Enhanced Brief CBT for Suicidal Inpatients With Mood Disorders

Not Applicable

Not yet recruiting

• Conditions: Suicidal Ideation and Behaviors; Suicide Attempt; Cognitive Behavioral Therapy

• Registration Number: NCT07072845
• Lead Sponsor: Hyung Keun Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-25
• Status Verified: 2025-07
• Study Start: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-04-22
• Study Completion: 2026-04-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Suicide Attempts from Baseline to 3 Months After Discharge	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.	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.
Time to First Suicide Attempt After Discharge	1 month, 2 months, and 3 months post-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.

Secondary Outcome Measures

Name	Time	Method
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.	Suicidal ideation intensity will be assessed using the Intensity of Ideation subscale of the C-SSRS. This clinician-administered interview includes five items (frequency, duration, controllability, deterrents, and reasons for ideation), each scored from 0 to 5. Higher scores indicate greater ideation intensity.
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.	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)	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.	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)	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.	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)	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 the level of hopelessness will be assessed at five time points: baseline, post-treatment, and monthly for 3 months following discharge. 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.