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Clinical Trials in Sweden / NCT06185244
Recruiting Not applicable

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

NCT06185244 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2024-03-11
Last updated
2024-03-13

Condition(s) studied

Posttraumatic Stress Disorder

Investigational drug(s) / intervention(s)

Therapist-supported internet-delivered trauma-focused CBT12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
17 Years
Healthy volunteers
No
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 outcome measure(s)

  • Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA) — Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion
    The CAPS-5-CA is a structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.

Trial sites (1)

FacilityCityRegionStatus
Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children Stockholm Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06185244 on ClinicalTrials.gov ↗ ← All trials in Sweden