Feasibility and Preliminary Effectiveness of Video Conference-Based Brief Cognitive Behavioral Therapy (V-BCBT) for Outpatients With Mood Disorders at High Risk for Suicide: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Suicide Attempts from Baseline to 3 Months After Treatment Completion
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of videoconference-based brief cognitive behavioral therapy (V-BCBT) for adult outpatients with mood disorders who are at high risk for suicide. Eligible participants will be randomized (1:1) to either V-BCBT + treatment as usual (TAU) or TAU alone. V-BCBT consists of eight structured videoconference sessions (approximately 50-60 minutes each, twice weekly for 4 weeks) focusing on crisis management (for example, understanding the "suicide mode," developing a crisis response plan, strengthening reasons for living), cognitive and behavioral coping skills (for example, relaxation, behavioral activation, cognitive restructuring, mindfulness), and relapse prevention (for example, coping rehearsal and a relapse prevention plan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High suicide risk, defined as either (a) a suicide attempt within the past 1 month or (b) Beck Scale for Suicide Ideation (SSI) ≥
- •Aged 18 years or older.
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of a depressive disorder or bipolar and related disorder, confirmed at screening using the Mini International Neuropsychiatric Interview (M.I.N.I.).
- •Able to read and write Korean without difficulty.
- •Has access to a device (e.g., computer, tablet, or smartphone) and internet connectivity to participate in remote intervention.
- •Able to understand the study, voluntarily provide written informed consent, and agree to comply with study procedures/precautions.
排除标准
- •Currently in an activated manic state with psychotic symptoms, or has a severe psychiatric disorder (e.g., schizophrenia spectrum disorder), or a clinically significant neurological disorder, brain injury, intellectual disability, or any other medical condition that would prevent study participation.
- •Has received psychotherapy within 3 months prior to screening (e.g., CBT, interpersonal psychotherapy, psychodynamic psychotherapy, or psychoanalysis).
- •Is in an acute suicidal crisis requiring immediate inpatient hospitalization.
研究组 & 干预措施
Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU)
Participants in this arm will receive Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) in addition to Treatment as Usual (TAU) provided in the outpatient setting. After randomization, they will complete 8 individual videoconference sessions of V-BCBT (approximately 50 minutes per session, twice weekly for 4 weeks), while continuing to receive routine outpatient care. TAU may include pharmacotherapy and supportive psychotherapy as typically provided in outpatient psychiatric services.
干预措施: Treatment as Usual (TAU) (Other)
Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU)
Participants in this arm will receive Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) in addition to Treatment as Usual (TAU) provided in the outpatient setting. After randomization, they will complete 8 individual videoconference sessions of V-BCBT (approximately 50 minutes per session, twice weekly for 4 weeks), while continuing to receive routine outpatient care. TAU may include pharmacotherapy and supportive psychotherapy as typically provided in outpatient psychiatric services.
干预措施: Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) (Behavioral)
Treatment as Usual (TAU) only
Participants in this arm will receive Treatment as Usual (TAU) only through outpatient psychiatric services. TAU is delivered according to clinical need and may include pharmacotherapy and supportive psychotherapy as routinely provided.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Number of Suicide Attempts from Baseline to 3 Months After Treatment Completion
时间窗: Baseline: within 7 days before treatment start; Post-treatment: within 7 days after treatment completion; Follow-up assessments: at 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
The number of suicide attempts will be assessed at five time points (baseline, post-treatment, and monthly during the 3-month follow-up) using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered via in-person or telephone interview. Data will be cross-checked against available medical records as applicable.
Time to First Suicide Attempt After Treatment Completion
时间窗: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
The number of days from treatment completion (end of Videoconference-Based Brief Cognitive Behavioral Therapy) to the first reported suicide attempt, assessed through monthly follow-up period (for example, using the Columbia-Suicide Severity Rating Scale, administered in person or by telephone).
次要结局
- Intensity of suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.)
- Severity of suicidal ideation measured by Beck Scale for Suicide Ideation (SSI)(Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.)
- Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D-17)(Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.)
- Change in depressive symptoms measured by Beck Depression Inventory-II (BDI-II)(Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.)
- Change in hopelessness measured by the Beck Hopelessness Scale (BHS)(Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.)
研究者
Hyung Keun Park
Clinical Assistant Professor, Department of Psychiatry
Asan Medical Center