Therapist-guided online treatment for PTSD in Swedish immigrants
Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
This study is testing an online therapy program for Swedish immigrants with PTSD to see if it helps reduce their symptoms and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Solna) |
| Trial ID | NCT06193161 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and preliminary efficacy of therapist-guided internet-delivered prolonged exposure (I-PE) therapy for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD). Participants will be randomly assigned to receive either I-PE or be placed on a waiting list for eight weeks. The study will assess various outcomes, including PTSD symptoms, depression, quality of life, and treatment satisfaction, using validated scales. A nested pilot phase will ensure effective recruitment and treatment strategies before the full trial commences.
Who should consider this trial
Good fit: Ideal candidates are immigrants residing in Sweden who are at least 18 years old, can read and write in easy English, and have a primary diagnosis of PTSD.
Not a fit: Patients with serious mental health issues, ongoing trauma-focused therapies, or those whose PTSD is not their primary concern may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide accessible and effective PTSD therapy for immigrants who face language barriers.
How similar studies have performed: Other studies have shown promise in using digital treatments for PTSD, but this specific approach tailored for immigrants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Current primary diagnosis of PTSD, according to the diagnostic criteria based on Diagnostic and statistical manual of mental disorders, 5th edition (DSM-5; American Psychiatric Association, 2013) * ≥ 18 years * Able to read and write in English * Immigrant residing in Sweden * Able to provide digital informed consent * Daily access to a computer or device with internet connection Exclusion Criteria: * PTSD is not the primary treatment 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
Where this trial is running
Solna
- Karolinska Institutet — Solna, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Bragesjö, PhD — Karolinska Institutet
- Study coordinator: Maria Bragesjö, PhD
- Email: maria.bragesjo@ki.se
- Phone: +46703399387
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.