Suicidal Ideation and BehaviorV-BCBT-BIONCT07857291
Videoconference-Based Brief Cognitive Behavioral Therapy for Patients With Mood Disorders at High Risk for Suicide
A study testing Videoconference-Based Brief Cognitive Behavioral Therapy and Treatment as Usual (TAU) in people with Suicidal Ideation and Behavior and Mood Disorders, run by Hyung Keun Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation and Behavior, Mood Disorders, Suicide Attempt
- What is being tested?
- Videoconference-Based Brief Cognitive Behavioral Therapy 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
- 320 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Diagnosis of cancer within the past 5 years.
- Physical injury or infectious illness within the past month.
- Night-shift work within the past 2 months.
- Receipt of psychotherapy or psychological treatment within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Suicidal Ideation and Behavior, Mood Disorders, Suicide Attempt, Cognitive Behavior Therapy
- Being tested
- Videoconference-Based Brief Cognitive Behavioral Therapy, Treatment as Usual (TAU)
- Keywords
- Mood Disorders, Suicide Attempt, Cognitive Behavior Therapy, Suicidal Ideation and Behavior
- Medical subject headings
- Suicidal Ideation, Behavior, Mood Disorders, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoconference-Based Brief Cognitive Behavioral TherapyBehavioural
Also called V-BCBT
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
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| V-BCBT Plus Treatment as Usual | Experimental | 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. Receives: Behavioral: Videoconference-Based Brief Cognitive Behavioral Therapy |
| Treatment as Usual | Active comparator | 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. Receives: Other: Treatment as Usual (TAU) |
| Low-Suicide-Risk Mood Disorder Group | No intervention | 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 Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: From treatment completion through the 2-month follow-up period, assessed at the post-treatment and follow-up assessments (±10 days).
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.
Measured: Baseline.
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.
Measured: 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 (6)
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Depressive Symptoms Assessed With the Beck Depression Inventory-II (BDI-II)
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.
Measured: 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).
Hopelessness Assessed With the Beck Hopelessness Scale (BHS)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Ideation and BehaviorStudies 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
- Model description
- Participants with mood disorders at high risk for suicide will be randomized in a 1:1 ratio to V-BCBT plus treatment as usual (TAU) or TAU alone. Participants with mood disorders at low risk for suicide and healthy controls will not undergo randomization or receive the study intervention and will participate only in baseline assessments for clinical and inflammatory biomarker comparisons.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
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
- NCT07857291
- Sponsor's protocol ID
- 2026-2173
- Other IDs
- RS-2026-25587647
- Acronym
- V-BCBT-BIO
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07857291
- Acronym / sponsor ID
- V-BCBT-BIO / 2026-2173
- Conditions
- Suicidal Ideation and Behavior, Mood Disorders, Suicide Attempt, Cognitive Behavior Therapy
- Keywords
- Mood Disorders, Suicide Attempt, Cognitive Behavior Therapy, Suicidal Ideation and Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hyung Keun ParkUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 5 Oct 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants with mood disorders at high risk for suicide will be randomized in a 1:1 ratio to V-BCBT plus treatment as usual (TAU) or TAU alone. Participants with mood disorders at low risk for suicide and healthy controls will not undergo randomization or receive the study intervention and will participate only in baseline assessments for clinical and inflammatory biomarker comparisons.
| Arm | Type | Receives |
|---|---|---|
| V-BCBT Plus Treatment as Usual | Experimental | Behavioral: Videoconference-Based Brief Cognitive Behavioral TherapyParticipants 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. |
| Treatment as Usual | Active comparator | Other: Treatment as Usual (TAU)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. |
| Low-Suicide-Risk Mood Disorder Group | No intervention | –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 Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Diagnosis of cancer within the past 5 years.
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 |
|---|---|---|
| Videoconference-Based Brief Cognitive Behavioral TherapyAlso: V-BCBTV-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. | Behavioural | V-BCBT Plus Treatment as Usual |
| Treatment as Usual (TAU)Also: TAUTreatment 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. | Other | Treatment as Usual |
Primary outcome
Number of Suicide Attempts Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
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).
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 Following Treatment Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From treatment completion through the 2-month follow-up period, assessed at the post-treatment and follow-up assessments (±10 days).
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.
Baseline Differences in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Baseline.
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.
Change in Serum Inflammatory Biomarker Levels Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
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).
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.
6 secondary outcomes
Severity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)
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).
Intensity of Suicidal Ideation Assessed With the Columbia-Suicide Severity Rating Scale (C-SSRS)
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).
Severity of Suicidal Ideation Assessed With the Beck Scale for Suicide Ideation (SSI)
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).
Depressive Symptoms Assessed With the Hamilton Depression Rating Scale (HAM-D)
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).
Depressive Symptoms Assessed With the Beck Depression Inventory-II (BDI-II)
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).
Hopelessness Assessed With the Beck Hopelessness Scale (BHS)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoconference-Based Brief Cognitive Behavioral Therapy and Treatment as Usual (TAU) in people with Suicidal Ideation and Behavior and Mood Disorders, 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Hyung Keun Park, M.D., Ph.D. (+82-2-3010-1657, hkpark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Suicide Attempts Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) (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).). The study lists 4 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 5 Oct 2026.