针对慢性疼痛退伍军人的两种在线干预措施评估：一项随机对照疗效试验方案

Assessment of Two Online Interventions for Veterans With Chronic Pain: Protocol for a Randomized Controlled Efficacy Trial.

作者信息

Reilly Erin D, Grigorian Hannah L, Heapy Alicia A, Etingen Bella, Kelly Megan M, Wolkowicz Noah R, Girouard Caitlin M, Hogan Timothy P, Bernice Katarina, Bickmore Timothy

机构信息

Mental Illness Research, Education, and Clinical Center, Veteran Affairs Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.

Department of Psychiatry, University of Massachusetts Chan Medical School, Worcester, MA, United States.

出版信息

JMIR Res Protoc. 2025 Aug 13;14:e70601. doi: 10.2196/70601.

DOI:10.2196/70601

PMID:40802968

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12391840/

Abstract

BACKGROUND

Chronic pain is a debilitating condition that disproportionately impacts US veterans who manage numerous negative pain-related outcomes. There is an urgent need for accessible, engaging, and innovative treatments that can help veterans with chronic pain better self-manage their pain at home and improve their daily functioning. Technology-delivered acceptance- and mindfulness-based interventions for pain have shown strong efficacy, particularly when they are engaging and tailored to specific client needs. However, more research is needed to assess the impact of such interventions, particularly in terms of pain-related functioning and quality of life.

OBJECTIVE

The primary aim of this study is to test the efficacy of Veteran Acceptance and Commitment Therapy for Chronic Pain (VACT-CP), an online self-management pain program, compared to an active online control (Online Pain School) for improving pain-related functioning in a 3-site randomized controlled trial. The secondary aim is to explore psychological flexibility as a potential mediator between pain severity and pain-related functioning.

METHODS

This study will use a mixed methods approach to examine the efficacy of VACT-CP in a 2-arm, multisite, randomized controlled superiority trial including 200 participants with chronic musculoskeletal pain compared to Online Pain School. Participants will be assigned to 1 of these 2 online interventions. Both interventions will include 7 modules delivered over 7 weeks, with each module lasting approximately 15 minutes. Mixed effects models will be used to analyze the primary hypothesis that participants in the VACT-CP group will have greater improvement in pain-related functioning (Brief Pain Inventory-Interference subscale) than those in the active control group (Online Pain School). The main acceptance and commitment therapy process mediator (ie, Multidimensional Psychological Flexibility Inventory), pain-related functioning outcomes (Brief Pain Inventory-Interference subscale), and quality of life (Veterans RAND 36-Item Health Survey) will be measured at baseline, end of treatment, and 3 and 6 months after treatment. In addition, qualitative exit interviews will be conducted with a random set of 30 VACT-CP users (n=10, 33% per site) to obtain intervention usability, feasibility, and acceptability information.

RESULTS

The recruitment for this study began in January 2025. It is expected to continue through January 2027. Data collection is expected to be completed by June 2027, and primary data analyses are expected to be completed by early 2028.

CONCLUSIONS

Online interventions such as VACT-CP and Online Pain School have the potential to expand access to behavioral interventions that improve quality of life and provide nonpharmacological pain treatment options for veterans experiencing chronic pain. However, research on their impact and underlying mechanisms of change is required to support this area of potential at-home programming.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06058624; https://clinicaltrials.gov/study/NCT06058624.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/70601.

摘要

背景

慢性疼痛是一种使人衰弱的疾病，对美国退伍军人的影响尤为严重，他们要应对众多与疼痛相关的负面后果。迫切需要可及、有趣且创新的治疗方法，以帮助患有慢性疼痛的退伍军人更好地在家中自我管理疼痛并改善日常功能。基于技术的疼痛接受和正念干预已显示出强大的疗效，特别是当它们有趣且能根据特定客户需求进行调整时。然而，需要更多研究来评估此类干预的影响，特别是在疼痛相关功能和生活质量方面。

目的

本研究的主要目的是在一项三中心随机对照试验中，测试退伍军人慢性疼痛接受与承诺疗法（VACT-CP）（一种在线自我管理疼痛项目）与积极的在线对照（在线疼痛学校）相比，在改善疼痛相关功能方面的疗效。次要目的是探索心理灵活性作为疼痛严重程度和疼痛相关功能之间的潜在中介。

方法

本研究将采用混合方法，在一项双臂、多中心、随机对照优势试验中检验VACT-CP的疗效，该试验纳入200名患有慢性肌肉骨骼疼痛的参与者，并与在线疼痛学校进行比较。参与者将被分配到这两种在线干预中的一种。两种干预都将包括在7周内提供的7个模块，每个模块持续约15分钟。混合效应模型将用于分析主要假设，即VACT-CP组的参与者在疼痛相关功能（简明疼痛问卷-干扰子量表）方面的改善将大于积极对照组（在线疼痛学校）的参与者。主要的接受与承诺疗法过程中介（即多维心理灵活性量表）、疼痛相关功能结果（简明疼痛问卷-干扰子量表）和生活质量（退伍军人兰德36项健康调查）将在基线、治疗结束时以及治疗后3个月和6个月进行测量。此外，将对30名随机抽取的VACT-CP用户（每个站点10名，占33%）进行定性退出访谈，以获取干预的可用性、可行性和可接受性信息。