Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• Recruitment rate — Baseline (enrollment, day 1)
  Proportion of eligible adolescents who consent to participate.
• Retention Rate — Baseline (day 1), poststabilization (completion after an average of 5 weeks), post-treatment (study completion up to 25 weeks) up to 6 months
  Proportion of enrolled participants completing post-stabilization, post-treatment, and 6-month follow-up assessments.
• Adherence to Treatment Components — Post-stabilization (an average of 5 weeks) and post-treatment (study completion up to 25 weeks).
  Adherence will be assessed as (1) the number of therapist-led sessions attended out of the planned total, and (2) the number of app-based modules (C0-C9) completed. Higher numbers reflect higher adherence.
• Adverse Events — From baseline through treatment completion (up to 25 weeks) to 6 months follow up after study completion.
  Number and type of adverse events reported during the intervention.
• Acceptability and User Experience (Qualitative Interviews) — Through study completion, up to 6 month follow up.
  Semi-structured qualitative interviews will explore overall acceptability, perceived helpfulness, usability, burden, and user experience of the blended TF-CBT with compassion.

Trial sites (1)

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