Prolonged Exposure for Swedish Immigrants

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

There is an urgent need for dissemination of evidence-based treatments for PTSD beyond the Swedish language criteria and developed in an easy-to-read manner and develop the treatment so that it can be easily made available to a large number of afflicted who are excluded from treatment.The overall aim of the study is to evaluate I-PE for immigrants with PTSD living in Sweden who can read and write easy English. The treatment will be written in easy English and adapted to the target population with regards to specific contextual characteristics. The study is a single-blind, parallel-group superiority randomized controlled trial with 100 participants that will compare I-PE with a waiting list condition. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary outcomes are self-rated symptoms of depression, PTSD, quality of life, dropout rate, level of health care utilization, satisfaction with treatment and negative effects. Patients in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint). Assessments will be conducted pre-treatment, post-treatment, 1 month (primary endpoint) and 6 months after treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06193161
Study type	Interventional
Source	Karolinska Institutet
Contact	Maria Bragesjö, PhD
Phone	+46703399387
Email	maria.bragesjo@ki.se
Status	Recruiting
Phase	N/A
Start date	February 15, 2024
Completion date	July 15, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03384706` - A Comparison of CPT Versus ART Versus WL	N/A
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03129204` - Sensation Awareness Focused Training for Spouses	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Completed	`NCT05113277` - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention	N/A
Recruiting	`NCT05327504` - Written Exposure Therapy for Veterans With SUD and PTSD	N/A
Recruiting	`NCT05843695` - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Completed	`NCT00644423` - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT02989987` - NET for SGBV Survivors in Eastern DR Congo	N/A
Completed	`NCT02320799` - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya	N/A
Recruiting	`NCT02293291` - Thermal Clinic Treatment in Gulf War Illness	Phase 1/Phase 2
Completed	`NCT02242136` - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants	N/A
Completed	`NCT01911585` - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure	N/A
Completed	`NCT02720497` - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01693978` - Contingency Outcomes in Prolonged Exposure	N/A
Completed	`NCT01469754` - Longitudinal Survey Analysis in Lymphoma Survivors	N/A
Completed	`NCT02362477` - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD	Phase 3
Terminated	`NCT01239173` - Emotional Memory Reactivation in Posttraumatic Stress Disorder	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.