Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-02 DOI:10.1016/j.cct.2025.107929

Eric Kuhn , Steven Sayers , Lindsey Zimmerman , Margaret-Anne Mackintosh , Jason E. Owen , Craig S. Rosen , Laura A. Meis , Hildi J. Hagedorn , Christopher R. Erbes

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引用次数: 0

Abstract

Background

Many veterans with posttraumatic stress disorder (PTSD) do not seek mental health care. Their significant others, including spouses and intimate partners, could be helpful in encouraging them to enter treatment. Community reinforcement and family training (CRAFT) has been shown to increase uptake in care among treatment-resistant individuals with alcohol and substance use disorders. We have adapted CRAFT for family members of veterans with PTSD and self-guided web-delivery with telephone coaching. A pilot study of this program showed promising results.

Methods

This paper describes a randomized controlled trial of the Veterans Affairs-CRAFT (VA-CRAFT) web program coupled with four telephone coaching calls from VA's Coaching Into Care (CIC) program compared to CIC as usual. Assessments will occur at baseline, posttreatment (3-mos.), and follow-up (6-mos.). Spouses and intimate partners of veterans with perceived, untreated PTSD (N = 230) will be randomized (1:1) to study conditions. We hypothesize that compared to CIC as usual, CIC + VA-CRAFT will result in more veterans initiating mental health care (Aim 1) without compromising CIC's existing high client satisfaction (Aim 2). We also will explore if participants show improved benefits in wellbeing in CIC + VA-CRAFT relative to CIC as usual (Exploratory Aim 1). Lastly, we will explore potential mediators and moderators of intervention effects (Exploratory Aim 2).

Conclusion

We expect results of this innovative trial will provide efficacy evidence for VA-CRAFT plus telephone coaching. If successful, findings can help support implementation efforts of VA-CRAFT into family services for veterans with PTSD who are reluctant to seek care.

Clinical Trial Registration Number: ClinicalTrials.gov NCT04501328

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使用基于互联网的家庭培训和电话辅导促进PTSD退伍军人心理健康治疗的启动：一项随机对照试验方案

背景：许多患有创伤后应激障碍（PTSD）的退伍军人不寻求心理健康护理。他们的另一半，包括配偶和亲密伴侣，可能有助于鼓励他们接受治疗。社区强化和家庭培训（CRAFT）已被证明可以增加酒精和物质使用障碍患者的治疗抵抗性。我们已经为患有创伤后应激障碍的退伍军人的家庭成员调整了CRAFT，并通过电话指导进行了自我指导的网络交付。对这一计划的初步研究显示出可喜的结果。方法：本文描述了一项随机对照试验，将退伍军人事务- craft （VA- craft）网络项目与VA的coaching Into Care （CIC）项目的4个电话辅导电话相结合，与常规的CIC进行比较。评估将在基线、治疗后（3个月）和随访（6个月）进行。患有未治疗PTSD的退伍军人的配偶和亲密伴侣（N = 230）将被随机（1:1）分配到研究条件中。我们假设，与通常的CIC相比，CIC + VA-CRAFT将导致更多的退伍军人开始心理健康护理（目标1），而不会影响CIC现有的高客户满意度（目标2）。我们还将探讨参与者在CIC + VA-CRAFT中是否表现出与常规CIC相比的健康改善（探索性目标1）。最后，我们将探讨干预效果的潜在中介和调节因子（探索性目标2）。结论：我们期待这一创新试验的结果将为VA-CRAFT +电话辅导的有效性提供证据。如果成功，研究结果可以帮助支持VA-CRAFT在不愿寻求治疗的创伤后应激障碍退伍军人家庭服务中的实施工作。临床试验注册号：ClinicalTrials.govNCT04501328。

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 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.