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

IntroductionHIV-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 analysisThis 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 disseminationEthical 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 numberNCT03483740

Adapting cognitive remediation group therapy: A community-based, focus group study

“…CBPR in this context means that people living with HIV and cognitive concerns have codesigned, -delivered, and -evaluated CRGT in partnership with community partners and researchers since 2017 [20,21] and the partnership is continuing in the present study [29]. The study protocol is published elsewhere [29].…”

“…CRGT blends mindfulness-based stress reduction (MBSR) with brain training activities (BTA) and was piloted as an in-person intervention in Canada in 2019 [20,21]. The pilot evaluated CRGT against mutual aid group therapy (an active control) in a randomized controlled trial (RCT) for people diagnosed with mild-to-moderate HIV-Associated Neurocognitive Disorder (HAND) [20,21]. When CRGT was delivered in person, it consisted of nine three-hour sessions delivered once weekly [20,21].…”

“…The pilot evaluated CRGT against mutual aid group therapy (an active control) in a randomized controlled trial (RCT) for people diagnosed with mild-to-moderate HIV-Associated Neurocognitive Disorder (HAND) [20,21]. When CRGT was delivered in person, it consisted of nine three-hour sessions delivered once weekly [20,21].…”

Mindfulness and cognitive training interventions that address intersecting cognitive and aging needs of older adults

“…(Juang et al, 2017;O'Rourke et al, 2018). Such activity-based therapies for people with cognitive impairment are often labeled as "cognitive remediation therapies" as their primary purpose is to help people manage symptoms and effects of cognitive decline by teaching compensatory strategies that can help individuals cope better in their daily lives (Eaton et al, 2022;Eaton et al, 2019;Eaton et al, 2017;Fan et al, 2017) Further, group therapies have been recommended over one-on-one interactions by this population (Eaton et al, 2017;Fan et al, 2017). Groups have the inherent ability of bringing together people who share a condition or issue (Schiff & Bargal, 2000), and this gathering may be particularly helpful for older adults with cognitive impairment who may feel isolated or as if they are alone in their experiences and struggles (O'Rourke et al, 2018).…”

“…(Juang et al, 2017; O’Rourke et al, 2018). Such activity-based therapies for people with cognitive impairment are often labeled as “cognitive remediation therapies” as their primary purpose is to help people manage symptoms and effects of cognitive decline by teaching compensatory strategies that can help individuals cope better in their daily lives (Eaton et al, 2022; Eaton et al, 2019; Eaton et al, 2017; Fan et al, 2017)…”