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RECRUITINGINTERVENTIONAL

Prolonged Exposure for Swedish Immigrants

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Daily access to a computer or device with internet connection Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

BEHAVIORAL

Therapist-supported internet delivered prolonged exposure

Therapist-supported internet delivered prolonged exposure for eight weeks.

Locations (1)

Karolinska Institutet
Solna, Sweden