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一项针对退伍军人及其伴侣的基于移动设备和网络的自我导向补充与综合健康计划(使命重连):混合方法随机对照试验方案

A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial.

作者信息

Haun Jolie N, Ballistrea Lisa M, Melillo Christine, Standifer Maisha, Kip Kevin, Paykel Jacquelyn, Murphy Jennifer L, Fletcher Carol E, Mitchinson Allison, Kozak Leila, Taylor Stephanie L, Glynn Shirley M, Bair Matthew

机构信息

Rehabilitation Outcomes Research Section, James A Haley Veterans' Hospital and Clinics, Veterans Health Administration, Tampa, FL, United States.

College of Public Health, University of South Florida, Tampa, FL, United States.

出版信息

JMIR Res Protoc. 2019 May 13;8(5):e13666. doi: 10.2196/13666.

Abstract

BACKGROUND

Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners.

OBJECTIVE

This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member).

METHODS

This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes.

RESULTS

Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022.

CONCLUSIONS

This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13666.

摘要

背景

补充与整合健康(CIH)是治疗创伤后应激障碍(PTSD)和慢性疼痛的可行方案。许多退伍军人认为CIH只能由医疗保健机构中的持牌专业人员实施。健康信息技术可以为退伍军人及其伴侣提供有效的CIH。

目的

本文描述了“使命重连”协议的基本原理、设计和方法,该协议旨在为退伍军人及其伴侣(如配偶、重要他人、照料者或家庭成员)提供基于移动设备和网络的补充与整合健康项目。

方法

这项为期4年、涉及三个地点的混合方法随机对照试验采用等待列表对照,以确定基于移动设备和网络的CIH项目对退伍军人及其伴侣(或二元组)的效果。该研究将在患有疼痛和创伤后应激障碍共病的退伍军人及其伴侣的临床样本中使用两个组(即治疗干预组和等待列表对照组)。该研究将评估“使命重连”项目在身体和心理症状、整体健康及社会结果方面的有效性和感知价值。

结果

该研究的资金于2018年11月开始投入,我们目前正处于研究的招募筛查和数据随机化阶段。主要数据收集将于2019年5月开始,并持续至2021年5月。每个地点预计的参与者将为76名伴侣/二元组,总共456名研究参与者。预期的研究结果将于2022年11月发表。

结论

这项工作突出了为退伍军人及其伴侣创新性地提供CIH以治疗创伤后应激障碍和慢性疼痛。

试验注册

ClinicalTrials.gov NCT03593772;https://clinicaltrials.gov/ct2/show/NCT03593772(由WebCite存档于http://www.webcitation.org/77Q2giwtw)。

国际注册报告识别码(IRRID):PRR1-10.2196/13666。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/669c/6535978/60444b4473a7/resprot_v8i5e13666_fig1.jpg

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