A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study

IntroductionAn Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (group relaxation).MethodsSingle-blind phase II randomized controlled trial (RCT) and nested qualitative study (ISRCTN registration number: 38971970). Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors were measured at baseline, after seven, 12 and 24 weeks. READY participants completed the purpose-built satisfaction questionnaire after 12 weeks. After trial completion, the control group also received READY. One-to-one participant interviews were conducted within three months of finishing the READY groups.ResultsFour intervention groups were conducted with 39 participants (20 READY, 19 relaxation). Two patients (READY) withdrew before beginning the intervention due to unexpected work commitments. Feasibility and acceptability of READY were good, with high participant engagement and satisfaction. No statistical effects of READY were detected vs relaxation. Thirty participants were interviewed (18 READY; 12 relaxation + READY). Content data analysis revealed seven overarching themes: “Attitudes towards participation”; “Perceptions of program composition”; “Program impacts on life domains”; “Program active elements”; “Program improvement trajectories”; “Program differences and similarities”; “Suggested READY improvements”.ConclusionREADY was well accepted by MS patients with varied socio-demographic and clinical characteristics. Qualitative (but not quantitative) data provided evidence in favour of READY. Our findings will inform methodological and intervention refinements for the multi-centre RCT that will follow.

引言：一项澳大利亚病例系列研究证实，基于接纳与承诺疗法（Acceptance and Commitment Therapy）的多发性硬化症（multiple sclerosis, MS）患者每日韧性与活动项目（READY for MS，下称READY for MS）可改善MS患者的生活质量。本研究旨在评估意大利版READY for MS项目的可行性与可接受性，并初步对比其与主动对照干预措施——团体放松疗法的疗效。
方法：本研究为单盲II期随机对照试验（randomized controlled trial, RCT）与嵌套式定性研究，临床试验注册号为ISRCTN 38971970。分别于基线、第7、12及24周测量健康相关生活质量（主要研究结局）、情绪、韧性、心理灵活性及其保护因素。READY组受试者于12周后填写定制化满意度问卷。试验结束后，对照组受试者亦可参与READY项目。在完成READY团体干预后的三个月内，对所有受试者开展一对一访谈。
结果：共设立4个干预组，纳入39名受试者（READY组20名，放松组19名）。2名READY组受试者因突发工作事务在干预开始前退出研究。READY项目的可行性与可接受性良好，受试者参与度与满意度均较高。未检测到READY组相较于放松组存在统计学差异。共对30名受试者进行访谈（READY组18名，接受READY干预的原放松组受试者12名）。内容分析法共提炼出7个核心主题：「参与态度」、「项目构成认知」、「项目对生活领域的影响」、「项目核心活性元素」、「项目改善轨迹」、「项目异同点」、「READY项目改进建议」。
结论：READY项目获得了具有不同社会人口学与临床特征的MS患者的认可。定性（而非定量）研究数据为READY项目提供了支持性证据。本研究结果将为后续开展的多中心RCT的方法学优化与干预方案完善提供依据。