NCT07294001 Shame-Focused Cognitive Behavioral Therapy For Reducing Suicide Risk In Adolescent Psychiatric Inpatients (SF-CBT)
| NCT ID | NCT07294001 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University |
| Condition | Adolescent Suicide |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-08-10 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot randomized controlled trial (RCT) aims to evaluate the feasibility, acceptability, and preliminary efficacy of Shame-Focused Cognitive Behavioral Therapy (SF-CBT) among high-risk psychiatric inpatient adolescents. Shame has been identified as a critical psychological mechanism underlying suicidal ideation and behavior, yet few interventions directly target it. SF-CBT is a structured, manualized intervention designed to reduce shame, improve coping strategies, and lower suicide risk. Approximately 42 adolescents aged 13-18 years, admitted for recent suicide attempt or severe suicidal ideation, will be randomized in a 2:1 ratio to receive either SF-CBT or supportive therapy (ST). Both conditions include 7 individual sessions for adolescents and 3 structured psychoeducation sessions for parents/guardians. Primary outcomes include feasibility metrics (recruitment, retention, adherence, fidelity, adverse events) and acceptability ratings from adolescents, parents, and therapists. Secondary outcomes include changes in suicidal ideation, suicidal behavior, shame, and coping styles, assessed at baseline, post-treatment, and 1-, 3-, and 6-month follow-ups. Findings will inform refinement of the intervention manual, establish feasibility benchmarks, and provide effect size estimates to guide a subsequent large-scale RCT.
Eligibility Criteria
Inclusion Criteria: * Adolescents aged 13-18 years, male or female. * Recent suicide risk, defined as: At least one suicide attempt in the past month, or Current suicidal ideation within the past month (with or without plan/intent) and at least one previous attempt. * Elevated shame level (baseline score ≥ 9 on the External and Internal Shame Scale, EISS). * Adequate cognitive capacity to participate in interviews and assessments. * Parent/legal guardian (or designated responsible adult authorized by guardian) provides informed consent and agrees to participate. Exclusion Criteria: * Current manic episode. * History of schizophrenia spectrum disorder, intellectual disability, or organic brain disease. * Severe psychiatric or medical conditions that impair capacity for consent or participation. * Expected to receive electroconvulsive therapy (ECT) during hospitalization. * Anticipated inpatient stay shorter than 14 days (to ensure intervention completion).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07294001 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Adolescent Suicide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07294001 currently recruiting?
Yes, NCT07294001 is actively recruiting participants. Contact the research team at 2301110717@stu.pku.edu.cn for enrollment information.
Where is the NCT07294001 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07294001 clinical trial?
NCT07294001 is sponsored by Peking University. The trial plans to enroll 42 participants.