Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
brief summary
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).
detailed description
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:
1. 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. 2. 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. 3. 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.
official title
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