NCT06193161 Prolonged Exposure for Swedish Immigrants
| NCT ID | NCT06193161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2025-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-15 with a primary completion date of 2025-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD). The main objectives are to establish feasibility and preliminary efficacy of I-PE for immigrants with PTSD in a single-blind, parallel-group superiority Randomized Controlled Trial (N=100) comparing I-PE with a waiting-list condition, starting with a nested pilot (N=30) to ensure feasible and acceptable recruitment and treatment strategies. Study participants will be randomly assigned to either eight weeks of I-PE or a waiting-list for the same amount of time on a 1:1 ratio without restriction. Feasibility and acceptability data will be reported including recruitment rate, sample demographics, data attrition, treatment adherence and a detailed dropout analysis. A preliminary investigation of the within-group effect size will also be conducted. Recruitment is designed to be broadly inclusive with minimal exclusion criteria.
Eligibility 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
Contact & Investigator
Maria Bragesjö, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06193161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193161 currently recruiting?
Yes, NCT06193161 is actively recruiting participants. Contact the research team at maria.bragesjo@ki.se for enrollment information.
Where is the NCT06193161 trial being conducted?
This trial is being conducted at Solna, Sweden.
Who is sponsoring the NCT06193161 clinical trial?
NCT06193161 is sponsored by Karolinska Institutet. The principal investigator is Maria Bragesjö, PhD at Karolinska Institutet. The trial plans to enroll 100 participants.