About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Treatment groups
Sponsors and collaborators
Umeå University
Lead sponsor
Region Västerbotten
Collaborator
Region Norrbotten
Collaborator
Forte
Collaborator
Visare Norr
Collaborator
Stiftelsen Kempe-Carlgrenska Fonden
Collaborator