Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUmeå University

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

40 Participants
are divided into 2 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