Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06193161

Prolonged Exposure for Swedish Immigrants

Led by Karolinska Institutet · Updated on 2025-04-09

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Prolonged Exposure for Swedish Immigrants

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current primary diagnosis of PTSD based on DSM-5 criteria
  • At least 18 years old
  • Able to read and write in English
  • Immigrant residing in Sweden
  • Able to provide digital informed consent
  • Daily access to a computer or internet-connected device
Not Eligible

You will not qualify if you...

  • PTSD is not the primary treatment concern
  • Started or changed psychotropic medication within 4 weeks before treatment
  • Serious mental health symptoms like mania, psychosis, substance use disorders, or current suicide risk needing immediate care
  • Currently receiving trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karolinska Institutet

Solna, Sweden

Actively Recruiting

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Research Team

M

Maria Bragesjö, PhD

CONTACT

O

Olof Molander, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Prolonged Exposure for Swedish Immigrants | DecenTrialz