Prolonged Exposure for Swedish Immigrants

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapist-supported internet delivered prolonged exposure: Therapist-supported internet delivered prolonged exposure for eight weeks.

Study 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

Primary outcome measure(s)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) — Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.
  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.

Trial sites (1)

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