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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorPeking University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adolescents aged 13-18 years, male or female.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Experimental: Shame-Focused Cognitive Behavioral Therapy (SF-CBT)Experimental treatment 1 intervention
Group B: Active Comparator: Supportive Therapy (ST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

The External and Internal Shame Scale, EISS

Shame will be measured using the External and Internal Shame Scale (EISS), which assesses two core dimensions of shame as a transdiagnostic emotion: external shame and internal shame. Both the subscales and total scores of the EISS demonstrate good internal consistency and concurrent validity and are significantly associated with depressive symptoms (Ferreira et al., 2022).

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

The Compass of Shame Scale (CoSS)

Coping or defensive strategies toward shame have a significant impact on psychological functioning. The Compass of Shame Scale (CoSS) will be used to assess four coping styles individuals employ when experiencing shame: attack self, withdrawal, attack others, and avoidance. Studies have shown that the CoSS has good reliability and validity, with internal consistency coefficients ranging from 0.74 to 0.91 across subscales (Elison et al., 2006).

Time frame
Baseline, Week 4, Month 2, Month 5, and Month 7
3

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

The Alexian Brothers Urge to Self-Injure Scale (ABUSI), which measures the severity of urges to engage in NSSI. The ABUSI shows good internal consistency, test-retest reliability, sensitivity to change, as well as convergent, predictive, and incremental validity (Washburn et al., 2010).

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

Deliberate Self-Harm Inventory (DSHI)

The Deliberate Self-Harm Inventory (DSHI), which assesses deliberate self-harming behaviors. The DSHI demonstrates high internal consistency and good structural, convergent, discriminant, and test-retest validity, supporting its reliability and validity as a measure of deliberate self-harm (Gratz, 2001).

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

Other outcomes

1

The Intervention Usability Scale (IUS)

The Intervention Usability Scale (IUS) (Aaron R. Lyon et al., 2021) will be used to assess therapists' perceptions of the usability of the intervention. Usability is defined as the degree to which a specific user can achieve goals effectively, efficiently, and satisfactorily in a given context. The IUS comprises two dimensions-Usability and Learnability-and demonstrates good internal consistency, with Cronbach's α coefficients of 0.83 (total), 0.84 (usability), and 0.67 (learnability), indicating acceptable reliability.

Time frame
Week 4

Sponsors and contacts

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Peking University

Lead sponsor

Peking University Sixth Hospital

Collaborator