Enhanced Brief CBT for Suicidal Inpatients With Mood Disorders

NCT07072845 | Active Not Recruiting

• 1 other identifier: 2025-0516
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether enhanced brief cognitive behavioral therapy (E-BCBT) can help reduce suicidal thoughts and behaviors among psychiatric inpatients. This therapy is designed to be feasible during hospitalization and includes self-directed worksheets that may later be used independently after discharge, offering potential benefits for suicide prevention outside the hospital setting as well. Participants will be randomly assigned to one of two groups:

• E-BCBT group: Participants will receive five sessions of cognitive behavioral therapy (approximately 50-60 minutes each) during their inpatient stay.
• TAU (treatment as usual) group: Participants will receive standard care provided on the psychiatric ward. All participants will take part in five assessments: one before treatment, one after treatment, and three monthly follow-up assessments over the three months after discharge. Assessments include interviews, conducted in person or by phone, and questionnaires, completed online via a survey link. The entire study period will take approximately four months.

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 Discharge

  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, with data cross-checked against electronic medical records.

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

• Time to First Suicide Attempt After Discharge

  The number of days from hospital discharge to the first reported suicide attempt, assessed through monthly follow-up interviews during the 3-month follow-up period.

  1 month, 2 months, and 3 months post-discharge

Secondary Outcomes (5)

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

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

• Severity of suicidal ideation measured by Beck Scale for Suicide Ideation (SSI)

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

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

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

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

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

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

  Baseline: Within 24 hours after informed consent and within 2 days before treatment start; Post-treatment: Within 48 hours after discharge; Follow-up assessments: At 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after discharge.

Other Outcomes (13)

• 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 to each scheduled assessment point: post-treatment (within 48 hours after discharge), and 1-month (±7 days), 2-month (±7 days), and 3-month (±7 days) follow-ups after discharge, for each participant.

• Adherence to treatment (as an indicator of feasibility)

  From the first to the fifth scheduled treatment session, over the intervention period (approximately 7 days), for each participant assigned to the intervention group.

Study Arms (2)

E-BCBT + TAU

EXPERIMENTAL

Participants in this arm will receive Enhanced Brief Cognitive Behavioral Therapy (E-BCBT), a brief intervention designed for suicide prevention among psychiatric inpatients, along with treatment as usual (TAU) provided on the ward. After randomization, they will participate in five sessions of E-BCBT during hospitalization (approximately 50-60 minutes per session), in addition to receiving standard care such as pharmacotherapy, case management, and general supportive therapy offered in the inpatient setting.

Behavioral: Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients; Other: Treatment as Usual (TAU)

TAU only

ACTIVE COMPARATOR

Participants in this arm will receive Treatment as Usual (TAU) only. TAU is based on a short-term stabilization model and includes 24-hour multidisciplinary care delivered by an inpatient psychiatric team. Individualized treatment is provided depending on the participant's needs. TAU may include treatments such as pharmacotherapy, occupational therapy, and supportive psychotherapy, as commonly practiced in the hospital setting.

Other: Treatment as Usual (TAU)

Interventions

Treatment as Usual (TAU) OTHER

TAU is based on a short-term inpatient stabilization model and includes 24-hour multidisciplinary care provided by the psychiatric ward. Individualized treatment may involve pharmacotherapy, occupational therapy, and supportive psychotherapy, depending on patient needs and hospital protocols.

E-BCBT + TAU; TAU only

Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients BEHAVIORAL

E-BCBT is a brief, structured cognitive behavioral therapy designed for psychiatric inpatients at risk of suicide. The primary goals are to reduce the risk of suicide attempts after discharge, improve problem-solving and coping with recent stressors related to suicidal crises, and help patients shift from maladaptive "suicidal modes" to more adaptive cognitive and behavioral patterns. The intervention consists of five individual sessions (approximately 50-60 minutes each) delivered during hospitalization. It includes two sessions on crisis management, two sessions on cognitive and behavioral strategies, and one relapse prevention session. Each session incorporates psychoeducation, skill-building, and worksheet-based self-practice to enhance self-regulation and promote continued use after discharge.

E-BCBT + TAU

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Hospitalized following a suicide crisis
• \*A suicide crisis is defined based on the Columbia-Suicide Severity Rating Scale (C-SSRS) as meeting at least one of the following: A. A suicide attempt within 1 week prior to admission B. Current suicidal ideation and plan at the time of admission (recorded as the reason for hospitalization) and at least one prior suicide attempt within the past 2 years
• Aged 18 years or older
• Diagnosed with a depressive disorder or bipolar and related disorder based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) using the Mini International Neuropsychiatric Interview (M.I.N.I.) at screening
• Able to read and write in Korean without difficulty
• Capable of understanding the study procedures and providing written informed consent voluntarily

You may not qualify if:

• Participants will be excluded if any of the following apply:
• Has an acute manic episode with psychotic features, a schizophrenia spectrum disorder, a clinically significant neurological disorder, brain injury, intellectual disability, or any other physical illness that would interfere with participation in the study.
• Receiving ongoing psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy) within 3 months prior to screening.
• Expected to be discharged within 6 working days of admission, as judged by the attending physician
• Scheduled to receive electroconvulsive therapy (ECT) during 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: June 25, 2025
• First Posted: July 18, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: June 3, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)