Video Conference-Based Brief Cognitive Behavioral Therapy for Suicidal High-Risk Outpatients With Mood Disorders

N/ANot Yet RecruitingNCT07395817

Hyung Keun Park40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Suicidal Ideation and Behaviors Suicide Attempt Cognitive Behavioral Therapy

Interventions

Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT)BEHAVIORAL

Behavioral: V-BCBT is a brief, structured cognitive behavioral therapy (CBT) program delivered via videoconference for suicidal high-risk outpatients with mood disorders. It aims to reduce post-treatment and follow-up suicide risk by improving crisis coping/self-regulation, strengthening reasons for living, and shifting maladaptive "suicide mode" responses to adaptive alternatives. It includes 8 individual sessions (approximately 50 minutes) in three phases: (1) Crisis management (1-2): alliance, psychoeducation, crisis response plan (warning signs, coping, supports/resources), hope kit, and means safety; (2) Skills (3-6): relaxation, sleep regulation, behavioral activation/values goals, cognitive restructuring, mindfulness; (3) Relapse prevention (7-8): skills review, coping rehearsal, and a relapse prevention plan (update crisis plan). Sessions include practice and homework. Other: TAU is routine outpatient care as indicated (e.g., medication and supportive psychotherapy).

Treatment as Usual (TAU)OTHER

Treatment as Usual (TAU) refers to routine outpatient care provided as clinically indicated, including medication treatment and supportive psychotherapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * High suicide risk, defined as either (a) a suicide attempt within the past 1 month or (b) Beck Scale for Suicide Ideation (SSI) ≥ 5. * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Number of Suicide Attempts from Baseline to 3 Months 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 frame: 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.

Time to First Suicide Attempt 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).

Time frame: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.

Secondary Outcomes

Intensity of suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Suicidal ideation intensity will be assessed using the Intensity of Ideation items of the C-SSRS (frequency, duration, controllability, deterrents, and reasons for ideation), each scored from 0 to 5. Higher scores indicate greater ideation intensity.

Time frame: 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)

Suicidal ideation severity will be assessed using the Beck Scale for Suicide Ideation, a 19-item self-report questionnaire. Each item is scored from 0 to 2, producing a total score from 0 to 38. Higher scores indicate greater severity of suicidal ideation.

Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D-17)

Depressive symptom severity will be assessed at five time points using the 17-item Hamilton Depression Rating Scale. This clinician-administered semi-structured interview yields total scores ranging from 0 to 52, with higher scores indicating more severe depression.

Change in depressive symptoms measured by Beck Depression Inventory-II (BDI-II)

Depressive symptom severity will be assessed at five time points using the Beck Depression Inventory-II, a 21-item self-report questionnaire. Each item is scored from 0 to 3, yielding total scores from 0 to 63. Higher scores indicate greater symptom severity.

Change in hopelessness measured by the Beck Hopelessness Scale (BHS)

Change in the level of hopelessness will be assessed at five time points: baseline, post-treatment, and monthly for 3 months following treatment completion. Hopelessness will be measured using the Beck Hopelessness Scale (BHS), a 20-item self-report questionnaire designed to assess negative expectations about the future. Each item is scored dichotomously (True/False), with total scores ranging from 0 to 20. Higher scores indicate greater levels of hopelessness and have been associated with increased suicide risk.