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
- Are there results?
- None posted in the registry
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.
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07072845
- Acronym / sponsor ID
- E-BCBT / 2025-0516
- Keywords
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy for Suicidality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hyung Keun ParkUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-BCBT + TAU | Experimental | Behavioral: Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal Inpatients, Other: Treatment as Usual (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. |
| TAU only | Active comparator | Other: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Brief Cognitive Behavioral Therapy (E-BCBT) for Suicidal InpatientsE-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. | Behavioural | E-BCBT + TAU |
| 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. | Other | E-BCBT + TAU, TAU only |
Primary outcome
Number of Suicide Attempts from Baseline to 3 Months After Discharge
Time frame: 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
Time frame: 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.
5 secondary outcomes
Intensity of suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Suicide Attempts from Baseline to 3 Months After Discharge (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.