Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessors
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Waiting list
Waiting list up for eight weeks and up until the 1-month follow up.
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.
干预措施: Therapist-supported internet delivered prolonged exposure (Behavioral)
结局指标
主要结局
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
时间窗: 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.
次要结局
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)(Baseline up to 1-month after treatment completion)
- Change in depression as assessed by The Patient Health Questionnaire (PHQ-9)(Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion)
- Change in general quality of life assessed by 12-Item Short-Form Health Survey (SF-12)(Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion)
- Treatment credibility assessed by the Credibility/expectancy scale (CEQ)(Treatment week 3 (three weeks from baseline).)
- Change in stigma and barriers related to mental health and competency in mental health assessed by the Stigma-9 Questionnaire (STIG-9),(Baseline, immediately after treatment completion and 1-month after treatment completion)
- Change in stigma and barriers related to mental health and competency in mental health assessed Barriers to Access to Care Evaluation Scale (BACES)(Baseline, immediately after treatment completion and 1-month after treatment completion)
- Change in stigma and barriers related to mental health and competency in mental health assessed Mental Health Knowledge Schedule (MHKS)(Baseline, immediately after treatment completion and 1-month after treatment completion)
- Change in Treatment inventory of costs associated with psychiatric illness (TIC-P)(Baseline, immediately after treatment completion and 1-month after treatment completion)
- Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8(Immediately after treatment completion)
- Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ)(Immediately after treatment completion)
- Adverse events related to treatment measured by the Negative effects questionnaire-20.(1-mont after treatment completion)
研究者
Maria Bragesjo
Principal investigator, Clinical psychologist, PhD
Karolinska Institutet