Eccles Fiona J R, Craufurd David, Smith Alistair, Davies Rhys, Glenny Kristian, Homberger Max, Peeren Siofra, Rogers Dawn, Rose Leona, Skitt Zara, Theed Rachael, Simpson Jane
Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.
Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL UK.
Pilot Feasibility Stud. 2020 Jun 24;6:90. doi: 10.1186/s40814-020-00631-z. eCollection 2020.
Huntington's disease (HD) is an inherited neurodegenerative condition which affects movement, coordination and cognitive functioning. Psychological difficulties are commonly experienced; however, psychological interventions have been little researched with this population. We investigated the feasibility of conducting a randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) with people with the HD genetic mutation, either pre-manifest (before onset of movement symptoms) or at an early disease stage. Specifically, we evaluated the willingness of participants to be recruited into and complete the intervention; the acceptability of the study measures in relation to completion; the feasibility of offering the standard MBCT course to people with HD; the acceptability of the intervention and the estimated effect sizes.
Participants were recruited from two UK HD centres and took part in an 8-week course of MBCT, with three reunions throughout the following year. Stress, depression, anxiety, and mindfulness were measured pre-, mid-, and post-course, at 3 months and at 1 year. Sleep, quality of life, positive affect and coping were measured pre- and post-course, at 3 months and at 1 year. Descriptive data and approximate effect sizes were calculated. Interviews were conducted post-course and at 1 year and data pertaining to the acceptability of the course were extracted.
Twelve participants took part in two groups; all were pre-manifest. Levels of depression and anxiety were low pre-course leaving little room for improvement. Changes in stress and in some aspects of mindfulness were medium to large. The qualitative data suggested participants rated the course highly and found it helpful and no changes to the standard course were needed. Recruitment levels were below those anticipated. Most measures were found to be acceptable.
Although the course was acceptable to those who took part, given the difficulties in recruiting and the rarity of HD, conducting an RCT of MBCT teaching groups in person does not seem feasible. However, alternative modes of course delivery (e.g. online) would allow the recruitment of people from a greater geographical area and may make an RCT feasible; this revised focus would be suitable for future feasibility studies.
ClinicalTrials.gov identifier NCT02464293, registered 8 June 2015.
亨廷顿舞蹈症（HD）是一种遗传性神经退行性疾病，会影响运动、协调能力和认知功能。患者普遍存在心理问题；然而，针对这一群体的心理干预研究较少。我们调查了对携带HD基因突变的人群（无论是症状前阶段（运动症状出现前）还是疾病早期阶段）进行基于正念的认知疗法（MBCT）随机对照试验（RCT）的可行性。具体而言，我们评估了参与者参与并完成干预的意愿；研究措施在完成方面的可接受性；向HD患者提供标准MBCT课程的可行性；干预措施的可接受性以及估计的效应大小。
参与者从英国的两个HD中心招募，参加为期8周的MBCT课程，并在接下来的一年中进行三次回访。在课程前、中、后、3个月和1年时测量压力、抑郁、焦虑和正念水平。在课程前和后、3个月和1年时测量睡眠、生活质量、积极情绪和应对方式。计算描述性数据和近似效应大小。在课程结束后和1年时进行访谈，并提取与课程可接受性相关的数据。
12名参与者分成两组；均处于症状前阶段。课程前抑郁和焦虑水平较低，改善空间不大。压力和正念某些方面的变化为中度到较大。定性数据表明参与者对课程评价很高，认为课程有帮助，无需对标准课程进行修改。招募水平低于预期。大多数测量方法被认为是可接受的。
尽管该课程对参与的人来说是可接受的，但考虑到招募困难和HD的罕见性，亲自开展MBCT教学组的RCT似乎不可行。然而，替代的课程授课方式（如在线授课）将允许从更大的地理区域招募人员，并可能使RCT可行；这种修订后的重点将适合未来的可行性研究。
ClinicalTrials.gov标识符NCT02464293，于2015年6月8日注册。
