Cognitive remediation group therapy versus mutual aid group therapy: A pilot randomized, controlled trial to determine the feasibility and acceptability of group therapy for people aging with HIV facing cognitive challenges

Abstract Background: Cognitive impairment is an important comorbidity for people aging with HIV, yet we lack non-medical techniques to address the associated anxiety and stress. Combination psychosocial interventions may have better outcomes than single technique approaches. Mindfulness-Based Stress Reduction (MBSR) and tablet-based Brain Training Activities (BTA) are promising techniques. Using community-based participatory research, our objective was to determine the feasibility and acceptability of group therapy for HIV, aging, and cognition. Methods: A pilot, parallel design, two-arm RCT recruited from a Toronto neurobehavioural research unit. Eligibility criteria included: diagnoses with mild-to-moderate HIV-associated neurocognitive disorder (HAND), age ≥ 40 years, HIV-positive for 5+ years, and English fluency. Randomization was 1:1 concealed allocation to Cognitive Remediation Group Therapy (Experimental; combination of BTA and MBSR) or Mutual Aid Group Therapy (Control). Primary outcomes were feasibility, measured by recruitment and completion, and acceptability, determined by a satisfaction questionnaire. The secondary outcome was intervention fidelity, assessed via facilitator session reports. Exploratory outcomes were anxiety, stress, coping, and use of mindfulness and brain training activities. Facilitators and analysts were blinded, however participants were not. Results: From 1 April 2018 to 19 March 2019, forty eligible participants were contacted, 12 randomized, and 10 completed the study and were analyzed for outcomes. The trial met its a priori feasibility targets with 30% recruited and 25% completed. At post-intervention, acceptability was 90% in the novel and 85% in the control arm. Assessors confirmed intervention delivery with satisfactory fidelity, with no missing components or significant deviations. Anxiety decreased for all in the novel arm and half of the control. Stress decreased and coping increased for half in both arms. All participants increased and sustained BTA use and half with mindfulness activities. There were no reported study harms. Conclusions: Although the combination of BTA and MBSR proved equal or slightly better to mutual aid therapy on all outcomes, recruitment of people with a formal HAND diagnosis from a single site was challenging. We recommend that future exploration of these techniques broaden to those aging with HIV with cognitive challenges regardless of a formal HAND diagnosis.Trial registration: clinicaltrials.gov, NCT03483740. Registered 30 March 2018, https://clinicaltrials.gov/ct2/show/NCT03483740