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

Karolinska Institute

Status: Enrolling

Conditions: Posttraumatic Stress Disorder

Treatments: Behavioral: Therapist-supported internet-delivered trauma-focused CBT; Behavioral: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06185244

2023-06501-01

Details and patient eligibility

About

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.

Full 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?

Enrollment: 240 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Therapist-supported internet delivered trauma-focused CBT

Experimental group

Description:

Therapist-supported internet delivered trauma-focused CBT. The protocol mirrors the exact content of first-line treatment for children with PTSD but is delivered through a digital platform and will comprise of text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. iTF-CBT will be therapist-assisted, and each participant will have a designated therapist to guide them through treatment. Treatment will span over 12 weeks and integrates cognitive, behavioral, interpersonal, and family therapy principles as well as trauma interventions. Parallel to the child's treatment, the caregivers are provided the same components and parenting practices, and joint child-parent activities are included. Participants will have access to a therapist that will guide them through treatment in a text based format.

Treatment:

Behavioral: Therapist-supported internet-delivered trauma-focused CBT

Therapist-supported psychoeducation and stress management

Active Comparator group

Description:

Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation/stress management techniques and relapse prevention. The treatment will be delivered in a digital platform for twelve weeks. Participants will have access to a therapist that will guide them through treatment in a text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially.

Treatment:

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