Asan Medical Center
Seoul, South Korea
NCT Number: NCT07072845
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be eligible for the study:
*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
Exclusion criteria
Participants will be excluded if any of the following apply:
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
Time frame: 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).
Consent rate will be used as a key feasibility indicator. It is defined as the percentage of eligible participants who provided informed consent and were randomized. The rate will be calculated by dividing the number of participants who consented and were randomized by the total number of eligible participants screened during the recruitment period.
Time frame: 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.
Retention rate will be used as a key feasibility indicator. It is defined as the percentage of randomized participants who remained in the study and provided valid primary outcome data at each designated follow-up time point. The rate will be calculated by dividing the number of participants who completed the primary outcome assessment at each time point by the total number of participants randomized.
Time frame: From the first to the fifth scheduled treatment session, over the intervention period (approximately 7 days), for each participant assigned to the intervention group.
Adherence to treatment will be used as a feasibility indicator. It is defined as the percentage of participants who attended all 5 scheduled treatment sessions. The rate will be calculated by dividing the number of participants who completed all sessions by the total number of participants assigned to the intervention group.
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.
Implicit identification with death will be assessed using the Death-Implicit Association Test (D-IAT), a computerized task measuring automatic associations between death-related concepts and the self. The Korean version of the D-IAT, validated for local use, consists of seven blocks administered via PsychoPy software. The outcome score (D-score) is computed using a standard scoring algorithm: a positive D-score indicates a stronger implicit association between death and self, while a negative score indicates a stronger association between life and self. Higher D-scores have been associated with increased risk of suicide attempts.
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.
Anxiety symptoms will be assessed at all scheduled time points using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is rated on a 0 to 3 scale, yielding a total score from 0 to 63. Higher scores indicate greater anxiety severity.
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.
Emotion dysregulation will be assessed at all scheduled time points using the 35-item Korean version of the Difficulties in Emotion Regulation Scale (DERS). This self-report questionnaire measures six dimensions of emotion regulation difficulties: Nonacceptance of emotional responses, Difficulties engaging in goal-directed behavior, Impulse control difficulties, Lack of emotional awareness, Limited access to emotion regulation strategies, and Lack of emotional clarity. Each item is rated on a 5-point Likert scale from 1 to 5, with higher scores indicating greater difficulties in emotion regulation.
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.
Distress tolerance will be assessed at all scheduled time points using the Distress Intolerance Index (DII), a 10-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 0 (not at all like me) to 4 (very much like me), with total scores ranging from 0 to 40. Higher scores indicate lower distress tolerance.
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.
Negative automatic thoughts will be assessed using the Automatic Thoughts Questionnaire-Negative (ATQ-N), a 30-item self-report measure. Participants rate how frequently they experienced each thought on a 5-point Likert scale from 1 (not at all) to 5 (all the time). Total scores range from 30 to 150, with higher scores indicating greater frequency of negative automatic thoughts.
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.
Positive automatic thoughts will be assessed using the Automatic Thoughts Questionnaire-Positive (ATQ-P), a 30-item self-report measure. Each item is rated on a 5-point Likert scale from 1 (not at all) to 5 (all the time). Total scores range from 30 to 150, with higher scores indicating more frequent positive automatic thoughts.
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.
Interpersonal needs will be assessed using the Interpersonal Needs Questionnaire (INQ), a 15-item self-report measure designed to assess two constructs: perceived burdensomeness and thwarted belongingness. Each item is rated on a 7-point Likert scale from 1 (not at all true for me) to 7 (very true for me). Higher scores reflect greater interpersonal distress.
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.
Fearlessness about death will be assessed using the Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD), a 7-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 0 (not at all like me) to 4 (very much like me), with higher scores indicating greater fearlessness about death.
Time frame: At post-treatment (within 48 hours after discharge), for each participant in the intervention group
Treatment satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item self-report instrument rated on a 4-point Likert scale. The measure assesses satisfaction with treatment quality, perceived effectiveness, and willingness to reuse or recommend the intervention. Higher total scores indicate greater satisfaction.
Time frame: At 1-month (±7 days), 2-month (±7 days), and 3-month (±7 days) follow-up assessments after discharge, for each participant in the intervention group.
The Utility of Techniques (UT) questionnaire will be used to assess participants' frequency of use and perceived helpfulness of specific intervention components. For each technique the participant reports having learned during the inpatient stay, they will rate frequency of use (from "not at all" to "more than 10 times per week") and helpfulness (if used, from "not at all" to "extremely"). Techniques include, for example, personalized safety planning tools and coping strategies taught during the intervention.
Hyung Keun Park
Other
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
Acronym: E-BCBT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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