Clinical Research Directory
Browse clinical research sites, groups, and studies.
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Sponsor: Umeå University
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).
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
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-23
Completion Date
2029-12-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Umeå University, Clinical Science, Child- and Adolescent Psychiatry
Umeå, Sweden