-behavioral-treatment-study-100615771","NCT07296939","Youth Emotional and Behavioral Treatment Study","Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation","Inclusion Criteria:\n\n* Children between the ages of 4-17 years\n* (a) a principal diagnosis of an anxiety or mood disorder per DSM-5 criteria, OR (b) parent report of clinically impairing irritability, emotional dysregulation, and\u002For disruptive behavior in youth\n* Child and parent must be able to complete consent documents, assessments, and participate in treatment in English without a translator\n* At least one parent must be available and willing to participant in both phases.\n\nExclusion Criteria:\n\n* Gross neurological, sensory, or motor impairment\n* History of seizure disorder, psychosis, or organic brain syndrome\n* Conditions requiring acute intervention, e.g., active suicidality\n* Non-English speaking child or parent","4 Years","17 Years",{"count":285,"type":23},500,[26],"This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.",[31],"2026-05-12",{"date":267,"type":43},{"date":292,"type":43},"2026-05-07",{"date":294,"type":23},"2027-07-31",{"name":296,"class":50},"Florida State University",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":51},"100591528","prevention-of-psychological-health-problems-via-integrated-operational-support-100591528","NCT06981598","Prevention of Psychological Health Problems Via Integrated Operational Support","Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support","IOS Toolkit","Inclusion Criteria:\n\n* Service members seeing a behavioral health (BH) technician.\n* Currently embedded BH technicians.\n\nExclusion Criteria:\n\n* Service members who are not currently seeing a BH technician.\n* BH technicians who are not embedded or have taken a clinic role.",{"count":306,"type":23},5586,[26],"Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.",[31,310,311,312],"Grief","Leadership","Dissatisfaction",{"date":314,"type":43},"2026-05-15",{"date":316,"type":43},"2025-03-10",{"date":318,"type":23},"2028-03-01",{"name":320,"class":50},"New York University",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":329,"maxAge":84,"enrollmentInfo":330,"targetDuration":4,"studyType":24,"phases":332,"briefSummary":333,"conditions":334,"keywords":338,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100472611","phase-2-modulating-exercise-dosage-to-improve-concussion-recovery-100472611","NCT05434130","Modulating Exercise Dosage to Improve Concussion Recovery","Modulating Exercise Dosage to Improve Concussion Recovery: A Randomized Clinical Trial","MEDIC","Inclusion Criteria:\n\n* 13-18 years of age\n* Post-Concussion Symptom Scale (PCSS) score \\>10 to ensure participants are not recovered by enrollment\n* Concussion diagnosis by a sports medicine physician\n\nExclusion Criteria:\n\n* Pre-existing neurological disorders\n* Exercise contraindications\n* Concussion \\\u003C6 months before enrollment (excluding the current injury)","13 Years",{"count":331,"type":23},216,[63],"Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.",[335,123,336,337,31],"Concussion, Brain","Aerobic Exercise","Inflammation",[126,127],"2026-05-04",{"date":341,"type":43},"2026-05-06",{"date":343,"type":43},"2022-08-05",{"date":345,"type":23},"2027-02-01",{"name":137,"class":50},3,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":24,"phases":359,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":51},"100491917","phase-1-acceptance-and-commitment-therapy-for-adolescents-and-young-adults-with-sickle-cell-disease-100491917","NCT05685368","Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease","Using Acceptance and Commitment Therapy (ACT) to Promote Mental Health and Transition Readiness in Youth With Sickle Cell Disease: A Community-Based Participatory Action Research (CBPAR) Approach","ACT for SCD","Youth Participant Inclusion and Exclusion Criteria The inclusion criteria for study participation are Be an adolescent and\u002For young adult (age 14-21) who has Sickle Cell Disease Willing to enroll in the ACT group jointly provided by the Division of Adolescent and Young Adult Medicine\u002FDepartment of Hematology and Oncology Participants can be active, waitlisted, or new patients at CHLA Participants must be able to understand and speak English, as the therapy will only be delivered in English Participants must have an English-speaking parent\u002Fguardian Able to provide consent\u002Fassent An adolescent or young adult that is pregnant is eligible to participate if consent can be obtained Participants must be developmentally typical Have a stable internet connection (via computer, tablet, or phone) with access to a webcam and a private space to engage in a group therapy sessions; Must consent to audio and video recording of initial interview. Must agree to attend 6 weekly ACT group session Youth participants will be asked to become a member of the CAB. To become a CAB member, the youth participant must consent\u002Fassent to participation in the ACT intervention. If a CAB member, they must be willing to engage in CAB interviews and meetings.\n\nThe exclusion criteria are:\n\nPrisoners or youth in detention centers Unable to understand or speak English Does not have SCD Clients who are at significant risk for suicide and self-injury will be excluded due to the intense levels of support required to support these individuals which would interfere with study procedures.\n\nAdolescents with families that require frequent intervention from the Department of Children and Family Services, are currently experiencing psychosis, or have severe health concerns that will impact study participation or attendance will be excluded.","21 Years",{"count":358,"type":23},66,[360,63],"PHASE1","The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.",[363,31,364,365],"Race-related Stress","Quality of Life","Stress Reaction",[367,368,369,370,371,372,373],"Black","African American","Adolescents","Acceptance and Commitment Therapy","race-related stress","racial trauma","coping","2026-04-30",{"date":341,"type":43},{"date":377,"type":43},"2025-04-01",{"date":379,"type":23},"2029-06-30",{"name":381,"class":50},"Children's Hospital Los Angeles",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":24,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":51},"100591264","just-in-time-adaptive-interventions-jitais-in-a-digital-mental-health-intervention-for-middle-aged-and-older-adults-with-chronic-pain-100591264","NCT06978166","Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain","Evaluating and Optimizing Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain","Inclusion Criteria:\n\n* 45 years or older\n* At least moderately severe depression and\u002For anxiety symptoms (Patient Health Questionnaire-9 (PHQ-9) and\u002For Generalized Anxiety Disorder-7 (GAD-7) score ≥ 10)\n* Chronic pain (i.e., pain on most days or every day in the past three months)\n\nExclusion Criteria:\n\n* Frequent active suicidal ideation\n* No access to a mobile device\n* Not living in the United States","45 Years",{"count":391,"type":23},1000,[26],"The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and\u002For anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio\u002Fvideo recorded call. Participating in the interview portion is optional.",[395,31],"Chronic Pain",[397,398,399,400,401,402,403,97,98,404],"JITAI","Digital mental health intervention","Older adults","Middle-aged adults","App","Smartphone","Chronic pain","Chatbot","2026-04-29",{"date":407,"type":43},"2026-05-05",{"date":409,"type":43},"2025-06-02",{"date":411,"type":23},"2026-12",{"name":413,"class":50},"Washington University School of Medicine",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":24,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":51},"100528580","pilot-effectiveness-trial-of-an-act-self-help-workbook-tailored-specifically-for-prisons-100528580","NCT06162624","Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons","Inclusion Criteria:\n\n* 18 years of age or older\n* Reading level of 6th grade or higher determined by the Wide Range Achievement Test\n* Moderate or severe anxiety and\u002For depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI)\n* No active self-harm or active suicidal intent\n* No scheduled transfer or release for at least three months\n* Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Active self-harm or suicidal intent\n* Scheduled transfer or release within three months",{"count":421,"type":23},96,[26],"The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook.\n\nParticipants can expect to be in the study for 13 weeks.",[98,97,31,425],"Anxiety Disorders",[427],"incarcerated","2026-04-28",{"date":339,"type":43},{"date":431,"type":43},"2024-12-09",{"date":433,"type":23},"2026-09-30",{"name":274,"class":50},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":24,"phases":445,"briefSummary":446,"conditions":447,"keywords":451,"overallStatus":458,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":51},"100546254","online-intervention-for-transgendernonbinary-young-adults-experiences-with-alcohol-and-romantic-relationships-100546254","NCT06392542","Online Intervention for Transgender\u002FNonbinary Young Adults' Experiences With Alcohol and Romantic Relationships","Developing an Online Intervention Addressing Transgender\u002FNonbinary Young Adults' Experiences With Alcohol and Romantic Relationships","Inclusion Criteria:\n\n* Self-identify as transgender and\u002For nonbinary\n* Between 18 and 30 years of age, inclusive\n* Able to read and write in English\n* Residency in the United States\n* Currently in a romantic relationship that began at least six weeks prior to enrollment\n\nExclusion Criteria:\n\n* Prospective participants will be excluded as potentially inauthentic (i.e., not genuinely eligible for the study) based on scoring criteria developed through the investigators' prior online survey research with similar populations.","30 Years",{"count":444,"type":23},107,[26],"The objective of this study is to learn more about Whole Selves, an interactive online resource (\"intervention\") to help transgender and\u002For nonbinary young adults reflect on their experiences and goals related to both alcohol use and romantic relationships. Existing online interventions focused on alcohol use often aren't a good fit for trans\u002Fnonbinary people, and existing relationship education programs don't account for how being trans\u002Fnonbinary might influence someone's relationships. For these reasons, the investigator is working with trans\u002Fnonbinary young adults and other community stakeholders to create a new intervention specifically for trans\u002Fnonbinary young adults. The goals of this clinical trial are to:\n\n1. Find out what transgender\u002Fnonbinary young adults think of the Whole Selves intervention in order to improve it\n2. See whether the Whole Selves intervention seems to work as expected\n3. Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention, which could tell us how well it works\n\nIn this study, participants will use the Whole Selves intervention; complete online surveys about themselves, their romantic relationship experiences, their mental health, their alcohol use; and provide feedback on the Whole Selves intervention.",[448,449,31,450],"Alcohol Use, Unspecified","Relationship, Social","Transgenderism",[452,453,454,455,456,457],"Transgender young adults","Nonbinary young adults","Interactive online alcohol education","Interactive online relationship education","Whole Selves intervention","Supportive romantic relationships","NOT_YET_RECRUITING","2026-04-27",{"date":428,"type":43},{"date":462,"type":23},"2026-07",{"date":464,"type":23},"2027-04",{"name":466,"class":50},"Boston University",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":51},"100614506","weekly-dynamics-of-psychopathological-and-symptom-networks-during-mindfulness-based-interventions-for-emotional-distress-100614506","NCT07280481","Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress","Inclusion Criteria:\n\n* experiencing emotional distress such as depression or anxiety (Kessler-10 score \\> 21)\n\nExclusion Criteria:\n\n* prior experience with mindfulness meditation\n* current self-harm or suicidal risk\n* bipolar disorder or schizophrenia\n* history of substance abuse\n* severe personal trauma history",{"count":285,"type":23},[26],"The goal of this clinical study is to learn how Mindfulness Intervention for Emotional Distress (MIED) helps people with emotional distress and how their symptoms and psychological patterns change over time.\n\nThe main questions it aims to answer are:\n\n* How do the relationships between emotions, thoughts, and behaviors change week by week during mindfulness training?\n* Which psychological skills, such as distress tolerance or cognitive flexibility, improve first and lead to later emotional relief? Two groups will be compared - one that takes part in an online mindfulness intervention and one that waits to join - to see how the intervention changes emotional and psychological networks over time.\n\nParticipants will:\n\n* Complete a 7-week online self-guided Mindfulness Intervention for Emotional Distress（iMIED） designed for people experiencing high emotional distress.\n* Fill out short weekly questionnaires about their emotions, thoughts, and behaviors before, during, and after the course (9 times in total).\n* Receive access to the mindfulness program after the study if they are in the wait-list group.\n\nThis study includes about 500 adults aged 18 and older who feel anxious, depressed, or emotionally distressed but have no major psychiatric disorders. By tracking weekly changes, the research aims to identify how mindfulness intervention leads to emotional improvement and which skills play the most important roles in that process.",[31,477],"Emotional Disorders","2026-04-24",{"date":459,"type":43},{"date":481,"type":43},"2025-11-16",{"date":483,"type":23},"2026-05-22",{"name":485,"class":50},"Peking University",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":250},"100522787","promoting-mental-health-of-teachers-and-caregiver-using-a-personalized-mhealth-toolkit-in-uganda-100522787","NCT06087159","Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda","Promoting Mental Health of Teachers and Caregivers Using a Personalized mHealth Toolkit in Uganda","Teachers Inclusion Criteria:\n\n* Teaching in recruited schools.\n* At least 18 years old.\n\nParents Inclusion Criteria:\n\n* At least 18 years old.\n* Have a child aged 6-14 years.\n\nExclusion Criteria:\n\n* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.\n* Parents\u002FTeachers\u002FCaregivers who are not in one of our recruited primary school\n* Participants under the age of 18\n* Participant who does not speak English and Luganda will not be able to participate",{"count":494,"type":23},1180,[26],"This study record describes a two-phase of clinical trial study. The first phase is a pilot study phase (to study feasibility and efficacy of the intervention), and the second phase is an effectiveness study phase (a fully powered evaluation study to test the intervention effectiveness). This proposal seeks to develop and test a new mHealth intervention, the mHealth Toolkit for Wellness \\& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-digial toolkit is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by peer-community health workers (P-CHWs).",[498,31],"Mental Health Literacy","2026-04-16",{"date":501,"type":43},"2026-04-20",{"date":503,"type":43},"2024-11-01",{"date":505,"type":23},"2028-01-31",{"name":507,"class":50},"NYU Langone Health",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":516,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":24,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":51},"100533464","adaptation-of-an-intervention-addressing-barriers-to-prep-use-among-pregnant-women-in-zimbabwe-100533464","NCT06226155","Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe","TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe","TENDAI4PrEP","Inclusion Criteria:\n\nAcross all aims participants must be\n\n1. Pregnant\n2. Presenting at the Chitungwiza Central Hospital ANC\n3. Aged 15+\n4. Willing to provide informed consent or assent\n5. Have HIV negative status\n6. At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and\u002For recent condomless sexual activity)\n7. Score \\>5 on the Shona Symptom Questionnaire\n\n   For the RCT, eligible participants must also be willing to\n8. Initiate PrEP prior to randomization\n9. Bring their pregnancy partner (if they are safe doing so).\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\u002Fassent and\u002For complete procedures in Shona or English\n2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)","15 Years","55 Years",{"count":519,"type":23},132,[26],"The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness\u002Fimplementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.",[523,524,31],"HIV Infections","Pregnancy Related","2026-03-30",{"date":527,"type":43},"2026-03-31",{"date":529,"type":43},"2024-10-21",{"date":531,"type":23},"2027-03-31",{"name":191,"class":50},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":541,"maxAge":59,"enrollmentInfo":542,"targetDuration":4,"studyType":544,"phases":4,"briefSummary":545,"conditions":546,"keywords":550,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100601942","validation-of-a-rapid-screening-tool-for-anxiety-depressive-disorders-in-children-adolescents-and-young-adults-treated-in-oncology-multicenter-study-100601942","NCT07117058","Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.","Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool","HARMONY-Tool","Inclusion Criteria\n\n* Patients diagnosed with pediatric cancer before the age of 18,\n* Patient whose intensive treatment had ended at least 3 months prior to inclusion,\n* Patients considered to be in complete remission by the doctor responsible for their treatment,\n* Patient affiliated to or entitled under a social security scheme,\n* Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.\n\nExclusion Criteria\n\n* Refusal to participate expressed by the patient or minor,\n* Patients whose cancer has relapsed or progressed,\n* Pregnant women, women in labor, breast-feeding mothers,\n* Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,\n* Adults under legal protection (guardianship) or unable to express their consent.","7 Years",{"count":543,"type":23},545,"OBSERVATIONAL","In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.",[547,548,31,549],"Generalized Anxiety","Introspective & Anxiety-Prone Patient","Survivors of Childhood Cancer",[551,552,553,554],"anxiety symptoms","childhood cancer","screening","psychological complication","2026-03-25",{"date":525,"type":43},{"date":558,"type":43},"2025-03-18",{"date":560,"type":23},"2027-09",{"name":562,"class":50},"Centre Hospitalier Universitaire de Saint Etienne",7,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":572,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":250},"100546486","internet-based-interventions-for-cardiac-arrest-survivors-100546486","NCT06395558","intErnet-based iNterventions FOR Cardiac arrEst suRvivors","Internet-Based Interventions for Cardiac Arrest Survivors","ENFORCER","Inclusion Criteria:\n\n* Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2\n* Informed consent for participation in the study\n* Native Italian speaker or adequate understanding of the Italian language\n* Adequate ability to use the web to guarantee access to the contents\n\nExclusion Criteria:\n\n* Previous cognitive dysfunction\n* Previous psychiatric disease\n* Previous episode of out-of-hospital cardiac arrest","80 Years",{"count":574,"type":23},106,[26],"This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms",[578,31,579,364,580,581],"Cognitive Impairment","Cardiac Arrest","Social Functioning","Sexual Dysfunction",{"date":525,"type":43},{"date":584,"type":43},"2024-08-05",{"date":586,"type":23},"2027-10-01",{"name":588,"class":589},"Azienda Usl di Bologna","OTHER_GOV",{"id":591,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":592,"targetDuration":4,"studyType":24,"phases":593,"briefSummary":27,"conditions":594,"keywords":595,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":602,"locationsCount":51},"100566159",{"count":22,"type":23},[26],[29,30,31,32],[34,35,36,37,38],"2026-03-19",{"date":598,"type":43},"2026-03-23",{"date":45,"type":43},{"date":601,"type":23},"2028-05-31",{"name":49,"class":50},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":24,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":458,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":622,"locationsCount":4},"100614388","act-based-parenting-program-for-caregivers-of-children-with-hearing-loss-post-cochlear-a-pilot-randomised-controlled-trial-100614388","NCT07278947","ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial","Effects of an Online Psychoeducational and Psychotherapeutic Programme for Caregivers of Children With Hearing Loss Post-Cochlear Implantation: A Pilot Randomised Controlled Trial","Inclusion Criteria:\n\n1. Mandarin-speaking Chinese residents aged ≥18 years.\n2. Their child is scheduled to undergo cochlear implant surgery within the next month or has undergone cochlear implant surgery within the past month.\n3. Living with their child with hearing loss who uses (or will use) a cochlear implant.\n4. Primary caregiver responsible for the child's daily care.\n5. Has reliable internet access via a computer and\u002For smartphone for video-conferencing (e.g., TenCent Meeting, Zoom) and is willing to maintain access for the duration of the intervention.\n\nExclusion Criteria:\n\n1. Parents with cognitive deficiency, severe mental illness and\u002For disability conditions that interfere with their ability to comprehend the programme's content.\n2. Current substance or alcohol dependence.\n3. Pregnancy or postpartum period (\\\u003C6 months).\n4. Participation in any ACT-based intervention within the past six months.",{"count":611,"type":23},64,[26],"The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.",[615,92,31],"Hearing Loss","2026-03-16",{"date":618,"type":43},"2026-03-17",{"date":620,"type":23},"2026-03-28",{"date":74,"type":23},{"name":623,"class":50},"Second Xiangya Hospital of Central South University",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":228,"enrollmentInfo":632,"targetDuration":4,"studyType":24,"phases":634,"briefSummary":635,"conditions":636,"keywords":644,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":250},"100545041","phase-2-search-for-novel-transcranial-magnetic-stimulation-tms-targets-for-mental-illness-100545041","NCT06376734","Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness","Transdiagnostic Circuit Mapping of Prefrontal Targets in Accelerated Transcranial Magnetic Stimulation","Expedition","Inclusion Criteria:\n\n* Age 18-65\n* English proficiency sufficient for informed consent, questionnaires\u002Ftasks, and treatment\n* Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured Clinical Interview for DSM-5)\n\n  * ≥20 on the Beck Depression Inventory for patients with MDD\n  * ≥16 on the Beck Anxiety Inventory for patients with GAD\n  * ≥16 on the Yale-Brown Obsessive-Compulsive Scale for patients with OCD\n  * ≥58 on the Positive and Negative Symptom Scale for patients with schizophrenia\n* Stable psychotropic medication regimen, or remain medication free, for 4 weeks prior to treatment (Medication changes during study enrollment period will be tracked for post hoc analysis).\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n\nExclusion Criteria:\n\n* Active pregnancy as determined by a urine pregnancy test\n* Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic personality disorder)\n* PTSD with active, clinically significant symptoms, as determined by clinician\n* Diagnosis of Schizoaffective Disorder, Bipolar Type\n* Recent (within 4 weeks) or concurrent use of rapid-acting antidepressant agent (ketamine\u002Fesketamine\u002FECT)\n* Ferromagnetic metallic implant that would contraindicate receiving TMS or obtaining MRI\n* Any other TMS or MRI safety concerns identified by the clinician\n* Receiving or planning to receive other TMS treatments during course of participation\n* History of:\n\n  * Neurosurgical intervention for mental illness\n  * Moderate to severe autism spectrum disorder\n  * Intellectual disability\n  * Severe cognitive impairment\n  * Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis)\n  * Untreated or insufficiently treated endocrine disorder\n  * Eating disorders\n  * Treatment with investigational drug or intervention during the study period\n* Current evidence of:\n\n  * Mania or hypomania\n  * Active suicidal ideation or a suicide attempt within the past year\n  * Contraindications to either TMS or MRI (e.g., metallic implants, etc.).\n  * Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal\n  * Significantly increased seizure risk as determined by a clinician\n* For participants with schizophrenia:\n\n  * Evidence of impaired capacity to consent, e.g. impaired insight into illness, as deemed by a licensed psychiatrist or psychologist on the study team\n  * Hospitalization with psychosis in the past 6 months\n* Positive urine drug screen for illicit substances\n* Existing tinnitus (ringing in the ears)\n* Any other condition deemed by the PI to interfere with the study or increase risk to the participant",{"count":633,"type":23},180,[63],"Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.",[637,638,639,640,641,642,643,31],"Major Depressive Disorder","Obsessive-Compulsive Disorder","Schizophrenia","Generalized Anxiety Disorder","Mood Disorders","Psychiatric Disorder","Mental Disorder",[645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660],"depression","anxiety","schizophrenia","OCD","obsessive-compulsive disorder","transcranial magnetic stimulation","TMS","accelerated TMS","accelerated intermittent theta burst stimulation","brain stimulation","neuromodulation","transdiagnostic","neuronavigation","functional connectivity","neuroimaging","theta burst stimulation","2026-02-13",{"date":663,"type":43},"2026-02-17",{"date":665,"type":43},"2025-01-30",{"date":667,"type":23},"2030-06-01",{"name":669,"class":50},"Brigham and Women's Hospital",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":17,"sex":18,"minAge":329,"maxAge":389,"enrollmentInfo":677,"targetDuration":4,"studyType":24,"phases":679,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":458,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":4},"100576525","phase-4-managing-hepatitis-b-hep-b-and-human-papilloma-virus-hpv-related-cancers-and-mental-health-100576525","NCT06786429","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.","Inclusion Criteria:\n\n* For the High school students' group:\n\nAll students aged 13 years and older, enrolled at the selected Mtshabezi and Matopo High Schools in the Gwanda and Matobo Rural Districts during the five-year period of the project are eligible to participate in the study.\n\nAbility to understand and respond to questions on the Youth Risk Behavior Scree questionnaire and PHQ-9 scale.\n\nRelevant history of HPV vaccine administration. Ability to obtain parental\u002Fguardian consent for participation.\n\n\\- For the women group: All women and young female adults thirteen to forty-five years old and requesting health services for prenatal, post-partum, family planning and other care during the five-year project period are eligible to participate.\n\nMust not have received Hep B and HPV vaccine in the past and have no known contraindications to either of these two vaccines.\n\nAre able to understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales.\n\nMust have a valid consent for participation in the study.\n\nExclusion Criteria:\n\n* males who are not enrolled in these participating High Schools.\n* children below the age of thirteen who are not enrolled in high schools and are not seeking prenatal, post-partum and family planning services at these selected health facilities during the project period.\n* Any eligible potential participant without a valid consent.\n* Any potential participant who is excluded by a doctor or midwife for a known contraindicating medical condition that can lead to potential harm to the participant or staff.\n\nAny potential participant who is unable to understand and respond to the questions being asked.\n\nParticipants with proof of prior vaccination will be excluded from this part of the study.",{"count":678,"type":23},1800,[680],"PHASE4","Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver.\n\nQuestion: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.",[683,684,685,686,687,688,31],"Hepatitis B","Human Papilloma Virus","Gall Stones (& [Calculus - Gall Bladder])","Mental Health Issue","Cancer Liver","Cancer of Cervix","2026-01-17",{"date":691,"type":43},"2026-01-21",{"date":693,"type":23},"2026-08-30",{"date":695,"type":23},"2031-12-30",{"name":697,"class":50},"Eunice Dube"]