Introduction

Transitioning to secondary progressive multiple sclerosis (SPMS) is a difficult time for people, fraught with uncertainty and an increase in physical disability. In parallel, healthcare appointments become less frequent, most disease modifying treatments are withdrawn, and social contacts typically become more difficult to maintain. The aim of this study was to assess whether providing a brief, Acceptance and Commitment Therapy (ACT)–based telephone support intervention during transition to SPMS is feasible, effective and valued by participants.

Method

A single centre, mixed-methods, two-arm feasibility randomised controlled trial (RCT), comparing (i) ACT-based support + treatment as usual to (ii) treatment as usual only, was conducted for those who had transitioned to SPMS. Feasibility, signal of efficacy and acceptability were assessed in both groups by self-report measures at 3 timepoints (baseline, 8 weeks, 12 weeks), and feedback interviews analysed using framework analysis following the completion of the study.

Results

The recruitment strategy was not feasible: 14 of 40 were recruited (35%) during the four-month time period (M^age = 53, 10 women). The data collection procedures and trial processes were feasible and acceptable to participants, reflected through all measures being completed, no attrition, and positive participant interview feedback. The intervention did not demonstrate a signal of efficacy between baseline and 8-week or 12-week follow up on measures, but wide confidence intervals preclude drawing strong conclusions. Positive interview feedback suggested outcomes not being captured through self-report measures.

Discussion

Due to an unsuccessful recruitment strategy and mixed evidence of efficacy, certain adjustments should be made to the intervention and methodology before progressing to a definitive trial. A more efficient recruitment strategy, or longer recruitment period is needed to recruit a large enough sample. Adaptations to the ACT intervention may be needed to ensure that it targets psychological flexibility, which could include changing the workbook or session delivery based on interview feedback, however the small sample size means we should interpret the efficacy findings with caution.

中文翻译：

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过渡到继发性进行性多发性硬化症期间基于验收的电话支持：一项可行性随机对照试验

介绍

过渡到继发性进行性多发性硬化症 (SPMS) 对人们来说是一个艰难的时期，充满不确定性和身体残疾的增加。与此同时，医疗预约变得不那么频繁，大多数疾病改善治疗被取消，社交联系通常变得更难维持。本研究的目的是评估在过渡到 SPMS 期间提供基于接受和承诺疗法 (ACT) 的简短电话支持干预是否可行、有效并受到参与者的重视。

方法

对已过渡到 SPMS 的患者进行了一项单中心、混合方法、双臂可行性随机对照试验 (RCT)，比较 (i) 基于 ACT 的支持 + 常规治疗与 (ii) 仅常规治疗。通过在 3 个时间点（基线、8 周、12 周）的自我报告措施评估两组的可行性、有效性信号和可接受性，并在研究完成后使用框架分析分析反馈访谈。

结果

招募策略不可行：在四个月的时间段内招募了 40 名中的 14 名 (35%)（M^年龄 = 53，10 名女性）。数据收集程序和试验过程对参与者来说是可行和可接受的，这体现在所有措施都已完成、无人员流失和积极的参与者访谈反馈中。干预措施并未在基线和 8 周或 12 周的后续措施之间显示出疗效的信号，但较宽的置信区间无法得出强有力的结论。积极的面试反馈表明结果没有通过自我报告措施获得。

讨论

由于不成功的招募策略和混合的有效性证据，在进入最终试验之前，应对干预和方法进行某些调整。需要更有效的招聘策略，或者更长的招聘周期，才能招募到足够大的样本。可能需要对 ACT 干预进行调整，以确保其针对心理灵活性，这可能包括根据访谈反馈更改工作簿或会话交付，但是样本量小意味着我们应该谨慎解释疗效结果。