Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

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).

Conditions

• Post-traumatic Stress Disorder (PTSD)

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Region Västerbotten

  collaborator OTHER_GOV

• Region Norrbotten

  collaborator UNKNOWN

• Forte

  collaborator INDUSTRY

• Visare Norr

  collaborator UNKNOWN

• Stiftelsen Kempe-Carlgrenska Fonden

  collaborator UNKNOWN

• Umeå University

  lead OTHER

Principal Investigators

• Inga Dennhag, PhD · Umeå University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-23

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• Sweden

Study Locations