Prolonged Exposure for Swedish Immigrants
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Therapist-supported internet delivered prolonged exposure.
- Кому может быть актуально
- Состояния в реестре: Posttraumatic Stress Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Therapist-supported internet delivered prolonged exposure
Therapist-supported internet delivered prolonged exposure for eight weeks.
Первичные конечные точки
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Срок оценки: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.]
Вторичные конечные точки (11)
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) [Срок оценки: Baseline up to 1-month after treatment completion]
- Change in depression as assessed by The Patient Health Questionnaire (PHQ-9) [Срок оценки: 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) [Срок оценки: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion]
- Treatment credibility assessed by the Credibility/expectancy scale (CEQ) [Срок оценки: 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), [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Change in Treatment inventory of costs associated with psychiatric illness (TIC-P) [Срок оценки: Baseline, immediately after treatment completion and 1-month after treatment completion]
- Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8 [Срок оценки: Immediately after treatment completion]
- Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ) [Срок оценки: Immediately after treatment completion]
- Adverse events related to treatment measured by the Negative effects questionnaire-20. [Срок оценки: 1-mont after treatment completion]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Karolinska Institutet — Solna
Публикации
- Sorman K, Jayaram-Lindstrom N, Ponten M, Bragesjo M, Kolaas K, Kraepelien M, El Alaoui S, Sarnholm J, Molander O. First 100 migrants seeking culturally inclusive internet-based treatment for PTSD: a Mind the Gap pilot outreach study. BMJ Public Health. 2026 Jul 14;4(3):e003156. doi: 10.1136/bmjph-2025-003156. eCollection 2026. PMID 42466459
- Molander O, Kolaas K, Jayaram-Lindstrom N, Ponten M, Sarnholm J, Bragesjo M. Mind the gap: a nested randomised pilot study of culturally inclusive, internet-delivered prolonged exposure for PTSD among immigrants. Eur J Psychotraumatol. 2025 Dec;16(1):2520637. doi: 10.1080/20008066.2025.2520637. Epub 2025 Jun 30. PMID 40587567
Идентификаторы
NCT: NCT06193161 · 2023-02715-01