Blended trauma-focused CBT with compassion for adolescents with PTSD
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
This trial will test whether a blended program combining an app and face-to-face trauma-focused CBT with added compassion elements helps adolescents (12–17) with PTSD compared with standard TF-CBT.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Trial ID | NCT07407946 on ClinicalTrials.gov |
What this trial studies
This is a two-arm, pilot randomized trial comparing a blended mHealth Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) to standard TF-CBT delivered in routine child and adolescent psychiatry in northern Sweden. Adolescents aged 12–17 who meet DSM-5 criteria for PTSD and a symptom threshold on the CATS-2 are randomized 1:1, with stratification by region, to receive either the blended or standard format. The main goals are to test feasibility and acceptability using recruitment, retention, adherence to sessions and app modules, data completeness, adverse events, and satisfaction measures, while also collecting preliminary clinical outcomes such as PTSD symptoms, emotion regulation, and self-compassion. Therapists and participants are unblinded due to the nature of psychological treatment, and the results will inform a future fully powered non-inferiority trial if promising.
Who should consider this trial
Good fit: Ideal candidates are Swedish-speaking adolescents aged 12–17 receiving care in participating child and adolescent psychiatry clinics in Regions Västerbotten or Norrbotten who meet DSM-5 PTSD criteria, score ≥25 on the CATS-2, and have a non-offending caregiver willing to join treatment components.
Not a fit: Patients with acute suicidality requiring inpatient care, active psychosis or severe dissociation, autism spectrum disorder or other primary conditions needing specialized treatment, ongoing trauma exposure, or unstable living conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the blended format could expand access to evidence-based PTSD care in rural areas by reducing travel burden and maintaining or improving treatment outcomes.
How similar studies have performed: Standard TF-CBT is a well-established first-line treatment for youth PTSD, and early studies of blended or digital TF-CBT show promising feasibility and acceptability but remain limited compared with face-to-face evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Umeå
- Umeå University, Clinical Science, Child- and Adolescent Psychiatry — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Inga Dennhag, PhD — Umeå University
- Study coordinator: Inga Dennhag, PhD
- Email: inga.dennhag@umu.se
- Phone: +46-706217414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.