NCT07407946

Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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. The digital components are delivered using the CE-marked Amnicare mobile application. Videoconferencing is delivered via GDPR-compliant platforms used in routine care (e.g., Visiba Care and Platform24). Participants use their own smartphone/tablet; technical support is available through the clinic. Control arm: standard TF-CBT Participants allocated to the control arm receive standard TF-CBT delivered face-to-face and with videoconference in routine care by clinicians trained in TF-CBT, including the core PRACTICE components and caregiver involvement in line with the manual. Usual clinical flexibility regarding number of sessions and pacing is retained, consistent with routine care delivery. Assessments and follow-up The trial includes assessments at baseline, after completion of the stabilization phase, post-treatment, and at 6-month follow-up. In addition, brief weekly process measures are collected during the intervention period to capture engagement, alliance, usability/experience of digital components (where applicable), and key mechanism-relevant processes (e.g., shame/guilt-related responses). Qualitative interviews with adolescents, caregivers, and therapists are conducted during and/or after treatment to capture experiences of the blended format, perceived helpfulness and burden, and recommendations for refinement. Safety and risk management A structured safety plan is developed with each adolescent and caregiver prior to the digital stabilization phase. Risk and emotional safety are monitored weekly through brief self-report items. Any indication of increased risk triggers clinician follow-up according to routine CAP procedures. Videoconferencing sessions follow a predefined protocol for interrupted calls (immediate reconnection attempts, phone contact, and escalation to welfare checks/emergency procedures as clinically indicated). Adverse events and serious adverse events are documented in a study safety log and reviewed in supervision. Data management and confidentiality Study data are pseudonymized and stored on secure, access-restricted servers. Data transfer from digital components uses encrypted channels and complies with GDPR and institutional requirements for sensitive personal data. Only authorized members of the research team have access to identifiable data. Statistical approach (pilot focus) Analyses will follow intention-to-treat principles. Feasibility and acceptability indicators will be summarized descriptively (e.g., proportions, means, and confidence intervals). Exploratory models (e.g., baseline-adjusted ANCOVA and/or mixed-effects models) will be used to describe symptom trajectories and estimate variability and preliminary effect size ranges for planning the future non-inferiority trial; the study is not powered for formal effectiveness testing. Qualitative interviews will be analyzed using reflexive thematic analysis. Progression criteria Predefined progression criteria will guide decisions about moving to a fully powered non-inferiority trial, focusing on recruitment, retention, acceptability, and data completeness thresholds consistent with pilot and feasibility trial guidance. Findings will be used to refine trial procedures, therapist training/support, and the blended intervention structure prior to scale-up.

Conditions

• Post-traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
BEHAVIORAL	Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)	Blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies, combining therapist-led videoconferencing and selected in-person sessions with self-paced app-based modules. The intervention includes an initial introduction and safety planning, a stabilization phase with digital psychoeducation and compassion-based emotion regulation skills, therapist-led trauma narrative and cognitive processing, and a recovery phase focusing on in vivo mastery, caregiver-adolescent conjoint work, and relapse prevention. Caregivers participate throughout treatment, including parallel app-based modules during stabilization and selected therapist-led sessions.
BEHAVIORAL	Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)	Standard trauma-focused cognitive behavioral therapy delivered face-to-face in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, affect regulation, 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.

Timeline

• Start date: 2026-02-23
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-27

Locations

1 site across 1 country: Sweden