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

NCT ID: NCT06185244

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2028-01-04

Brief 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.

Detailed 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?

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapist-supported internet delivered trauma-focused CBT

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.

Group Type: EXPERIMENTAL

Therapist-supported internet-delivered trauma-focused CBT

Intervention Type: BEHAVIORAL

12 weeks of therapist-supported internet-delivered trauma-focused CBT for both the youth and the care giver.

Therapist-supported psychoeducation and stress management

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

Therapist-supported internet-delivered trauma-focused CBT

12 weeks of therapist-supported internet-delivered trauma-focused CBT for both the youth and the care giver.

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Child and Adolescent Psychiatry, Stockholm

INDUSTRY

Sponsor Role: collaborator

Save the Children

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Maria Bragesjo

PhD, clinical psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Bragesjö, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet/Region Stockholm

Locations

Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Maria Bragesjö

Role: CONTACT

maria.bragesjo@ki.se

+46(0)703399387

Erica Mattelin

Role: CONTACT

erica.mattelin@rb.se

Facility Contacts

Maria Bragesjö, PhD

Role: primary

Other Identifiers

2023-06501-01

Identifier Type: -

Identifier Source: org_study_id