Shame-Focused Cognitive Behavioral Therapy For Reducing Suicide Risk In Adolescent Psychiatric Inpatients (SF-CBT)
NCT ID: NCT07294001
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2025-08-10
2026-09-30
Brief Summary
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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.
Detailed Description
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Objectives The primary objective is to test the feasibility and acceptability of SF-CBT in an inpatient psychiatric setting. Secondary objectives are to explore its preliminary efficacy in reducing shame, suicidal ideation, and suicidal behavior, and to evaluate the maintenance of effects at 1-, 3-, and 6-month follow-ups.
Design and Participants This is a single-site, single-blind pilot RCT conducted at Peking University Sixth Hospital adolescent psychiatric ward. Forty-two adolescents (ages 13-18) admitted with recent suicidal ideation or attempt and elevated baseline shame will be recruited. Exclusion criteria include acute mania, psychotic disorders, severe cognitive impairment, or expected hospitalization shorter than 14 days. Eligible participants will be randomized (2:1) to SF-CBT (\~28) or ST (\~14).
Intervention
SF-CBT: Seven 50-60 minute individual sessions covering motivation building, emotion recognition and chain analysis, shame-coping strategies, self-esteem enhancement, and relapse prevention. Parents/guardians will attend 3 psychoeducation sessions on empathic communication, crisis management, and family boundary-setting, supported by AI-based scenario simulations.
Supportive Therapy (ST): Seven supportive counseling sessions focusing on emotional support and inpatient adjustment. Parent psychoeducation sessions identical to SF-CBT arm.
Outcomes
Primary outcomes: Feasibility (recruitment and retention rates, adherence, fidelity, adverse events) and acceptability (satisfaction ratings by adolescents, parents, therapists).
Secondary outcomes: Suicidal ideation and behavior (C-SSRS, SIQ), shame (EISS), and shame-coping (CoSS), assessed at baseline, post-treatment, and 1-, 3-, and 6-month follow-ups.
Analysis and Significance Feasibility benchmarks (e.g., ≥70% recruitment, ≥80% completion) will guide readiness for a full-scale RCT. Preliminary efficacy will be explored using multilevel models, with effect sizes reported to inform sample size estimation.
This pilot study will establish the feasibility and safety of SF-CBT in high-risk adolescent inpatients and provide initial evidence for its impact on shame and suicide risk. Results will directly inform a larger RCT and contribute to evidence-based, mechanism-driven suicide prevention strategies for adolescents.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Shame-Focused Cognitive Behavioral Therapy (SF-CBT)
Participants in this arm will receive Shame-Focused Cognitive Behavioral Therapy (SF-CBT), a structured individual intervention targeting maladaptive shame coping patterns. The intervention consists of 7 individual sessions (50-60 minutes each), focusing on motivation building, emotion identification, behavioral chain analysis, cognitive restructuring of shame-related self-criticism and withdrawal, development of healthy self-esteem, and relapse prevention. Additionally, caregivers will participate in 3 psychoeducation sessions covering empathic communication, crisis management, and boundary setting, supported by AI-based scenario practice.
Shame-Focused Cognitive Behavioral Therapy (SF-CBT)
A structured, manualized individual psychotherapy program consisting of 7 sessions (50-60 minutes each), delivered during hospitalization. The intervention includes modules on motivation building, emotional recognition, behavior chain analysis, shame coping strategies, self-esteem enhancement, and relapse prevention. In addition, caregivers participate in 3 psychoeducation sessions covering empathic communication, crisis response, and boundary management, supplemented by AI-assisted scenario simulations.
Active Comparator: Supportive Therapy (ST)
Participants in this arm will receive Supportive Therapy (ST), which emphasizes emotional support, therapeutic alliance, and adjustment to hospitalization. The intervention includes 7 individual sessions (50-60 minutes each) focusing on relationship building, emotional expression, and support for daily coping. Caregivers in this arm will also attend 3 psychoeducation sessions identical to those provided in the experimental group, covering empathic communication, crisis management, and boundary management.
Supportive Therapy (ST)
A supportive counseling program consisting of 7 sessions (50-60 minutes each), focusing on relationship building, emotional support, and adaptation to hospitalization. Caregivers in this arm also receive 3 psychoeducation sessions identical to those in the experimental arm, covering communication, crisis management, and boundary setting, with AI-assisted practice.
Interventions
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Shame-Focused Cognitive Behavioral Therapy (SF-CBT)
A structured, manualized individual psychotherapy program consisting of 7 sessions (50-60 minutes each), delivered during hospitalization. The intervention includes modules on motivation building, emotional recognition, behavior chain analysis, shame coping strategies, self-esteem enhancement, and relapse prevention. In addition, caregivers participate in 3 psychoeducation sessions covering empathic communication, crisis response, and boundary management, supplemented by AI-assisted scenario simulations.
Supportive Therapy (ST)
A supportive counseling program consisting of 7 sessions (50-60 minutes each), focusing on relationship building, emotional support, and adaptation to hospitalization. Caregivers in this arm also receive 3 psychoeducation sessions identical to those in the experimental arm, covering communication, crisis management, and boundary setting, with AI-assisted practice.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
13 Years
18 Years
ALL
No
Sponsors
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Peking University Sixth Hospital
OTHER
Peking University
OTHER
Responsible Party
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Yinyin Zang, PhD
Principle Investigator
Locations
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Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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wanyan hu
Role: primary
Other Identifiers
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IRB Approval No. 2025-69
Identifier Type: OTHER
Identifier Source: secondary_id
SF-CBT-YouthSuicide-2025
Identifier Type: -
Identifier Source: org_study_id