Videoconference-Based Brief Cognitive Behavioral Therapy for Patients With Mood Disorders at High Risk for Suicide

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHyung Keun Park

About this trial

This study aims to investigate inflammatory biomarkers associated with suicide risk and to evaluate the efficacy of videoconference-based brief cognitive-behavioral therapy (V-BCBT) in patients with mood disorders at high risk for suicide. The study consists of a cross-sectional baseline comparison followed by a randomized controlled trial.

Participants will include patients with depressive disorders or bipolar and related disorders who are experiencing a major depressive episode, as well as healthy controls with no lifetime history of DSM-5 psychiatric disorders. Patients with mood disorders will be classified as being at high or low risk for suicide. At baseline, all participants, including those in the high-suicide-risk, low-suicide-risk, and healthy control groups, will undergo clinical interviews, self-report questionnaires, a computer-based Death Implicit Association Test (D-IAT), and blood sampling. Clinical characteristics and inflammatory biomarker profiles will be compared across the three groups to examine the potential utility of inflammatory biomarkers for identifying individuals at high risk for suicide.

Participants in the high-suicide-risk group who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to V-BCBT plus treatment as usual (TAU) or TAU alone. For participants in the high-suicide-risk group, the baseline assessment will also serve as the pre-treatment assessment and will be conducted within 7 days before the start of treatment. V-BCBT consists of eight individual sessions of approximately 50-60 minutes, delivered once weekly via secure videoconferencing by trained therapists. The intervention includes crisis management, development of a suicide-focused coping plan, exploration of reasons for living, relaxation training, behavioral activation, cognitive restructuring, mindfulness, coping strategies for high-risk situations, and relapse prevention. TAU consists of routine outpatient psychiatric care and may include pharmacotherapy and supportive psychotherapy.

Participants in the high-suicide-risk group will subsequently undergo a post-treatment assessment at 2 months after the baseline assessment (±7 days) and a follow-up assessment at 2 months after the post-treatment assessment (±10 days). The post-treatment and follow-up assessments will include clinical interviews, self-report questionnaires, the D-IAT, and blood sampling. Participants in the low-suicide-risk and healthy control groups will complete the baseline assessment only and will not undergo post-treatment or follow-up assessments. Post-treatment and follow-up clinical assessments of randomized participants will be conducted by evaluators blinded to treatment allocation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 to 64 years.

For patient groups: diagnosis of a depressive disorder or bipolar and related disorder with a current major depressive episode according to DSM-5 criteria, as assessed using the Mini International Neuropsychiatric Interview (MINI).

For the high-suicide-risk group: either a suicide attempt within the past month or a Beck Scale for Suicide Ideation (SSI) score of ≥15.

For healthy controls: no lifetime history of any DSM-5 psychiatric disorder, as assessed using the MINI.

Disqualifiers

Presence of psychotic symptoms or a current substance use disorder.

Diagnosis of an inflammatory or autoimmune disease.

Current use of corticosteroids or immunosuppressive medications.

Current pregnancy or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Videoconference-Based Brief Cognitive Behavioral Therapy

    Behavioral

    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.

  • Treatment as Usual (TAU)

    Other intervention

    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.

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: V-BCBT Plus Treatment as UsualExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention
Group C: Low-Suicide-Risk Mood Disorder GroupNo intervention 0 interventions
Group D: Healthy Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of Suicide Attempts Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

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 frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
2

Time to First Suicide Attempt Following Treatment Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

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.

Time frame
From treatment completion through the 2-month follow-up period, assessed at the post-treatment and follow-up assessments (±10 days).
3

Baseline Differences in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

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.

Time frame
Baseline.
4

Change in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).

Secondary outcomes

1

Severity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
2

Intensity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
3

Severity of Suicidal Ideation Assessed With the Beck Scale for Suicide Ideation (SSI)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
4

Depressive Symptoms Assessed With the Hamilton Depression Rating Scale (HAM-D)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).

Other outcomes

1

Death-Self Implicit Association Assessed With the Death Implicit Association Test (D-IAT)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
2

Fearlessness About Death Assessed With the Acquired Capability for Suicide Scale-Fearlessness About Death (ACSS-FAD)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
3

Interpersonal Needs Assessed With the Interpersonal Needs Questionnaire (INQ)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).
4

Manic Symptoms Assessed With the Young Mania Rating Scale (YMRS)

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.

Time frame
Baseline for all participants; for randomized high-suicide-risk participants, post-treatment at baseline +2 months (±7 days) and follow-up at post-treatment +2 months (±10 days).

Sponsors and contacts

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Hyung Keun Park

Lead sponsor

Asan Medical Center

Sponsor institution

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