Expressive writing to reduce depressive and anxiety symptoms among sexual minority veterans: Study design for a pilot randomized controlled trial

IF 1.5 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2026-06-01 Epub Date: 2026-05-27 DOI:10.1016/j.conctc.2026.101650

Kelly L. Harper , Katherine Kelton , Nicholas A. Livingston , Katherine M. Iverson , Colleen A. Sloan , Abigail Batchelder , Brian P. Marx

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引用次数: 0

Abstract

Background

Sexual minority veterans (e.g., gay, lesbian, bisexual) are at increased risk for depression and anxiety due in part to the experience of sexual minority stressors. However, few interventions target distress related to sexual minority stressors, and even fewer have been tested in Veterans Health Administration (VHA). Brief, easy to implement interventions, such as expressive writing-based interventions, that target distress related to sexual minority stressors are needed to reduce disparities in depression and anxiety.

Method

We describe the design of a two-phase study consisting of an open trial and a pilot randomized controlled trial (RCT) comparing Expressive Writing on Minority Stressors (EWMS) and a neutral writing condition among sexual minority veterans. The EWMS protocol will be iteratively refined in a case series (n = 10) and then tested in a pilot randomized control trial (RCT; n = 54). Aims of the pilot RCT are to: 1) demonstrate feasibility and acceptability of study procedures and EWMS using quantitative and qualitative data; and 2) examine preliminary trends in depressive and anxiety symptoms to inform the design of a future, fully powered efficacy trial. Participants will be assessed at baseline, posttreatment, and 3 months after treatment. Qualitative exit interviews will be conducted to inform refinements to the intervention with an eye towards usefulness, satisfaction, and implementation.

Conclusions

This pilot RCT will inform the first fully powered clinical trial to test an individually delivered intervention for sexual minority veterans to reduce depressive and anxiety symptoms associated with minority stress.

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表达性写作减轻性少数退伍军人的抑郁和焦虑症状：一项试点随机对照试验的研究设计

性少数派退伍军人（如男同性恋、女同性恋、双性恋）患抑郁和焦虑的风险增加，部分原因是性少数派压力源的经历。然而，很少有干预措施针对与性少数压力源相关的痛苦，在退伍军人健康管理局（VHA）中进行的测试就更少了。为了减少抑郁和焦虑的差异，我们需要针对与性少数压力源相关的痛苦的简短、易于实施的干预措施，例如基于表达性写作的干预措施。方法采用开放试验和随机对照试验（RCT）两阶段的研究设计，比较性取向少数族裔退伍军人在少数民族应激源（EWMS）和中性写作条件下的表达性写作。EWMS方案将在病例系列（n = 10）中迭代完善，然后在随机对照试验（RCT; n = 54）中进行测试。试验RCT的目的是：1)利用定量和定性数据证明研究程序和EWMS的可行性和可接受性；2)检查抑郁和焦虑症状的初步趋势，以便为未来全面疗效试验的设计提供信息。参与者将在基线、治疗后和治疗后3个月进行评估。将进行定性的退出访谈，以告知干预措施的改进，着眼于有用性、满意度和实施。该试点RCT将为第一个全面的临床试验提供信息，以测试对性少数群体退伍军人进行单独干预，以减轻与少数群体压力相关的抑郁和焦虑症状。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles 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 a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.