Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapist-supported internet-delivered trauma-focused CBT, 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver..
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder. Basic parameters: 13 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
Overview
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?
Interventions
- Behavioral 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. - 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.
Primary outcome measures
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA) [Time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion]
Secondary outcome measures (12)
- Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2) [Time frame: Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion]
- Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ) [Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion]
- Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS) [Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion]
- Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P) [Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion]
- Adverse events related to treatment measured by the Negative effects questionnaire [Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion]
- Quality of life measured by Assessment of Quality of Life KIDSCREEN-10 [Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion]
- Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). [Time frame: Immediately after treatment completion.]
- Number of completed treatment modules [Time frame: Baseline up to 12 weeks]
- Number of messages sent and received in the digital platform [Time frame: Baseline up to 12 weeks]
- Number of home work assignments made by the participant during the treatment period [Time frame: up to 12 weeks]
- The proportion of participants that conducts the weekly measures and further assessment points [Time frame: up to the 6 months follow up]
- The proportion of participants that go through the entire treatment period [Time frame: up to 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children — Stockholm
Publications
- Mattelin E, Weyler H, Andersson R, Paulsen J, Tielman S, Vikgren A, Bondjers K, Serlachius E, Mataix-Cols D, Bragesjo M. Feasibility and acceptability of therapist-guided, asynchronous, internet-delivered trauma-focused CBT for adolescents with PTSD: a single-group feasibility trial in Sweden. BMJ Open. 2026 May 27;16(5):e117024. doi: 10.1136/bmjopen-2026-117024. PMID 42203279
Identifiers
NCT: NCT06185244 · 2023-06501-01