Videoconference-Based Brief Cognitive Behavioral Therapy for Patients With Mood Disorders at High Risk for Suicide (V-BCBT-BIO)

Participants with mood disorders at high risk for suicide who are randomized to this arm will receive videoconference-based brief cognitive-behavioral therapy (V-BCBT) in addition to treatment as usual (TAU). V-BCBT consists of eight 50-60-minute sessions delivered once weekly via secure videoconferencing. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.

V-BCBT is a structured, brief cognitive behavioral intervention delivered via secure videoconferencing to outpatients with mood disorders who are at high risk for suicide. It comprises eight individual sessions of approximately 50 minutes, delivered once weekly. Treatment focuses on crisis management, development of an individualized crisis response plan, reasons for living, relaxation, sleep management, behavioral activation, cognitive restructuring, mindfulness, coping with high-risk situations, and relapse prevention. V-BCBT is provided in addition to treatment as usual (TAU), which consists of routine outpatient psychiatric care such as pharmacotherapy and supportive psychotherapy according to clinical need.

• V-BCBT

Participants with mood disorders at high risk for suicide who are randomized to this arm will receive treatment as usual (TAU) without V-BCBT. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.

Treatment as usual (TAU) refers to routine outpatient psychiatric care provided according to each participant's clinical needs and the treating clinician's judgment. It may include pharmacotherapy, supportive psychotherapy, clinical monitoring, and other standard psychiatric services ordinarily available in outpatient practice. The specific components and intensity of TAU are not standardized by the study protocol and may vary across participants based on usual clinical care.

• TAU

Participants with depressive disorders or bipolar and related disorders who are classified as being at low risk for suicide will serve as a baseline comparison group. They will not undergo randomization or receive V-BCBT. Participants will complete baseline clinical interviews, self-report questionnaires, the death implicit association test (D-IAT), and blood sampling for comparison of clinical characteristics and inflammatory biomarkers.

Healthy participants with no lifetime history of DSM-5 psychiatric disorders will serve as a baseline comparison group. They will not undergo randomization or receive V-BCBT. Participants will complete baseline clinical interviews, self-report questionnaires, the death implicit association test (D-IAT), and blood sampling for comparison of clinical characteristics and inflammatory biomarkers.

The occurrence of suicide attempts will be assessed at baseline, post-treatment, and follow-up using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered through in-person or telephone interviews. When available, reported suicide attempts will be cross-checked with relevant medical records.

Time to first suicide attempt will be defined as the number of days from treatment completion to the first subsequently reported suicide attempt. Suicide attempts will be assessed at the post-treatment and follow-up assessments using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered in person or by telephone.

Serum concentrations of IL-1β, IL-6, IL-8, IL-10, TNF-α, sTNF-αR1, CRP, CCL-2, CXCL-1, and IFN-γ will be measured using enzyme-linked immunosorbent assays (ELISA). Baseline inflammatory biomarker levels will be compared among patients with mood disorders at high risk for suicide, patients with mood disorders at low risk for suicide, and healthy controls.

Changes in serum concentrations of IL-1β, IL-6, IL-8, IL-10, TNF-α, sTNF-αR1, CRP, CCL-2, CXCL-1, and IFN-γ will be assessed among participants with mood disorders at high risk for suicide who are randomized to V-BCBT plus TAU or TAU alone. Biomarker changes will also be examined in relation to treatment effects on suicide-related outcomes. Participants in the low-suicide-risk and healthy control groups will undergo biomarker assessment at baseline only.

Suicidal ideation severity will be assessed using the C-SSRS severity scale, which ranges from 1 (wish to be dead) to 5 (active suicidal ideation with a specific plan and intent). Higher scores indicate greater severity of suicidal ideation.

The intensity of suicidal ideation will be assessed using the C-SSRS Intensity of Ideation items, which evaluate frequency, duration, controllability, deterrents, and reasons for suicidal thoughts. The five item scores are summed to yield a total score ranging from 0 to 25, with higher scores indicating greater suicidal ideation intensity. The measure will be administered at baseline to all participants and longitudinally only to randomized high-suicide-risk participants.

Suicidal ideation will be assessed using the self-report Beck Scale for Suicide Ideation (SSI). Items assess the presence and severity of suicidal thoughts and related characteristics. The total score ranges from 0 to 38, with higher scores indicating greater suicidal ideation severity. The SSI will be administered at baseline to all participants and longitudinally only to randomized high-suicide-risk participants.

Depressive symptom severity will be assessed using the clinician-rated Hamilton Depression Rating Scale (HAM-D). For the 17-item HAM-D, total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.

Depressive symptoms will be assessed using the 21-item self-report Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.

Hopelessness will be assessed using the 20-item Beck Hopelessness Scale (BHS). Total scores range from 0 to 20, with higher scores indicating greater hopelessness and more negative expectations regarding the future.

Implicit associations between death and the self will be assessed using the computer-based Death Implicit Association Test (D-IAT). A D-score will be calculated from reaction times during death-self and life-self classification conditions. Positive values indicate a relatively stronger death-self association, whereas negative values indicate a relatively stronger life-self association.

Fearlessness about death will be assessed using the 7-item Acquired Capability for Suicide Scale-Fearlessness About Death (ACSS-FAD). Items are rated from 0 to 4. Total scores range from 0 to 28, with higher scores reflecting greater fearlessness about death.

Perceived burdensomeness and thwarted belongingness will be assessed using the 15-item Interpersonal Needs Questionnaire (INQ). The INQ consists of 9 items assessing thwarted belongingness and 6 items assessing perceived burdensomeness. Each item is rated on a 7-point scale from 1 (not at all true for me) to 7 (very true for me). After reverse-scoring the appropriate items, items are summed to calculate the respective subscale scores, which range from 9 to 63 for thwarted belongingness and from 6 to 42 for perceived burdensomeness. Higher scores indicate greater thwarted belongingness and perceived burdensomeness.

Manic symptom severity will be assessed using the 11-item clinician-rated Young Mania Rating Scale (YMRS). Total scores range from 0 to 60, with higher scores indicating greater severity of manic symptoms.

Manic symptoms will be assessed using the 5-item Altman Self-Rating Mania Scale (ASRM). Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating greater severity of manic symptoms.

Anxiety symptoms will be assessed using the 21-item Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale from 0 to 3. Total scores range from 0 to 63, with higher scores indicating greater anxiety symptom severity.

Anxiety symptom severity will be assessed using the 14-item clinician-rated Hamilton Anxiety Rating Scale (HAM-A), which evaluates both psychic and somatic anxiety symptoms. Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating greater anxiety symptom severity.

Positive and negative automatic thoughts will be assessed using the 30-item Automatic Thoughts Questionnaire-Negative (ATQ-N) and the 30-item Automatic Thoughts Questionnaire-Positive (ATQ-P). Each item is rated on a 5-point scale from 1 to 5. Total scores for each questionnaire range from 30 to 150, with higher scores indicating a greater frequency of negative or positive automatic thoughts, respectively.

Reasons for living will be assessed using the 48-item Reasons for Living Inventory (RFL). Each item is rated on a 6-point scale from 1 (not at all important) to 6 (extremely important). Total scores range from 48 to 288, with higher scores indicating stronger endorsement of reasons for living.

Difficulties in emotion regulation will be assessed using the 35-item Korean version of the Difficulties in Emotion Regulation Scale (K-DERS). Each item is rated on a 5-point scale from 1 to 5. After reverse-scoring the appropriate items, total scores range from 35 to 175, with higher scores indicating greater difficulties in emotion regulation.

Distress intolerance will be assessed using the 10-item Distress Intolerance Index (DII). Each item is rated on a 5-point scale from 0 (very little) to 4 (very much). Item scores are summed to yield a total score ranging from 0 to 40, with higher scores indicating greater difficulty tolerating psychological distress and negative emotional states.

Childhood maltreatment will be assessed using the 28-item Childhood Trauma Questionnaire-Short Form (CTQ-SF). Items are rated on a 5-point scale from 1 to 5. The total maltreatment score ranges from 25 to 125, with higher scores indicating greater exposure to childhood maltreatment. Three additional minimization/denial items serve as a validity scale and are not included in the total maltreatment score.

Life event experiences will be assessed using the Life Experiences Survey (LES), which evaluates the occurrence of major life events and participants' perceived impact of these events. For each experienced event, perceived impact is rated on a 7-point scale ranging from -3 (extremely negative) to +3 (extremely positive), with 0 indicating no impact. Positive and negative life-event impact scores can be derived separately based on participants' ratings.

Borderline personality features will be assessed using the 24-item Personality Assessment Inventory-Borderline Features Scale (PAI-BOR), which evaluates affective instability, identity problems, negative relationships, and self-harming behavior. Each item is rated on a 4-point scale from 0 to 3. Total scores range from 0 to 72, with higher scores indicating greater borderline personality features.

Impulsivity will be assessed using the 30-item Barratt Impulsiveness Scale-11-Revised (BIS-11-R), which evaluates attentional, motor, and non-planning impulsivity. Each item is rated on a 4-point scale from 1 to 4. After reverse-scoring the appropriate items, total scores range from 30 to 120, with higher scores indicating greater impulsivity.

Alcohol use and alcohol-related problems will be assessed using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Total scores range from 0 to 40, with higher scores indicating greater severity of problematic alcohol use.

Sleep quality and sleep-related difficulties during the previous month will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.

Insomnia symptoms and associated functional difficulties will be assessed using the 7-item Insomnia Severity Index (ISI). Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.

Cigarette dependence will be assessed using the 12-item Cigarette Dependence Scale (CDS-12), which evaluates multiple aspects of dependence, including compulsive smoking, withdrawal symptoms, and loss of control. Responses to each item are coded on a 5-point scale from 1 to 5 and summed to yield a total score ranging from 12 to 60, with higher scores indicating greater cigarette dependence.

Physical health behaviors will be assessed using the 40-item Physical Health Behavior Scale. Each item is rated on a 5-point scale from 1 to 5. Health-risk behavior items are reverse-scored, and item scores are summed to yield a total score ranging from 40 to 200, with higher scores indicating healthier physical health behaviors.

Dietary intake will be assessed using a 24-hour dietary recall in which participants report foods and beverages consumed during the previous day, including the amount, timing, and location of intake. The collected data will be used to estimate total energy intake and major nutrient intake.

Participants assigned to V-BCBT plus TAU will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to assess perceived treatment quality, effectiveness, overall satisfaction, willingness to receive similar treatment again, and willingness to recommend the treatment to others. Higher scores indicate greater treatment satisfaction.

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 V-BCBT treatment period, 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.

Treatment acceptability will be evaluated based on rates of study participation refusal and premature treatment discontinuation. Reasons for refusal or discontinuation and suggestions for improving the acceptability of V-BCBT will also be collected when available.

Consent rate will be used as a key feasibility indicator. It is defined as the percentage of eligible high-suicide-risk 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 high-suicide-risk participants screened during the recruitment period.

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.