(WITHDRAWN) Cognitive Remediation Group Therapy Versus Mutual Aid Group Therapy: A Pilot Randomized, Controlled Trial to Determine the Feasibility and Acceptability of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-Associated Neurocognitive Disorder (HAND)

Background and Purpose: Approximately half of the aging HIV-positive population will be affected to some degree by HIV-associated neurocognitive disorder (HAND). HAND’s symptoms include forgetfulness, trouble concentrating, and difficulty learning new skills. HAND’s effects include increased anxiety and stress. Psychosocial interventions have not been tested to improve coping with HAND’s symptoms and ameliorate associated anxiety and stress. Combination psychosocial interventions that may have better outcomes than single technique approaches. Mindfulness-Based Stress Reduction (MBSR) and tablet-based Brain Training Activities (BTA) are emerging as promising techniques to combine—particularly in a group format—based on extant research. Led by social workers, we tested the feasibility, acceptability, fidelity, and exploratory outcomes of stress, anxiety, and coping of a combination approach to group therapy, compared with mutual aid, for people aging with HAND.

Methods: A pilot, parallel design, two-arm randomized, controlled trial (RCT) used random sampling from a neurobehavioural research unit in Toronto, Canada. Eligibility criteria included: diagnoses with the mild-to-moderate form of HAND, age ≥ 40 years, HIV-positive for 5+ years, and English fluency. All persons diagnosed with HAND at the recruiting site since January 1, 2016 were contacted at equal frequency. Randomization was 1:1 concealed allocation to Cognitive Remediation Group Therapy (Experimental; combination of BTA and MBSR) or Mutual Aid Group Therapy (Control). Both interventions consisted of an orientation and eight weekly, three-hour group sessions and were facilitated by social workers and peers aging with HIV. Primary outcomes were feasibility—measured by recruitment and completion—and acceptability, determined by the Helping Characteristics of Self-Help and Support Groups Measure (α=0.87) at postintervention. The secondary outcome was intervention fidelity, assessed through content analysis of facilitator session reports. Exploratory outcomes were assessed using non-parametric Wilcoxon rank sum tests at preintervention (T1), postintervention (T2), and 3-month follow-up (T3) using the HIV/AIDS Stress Scale (29-items, α=0.91), Anxiety in Cognitive Impairment and Dementia Scale (α =0.87), and Coping Self-Efficacy Scale of Health Problems (α=0.85).

Results: From April-September 2018, a clinical psychologist attempted contact with 40 eligible participants of whom 15 replied, 12 recruited, and 10 completed the study. 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 participants in the novel arm and for half of the control, although a change was not significantly different between the two groups at T3 relative to T1 (p=0.17). Stress decreased for approximately half of the participants in each arm, and this decrease was significantly greater in the novel arm compared to the control at T3 relative to T1 (p<0.01). Coping also improved for half of each group, with an insignificant difference between the novel arm and control at T3 compared to T1 (p=0.75).

Conclusion and Implications: This pilot study presents the first known implementation of group therapy for people with HAND, with a multifaceted evaluation and an active comparator. This presentation will discuss implications for a larger trial of group therapy for people aging with HIV and cognitive challenges.