Shame-Focused Cognitive Behavioral Therapy For Reducing Suicide Risk In Adolescent Psychiatric Inpatients (SF-CBT)

NCT07294001 | Recruiting DMC

• 2 other identifiers: SF-CBT-YouthSuicide-2025IRB Approval No. 2025-69
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Suicide; Suicidal Ideation; Suicidal Behavior; Shame

Keywords

Adolescents; Suicide Prevention; Suicidal Ideation; Suicidal Behavior; Shame; Cognitive Behavioral Therapy (CBT); Shame-Focused Cognitive Behavioral Therapy (SF-CBT); Randomized Controlled Trial (RCT); Feasibility Study; Pilot Trial; Psychiatric Inpatient

Outcome Measures

Primary Outcomes (2)

• The Columbia-Suicide Severity Rating Scale (C-SSRS)

  It will be used to assess suicidal ideation and suicidal behaviors (Posner et al., 2011). The C-SSRS is widely utilized in suicide risk assessment. It evaluates several aspects, including the presence of a suicide attempt, an interrupted attempt (prevented by external factors), an aborted attempt (self-terminated by the individual), preparatory or related suicidal behaviors, and lethality ratings. The actual lethality is rated on a 6-point scale. The potential lethality is rated on a 3-point scale (if actual lethality = 0), where 0 = "behavior unlikely to result in injury," and 2 = "likely to result in death even with medical intervention." Additionally, the presence of non-suicidal self-injury (NSSI) will be assessed, as it is associated with future suicide attempt risk. it is highly sensitive in detecting changes in suicidal behavior during treatment and can predict future suicidal behaviors and readmission(Ji et al., 2023).

  Time Frame: Baseline, Week 4, Month 2, Month 5, and Month 7

• The Columbia-Suicide Severity Rating Scale (C-SSRS)

  The C-SSRS will also be used to evaluate suicidal ideation and intent, with assessment time points identical to those above. Two subscales will be extracted for this study: Severity: Scores range from 1 to 5, representing "wish to be dead," "non-specific active suicidal thoughts," "suicidal thoughts with method," "suicidal intent," and "suicidal intent with a specific plan," respectively. Intensity: Evaluates the frequency, duration, controllability, deterrents, and reasons for suicidal ideation.

  Time Frame: Baseline, Week 4, Month 2, Month 5, and Month 7

Secondary Outcomes (28)

• The External and Internal Shame Scale, EISS

  Baseline, Week 4, Month 2, Month 5, and Month 7

• The Compass of Shame Scale (CoSS)

  Baseline, Week 4, Month 2, Month 5, and Month 7

• The Alexian Brothers Urge to Self-Injure Scale (ABUSI)

  Baseline, Week 4, Month 2, Month 5, and Month 7

• Deliberate Self-Harm Inventory (DSHI)

  Baseline, Week 4, Month 2, Month 5, and Month 7

• Patient Health Questionnaire-9, PHQ-9

  Baseline, Week 4, Month 2, Month 5, and Month 7

Other Outcomes (1)

• The Intervention Usability Scale (IUS)

  Week 4

Study Arms (2)

Experimental: Shame-Focused Cognitive Behavioral Therapy (SF-CBT)

EXPERIMENTAL

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.

Behavioral: Shame-Focused Cognitive Behavioral Therapy (SF-CBT)

Active Comparator: Supportive Therapy (ST)

ACTIVE COMPARATOR

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.

Behavioral: Supportive Therapy (ST)

Interventions

Shame-Focused Cognitive Behavioral Therapy (SF-CBT) BEHAVIORAL

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.

Experimental: Shame-Focused Cognitive Behavioral Therapy (SF-CBT)

Supportive Therapy (ST) BEHAVIORAL

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.

Active Comparator: Supportive Therapy (ST)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University: lead
• Peking University Sixth Hospital: collaborator

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100871, China

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Suicide Prevention

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Wanyan Hu, PhD Candidate

CONTACT

86 13071171218; 2301110717@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses a single-blind design. Only the independent outcomes assessors are masked to treatment allocation. Participants, care providers, and investigators are aware of group assignments due to the nature of the intervention. Outcome assessors remain blinded throughout baseline, post-treatment, and follow-up assessments to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This is a randomized, parallel-group pilot trial. Participants will be allocated in a 2:1 ratio to receive either Shame-Focused Cognitive Behavioral Therapy (SF-CBT) plus parent sessions or supportive therapy plus parent sessions. Both groups will undergo 7 individual sessions and 3 parent sessions during hospitalization, followed by follow-up assessments at 1, 3, and 6 months.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 19, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

CN (1)