The Compassionate Engagement and Action Scale for Youths: psychometric properties in a clinical psychiatric Swedish sample.
Linda Wallin, Carl-Göran Svedin, Marie Wiberg...
https://pubmed.ncbi.nlm.nih.gov/41561593Actively Recruiting
Phase Not Applicable
Age: 12Years - 17Years
All Genders
ID07407946
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
Led by Umeå University · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a blended form of Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) for adolescents aged 12 to 17 years who have post-traumatic stress disorder (PTSD). This trial aims to see if delivering this therapy using both digital tools and therapist sessions is feasible and acceptable in routine child and adolescent psychiatric care in northern Sweden. The study compares this blended therapy with standard TF-CBT to explore clinical outcomes like PTSD symptoms, emotion regulation, and self-compassion. Participants are randomly assigned to either the blended bTF-CBT-C or standard TF-CBT. The blended therapy includes an initial clinic session, app-based stabilization modules with exercises, therapist-led video sessions, and some in-person meetings when needed. The standard TF-CBT is delivered face-to-face and through videoconference, following established treatment components and caregiver involvement. Both treatments focus on trauma processing and involve caregivers throughout. The study is conducted in public psychiatric clinics, with randomization stratified by region. Participants complete assessments at baseline, after stabilization, post-treatment, and six months after finishing treatment. These include diagnostic interviews, questionnaires, brief weekly measures of engagement and mood, and qualitative interviews about their experience. Researchers monitor recruitment, retention, treatment adherence, adverse events, and satisfaction. Safety plans and risk monitoring are integrated, and study data are securely managed. The total treatment period lasts up to 25 weeks, with follow-up continuing to six months post-treatment.
CONDITIONS
Brief Title
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Who Can Participate
Age: 12Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12-17 years
- Diagnosed with post-traumatic stress disorder (PTSD) confirmed by diagnostic interview
- Score 25 or higher on the Child and Adolescent Trauma Screen (CATS-2) at baseline
- Receiving care in routine child and adolescent psychiatric services in participating regions
- Have a non-offending caregiver willing and able to participate in treatment
- Able to communicate in Swedish to engage in treatment and assessments
- Provide informed assent/consent with caregiver consent as required
You will not qualify if you...
- Acute suicidality or risk requiring inpatient care
- Active psychotic disorder or severe dissociative symptoms interfering with participation
- Autism spectrum disorder, severe eating disorder, or obsessive-compulsive disorder requiring specialized treatment
- Ongoing trauma exposure or unstable living conditions preventing safe participation
- Cognitive impairment or medical condition preventing psychotherapy or digital participation
- Substance use disorder requiring treatment or regular benzodiazepine use (more than once per week)
- Currently receiving trauma-focused psychotherapy or recent changes in psychotropic medication (within 6 weeks), or planned medication changes during the study period
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Up to 25 weeks
Participants undergo trauma-focused cognitive behavioral therapy delivered either as a blended intervention combining therapist-led sessions, videoconferencing, and app-based modules with compassion-focused strategies, or as standard face-to-face and videoconference therapy. Treatment includes stabilization with psychoeducation and skills training, trauma processing, and integration and recovery phases involving caregiver participation.
Weekly therapist-led sessions via videoconference or in-person, with additional self-paced app modules for participants in the blended therapy arm
Follow-up
Duration - 6 months
Participants are monitored after treatment completion to assess long-term outcomes including symptom changes, treatment satisfaction, and safety.
1 follow-up visit at 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Umeå University, Clinical Science, Child- and Adolescent Psychiatry
Umeå, Sweden, 901 87
Actively Recruiting
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Research Team
I
Inga Dennhag, PhD
L
Linda Wallin, MD
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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Published Research Related To This Trial
Internet-based group compassion-focused therapy for Swedish young people with stress, anxiety and depression: a pilot waitlist randomized controlled trial.
Magnus Vestin, Linda Wallin, Matilda Naesström...
https://pubmed.ncbi.nlm.nih.gov/40236966