One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT

Afia Ali, E. Mckenzie, Zara Rasoul, A. Hassiotis, S. Priebe, B. Lloyd-Evans, Rebecca Jones, M. Panca, R. Omar, S. Finning, S. Moore, Christine Roe, M. King
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Abstract

Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of < 30% of participants and volunteers; adherence to the intervention (10 meetings between pairs); acceptability of the intervention; and feasibility of collecting data on costs and resource use for an economic evaluation. Changes in depressive symptoms (primary clinical outcome: Glasgow Depression Scale) and self-esteem, quality of life, social participation, social support, health-related quality of life and service use were recorded at 6 months. Outcomes in volunteers were also assessed. We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data. Delays to the study prevented the use of alternative recruitment strategies and the planned 12-month follow-up could not be completed. Recruitment was not feasible, but other feasibility outcomes were more positive. Evaluating befriending for people with intellectual disability could be explored through alternative study designs, such as observational studies. Current Controlled Trials ISRCTN63779614. This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.
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一对一志愿者交友减轻智障患者抑郁症状:可行性随机对照试验
对智障人士交朋友的有效性知之甚少,也不知道交朋友是否能改善抑郁症状和社会结果。本试点试验旨在评估对有抑郁症状的智障人士进行一对一交友的未来全面随机对照试验的可行性和可接受性。这是一项平行组、双臂随机对照试验,包括探索性经济分析和混合方法过程评估。结果评估在基线和随机化后6个月由一名对分配不知情的研究助理进行。我们的目标是接近50名参与者,以期招募40名。智力残疾的参与者是从一个NHS信托机构和转介到两个社区友好服务机构招募的。干预是由社区友好服务提供的。研究对象为轻度或中度智力障碍的成人,其格拉斯哥抑郁量表(Glasgow Depression Scale)的学习障碍评分≥5分。每周参加日班或学院≥3天者排除在外。志愿者年龄≥18岁,无犯罪前科。干预组的参与者与一名志愿者朋友配对,并期望每周见一次面,持续1小时,持续6个月。志愿者在日志上记录活动。志愿者接受培训和定期监督。两组都得到了常规护理和当地活动的资料小册子。可行性结果和进展标准是招募至少70%的参与者;干预组中至少70%的参与者与志愿者匹配;参与者和志愿者的退学率< 30%;坚持干预措施(两组间10次会议);干预的可接受性;收集成本和资源利用数据进行经济评价的可行性。在6个月时记录抑郁症状(主要临床结果:格拉斯哥抑郁量表)和自尊、生活质量、社会参与、社会支持、与健康相关的生活质量和服务使用的变化。对志愿者的结果也进行了评估。我们只招募了16名智力残疾的参与者(目标的40%)和10名志愿者。干预组8名参与者中有6名(75%)与朋友配对,并且有良好的依从性(平均参加会议次数11.8;范围1-21次会议)。去咖啡馆/餐馆和聊天是最常见的活动。所有参与者都在随访中被保留,但有两名志愿者退出。试验程序和干预可能是可以接受的,但建议进行修改。获得了成本和资源使用的数据,但与健康有关的生活质量数据存在差异。这项研究的延误妨碍了其他征聘战略的使用,计划的12个月后续行动也无法完成。招聘不可行,但其他可行性结果较为积极。可以通过其他研究设计,如观察性研究,来评估对智障人士的友好程度。当前对照试验ISRCTN63779614。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第九卷,第10期请参阅NIHR期刊图书馆网站了解更多项目信息。
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