Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUmeå University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)
BehavioralBlended 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.
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
BehavioralStandard 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Blended TF-CBT with Compassion (bTF-CBT-C)Experimental treatment 1 intervention
Group B: Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Proportion of eligible adolescents who consent to participate.
Time frame
Baseline (enrollment, day 1)2
Retention Rate
Proportion of enrolled participants completing post-stabilization, post-treatment, and 6-month follow-up assessments.
Time frame
Baseline (day 1), poststabilization (completion after an average of 5 weeks), post-treatment (study completion up to 25 weeks) up to 6 months3
Adherence to Treatment Components
Adherence will be assessed as (1) the number of therapist-led sessions attended out of the planned total, and (2) the number of app-based modules (C0-C9) completed. Higher numbers reflect higher adherence.
Time frame
Post-stabilization (an average of 5 weeks) and post-treatment (study completion up to 25 weeks).4
Adverse Events
Number and type of adverse events reported during the intervention.
Time frame
From baseline through treatment completion (up to 25 weeks) to 6 months follow up after study completion.Secondary outcomes
1
Treatment Satisfaction
Overall treatment satisfaction will be assessed using a single-item rating scale where adolescents rate their satisfaction with the blended TF-CBT with compassion. Higher scores indicate greater satisfaction.
Time frame
Post-treatment, study completion (up to 25 weeks).2
Therapeutic Alliance
Therapeutic alliance will be assessed using a brief alliance scale based on goals, tasks, and bond. Higher scores indicate stronger alliance.
Time frame
Post-treatment, study completion (up to 25 weeks).3
Post-traumatic stress disorder symptoms
PTSD symptoms will be assessed using the Child and Adolescent Trauma Screen (CATS-2). CATS-2 includes three subscales: (1) Traumatic Events (15 items, score range 0-15; higher scores indicate more trauma exposure), (2) Posttraumatic Stress Symptoms (20 items, score range 0-60; higher scores indicate more severe PTSD symptoms), and (3) Functional Impairment (5 items, score range 0-5; higher scores indicate greater impairment).
Time frame
Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion)4
Post-traumatic stress disorder symptoms
Post-traumatic stress symptoms will also be assessed using the Children's Revised Impact of Event Scale - 13 items (CRIES-13). The CRIES-13 includes 13 items rated on a 4-point scale (0 = not at all, 1 = rarely, 3 = sometimes, 5 = often), with a total score range of 0-65. The scale comprises three subscales: Intrusion, Avoidance, and Arousal. Higher scores indicate more severe post-traumatic stress reactions. A total score ≥30 is considered indicative of clinically significant PTSD risk.
Time frame
Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion)Sponsors and contacts
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Umeå University
Lead sponsor
Region Västerbotten
Collaborator
Region Norrbotten
Collaborator
Forte
Collaborator
Visare Norr
Collaborator
Stiftelsen Kempe-Carlgrenska Fonden
Collaborator
Source ClinicalTrials.gov