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

NCT07395817 | Active Not Recruiting

• 1 other identifier: 2026-0177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Suicidal Ideation and Behaviors; Suicide Attempt; Cognitive Behavioral Therapy

Keywords

Suicidal Ideation and Behaviors; Suicide Attempt; Cognitive Behavioral Therapy for Suicidality

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

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

Secondary Outcomes (5)

• 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.

Other Outcomes (15)

• Consent rate (as an indicator of feasibility)

  For each participant, from the time they are found eligible through screening until the time they provide informed consent and are randomized, during the study's active recruitment period (approximately 6 months).

• Retention rate (as an indicator of feasibility)

  From randomization: Baseline (≤7 days pre-start); Post-treatment (≤7 days post-completion); follow-ups at 1, 2, and 3 months (±7 days) after completion.

• Adherence to treatment (as an indicator of feasibility)

  From the first to the eighth scheduled treatment session, over the intervention period (approximately 4 weeks), for each participant assigned to the intervention group.

Study Arms (2)

Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU)

EXPERIMENTAL

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.

Behavioral: Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT); Other: Treatment as Usual (TAU)

Treatment as Usual (TAU) only

ACTIVE COMPARATOR

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.

Other: Treatment as Usual (TAU)

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).

Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU)

Treatment as Usual (TAU) OTHER

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

Treatment as Usual (TAU) only; Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyung Keun Park: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)