Clinical Research Directory

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

Sponsor: Hyung Keun Park

Summary

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.

Official title: Efficacy of Videoconference-Based Brief Cognitive-Behavioral Therapy (V-BCBT) for Patients With Mood Disorders at High Risk for Suicide: Identifying Inflammatory Biomarkers of Suicide Risk and Examining Their Mediating Role in Treatment Effects

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