JMIR Publications

ABSTRACT

Background:

Posttraumatic stress disorder (PTSD) affects up to 25% of trauma-exposed adolescents, yet access to evidence-based treatment remains limited in rural regions. Trauma-focused cognitive behavioral therapy (TF-CBT) is the first-line intervention, but structural barriers such as long travel distances and therapist shortages hinder implementation. Digital and blended formats may improve feasibility and accessibility, but evidence for adolescents with PTSD is scarce. Shame and self-criticism are common in interpersonal trauma and may affect engagement; compassion-focused strategies target these mechanisms and have the potential to enhance emotional safety.

Objective:

This protocol will describe a pilot randomized controlled trial (RCT) designed to evaluate the feasibility and acceptability of blended TF CBT with compassion (bTF CBT C) for adolescents with PTSD. The study will also explore preliminary patterns and variability in clinical outcomes to inform a future non-inferiority trial.

Methods:

A two-arm, parallel-group pilot RCT will randomize 40 adolescents (12–17 years) with DSM-5 PTSD to bTF-CBT-C or standard TF-CBT within routine child and adolescent psychiatric services. The blended intervention will integrate app-based stabilization modules with therapist-led video sessions and selected in-person sessions. Primary outcomes will assess feasibility (recruitment, retention, adherence, data completeness, adverse events) and acceptability (satisfaction, alliance, qualitative interviews). Exploratory clinical outcomes will include PTSD symptoms, self-compassion, emotion regulation, depression/anxiety/suicidality, and dissociation. Assessments will occur at baseline, post-stabilization, post-treatment, and 6-month follow-up. Analyses will summarize feasibility and acceptability descriptively; exploratory ANCOVA and mixed-effects models will estimate variability and preliminary effect sizes without hypothesis testing. Qualitative interviews will be analyzed using reflexive thematic analysis.

Results:

Recruitment is anticipated to start in spring 2026, and data collection will be completed by 2028. Feasibility and acceptability outcomes, alongside exploratory clinical patterns, will be reported in accordance with the CONSORT extension for pilot and feasibility trials.

Conclusions:

The findings will inform the refinement of the blended intervention, the feasibility of the trial procedures, and the selection of primary outcomes for a fully powered non-inferiority RCT. The study will contribute knowledge on how compassion-focused strategies may support emotional safety and engagement during trauma-focused treatment for adolescents. Clinical Trial: ClinicalTrials.gov ID:2024-07057-01MixadTFKBT.