Clinical trial NCT06185244: Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD
Official title: Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
digital treatment
trauma-focused CBT
therapist-guided
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Child and Adolescent Psychiatry, Stockholm
name: Save the Children
First posted: 2023-12-29
Enrollment: 240
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)
timeFrame: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion
Secondary outcomes:
measure: Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2)
timeFrame: Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion
measure: Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
measure: Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS)
timeFrame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
measure: Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
timeFrame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
measure: Adverse events related to treatment measured by the Negative effects questionnaire
timeFrame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
measure: Quality of life measured by Assessment of Quality of Life KIDSCREEN-10
timeFrame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
measure: Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Immediately after treatment completion.
measure: Number of completed treatment modules
timeFrame: Baseline up to 12 weeks
measure: Number of messages sent and received in the digital platform
timeFrame: Baseline up to 12 weeks
measure: Number of home work assignments made by the participant during the treatment period
timeFrame: up to 12 weeks
measure: The proportion of participants that conducts the weekly measures and further assessment points
timeFrame: up to the 6 months follow up
measure: The proportion of participants that go through the entire treatment period
timeFrame: up to 12 weeks
measure: Number of drop-outs from treatment
timeFrame: up to 12 weeks
measure: Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
timeFrame: up to the 6-month follow up
Other outcomes:
measure: Differences in treatment credibility between arms
timeFrame: After completion of the first treatment module (week 1 from baseline)
measure: Differences in experience of working alliance between arms
timeFrame: After completion of the third module (week 3 from baseline)
Locations:
city: Stockholm
country: Sweden
facility: Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children
Study officials:
affiliation: Karolinska Institutet/Region Stockholm
name: Maria Bragesjö, PhD
role: PRINCIPAL_INVESTIGATOR
References: