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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Solna
Contact Information
Primary
Maria Bragesjö, PhD
maria.bragesjo@ki.se
+46703399387
Backup
Olof Molander, PhD
olof.molander@ki.se
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 100
Treatments
Experimental: 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.
No_intervention: Waiting list
Waiting list up for eight weeks and up until the 1-month follow up.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov