Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Recruiting now · Not applicable
Conditions studied: Post-traumatic Stress Disorder (PTSD)
In brief
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).
Key facts
- Study ID
- NCT07407946
- Run by
- Umeå University
- People needed
- 40
- Starts
- 2026-02-23
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Have a non-offending caregiver willing and able to participate in caregiver components of treatment.
- Able to communicate in Swedish sufficiently to engage in treatment and assessments.
- Provide informed assent/consent, with caregiver consent according to age and regulations.
You may not qualify if…
- 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.
- Cognitive impairment or medical condition that precludes participation in psychotherapy or digital components.
- Substance use disorder requiring treatment, or regular use of benzodiazepines (> once per week).
- Concurrent trauma-focused psychotherapy or recent initiation/discontinuation of psychotropic medication (within the past 6 weeks), or planned medication changes during the study period.
Where it is running
- Umeå University, Clinical Science, Child- and Adolescent Psychiatry — Umeå, Sweden (enrolling)
Full record on ClinicalTrials.gov
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