Blended (mHealth) Trauma-Focused Cognitive Behavioral Therapy With Compassion for Adolescents With Post-Traumatic Stress Disorder: Protocol for a Pilot Randomized Controlled Trial in Northern Sweden
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Brief Summary
The goal of this clinical trial is to evaluate the feasibility and acceptability of a blended (mHealth) Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) for adolescents with post-traumatic stress disorder (PTSD) in routine child and adolescent psychiatric services in northern Sweden. The main questions it aims to answer are:
- Is bTF-CBT-C feasible to deliver in routine care, as indicated by recruitment, retention, adherence to sessions and app modules, data completeness, and adverse events?
- Is bTF-CBT-C acceptable to adolescents, caregivers, and therapists, as indicated by satisfaction, therapeutic alliance, digital treatment evaluation, and qualitative interviews? Researchers will compare bTF-CBT-C to standard TF-CBT to explore whether the blended format shows similar or potentially improved patterns in clinical outcomes (e.g., PTSD symptoms, emotion regulation, and self-compassion) and to estimate variability needed to plan a future non-inferiority trial.
Participants will:
- Complete eligibility screening and baseline assessments, including a diagnostic interview for PTSD.
- Be randomized to either bTF-CBT-C or standard TF-CBT.
- Receive trauma-focused treatment over time, with caregiver involvement in both groups.
- In the bTF-CBT-C group, use a secure mobile app for stabilization modules and exercises, together with therapist-led video sessions and selected in-person meetings.
- Complete assessments at baseline, after stabilization, post-treatment, and at 6-month follow-up, and provide feedback about their experiences (questionnaires and interviews).
详细描述
Detailed Description This study is a two-arm, parallel-group, pilot randomized controlled trial designed to evaluate the delivery of a blended (mHealth) Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) for adolescents with post-traumatic stress disorder (PTSD) within routine child and adolescent psychiatric services in northern Sweden. The trial primarily targets feasibility and acceptability of trial procedures and intervention delivery in real-world clinical settings, and will generate preliminary estimates of variability in key clinical and mechanism-related measures to inform the design of a subsequent fully powered non-inferiority trial.
Design and setting The trial will be conducted in publicly funded child and adolescent psychiatry (CAP) clinics in Regions Västerbotten and Norrbotten, Sweden. Participants will be randomized 1:1 to bTF-CBT-C (experimental) or standard TF-CBT (control). Randomization will be generated by an independent researcher using permuted blocks (block size 4) and stratified by geographic region. Allocation concealment will be maintained using sequentially numbered sealed opaque envelopes. Due to the nature of psychological treatment, participants and therapists cannot be blinded.
Intervention rationale and structure Standard TF-CBT is the recommended first-line psychological treatment for youth PTSD, but access in rural regions is challenged by long travel distances and limited therapist availability. bTF-CBT-C has been developed to reduce structural barriers while maintaining therapeutic alliance and emotional safety, with particular attention to shame and self-criticism commonly present after interpersonal trauma. The intervention follows the TF-CBT PRACTICE framework and integrates compassion-focused strategies intended to support engagement and reduce threat-based responding during trauma-focused work.
Experimental arm: bTF-CBT-C (blended TF-CBT with compassion) bTF-CBT-C combines (1) an initial therapist-led clinic session, (2) self-paced app-based stabilization modules with between-session practice, (3) therapist-led videoconferencing sessions, and (4) selected in-person sessions when clinically indicated. The intervention is delivered across three overarching phases:
- Stabilization (Modules C0-C5): app-based psychoeducation and skills training for adolescents and caregivers (e.g., emotion regulation strategies and compassion-based practices such as soothing rhythm breathing and compassionate imagery). The stabilization phase is supported by therapist check-ins (video) and clinic routines, and includes an individualized safety plan developed together with the adolescent and caregiver.
- Trauma processing (Module C6): therapist-led trauma narration and cognitive processing using TF-CBT procedures, delivered primarily via secure videoconferencing and supplemented with in-person sessions as needed. Compassion-focused strategies are used to address shame and self-criticism and to support emotional safety and approach behavior during trauma-focused work.
- Integration and recovery (Modules C7-C9): consolidation of gains, in-vivo mastery/exposure planning where relevant, conjoint caregiver-adolescent work, and future-oriented relapse prevention supported by compassionate imagery and values-consistent planning.
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
Due to the nature of psychological treatment, participants and care providers cannot be blinded to group assignment. Outcome assessors are blinded to treatment allocation.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12-17 years.
- •Meet DSM-5 criteria for post-traumatic stress disorder (PTSD) confirmed by diagnostic interview (MINI-KID).
- •Score ≥25 on the Child and Adolescent Trauma Screen (CATS-2) at baseline.
- •Receiving care within routine child and adolescent psychiatric services in participating regions.
- •Have a non-offending caregiver willing and able to participate in caregiver components of treatment.
- •Able to communicate in Swedish sufficiently to engage in treatment and assessments.
- •Provide informed assent/consent, with caregiver consent according to age and regulations.
排除标准
- •Acute suicidality or risk requiring inpatient care.
- •Active psychotic disorder or severe dissociative symptoms that interfere with participation.
- •Autism spectrum disorder, severe eating disorder, or obsessive-compulsive disorder requiring primary specialized treatment.
- •Ongoing trauma exposure or unstable living conditions that would prevent safe participation.
- •Cognitive impairment or medical condition that precludes participation in psychotherapy or digital components.
- •Substance use disorder requiring treatment, or regular use of benzodiazepines (> once per week).
- •Concurrent trauma-focused psychotherapy or recent initiation/discontinuation of psychotropic medication (within the past 6 weeks), or planned medication changes during the study period.
研究组 & 干预措施
Blended TF-CBT with Compassion (bTF-CBT-C)
Participants assigned to this arm receive blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies (bTF-CBT-C), delivered in a structured sequence combining therapist-led sessions and self-paced app-based modules. The intervention includes an initial clinic-based introduction with safety planning (C0), app-supported psychoeducation and compassion-based stabilization modules targeting emotion regulation and compassionate coping (C1-C5), therapist-led trauma narrative and cognitive processing delivered via videoconferencing and selected in-person sessions (C6), followed by in vivo mastery, conjoint caregiver-adolescent work, and future-oriented relapse prevention and recovery planning (C7-C9).
Caregiver involvement follows TF-CBT principles and compassion-focused strategies and is integrated throughout treatment. Caregivers participate in the initial session and safety planning, complete parallel app-based modules during the stabilization phase.
干预措施: Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) (Behavioral)
Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Participants assigned to this arm receive standard trauma-focused cognitive behavioral therapy (TF-CBT) delivered face-to-face and through videoconference in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, emotion regulation skills, cognitive coping, trauma narrative and processing, in vivo exposure, conjoint caregiver-adolescent sessions, and safety planning, with caregiver involvement according to the TF-CBT manual.
干预措施: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Baseline (enrollment, day 1)
Proportion of eligible adolescents who consent to participate.
Retention Rate
时间窗: Baseline (day 1), poststabilization (completion after an average of 5 weeks), post-treatment (study completion up to 25 weeks) up to 6 months
Proportion of enrolled participants completing post-stabilization, post-treatment, and 6-month follow-up assessments.
Adherence to Treatment Components
时间窗: Post-stabilization (an average of 5 weeks) and post-treatment (study completion up to 25 weeks).
Adherence will be assessed as (1) the number of therapist-led sessions attended out of the planned total, and (2) the number of app-based modules (C0-C9) completed. Higher numbers reflect higher adherence.
Adverse Events
时间窗: From baseline through treatment completion (up to 25 weeks) to 6 months follow up after study completion.
Number and type of adverse events reported during the intervention.
Acceptability and User Experience (Qualitative Interviews)
时间窗: Through study completion, up to 6 month follow up.
Semi-structured qualitative interviews will explore overall acceptability, perceived helpfulness, usability, burden, and user experience of the blended TF-CBT with compassion.
次要结局
- Treatment Satisfaction(Post-treatment, study completion (up to 25 weeks).)
- Therapeutic Alliance(Post-treatment, study completion (up to 25 weeks).)
- Post-traumatic stress disorder symptoms(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))
- Emotion regulation difficulties(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))
- Self-compassion(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))
- Depression(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))
- Dissociative symptoms(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))
- Depression and anxiety(Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion))