Enhanced Brief CBT for Suicidal Inpatients With Mood Disorders

NCT ID: NCT07072845

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2026-04-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

E-BCBT + TAU

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Treatment as Usual (TAU)

Intervention Type: 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.

TAU only

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyung Keun Park

OTHER

Sponsor Role: lead

Responsible Party

Hyung Keun Park

Clinical Assistant Professor, Department of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2025-0516

Identifier Type: -

Identifier Source: org_study_id