Clinical trial NCT06193161: Prolonged Exposure for Swedish Immigrants
Official title: Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
digital treatment
therapist-guided treatment
migrants
prolonged exposure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are randomized to I-PE for eight weeks or to a waitlist. Participants in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint).
Primary purpose: TREATMENT

Brief 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.

Detailed 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 self-rated Posttraumatic Stress Disorder Checklist version 5 (PCL-5) at the 1-month follow up. Secondary outcomes are the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), self-rated symptoms of depression 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline up to 1-month after treatment completion
measure: Change in depression as assessed by The Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
measure: Change in general quality of life assessed by 12-Item Short-Form Health Survey (SF-12)
timeFrame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
measure: Treatment credibility assessed by the Credibility/expectancy scale (CEQ)
timeFrame: Treatment week 3 (three weeks from baseline).
measure: Change in stigma and barriers related to mental health and competency in mental health assessed by the Stigma-9 Questionnaire (STIG-9),
timeFrame: Baseline, immediately after treatment completion and 1-month after treatment completion
measure: Change in stigma and barriers related to mental health and competency in mental health assessed Barriers to Access to Care Evaluation Scale (BACES)
timeFrame: Baseline, immediately after treatment completion and 1-month after treatment completion
measure: Change in stigma and barriers related to mental health and competency in mental health assessed Mental Health Knowledge Schedule (MHKS)
timeFrame: Baseline, immediately after treatment completion and 1-month after treatment completion
measure: Change in Treatment inventory of costs associated with psychiatric illness (TIC-P)
timeFrame: Baseline, immediately after treatment completion and 1-month after treatment completion
measure: Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8
timeFrame: Immediately after treatment completion
measure: Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ)
timeFrame: Immediately after treatment completion
measure: Adverse events related to treatment measured by the Negative effects questionnaire-20.
timeFrame: 1-mont after treatment completion
Other outcomes:
measure: Number of completed treatment modules
timeFrame: Baseline up to treatment completion at 8 weeks
measure: Number of messages sent and received in the digital platform
timeFrame: Baseline up to treatment completion at 8 weeks
measure: Experience with the digital treatment as assessed by qualitative interviews
timeFrame: Immediately after treatment completion
measure: The proportion of participants that conducts the weekly measures and further assessment points
timeFrame: Baseline up to 6-month after treatment completion
measure: Number of drop-outs from treatment
timeFrame: Completion of the treatment period, up to 8 weeks
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Maria Bragesjö, PhD
role: PRINCIPAL_INVESTIGATOR
References: