RecruitingNot ApplicableNCT07407946

Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

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

Sponsor

Umeå University

Enrollment

40 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder (PTSD)

Summary

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).

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria7

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 Criteria7

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.

Interventions

BEHAVIORALBlended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)

Blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies, combining therapist-led videoconferencing and selected in-person sessions with self-paced app-based modules. The intervention includes an initial introduction and safety planning, a stabilization phase with digital psychoeducation and compassion-based emotion regulation skills, therapist-led trauma narrative and cognitive processing, and a recovery phase focusing on in vivo mastery, caregiver-adolescent conjoint work, and relapse prevention. Caregivers participate throughout treatment, including parallel app-based modules during stabilization and selected therapist-led sessions.

BEHAVIORALTrauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Standard trauma-focused cognitive behavioral therapy delivered face-to-face in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, affect regulation, cognitive coping, trauma narrative and processing, in vivo exposure, conjoint caregiver-adolescent sessions, and safety planning, with caregiver involvement according to the TF-CBT manual.