Actively Recruiting
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Led by Umeå University · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12-17 years
- Meet DSM-5 criteria for post-traumatic stress disorder (PTSD) confirmed by diagnostic interview (MINI-KID)
- Score 25 or higher 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 will not qualify if you...
- 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 (more than 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Umeå University, Clinical Science, Child- and Adolescent Psychiatry
Umeå, Sweden, 901 87
Actively Recruiting
Research Team
I
Inga Dennhag, PhD
CONTACT
L
Linda Wallin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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