A Pilot Randomized Controlled Trial Of Shame-Focused Cognitive Behavioral Therapy For Suicide Prevention In Adolescent Psychiatric Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The Columbia-Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
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.
详细描述
Adolescent suicide is a major public health concern in China and worldwide. Shame, a powerful and often overlooked psychological driver of suicide risk, has rarely been the focus of intervention efforts. This study introduces and tests Shame-Focused Cognitive Behavioral Therapy (SF-CBT), a manualized and structured therapy designed specifically to reduce shame, enhance adaptive coping, and mitigate suicide risk in high-risk inpatient adolescents.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
The Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Time Frame: Baseline, Week 4, Month 2, Month 5, and Month 7
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).
次要结局
- 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)
- The Generalized Anxiety Disorder-7 (GAD-7)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- Emotional Awareness Questionnaire, EAQ(Baseline, Week 4, Month 2, Month 5, and Month 7)
- A self-developed Adolescent Irritability Scale(Baseline, Week 4, Month 2, Month 5, and Month 7)
- Rosenberg Positive Self-Esteem Scale, RSES(Baseline, Week 4, Month 2, Month 5, and Month 7)
- Instability of Self-Esteem Scale, ISES(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The Self-Compassion Scale-Youth Version (SCS-Y)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The 2-Way Social Support Scale (2-Way SSS)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The Patient Health Questionnaire-15 (PHQ-15)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The State Hopelessness Scale(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The Chinese version of the Difficulties in Emotion Regulation Scale (DERS)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- the catastrophizing subscale of the Cognitive Emotion Regulation Questionnaire (CERQ)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- A self-developed Adult Alexithymia Scale(Baseline, Week 4, Month 2, Month 5, and Month 7)
- A self-developed Adult Irritability Scale(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The Family Attitude Scale (FAS)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- The Caregiver Strain Questionnaire (CSQ)(Baseline, Month 2, Month 5, and Month 7)
- An adapted version of the Intervention Usability Scale (IUS)(Week 4)
- laboratory assessments and peripheral venous blood collection(Baseline, Week 4)
- Sheehan Disability Scale (SDS)(Baseline, Week 4, Month 2, Month 5, and Month 7)
- Clinical Global Impression - Efficacy Index (CGI-E)(Week 4)
- the Client Satisfaction Questionnaire (CSQ)(Week 4)
- the Working Alliance Inventory (WAI)(Week 4)
- an adapted version of the Working Alliance Inventory (WAI)(Week 4)
- CGI-Improvement (CGI-I)(Week 4)
研究者
Yinyin Zang, PhD
Principle Investigator
Peking University