[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658835":3},{"organization":4,"outcomesModule":7,"designInfo":127,"detailedDescription":132,"studyPopulation":132,"armGroups":137,"interventions":157,"overallOfficials":132,"centralContacts":171,"locations":177,"responsibleParty":187,"collaborators":132,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":199,"sex":200,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":132,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":216,"whyStopped":132,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Asan Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":43},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Number of Suicide Attempts Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)","The occurrence of suicide attempts will be assessed at baseline, post-treatment, and follow-up using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered through in-person or telephone interviews. When available, reported suicide attempts will be cross-checked with relevant medical records.","Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).",{"measure":14,"description":15,"timeFrame":16},"Time to First Suicide Attempt Following Treatment Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)","Time to first suicide attempt will be defined as the number of days from treatment completion to the first subsequently reported suicide attempt. Suicide attempts will be assessed at the post-treatment and follow-up assessments using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered in person or by telephone.","From treatment completion through the 2-month follow-up period, assessed at the post-treatment and follow-up assessments (±10 days).",{"measure":18,"description":19,"timeFrame":20},"Baseline Differences in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)","Serum concentrations of IL-1β, IL-6, IL-8, IL-10, TNF-α, sTNF-αR1, CRP, CCL-2, CXCL-1, and IFN-γ will be measured using enzyme-linked immunosorbent assays (ELISA). Baseline inflammatory biomarker levels will be compared among patients with mood disorders at high risk for suicide, patients with mood disorders at low risk for suicide, and healthy controls.","Baseline.",{"measure":22,"description":23,"timeFrame":12},"Change in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)","Changes in serum concentrations of IL-1β, IL-6, IL-8, IL-10, TNF-α, sTNF-αR1, CRP, CCL-2, CXCL-1, and IFN-γ will be assessed among participants with mood disorders at high risk for suicide who are randomized to V-BCBT plus TAU or TAU alone. Biomarker changes will also be examined in relation to treatment effects on suicide-related outcomes. Participants in the low-suicide-risk and healthy control groups will undergo biomarker assessment at baseline only.",[25,28,31,34,37,40],{"measure":26,"description":27,"timeFrame":12},"Severity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)","Suicidal ideation severity will be assessed using the C-SSRS severity scale, which ranges from 1 (wish to be dead) to 5 (active suicidal ideation with a specific plan and intent). Higher scores indicate greater severity of suicidal ideation.",{"measure":29,"description":30,"timeFrame":12},"Intensity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)","The intensity of suicidal ideation will be assessed using the C-SSRS Intensity of Ideation items, which evaluate frequency, duration, controllability, deterrents, and reasons for suicidal thoughts. The five item scores are summed to yield a total score ranging from 0 to 25, with higher scores indicating greater suicidal ideation intensity. The measure will be administered at baseline to all participants and longitudinally only to randomized high-suicide-risk participants.",{"measure":32,"description":33,"timeFrame":12},"Severity of Suicidal Ideation Assessed With the Beck Scale for Suicide Ideation (SSI)","Suicidal ideation will be assessed using the self-report Beck Scale for Suicide Ideation (SSI). Items assess the presence and severity of suicidal thoughts and related characteristics. The total score ranges from 0 to 38, with higher scores indicating greater suicidal ideation severity. The SSI will be administered at baseline to all participants and longitudinally only to randomized high-suicide-risk participants.",{"measure":35,"description":36,"timeFrame":12},"Depressive Symptoms Assessed With the Hamilton Depression Rating Scale (HAM-D)","Depressive symptom severity will be assessed using the clinician-rated Hamilton Depression Rating Scale (HAM-D). For the 17-item HAM-D, total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.",{"measure":38,"description":39,"timeFrame":12},"Depressive Symptoms Assessed With the Beck Depression Inventory-II (BDI-II)","Depressive symptoms will be assessed using the 21-item self-report Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.",{"measure":41,"description":42,"timeFrame":12},"Hopelessness Assessed With the Beck Hopelessness Scale (BHS)","Hopelessness will be assessed using the 20-item Beck Hopelessness Scale (BHS). Total scores range from 0 to 20, with higher scores indicating greater hopelessness and more negative expectations regarding the future.",[44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,104,107,111,115,119,123],{"measure":45,"description":46,"timeFrame":12},"Death-Self Implicit Association Assessed With the Death Implicit Association Test (D-IAT)","Implicit associations between death and the self will be assessed using the computer-based Death Implicit Association Test (D-IAT). A D-score will be calculated from reaction times during death-self and life-self classification conditions. Positive values indicate a relatively stronger death-self association, whereas negative values indicate a relatively stronger life-self association.",{"measure":48,"description":49,"timeFrame":12},"Fearlessness About Death Assessed With the Acquired Capability for Suicide Scale-Fearlessness About Death (ACSS-FAD)","Fearlessness about death will be assessed using the 7-item Acquired Capability for Suicide Scale-Fearlessness About Death (ACSS-FAD). Items are rated from 0 to 4. Total scores range from 0 to 28, with higher scores reflecting greater fearlessness about death.",{"measure":51,"description":52,"timeFrame":12},"Interpersonal Needs Assessed With the Interpersonal Needs Questionnaire (INQ)","Perceived burdensomeness and thwarted belongingness will be assessed using the 15-item Interpersonal Needs Questionnaire (INQ). The INQ consists of 9 items assessing thwarted belongingness and 6 items assessing perceived burdensomeness. Each item is rated on a 7-point scale from 1 (not at all true for me) to 7 (very true for me). After reverse-scoring the appropriate items, items are summed to calculate the respective subscale scores, which range from 9 to 63 for thwarted belongingness and from 6 to 42 for perceived burdensomeness. Higher scores indicate greater thwarted belongingness and perceived burdensomeness.",{"measure":54,"description":55,"timeFrame":12},"Manic Symptoms Assessed With the Young Mania Rating Scale (YMRS)","Manic symptom severity will be assessed using the 11-item clinician-rated Young Mania Rating Scale (YMRS). Total scores range from 0 to 60, with higher scores indicating greater severity of manic symptoms.",{"measure":57,"description":58,"timeFrame":12},"Manic Symptoms Assessed With the Altman Self-Rating Mania Scale (ASRM)","Manic symptoms will be assessed using the 5-item Altman Self-Rating Mania Scale (ASRM). Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating greater severity of manic symptoms.",{"measure":60,"description":61,"timeFrame":12},"Anxiety Symptoms Assessed With the Beck Anxiety Inventory (BAI)","Anxiety symptoms will be assessed using the 21-item Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale from 0 to 3. Total scores range from 0 to 63, with higher scores indicating greater anxiety symptom severity.",{"measure":63,"description":64,"timeFrame":12},"Anxiety Symptoms Assessed With the Hamilton Anxiety Rating Scale (HAM-A)","Anxiety symptom severity will be assessed using the 14-item clinician-rated Hamilton Anxiety Rating Scale (HAM-A), which evaluates both psychic and somatic anxiety symptoms. Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating greater anxiety symptom severity.",{"measure":66,"description":67,"timeFrame":12},"Positive and Negative Automatic Thoughts Assessed With the Automatic Thoughts Questionnaire-Negative (ATQ-N) and Automatic Thoughts Questionnaire-Positive (ATQ-P)","Positive and negative automatic thoughts will be assessed using the 30-item Automatic Thoughts Questionnaire-Negative (ATQ-N) and the 30-item Automatic Thoughts Questionnaire-Positive (ATQ-P). Each item is rated on a 5-point scale from 1 to 5. Total scores for each questionnaire range from 30 to 150, with higher scores indicating a greater frequency of negative or positive automatic thoughts, respectively.",{"measure":69,"description":70,"timeFrame":12},"Reasons for Living Assessed With the Reasons for Living Inventory (RFL)","Reasons for living will be assessed using the 48-item Reasons for Living Inventory (RFL). Each item is rated on a 6-point scale from 1 (not at all important) to 6 (extremely important). Total scores range from 48 to 288, with higher scores indicating stronger endorsement of reasons for living.",{"measure":72,"description":73,"timeFrame":12},"Emotion Regulation Difficulties Assessed With the Difficulties in Emotion Regulation Scale (DERS)","Difficulties in emotion regulation will be assessed using the 35-item Korean version of the Difficulties in Emotion Regulation Scale (K-DERS). Each item is rated on a 5-point scale from 1 to 5. After reverse-scoring the appropriate items, total scores range from 35 to 175, with higher scores indicating greater difficulties in emotion regulation.",{"measure":75,"description":76,"timeFrame":12},"Distress Intolerance Assessed With the Distress Intolerance Index (DII)","Distress intolerance will be assessed using the 10-item Distress Intolerance Index (DII). Each item is rated on a 5-point scale from 0 (very little) to 4 (very much). Item scores are summed to yield a total score ranging from 0 to 40, with higher scores indicating greater difficulty tolerating psychological distress and negative emotional states.",{"measure":78,"description":79,"timeFrame":12},"Childhood Trauma Assessed With the Childhood Trauma Questionnaire-Short Form (CTQ-SF)","Childhood maltreatment will be assessed using the 28-item Childhood Trauma Questionnaire-Short Form (CTQ-SF). Items are rated on a 5-point scale from 1 to 5. The total maltreatment score ranges from 25 to 125, with higher scores indicating greater exposure to childhood maltreatment. Three additional minimization\u002Fdenial items serve as a validity scale and are not included in the total maltreatment score.",{"measure":81,"description":82,"timeFrame":12},"Life Events Assessed With the Life Experiences Survey (LES)","Life event experiences will be assessed using the Life Experiences Survey (LES), which evaluates the occurrence of major life events and participants' perceived impact of these events. For each experienced event, perceived impact is rated on a 7-point scale ranging from -3 (extremely negative) to +3 (extremely positive), with 0 indicating no impact. Positive and negative life-event impact scores can be derived separately based on participants' ratings.",{"measure":84,"description":85,"timeFrame":12},"Borderline Personality Features Assessed With the Personality Assessment Inventory-Borderline Features Scale (PAI-BOR)","Borderline personality features will be assessed using the 24-item Personality Assessment Inventory-Borderline Features Scale (PAI-BOR), which evaluates affective instability, identity problems, negative relationships, and self-harming behavior. Each item is rated on a 4-point scale from 0 to 3. Total scores range from 0 to 72, with higher scores indicating greater borderline personality features.",{"measure":87,"description":88,"timeFrame":12},"Impulsivity Assessed With the Barratt Impulsiveness Scale-11-Revised (BIS-11-R)","Impulsivity will be assessed using the 30-item Barratt Impulsiveness Scale-11-Revised (BIS-11-R), which evaluates attentional, motor, and non-planning impulsivity. Each item is rated on a 4-point scale from 1 to 4. After reverse-scoring the appropriate items, total scores range from 30 to 120, with higher scores indicating greater impulsivity.",{"measure":90,"description":91,"timeFrame":12},"Alcohol-Related Problems Assessed With the Alcohol Use Disorders Identification Test (AUDIT)","Alcohol use and alcohol-related problems will be assessed using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Total scores range from 0 to 40, with higher scores indicating greater severity of problematic alcohol use.",{"measure":93,"description":94,"timeFrame":12},"Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)","Sleep quality and sleep-related difficulties during the previous month will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.",{"measure":96,"description":97,"timeFrame":12},"Insomnia Severity Assessed With the Insomnia Severity Index (ISI)","Insomnia symptoms and associated functional difficulties will be assessed using the 7-item Insomnia Severity Index (ISI). Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.",{"measure":99,"description":100,"timeFrame":12},"Cigarette Dependence Assessed With the Cigarette Dependence Scale (CDS-12)","Cigarette dependence will be assessed using the 12-item Cigarette Dependence Scale (CDS-12), which evaluates multiple aspects of dependence, including compulsive smoking, withdrawal symptoms, and loss of control. Responses to each item are coded on a 5-point scale from 1 to 5 and summed to yield a total score ranging from 12 to 60, with higher scores indicating greater cigarette dependence.",{"measure":102,"description":103,"timeFrame":12},"Physical Health Behaviors Assessed With the Physical Health Behavior Scale","Physical health behaviors will be assessed using the 40-item Physical Health Behavior Scale. Each item is rated on a 5-point scale from 1 to 5. Health-risk behavior items are reverse-scored, and item scores are summed to yield a total score ranging from 40 to 200, with higher scores indicating healthier physical health behaviors.",{"measure":105,"description":106,"timeFrame":12},"Dietary Intake Assessed With a 24-Hour Dietary Recall","Dietary intake will be assessed using a 24-hour dietary recall in which participants report foods and beverages consumed during the previous day, including the amount, timing, and location of intake. The collected data will be used to estimate total energy intake and major nutrient intake.",{"measure":108,"description":109,"timeFrame":110},"Treatment Satisfaction Assessed With the Client Satisfaction Questionnaire (CSQ-8)","Participants assigned to V-BCBT plus TAU will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to assess perceived treatment quality, effectiveness, overall satisfaction, willingness to receive similar treatment again, and willingness to recommend the treatment to others. Higher scores indicate greater treatment satisfaction.","For participants randomized to V-BCBT plus TAU, post-treatment at baseline +2 months (±7 days).",{"measure":112,"description":113,"timeFrame":114},"Use and perceived helpfulness of intervention techniques measured by the Utility of Techniques (UT) questionnaire","The Utility of Techniques (UT) questionnaire will be used to assess participants' frequency of use and perceived helpfulness of specific intervention components. For each technique the participant reports having learned during the V-BCBT treatment period, they will rate frequency of use (from \"not at all\" to \"more than 10 times per week\") and helpfulness (if used, from \"not at all\" to \"extremely\"). Techniques include, for example, personalized safety planning tools and coping strategies taught during the intervention.","For participants randomized to V-BCBT plus TAU, at follow-up at post-treatment +2 months (±10 days).",{"measure":116,"description":117,"timeFrame":118},"Treatment Acceptability Assessed by Refusal and Discontinuation Rates","Treatment acceptability will be evaluated based on rates of study participation refusal and premature treatment discontinuation. Reasons for refusal or discontinuation and suggestions for improving the acceptability of V-BCBT will also be collected when available.","For participants randomized to V-BCBT plus TAU, at the post-treatment assessment at baseline +2 months (±7 days).",{"measure":120,"description":121,"timeFrame":122},"Consent Rate (as an Indicator of Feasibility)","Consent rate will be used as a key feasibility indicator. It is defined as the percentage of eligible high-suicide-risk participants who provided informed consent and were randomized. The rate will be calculated by dividing the number of participants who consented and were randomized by the total number of eligible high-suicide-risk participants screened during the recruitment period.","At enrollment and randomization for each eligible participant; consent rate will be assessed throughout the active recruitment period (approximately 5 years).",{"measure":124,"description":125,"timeFrame":126},"Retention rate (as an indicator of feasibility)","Retention rate will be used as a key feasibility indicator. It is defined as the percentage of randomized participants who remained in the study and provided valid primary outcome data at each designated follow-up time point. The rate will be calculated by dividing the number of participants who completed the primary outcome assessment at each time point by the total number of participants randomized.","Post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).",{"allocation":128,"interventionModel":129,"interventionModelDescription":130,"primaryPurpose":131,"observationalModel":132,"timePerspective":132,"maskingInfo":133},"RANDOMIZED","PARALLEL","Participants with mood disorders at high risk for suicide will be randomized in a 1:1 ratio to V-BCBT plus treatment as usual (TAU) or TAU alone. Participants with mood disorders at low risk for suicide and healthy controls will not undergo randomization or receive the study intervention and will participate only in baseline assessments for clinical and inflammatory biomarker comparisons.","TREATMENT",null,{"masking":134,"maskingDescription":132,"whoMasked":135},"SINGLE",[136],"OUTCOMES_ASSESSOR",[138,144,150,154],{"label":139,"type":140,"description":141,"interventionNames":142},"V-BCBT Plus Treatment as Usual","EXPERIMENTAL","Participants with mood disorders at high risk for suicide who are randomized to this arm will receive videoconference-based brief cognitive-behavioral therapy (V-BCBT) in addition to treatment as usual (TAU). V-BCBT consists of eight 50-60-minute sessions delivered once weekly via secure videoconferencing. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.",[143],"Behavioral: Videoconference-Based Brief Cognitive Behavioral Therapy",{"label":145,"type":146,"description":147,"interventionNames":148},"Treatment as Usual","ACTIVE_COMPARATOR","Participants with mood disorders at high risk for suicide who are randomized to this arm will receive treatment as usual (TAU) without V-BCBT. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.",[149],"Other: Treatment as Usual (TAU)",{"label":151,"type":152,"description":153,"interventionNames":132},"Low-Suicide-Risk Mood Disorder Group","NO_INTERVENTION","Participants with depressive disorders or bipolar and related disorders who are classified as being at low risk for suicide will serve as a baseline comparison group. They will not undergo randomization or receive V-BCBT. Participants will complete baseline clinical interviews, self-report questionnaires, the death implicit association test (D-IAT), and blood sampling for comparison of clinical characteristics and inflammatory biomarkers.",{"label":155,"type":152,"description":156,"interventionNames":132},"Healthy Control Group","Healthy participants with no lifetime history of DSM-5 psychiatric disorders will serve as a baseline comparison group. They will not undergo randomization or receive V-BCBT. Participants will complete baseline clinical interviews, self-report questionnaires, the death implicit association test (D-IAT), and blood sampling for comparison of clinical characteristics and inflammatory biomarkers.",[158,165],{"type":159,"name":160,"description":161,"armGroupLabels":162,"otherNames":163},"BEHAVIORAL","Videoconference-Based Brief Cognitive Behavioral Therapy","V-BCBT is a structured, brief cognitive behavioral intervention delivered via secure videoconferencing to outpatients with mood disorders who are at high risk for suicide. It comprises eight individual sessions of approximately 50 minutes, delivered once weekly. Treatment focuses on crisis management, development of an individualized crisis response plan, reasons for living, relaxation, sleep management, behavioral activation, cognitive restructuring, mindfulness, coping with high-risk situations, and relapse prevention. V-BCBT is provided in addition to treatment as usual (TAU), which consists of routine outpatient psychiatric care such as pharmacotherapy and supportive psychotherapy according to clinical need.",[139],[164],"V-BCBT",{"type":6,"name":166,"description":167,"armGroupLabels":168,"otherNames":169},"Treatment as Usual (TAU)","Treatment as usual (TAU) refers to routine outpatient psychiatric care provided according to each participant's clinical needs and the treating clinician's judgment. It may include pharmacotherapy, supportive psychotherapy, clinical monitoring, and other standard psychiatric services ordinarily available in outpatient practice. The specific components and intensity of TAU are not standardized by the study protocol and may vary across participants based on usual clinical care.",[145],[170],"TAU",[172],{"name":173,"role":174,"phone":175,"phoneExt":132,"email":176},"Christopher Hyung Keun Park, M.D., Ph.D.","CONTACT","+82-2-3010-1657","hkpark@gmail.com",[178],{"facility":5,"status":132,"city":179,"state":132,"zip":132,"country":180,"countryCode":132,"cosmosGeoPoint":181,"geoPoint":186,"contacts":132},"Seoul","South Korea",{"type":182,"coordinates":183},"Point",[184,185],126.9784,37.566,{"lat":185,"lon":184},{"type":188,"investigatorFullName":189,"investigatorTitle":190,"investigatorAffiliation":5,"oldNameTitle":132,"oldOrganization":132},"SPONSOR_INVESTIGATOR","Hyung Keun Park","Clinical Assistant Professor, Department of Psychiatry","100658835","videoconference-based-brief-cognitive-behavioral-therapy-for-patients-with-mood-disorders-at-high-risk-for-suicide-100658835",false,"NCT07857291","Videoconference-Based Brief Cognitive Behavioral Therapy for Patients With Mood Disorders at High Risk for Suicide","Efficacy of Videoconference-Based Brief Cognitive-Behavioral Therapy (V-BCBT) for Patients With Mood Disorders at High Risk for Suicide: Identifying Inflammatory Biomarkers of Suicide Risk and Examining Their Mediating Role in Treatment Effects","V-BCBT-BIO","Inclusion Criteria:\n\n* Adults aged 18 to 64 years.\n* For patient groups: diagnosis of a depressive disorder or bipolar and related disorder with a current major depressive episode according to DSM-5 criteria, as assessed using the Mini International Neuropsychiatric Interview (MINI).\n* For the high-suicide-risk group: either a suicide attempt within the past month or a Beck Scale for Suicide Ideation (SSI) score of ≥15.\n* For healthy controls: no lifetime history of any DSM-5 psychiatric disorder, as assessed using the MINI.\n\nExclusion Criteria:\n\n* Presence of psychotic symptoms or a current substance use disorder.\n* Diagnosis of an inflammatory or autoimmune disease.\n* Current use of corticosteroids or immunosuppressive medications.\n* Current pregnancy or breastfeeding.\n* Diagnosis of cancer within the past 5 years.\n* Physical injury or infectious illness within the past month.\n* Night-shift work within the past 2 months.\n* Receipt of psychotherapy or psychological treatment within the past 3 months.",true,"ALL","18 Years","64 Years",{"count":204,"type":205},320,"ESTIMATED","INTERVENTIONAL",[208],"NA","This study aims to investigate inflammatory biomarkers associated with suicide risk and to evaluate the efficacy of videoconference-based brief cognitive-behavioral therapy (V-BCBT) in patients with mood disorders at high risk for suicide. The study consists of a cross-sectional baseline comparison followed by a randomized controlled trial.\n\nParticipants will include patients with depressive disorders or bipolar and related disorders who are experiencing a major depressive episode, as well as healthy controls with no lifetime history of DSM-5 psychiatric disorders. Patients with mood disorders will be classified as being at high or low risk for suicide. At baseline, all participants, including those in the high-suicide-risk, low-suicide-risk, and healthy control groups, will undergo clinical interviews, self-report questionnaires, a computer-based Death Implicit Association Test (D-IAT), and blood sampling. Clinical characteristics and inflammatory biomarker profiles will be compared across the three groups to examine the potential utility of inflammatory biomarkers for identifying individuals at high risk for suicide.\n\nParticipants in the high-suicide-risk group who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to V-BCBT plus treatment as usual (TAU) or TAU alone. For participants in the high-suicide-risk group, the baseline assessment will also serve as the pre-treatment assessment and will be conducted within 7 days before the start of treatment. V-BCBT consists of eight individual sessions of approximately 50-60 minutes, delivered once weekly via secure videoconferencing by trained therapists. The intervention includes crisis management, development of a suicide-focused coping plan, exploration of reasons for living, relaxation training, behavioral activation, cognitive restructuring, mindfulness, coping strategies for high-risk situations, and relapse prevention. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.\n\nParticipants in the high-suicide-risk group will subsequently undergo a post-treatment assessment at 2 months after the baseline assessment (±7 days) and a follow-up assessment at 2 months after the post-treatment assessment (±10 days). The post-treatment and follow-up assessments will include clinical interviews, self-report questionnaires, the D-IAT, and blood sampling. Participants in the low-suicide-risk and healthy control groups will complete the baseline assessment only and will not undergo post-treatment or follow-up assessments. Post-treatment and follow-up clinical assessments of randomized participants will be conducted by evaluators blinded to treatment allocation.",[211,212,213,214],"Suicidal Ideation and Behavior","Mood Disorders","Suicide Attempt","Cognitive Behavior Therapy",[212,213,214,211],"NOT_YET_RECRUITING","2026-10-01",{"date":219,"type":220},"2026-10-05","ACTUAL",{"date":222,"type":205},"2026-10",{"date":224,"type":205},"2031-08",{"name":189,"class":6},1]