Prolonged Exposure for Swedish Immigrants

NCT06193161 | Recruiting

• 1 other identifier: 2023-02715-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; digital treatment; therapist-guided treatment; migrants; prolonged exposure

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.

  Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.

Secondary Outcomes (11)

• Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)

  Baseline up to 1-month after treatment completion

• Change in depression as assessed by The Patient Health Questionnaire (PHQ-9)

  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)

  Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion

• Treatment credibility assessed by the Credibility/expectancy scale (CEQ)

  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),

  Baseline, immediately after treatment completion and 1-month after treatment completion

Other Outcomes (5)

• Number of completed treatment modules

  Baseline up to treatment completion at 8 weeks

• Number of messages sent and received in the digital platform

  Baseline up to treatment completion at 8 weeks

• Experience with the digital treatment as assessed by qualitative interviews

  Immediately after treatment completion

Study Arms (2)

Therapist-guided internet delivered prolonged exposure

EXPERIMENTAL

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.

Behavioral: Therapist-supported internet delivered prolonged exposure

Waiting list

NO INTERVENTION

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

Interventions

Therapist-supported internet delivered prolonged exposure BEHAVIORAL

Therapist-supported internet delivered prolonged exposure for eight weeks.

Therapist-guided internet delivered prolonged exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Maria Bragesjö, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Bragesjö, PhD

CONTACT

+46703399387; maria.bragesjo@ki.se

Olof Molander, PhD

CONTACT

olof.molander@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical psychologist, PhD

Model Details: Participants are randomized to I-PE for eight weeks or to a waitlist. Participants in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint).

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: March 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: March 15, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)