Suicidal Ideation and BehaviorsE-BCBTNCT07072845
Enhanced Brief CBT for Suicidal Inpatients With Mood Disorders
A study testing Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients and Treatment as Usual (TAU) in people with Suicidal Ideation and Behaviors and Suicide Attempt, run by Hyung Keun Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy
- What is being tested?
- Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2025to 10 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial to Assess the Feasibility and the Efficacy of Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients With Mood Disorder
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:
Read more
- 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.
- Being tested
- Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients, Treatment as Usual (TAU)
- Keywords
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy for Suicidality
- Medical subject headings
- Suicidal Ideation, Behavior, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal InpatientsBehavioural
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start30 Jul 2025
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Ideation and BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyung Keun Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyung Keun Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072845
- Sponsor's protocol ID
- 2025-0516
- Acronym
- E-BCBT
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No