Clinical Trial

Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

Study acronym: b-TF-CBT-C
Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-05.
Status change: Not Yet Recruiting → Recruiting 2026-02-24
Trial Details
NCT Number NCT07407946
Lead Sponsor Umeå University
Collaborators: Region Västerbotten, Region Norrbotten, Forte, Visare Norr, Stiftelsen Kempe-Carlgrenska Fonden
Conditions Post-traumatic Stress Disorder (PTSD)
Enrollment 40 participants
Start Date 2026-02-23
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-27