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

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?

• Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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). [Срок оценки: Immediately after treatment completion.]
• Number of completed treatment modules [Срок оценки: Baseline up to 12 weeks]
• Number of messages sent and received in the digital platform [Срок оценки: Baseline up to 12 weeks]
• Number of home work assignments made by the participant during the treatment period [Срок оценки: up to 12 weeks]
• The proportion of participants that conducts the weekly measures and further assessment points [Срок оценки: up to the 6 months follow up]
• The proportion of participants that go through the entire treatment period [Срок оценки: up to 12 weeks]