Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
PLoS One. 2022 May 2;17(5):e0267245. doi: 10.1371/journal.pone.0267245. eCollection 2022.
REsilience and Activities for every DaY (READY) is an Acceptance and Commitment Therapy-based group resilience-training program that has preliminary empirical support in promoting quality of life and other psychosocial outcomes in people with multiple sclerosis (PwMS). Consistent with the Medical Research Council framework for developing and evaluating complex interventions, we conducted a pilot randomized controlled trial (RCT), followed by a phase III RCT. The present paper describes the phase III RCT protocol.
This is a multi-centre cluster RCT comparing READY with a group relaxation program (1:1 ratio) in 240 PwMS from eight centres in Italy (trial registration: isrctn.org Identifier: ISRCTN67194859). Both interventions are composed of 7 weekly sessions plus a booster session five weeks later. Resilience (primary outcome), mood, health-related quality of life, well-being and psychological flexibility will be assessed at baseline, after the booster session, and at three and six month follow-ups. If face-to-face group meetings are interrupted because of COVID-19 related-issues, participants will be invited to complete their intervention via teleconferencing. Relevant COVID-19 information will be collected and the COVID-19 Peritraumatic Distress scale will be administered (ancillary study) at baseline and 3-month follow-up. Analysis will be by intention-to-treat to show superiority of READY over relaxation. Longitudinal changes will be compared between the two arms using repeated-measures, hierarchical generalized linear mixed models.
It is expected that his study will contribute to the body of evidence on the efficacy and effectiveness of READY by comparing it with an active group intervention in frontline MS rehabilitation and clinical settings. Results will be disseminated in peer-reviewed journals and at other relevant conferences.
REsilience and Activities for every DaY (READY) 是一种基于接纳与承诺疗法的团体韧性训练计划，初步的实证研究支持该计划可以提高多发性硬化症患者（PwMS）的生活质量和其他心理社会结果。根据医学研究委员会制定和评估复杂干预措施的框架，我们进行了一项试点随机对照试验（RCT），随后进行了一项 III 期 RCT。本文介绍了 III 期 RCT 方案。
这是一项多中心集群 RCT，比较了 READY 与意大利 8 个中心的团体放松计划（1:1 比例）在 240 名 PwMS 中的效果。两种干预措施均由 7 周的课程和 5 周后的强化课程组成。在基线、强化课程后以及 3 个月和 6 个月随访时，将评估韧性（主要结局）、情绪、健康相关生活质量、幸福感和心理灵活性。如果由于 COVID-19 相关问题而中断面对面的小组会议，将邀请参与者通过电话会议完成干预。将收集相关的 COVID-19 信息，并在基线和 3 个月随访时进行 COVID-19 创伤后应激障碍量表评估（辅助研究）。分析将采用意向治疗，以显示 READY 优于放松的优势。使用重复测量、层次广义线性混合模型比较两组之间的纵向变化。
预计该研究将通过将 READY 与一线 MS 康复和临床环境中的积极团体干预进行比较，为其疗效和有效性提供证据。结果将在同行评议期刊和其他相关会议上发表。
