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Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada

Abstract：

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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Eaton AD,Walmsley SL,Craig SL,Rourke SB,Sota T,McCullagh JW,Fallon BA

doi

10.1136/bmjopen-2019-033183

subject

Has Abstract

pub_date

2019-10-31 00:00:00

pages

e033183

issue

10

issn

2044-6055

pii

bmjopen-2019-033183

journal_volume

9

pub_type

杂志文章

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