RecruitingNot ApplicableNCT07407946

Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

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

Sponsor

Umeå University

Enrollment

40 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

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

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combined form of trauma therapy for teenagers with PTSD (post-traumatic stress disorder). The approach blends in-person cognitive behavioral therapy (CBT) focused on trauma with digital tools and a compassion-focused component — and includes a caregiver in the process. **You may be eligible if...** - You are 12 to 17 years old - You have been diagnosed with PTSD based on a clinical interview - You score 25 or above on a trauma screening questionnaire (CATS-2) - You are receiving care within standard child and adolescent psychiatric services in a participating region - You have a non-offending caregiver willing to participate in parts of the treatment - You can communicate in Swedish well enough to engage in therapy **You may NOT be eligible if...** - You are currently at acute risk of suicide and need inpatient care - You have an active psychotic disorder or severe dissociation symptoms - You have autism spectrum disorder, severe eating disorder, or severe OCD that needs to be treated first - You are currently in an unsafe living situation or ongoing traumatic exposure - You have a substance use disorder requiring treatment or use benzodiazepines more than once a week - You are currently in another trauma-focused therapy or recently changed psychiatric medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBlended 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.

BEHAVIORALTrauma-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

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NCT07407946