Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

NCT07407946 | Recruiting

• 1 other identifier: EtikDnr2024-07057-01MixadTFKBT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

post-traumatic stress disorder (ptsd); Adolescent; Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Blended psychotherapy; Digital mental health; mHealth intervention; Compassion-focused therapy; Self-compassion; Emotion regulation; Shame and self-criticism; Caregiver involvement; Child and adolescent psychiatry; Rural mental health; Telehealth; Pilot randomized controlled trial

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Proportion of eligible adolescents who consent to participate.

  Baseline (enrollment, day 1)

• Retention Rate

  Proportion of enrolled participants completing post-stabilization, post-treatment, and 6-month follow-up assessments.

  Baseline (day 1), poststabilization (completion after an average of 5 weeks), post-treatment (study completion up to 25 weeks) up to 6 months

• 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.

  Post-stabilization (an average of 5 weeks) and post-treatment (study completion up to 25 weeks).

• Adverse Events

  Number and type of adverse events reported during the intervention.

  From baseline through treatment completion (up to 25 weeks) to 6 months follow up after study completion.

• Acceptability and User Experience (Qualitative Interviews)

  Semi-structured qualitative interviews will explore overall acceptability, perceived helpfulness, usability, burden, and user experience of the blended TF-CBT with compassion.

  Through study completion, up to 6 month follow up.

Secondary Outcomes (9)

• Treatment Satisfaction

  Post-treatment, study completion (up to 25 weeks).

• Therapeutic Alliance

  Post-treatment, study completion (up to 25 weeks).

• Post-traumatic stress disorder symptoms

  Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion)

• Post-traumatic stress disorder symptoms

  Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion)

• Emotion regulation difficulties

  Baseline, Post-stabilization (an average of 5 weeks), Post-treatment (study completion up to 25 weeks) and Follow-up (6 months after treatment completion)

Study Arms (2)

Blended TF-CBT with Compassion (bTF-CBT-C)

EXPERIMENTAL

Participants assigned to this arm receive blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies (bTF-CBT-C), delivered in a structured sequence combining therapist-led sessions and self-paced app-based modules. The intervention includes an initial clinic-based introduction with safety planning (C0), app-supported psychoeducation and compassion-based stabilization modules targeting emotion regulation and compassionate coping (C1-C5), therapist-led trauma narrative and cognitive processing delivered via videoconferencing and selected in-person sessions (C6), followed by in vivo mastery, conjoint caregiver-adolescent work, and future-oriented relapse prevention and recovery planning (C7-C9). Caregiver involvement follows TF-CBT principles and compassion-focused strategies and is integrated throughout treatment. Caregivers participate in the initial session and safety planning, complete parallel app-based modules during the stabilization phase.

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

Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

ACTIVE COMPARATOR

Participants assigned to this arm receive standard trauma-focused cognitive behavioral therapy (TF-CBT) delivered face-to-face and through videoconference in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, emotion regulation skills, 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.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Interventions

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

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.

Also known as: bTF-CBT-C, Blended TF-CBT with Compassion

Blended TF-CBT with Compassion (bTF-CBT-C)

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) BEHAVIORAL

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.

Also known as: TF-CBT

Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Forte: collaborator
• Visare Norr: collaborator
• Stiftelsen Kempe-Carlgrenska Fonden: collaborator
• Region Västerbotten: collaborator
• Region Norrbotten: collaborator

Study Sites (1)

Umeå University, Clinical Science, Child- and Adolescent Psychiatry

Umeå, 901 87, Sweden

RECRUITING

Related Publications (4)

• Wallin, L., Svedin, C.-G., Wiberg, M., & Dennhag, I. (2026). The Compassionate Engagement and Action Scale for Youths: psychometric properties in a clinical psychiatric Swedish sample [Original Research]. Frontiers in Psychology, Volume 16 - 2025. https://doi.org/10.3389/fpsyg.2025.1653979

  BACKGROUND

• Wallin, L., Lundqvist, U., Svedin, C.-G., & Dennhag, I. (2024). "Longing to be cared about and cared for" Exploring Experiences of Trauma Therapy and Views on Future Trauma Therapy (Including Digital) for Young People in Rural Northern Sweden. Children and Youth Services Review, 166, 107953. https://doi.org/https://doi.org/10.1016/j.childyouth.2024.107953

  BACKGROUND

• Vestin, M., Wallin, L., Naesstrom, M., Blomqvist, I., Svedin, C. G., Beaumont, E., Jokinen, J., & Dennhag, I. (2025). Internet-based group compassion-focused therapy for Swedish young people with stress, anxiety and depression: a pilot waitlist randomized controlled trial. Frontiers in Psychology, 16(1547046), 1547046. https://doi.org/10.3389/fpsyg.2025.1547046

  BACKGROUND

• Cohen, J., Mannarino, A., & Deblinger, E. (2017). Treating trauma and traumatic grief in children and adolescents. (2 ed.). The Guilford Press.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Inga Dennhag, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inga Dennhag, PhD

CONTACT

+46-706217414; inga.dennhag@umu.se

Linda Wallin, MD

CONTACT

+46-702101726; linda.wallin@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of psychological treatment, participants and care providers cannot be blinded to group assignment. Outcome assessors are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel-group, pilot randomized controlled design. Eligible adolescents are randomized in a 1:1 ratio to either the experimental blended intervention (bTF-CBT-C) or standard TF-CBT delivered in routine care. Randomization is stratified by geographic region and uses permuted blocks to ensure balance between groups. Participants remain in their assigned group throughout the study, and outcomes are assessed concurrently across groups at predefined time points.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 12, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)