Prolonged Exposure for Swedish Immigrants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapist-supported internet delivered prolonged exposure.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
Overview
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.
Detailed description
There is an urgent need for dissemination of evidence-based treatments for PTSD beyond the Swedish language criteria and developed in an easy-to-read manner and develop the treatment so that it can be easily made available to a large number of afflicted who are excluded from treatment.The overall aim of the study is to evaluate I-PE for immigrants with PTSD living in Sweden who can read and write easy English. The treatment will be written in easy English and adapted to the target population with regards to specific contextual characteristics.
The study is a single-blind, parallel-group superiority randomized controlled trial with 100 participants that will compare I-PE with a waiting list condition. The primary outcome is the self-rated Posttraumatic Stress Disorder Checklist version 5 (PCL-5) at the 1-month follow up. Secondary outcomes are the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), self-rated symptoms of depression quality of life, dropout rate, level of health care utilization, satisfaction with treatment and negative effects. Patients in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint). Assessments will be conducted pre-treatment, post-treatment, 1 month (primary endpoint) and 6 months after treatment.
Interventions
- Behavioral Therapist-supported internet delivered prolonged exposure
Therapist-supported internet delivered prolonged exposure for eight weeks.
Primary outcome measures
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Time frame: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.]
Secondary outcome measures (11)
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) [Time frame: Baseline up to 1-month after treatment completion]
- Change in depression as assessed by The Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion]
- Change in general quality of life assessed by 12-Item Short-Form Health Survey (SF-12) [Time frame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion]
- Treatment credibility assessed by the Credibility/expectancy scale (CEQ) [Time frame: Treatment week 3 (three weeks from baseline).]
- Change in stigma and barriers related to mental health and competency in mental health assessed by the Stigma-9 Questionnaire (STIG-9), [Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Change in stigma and barriers related to mental health and competency in mental health assessed Barriers to Access to Care Evaluation Scale (BACES) [Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Change in stigma and barriers related to mental health and competency in mental health assessed Mental Health Knowledge Schedule (MHKS) [Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Change in Treatment inventory of costs associated with psychiatric illness (TIC-P) [Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8 [Time frame: Immediately after treatment completion]
- Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ) [Time frame: Immediately after treatment completion]
- Adverse events related to treatment measured by the Negative effects questionnaire-20. [Time frame: 1-mont after treatment completion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska Institutet — Solna
Publications
- Sorman K, Jayaram-Lindstrom N, Ponten M, Bragesjo M, Kolaas K, Kraepelien M, El Alaoui S, Sarnholm J, Molander O. First 100 migrants seeking culturally inclusive internet-based treatment for PTSD: a Mind the Gap pilot outreach study. BMJ Public Health. 2026 Jul 14;4(3):e003156. doi: 10.1136/bmjph-2025-003156. eCollection 2026. PMID 42466459
- Molander O, Kolaas K, Jayaram-Lindstrom N, Ponten M, Sarnholm J, Bragesjo M. Mind the gap: a nested randomised pilot study of culturally inclusive, internet-delivered prolonged exposure for PTSD among immigrants. Eur J Psychotraumatol. 2025 Dec;16(1):2520637. doi: 10.1080/20008066.2025.2520637. Epub 2025 Jun 30. PMID 40587567
Identifiers
NCT: NCT06193161 · 2023-02715-01