Prolonged Exposure for Swedish Immigrants

NCT ID: NCT06193161

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-03-15

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.

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapist-guided internet delivered prolonged exposure

Therapist-supported internet delivered prolonged exposure comprising psychoeducation about PTSD, controlled breathing, imaginal exposure including processing, in vivo exposure and relapse prevention. The treatment will be delivered in a digital platform for eight weeks. Participants will have access to a therapist that will guide them through treatment in a text based format.

Group Type: EXPERIMENTAL

Therapist-supported internet delivered prolonged exposure

Intervention Type: BEHAVIORAL

Therapist-supported internet delivered prolonged exposure for eight weeks.

Waiting list

Waiting list up for eight weeks and up until the 1-month follow up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapist-supported internet delivered prolonged exposure

Therapist-supported internet delivered prolonged exposure for eight weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Maria Bragesjo

Principal investigator, Clinical psychologist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Bragesjö, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Solna, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Maria Bragesjö, PhD

Role: CONTACT

maria.bragesjo@ki.se

+46703399387

Olof Molander, PhD

Role: CONTACT

olof.molander@ki.se

Facility Contacts

Maria Bragesjö, PhD

Role: primary

maria.bragesjo@ki.se

+46703399387

Olof Molander, PhD

Role: backup

olof.molander@ki.se

References

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.

Reference Type: DERIVED

PMID: 40587567 (View on PubMed)

Other Identifiers

2023-02715-01

Identifier Type: -

Identifier Source: org_study_id