RecruitingNot ApplicableNCT06193161

Prolonged Exposure for Swedish Immigrants

Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial


Sponsor

Karolinska Institutet

Enrollment

100 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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

Interventions

BEHAVIORALTherapist-supported internet delivered prolonged exposure

Therapist-supported internet delivered prolonged exposure for eight weeks.


Locations(1)

Karolinska Institutet

Solna, Sweden

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NCT06193161


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