A protocol for a randomized comparative effectiveness trial for treating PTSD symptoms for LGBTQIA+ people

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI:10.1016/j.cct.2026.108246

Madeline Price , Gowri Sunder , Marylene Cloitre , Debra Kaysen , Martha Shumway , James W. Dilley , Nadra E. Lisha , Belin Marko , William Hua , Tiffany Artime , Ell Hundertmark , Emily Huang , Antonia Clifford , Annesa Flentje

{"title":"A protocol for a randomized comparative effectiveness trial for treating PTSD symptoms for LGBTQIA+ people","authors":"Madeline Price , Gowri Sunder , Marylene Cloitre , Debra Kaysen , Martha Shumway , James W. Dilley , Nadra E. Lisha , Belin Marko , William Hua , Tiffany Artime , Ell Hundertmark , Emily Huang , Antonia Clifford , Annesa Flentje","doi":"10.1016/j.cct.2026.108246","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) individuals face higher rates of posttraumatic stress disorder (PTSD) due to increased trauma exposure. Further, they may experience factors that complicate treatment, like exposure to minority stress and increased substance use. No prior large-scale clinical trial has compared the effectiveness of PTSD treatments among LGBTQIA+ populations.</div></div><div><h3>Study objectives</h3><div>We are conducting a comparative effectiveness study that will compare two evidence-based psychotherapeutic interventions to reduce PTSD and depression symptoms and improve quality of life in LGBTQIA+ populations. Treatment dropout and satisfaction will be compared between the interventions. Minority stress and substance use will be examined as moderators for treatment effectiveness. We will also examine heterogeneity of treatment effects by gender subgroups, participant residence (urban versus suburban or rural), and race and ethnicity.</div></div><div><h3>Methods</h3><div>Participants will be recruited from community mental health settings, from the community, and through organizations throughout California. Eligibility will be based on PTSD symptom severity as determined by PTSD Checklist for DSM-5 (PCL-5) scores ≥33 during an initial phone screening. Each participant will be randomized to receive either Cognitive Processing Therapy (CPT) or STAIR Narrative Therapy (SNT). Study participants will complete survey assessments at baseline, 3 months, 6 months, and 12 months.</div></div><div><h3>Discussion</h3><div>This study will fill critical research gaps to inform effective PTSD treatments for LGBTQIA+ communities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108246"},"PeriodicalIF":1.9000,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714426000327","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/29 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) individuals face higher rates of posttraumatic stress disorder (PTSD) due to increased trauma exposure. Further, they may experience factors that complicate treatment, like exposure to minority stress and increased substance use. No prior large-scale clinical trial has compared the effectiveness of PTSD treatments among LGBTQIA+ populations.

Study objectives

We are conducting a comparative effectiveness study that will compare two evidence-based psychotherapeutic interventions to reduce PTSD and depression symptoms and improve quality of life in LGBTQIA+ populations. Treatment dropout and satisfaction will be compared between the interventions. Minority stress and substance use will be examined as moderators for treatment effectiveness. We will also examine heterogeneity of treatment effects by gender subgroups, participant residence (urban versus suburban or rural), and race and ethnicity.

Methods

Participants will be recruited from community mental health settings, from the community, and through organizations throughout California. Eligibility will be based on PTSD symptom severity as determined by PTSD Checklist for DSM-5 (PCL-5) scores ≥33 during an initial phone screening. Each participant will be randomized to receive either Cognitive Processing Therapy (CPT) or STAIR Narrative Therapy (SNT). Study participants will complete survey assessments at baseline, 3 months, 6 months, and 12 months.

Discussion

This study will fill critical research gaps to inform effective PTSD treatments for LGBTQIA+ communities.

查看原文本刊更多论文

治疗LGBTQIA+人群PTSD症状的随机比较有效性试验方案

背景：LGBTQIA+（女同性恋、男同性恋、双性恋、变性人、酷儿、双性人和无性恋者）个体由于创伤暴露的增加而面临更高的创伤后应激障碍（PTSD）发病率。此外，他们可能会遇到使治疗复杂化的因素，如暴露于少数民族压力和增加药物使用。之前没有大规模的临床试验比较过LGBTQIA+人群治疗PTSD的有效性。研究目的：我们正在进行一项比较有效性的研究，将比较两种基于证据的心理治疗干预措施，以减少LGBTQIA+人群的创伤后应激障碍和抑郁症状，并改善生活质量。将比较干预措施之间的治疗退出率和满意度。少数民族压力和物质使用将作为治疗效果的调节因素进行研究。我们还将根据性别亚组、参与者居住地（城市与郊区或农村）以及种族和民族来检查治疗效果的异质性。方法：参与者将从社区心理健康机构、社区和整个加州的组织中招募。入选资格将基于PTSD症状严重程度，在最初的电话筛查中，PTSD检查表DSM-5 （PCL-5）评分≥33分。每位参与者将随机接受认知加工疗法（CPT）或STAIR叙事疗法（SNT）。研究参与者将在基线、3 个月、6 个月和12 个月完成调查评估。讨论：这项研究将填补关键的研究空白，为LGBTQIA+社区提供有效的创伤后应激障碍治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.