Internet-delivered therapy for PTSD
Efficacy and Mediators of Change of Cognitive-behavior Therapy for PTSD: a Randomized Controlled Trial
NA · Karolinska Institutet · NCT05934162
This study is testing whether an online therapy focused on facing fears can help adults with PTSD more effectively than another online therapy that uses relaxation techniques.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05934162 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of therapist-guided internet-delivered prolonged exposure therapy with an active control condition of therapist-guided internet-delivered cognitive-behavioral therapy that includes relaxation techniques for adults with post-traumatic stress disorder (PTSD). Participants will be randomly assigned to one of the two treatment groups for a duration of 10 weeks. The study will evaluate not only the effectiveness of the interventions but also the mechanisms of change and cost-effectiveness. The primary outcome will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of PTSD who can communicate in Swedish and have stable psychotropic medication.
Not a fit: Patients with severe mental health symptoms, ongoing trauma-focused therapy, or those whose PTSD is not the primary concern may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more accessible and effective option for individuals suffering from PTSD.
How similar studies have performed: Preliminary research has shown that therapist-guided internet-delivered treatments can be effective, but this specific approach with severe PTSD patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * current primary diagnosis PTSD according to DSM-5 diagnostic criteria * be 18 years of age or older * be able to read and communicate fluently in Swedish * have had a stable dose of any psychotropic medication for at least 4 weeks prior to study entry * Daily access to a computer or device with internet connection 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 (e.g. living with a violent spouse)
Where this trial is running
Stockholm
- Traumaprogrammet, Psykiatri Sydväst — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Maria Bragesjö, PhD — Karolinska Institutet
- Study coordinator: Maria Bragesjö, PhD
- Email: maria.bragesjo@ki.se
- Phone: 0703399387
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.
Conditions: Post Traumatic Stress Disorder, PTSD, therapist-guided treatment, internet delivered treatment, digital treatment, therapist-assisted treatment, prolonged exposure, trauma focused CBT