Eaton Andrew David, Walmsley Sharon L, Craig Shelley L, Rourke Sean B, Sota Teresa, McCullagh John W, Fallon Barbara A
Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada
Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada.
BMJ Open. 2019 Oct 31;9(10):e033183. doi: 10.1136/bmjopen-2019-033183.
INTRODUCTION: HIV-associated neurocognitive disorder (HAND) may affect 30%-50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND's symptoms, yet the ideal intervention is unclear. This protocol outlines a pilot randomised controlled trial (RCT)-designed using community-based participatory research-to pilot cognitive remediation group therapy (CRGT) against an active comparator. METHODS AND ANALYSIS: This is a pilot, parallel design, two-arm RCT that will recruit participants diagnosed with the mild neurocognitive disorder form of HAND from a neurobehavioural research unit at a tertiary care hospital in Toronto, Canada. Eligibility criteria include age ≥40 years, known HIV status for 5+ years, English fluency, able to consent and able to attend 8 weeks of group therapy. Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3 hours per session. Arm 1 (novel) is CRGT, combining mindfulness-based stress reduction with brain training activities. Arm 2 (active control) is mutual aid group therapy. The primary outcomes are feasibility, measured by proportions of recruitment and completion, and acceptability, determined by a satisfaction questionnaire. The secondary outcome is intervention fidelity, where content analysis will be used to assess facilitator session reports. A between-group analysis will be conducted on exploratory outcomes of stress, anxiety, coping and use of intervention activities that will be collected at three time points. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Research Ethics Boards of St. Michael's Hospital and the University of Toronto. Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study could provide insight into design (eg, recruitment, measures) and intervention considerations (eg, structure, content) for a larger trial to lessen the burden of cognitive decline among people ageing with HIV. TRIAL REGISTRATION NUMBER: NCT03483740; Pre-results.
引言：与艾滋病病毒相关的神经认知障碍（HAND）可能影响30%-50%的艾滋病病毒感染者。HAND可能会增加压力和焦虑，并妨碍应对能力。心理社会小组治疗可能会改善HAND的症状，但理想的干预措施尚不清楚。本方案概述了一项试点随机对照试验（RCT）——采用基于社区的参与性研究设计——以针对积极对照开展认知康复小组治疗（CRGT）的试点。 方法与分析：这是一项试点、平行设计、双臂RCT，将从加拿大多伦多一家三级护理医院的神经行为研究单位招募被诊断为轻度神经认知障碍形式的HAND患者。纳入标准包括年龄≥40岁、已知感染艾滋病病毒5年以上、英语流利、能够签署知情同意书且能够参加8周的小组治疗。符合条件的参与者将被随机分配到两个治疗组之一，每个组均包括为期八节的小组干预，每周进行一次，每次3小时。第一组（新方法）为CRGT，将基于正念的减压与大脑训练活动相结合。第二组（积极对照）为互助小组治疗。主要结局为可行性（通过招募和完成比例衡量）和可接受性（由满意度问卷确定）。次要结局为干预保真度，将通过内容分析评估主持人的会议报告。将对在三个时间点收集的压力、焦虑、应对和干预活动使用情况的探索性结局进行组间分析。 伦理与传播：已获得圣迈克尔医院和多伦多大学研究伦理委员会的伦理批准。研究结果将通过同行评审出版物、会议报告和社区报告进行传播。本研究可为规模更大的试验的设计（如招募、测量）和干预考量（如结构、内容）提供见解，以减轻艾滋病病毒感染者认知衰退的负担。 试验注册号：NCT0348
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