Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD

Last updated: March 10, 2024
Sponsor: Karolinska Institutet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.

Therapist-supported internet-delivered trauma-focused CBT

Clinical Study ID

NCT06185244
2023-06501-01
  • Ages 13-17
  • All Genders

Study Summary

The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness.

Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 13-17 years,
  • Primary PTSD diagnosis
  • Fluent in Swedish
  • Access to the Internet at home or can use vouchers for internet-access to their phone.
  • Parent/guardian willing and able to take part in treatment.

Exclusion

Exclusion Criteria:

  • PTSD is not the primary concern
  • Initiation or adjustment of any psychotropic medication within the last 4 weeks priorto commencement of treatment
  • Serious mental health symptoms, such as mania, psychosis, alcohol, or substance usedisorders or current suicide risk warranting immediate clinical attention.
  • Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing Therapy
  • Ongoing trauma-related threat

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
January 04, 2028

Study Description

There is an urgent need for evidence-based treatments for children with PTSD that can easily be made available to a large number of afflicted. The overall aim of the project is to increase the availability of evidence-based psychological treatments for adolescents with PTSD by developing and evaluating iTF-CBT for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of iTF-CBT for adolescents with PTSD in an RCT (N=140) by comparing guided iTF-CBT with an attention control group consisting of therapist-supported internet-delivered psychoeducation and support.

The study is a single-blind, parallel-group superiority randomized controlled trial with 240 patients (120 per arm) that will compare therapist-guided internet delivered trauma-focused cognitive behavior CBT with therapist-guided internet delivered cognitive-behavioral therapy comprising relaxation and psychoeducation. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-CA). An internal pilot is built in in the design and the first 20 enrolled participants will not be randomized but receive the active intervention. They will also be asked to participate in qualitative interviews about their experience of the intervention.

Secondary outcomes are cost effectiveness, predictors of clinically meaningful change in symptoms, mediators of change, dropout rate, and negative effects.

Research questions:

  1. Is guided iTF-CBT more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?

  2. Is guided iTF-CBT more cost-effective than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?

  3. Are the therapeutic gains of iTF-CBT maintained at long term follow up (6 and 12 months after treatment)?

  4. How do children, parents and therapists perceive iTF-CBT?

Connect with a study center

  • Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children

    Stockholm,
    Sweden

    Active - Recruiting

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