Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Queen Mary University of London, London, UK.
Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
BMJ Open. 2016 Aug 3;6(8):e011582. doi: 10.1136/bmjopen-2016-011582.
Social isolation is common in patients with psychosis and associated with a number of negative outcomes. Programmes in which volunteers provide one-to-one support-often referred to as befriending-have been reputed to achieve favourable outcomes. However, trial-based evidence for their effectiveness is limited.
This is a randomised controlled trial comparing the effects of one-to-one volunteer support with an active control condition for patients with psychosis over a 1-year period. Patients in the intervention group will receive the support of a volunteer for 1 year, who will meet them weekly and engage them in social and recreational activities. Patients in the control group will not receive support from a volunteer. In both groups, patients will be given a booklet detailing locally available social activities and otherwise receive treatment as usual. Patients, volunteers, clinicians and researchers involved in the delivery of the intervention will not be blinded to group assignment, while researchers carrying out data collection will be blinded. Data collection will be conducted at baseline, at 6 and 12 months. The primary outcome is the amount of time spent engaging in social activities per day. Secondary outcomes include symptoms, quality of life, self-esteem and costs of care. Attitudes of volunteers towards mentally ill people will be assessed. Finally, in-depth interviews will be conducted with patients and volunteers.
The study has been approved by the National Research Ethics Service (NRES) Committee London-Camden & Kings Cross (reference 15/LO/0674). The findings of the trial will be published in open access peer-reviewed journals and in the National Institute for Health Research (NIHR) journals library, and presented at scientific conferences. In addition, findings will be summarised for a lay audience and circulated to all relevant National Health Service (NHS) and voluntary organisations.
ISRCTN14021839; Pre-results.
精神分裂症患者普遍存在社会孤立现象，这种现象与许多负面后果有关。志愿者提供一对一支持的项目——通常被称为“交友”——被认为可以取得有利的结果。然而，基于试验的证据对此类项目的有效性有限。
这是一项随机对照试验，比较了精神分裂症患者在 1 年内接受一对一志愿者支持与积极对照条件的效果。干预组的患者将接受志愿者的支持 1 年，志愿者将每周与患者见面，并与他们一起参加社交和娱乐活动。对照组的患者不会从志愿者那里得到支持。在两组中，患者都会收到一本详细介绍当地社交活动的小册子，并接受常规治疗。参与干预措施实施的患者、志愿者、临床医生和研究人员不会对分组情况进行盲法处理，而进行数据收集的研究人员将进行盲法处理。数据收集将在基线、6 个月和 12 个月进行。主要结果是每天参与社交活动的时间量。次要结果包括症状、生活质量、自尊和护理费用。还将评估志愿者对精神疾病患者的态度。最后，将对患者和志愿者进行深入访谈。
该研究已获得国家研究伦理服务（NRES）委员会伦敦-卡姆登和国王十字（参考 15/LO/0674）的批准。试验结果将在开放获取同行评议期刊和国家卫生研究所（NIHR）期刊图书馆发表，并在科学会议上展示。此外，研究结果将为非专业观众进行总结，并分发给所有相关的国家卫生服务（NHS）和志愿组织。
ISRCTN14021839；预结果。
