Internet-delivered therapy for young people with PTSD
Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
This study is testing if a special online therapy for PTSD can help young people aged 13-17 feel better compared to a different online therapy that focuses on relaxation and education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06185244 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and cost-effectiveness of therapist-guided internet-delivered trauma-focused cognitive behavior therapy (iTF-CBT) compared to an active control group receiving therapist-guided internet-delivered cognitive behavioral therapy that includes relaxation techniques and psychoeducation. Young participants aged 13-17 with a primary diagnosis of PTSD will be randomly assigned to one of the two treatment arms over a 12-week period. The study will assess outcomes using the Clinician-Administered PTSD Scale for DSM-5 and will also explore secondary outcomes such as cost-effectiveness and predictors of symptom change. An internal pilot will be conducted with the first 20 participants to gather qualitative feedback on their experiences.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-17 with a primary diagnosis of PTSD who are fluent in Swedish and have internet access.
Not a fit: Patients whose PTSD is not the primary concern or who have serious mental health symptoms requiring immediate clinical attention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an accessible and effective treatment option for young people suffering from PTSD.
How similar studies have performed: Other studies have shown promise in using internet-delivered therapies for mental health conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Bragesjö, PhD — Karolinska Institutet/Region Stockholm
- Study coordinator: Maria Bragesjö
- Email: maria.bragesjo@ki.se
- Phone: +46(0)703399387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.