Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT07407946

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

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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