Written Exposure Therapy for Veterans With SUD and PTSD

Официальное название

Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD

Обзор

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

Подробное описание

This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Вмешательства

• Поведенческое Written Exposure Therapy
  Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.
• Поведенческое Neutral Topic Writing
  Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.

Первичные конечные точки

• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: 8-week Post-Baseline Follow-up]
• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: 12-week Post-Baseline Follow-up]

Вторичные конечные точки (1)

• Timeline Follow-Back (TLFB) [Срок оценки: 8-week Post-Baseline Follow-up]

Критерии участия

Критерии включения

• Veterans ages 18 years old or older;
• Meets DSM-5 criteria for at least one substance use disorder (SUD);
• Meets DSM-5 criteria for PTSD;
• Approved for SUD treatment at VA Connecticut Healthcare System.

Критерии исключения

• Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
• current suicidal or homicidal risks necessitating a higher level of care;
• Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
• Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Публикации

• Meshberg-Cohen S, Cook JM, Bin-Mahfouz A, Petrakis IL. Written exposure therapy for veterans with co-occurring substance use disorders and PTSD: Study design of a randomized clinical trial. Contemp Clin Trials. 2024 Apr;139:107475. doi: 10.1016/j.cct.2024.107475. Epub 2024 Feb 15. PMID 38365173

Идентификаторы

NCT: NCT05327504 · MHBP-010-21F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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