Psychosocial interventions for aging with HIV and cognitive challenges

A scoping review of non-pharmacological dementia interventions for people with mild cognitive impairment found that most interventions focused on cognitive training (i.e., Brain Training Activities, or BTA) (Rodakowski et al., Citation2015). BTA is constituted of games and activities that can be delivered via computer, tablet, or with pen and paper (Barnes et al., Citation2009). These activities focus on a specific cognitive domain (such as speed of processing) or cognition more broadly, based on an assessment of individual deficits (Barnes et al., Citation2009). When practised for 1–3 hours per week for 6–10 weeks, BTA has improved self-reported outcomes of coping and ability in the cognitive domains that the games are targeted toward (Tappen & Hain, Citation2014).

Psychosocial interventions have also been trialed for people with mild-to-moderate dementia, with mindfulness approaches among the most frequently used modalities (Berk et al., Citation2017). Group therapies are particularly recommended due to their inherent ability to foster social connection (Toms et al., Citation2015). Mindfulness-Based Stress Reduction (MBSR) groups may be the preferential mindfulness approach for cognitive impairment due to its ability to reduce anxiety and cultivate calmness (Russell-Williams et al., Citation2018). The MBSR curriculum of eight weekly 1.5–2-hour sessions, which teaches meditation, breathing, and grounding techniques (Kabat-Zinn et al., Citation2017), has been found to create lasting practices for emotional regulation in participants following the intervention’s conclusion (Goldin & Gross, Citation2010).

Combination approaches, blending intervention models, may be better suited to the complexity of HIV-associated health problems than a single technique approach (Bateganya et al., Citation2015). Given BTA’s and MBSR’s promising results with the general population living with dementia, this study combined these interventions into cognitive remediation group therapy (CRGT). CRGT was tested against mutual aid group therapy, widely considered the most recognizable form of group support and widely practiced in HIV and dementia (Bateganya et al., Citation2015; Toms et al., Citation2015). These groups use the single technique of talk therapy whereby one or two facilitators – often social workers – help the group maintain respect, stay on topic, and explicate connection and shared experience between group members (Toms et al., Citation2015). CRGT was tested against mutual aid in a pilot randomized, controlled trial for people aging with HAND to assess feasibility, acceptability, intervention fidelity, and exploratory outcomes.

This pilot trial’s objective was to assess and compare the feasibility, acceptability, intervention fidelity, and exploratory outcomes (stress, anxiety, coping, use of mindfulness and BTA) of the novel and control arms.

Cognitive remediation group therapy (novel arm)

The novel arm of cognitive remediation group therapy (CRGT) was held at the Center for Mindfulness Studies in Toronto and blended mindfulness-based stress reduction (MBSR) and brain training activities (BTA). Each weekly session was divided into 2 hours of manualized MBSR facilitated by a physician and a social worker followed by 1 hour of BTA facilitated by a peer aging with HIV. For BTA, participants were provided with a Samsung tablet and a 1-year license to BrainHQ training by PositScience. As BTA has predominantly been administered as a passive, individual exercise where a participant is given the software and written instructions for use with minimal follow-up (Tappen & Hain, Citation2014), a participatory approach was required to incorporate BTA into active group therapy whereby the facilitator sought participant feedback on how to structure this component of CRGT. The group decided on 40 minutes of discussion on training progress and challenges and 20 minutes dedicated to individual practice. The BTA facilitator incorporated mutual aid elements like the strength in numbers phenomenon (Shulman, Citation1986) to help members feel less isolated in their experiences living with HAND.

Mutual aid group therapy (control arm)

The control arm of mutual aid group therapy was held at the AIDS Committee of Toronto and was facilitated by a social worker and a peer aging with HIV. The facilitators followed the intervention’s manual (Eaton et al., Citation2019a) of helping participants get to know each other, agree to the group’s mandate of mutual aid, and set norms that would assist in maintaining group safety (Steinberg, Citation2000) whereas encouraging participants to share their experiences living with HIV-related cognitive impairment and associated coping strategies with one another. Facilitators were trained to employ the nine processes of mutual aid as defined by Shulman (Citation1986). For example, facilitators encouraged participants to explore taboo subjects such as discussing cognitive deficits, feel “all in the same boat” as they had all received an MND-HAND diagnosis, and rehearse how they may disclose their HAND diagnosis to friends and family. Overall, facilitators attempted to create connections between participants by identifying commonalities in their experiences with the aim of creating a community within the group to support one another through shared challenges.

Outcomes

Feasibility was assessed against a priori targets that the research team agreed would be necessary to proceed with a larger trial, based on relevant literature (Eldridge et al., Citation2016) and the team’s experience with piloting and implementing interventions of this nature (Eaton et al., Citation2017b, Eaton et al., Citation2019b). The targets, based on a sampling frame of 40 people, were: $\ge$ 30% of those contacted agreed to participate, $\ge$ 25% completed the initial assessment, $\ge$ 20% attended the first orientation session of their treatment arm, $\ge$ 16% completed their entire arm’s group series the final 3-month follow-up assessment.

Acceptability was measured via a satisfaction questionnaire conducted at midpoint and endpoint of each arm’s group therapy, involving the Likert-style Helping Characteristics of Self-Help and Support Groups Measure (22-items, α = 0.87) (Schiff & Bargal, Citation2000) and open-ended questions about session length, number of sessions, activities used, and evaluation of facilitators.

For intervention fidelity, facilitators submitted weekly session reports constituted of checklists of therapy components and open-ended questions about activities completed in each group, dynamics between participants, and facilitation challenges. An a priori target of 80% of checklist therapy components per session was set, based on prior research (Borrelli, Citation2011).

Exploratory outcomes of stress, anxiety, coping, use of mindfulness strategies, and use of brain training activities were assessed at three times: preintervention, postintervention, and 3-month follow-up. Standardized measures used were HIV/AIDS Stress Scale (29-items, Likert, α = 0.91) (Packenham & Rinaldis, Citation2002), Anxiety in Cognitive Impairment and Dementia Scale (26-items, dyadic, α = 0.87) (Gerolimatos et al., Citation2015), Coping Self-Efficacy Scale of Health Problems (10-items, Likert, α = 0.85) (Gandoy-Crego et al., Citation2016), and the Five Facet Mindfulness Questionnaire–Short Form⁴³ (24-items, α = 0.80) (Bohlmeijer et al., Citation2011).

Sample size

A sampling frame of 40 individuals from the recruiting site met an initial screen for entry criteria. From this frame, 12 to 16 participants was chosen as the numbers necessary to initiate this pilot RCT as: a) that would permit six to eight people in each trial arm, which is ideal for group therapy of this nature (Lenferink et al., Citation2019); and b) although this number limits analytical options and outcome assessment, similar numbers have been used to assess feasibility and acceptability in other pilot group therapy RCTs (Bateganya et al., Citation2015).

Randomization

A research coordinator enrolled participants by confirming their eligibility, attaining their informed consent, and collecting their availability for group therapy. Concealed allocation was then employed, whereby the first author provided the study sponsor with unique identifiers for each enrolled person and the sponsor then randomized participants in a 1:1 fashion using size two blocks to either the novel or control arm. These results were then communicated individually to each participant, alongside details regarding the schedule of their group therapy series.

Masking

Intervention facilitators were masked to outcome assessments, which were conducted by a research coordinator. Participants in one arm were masked to participants in the other arm. Analysts were masked to participant identities. Participants were not masked regarding the content of each arm; detail of the interventions – both group therapies with one more focused on discussion (control) and one on mindfulness and brain training (novel) – was described.

Data analysis

For feasibility, proportions of participant recruitment, enrollment, and completion were calculated. Acceptability was analyzed as average scores on a satisfaction measure and reasons for participant withdrawal were also described. Fidelity was analyzed by tabulating intervention checklist items and qualitatively by two independent coders trained in the intervention models who employed content analysis for the open-ended responses to determine if interventions were delivered as designed. Exploratory outcomes were analyzed using non-parametric Wilcoxon rank sum tests run in R 3.5.1 (Feather Spray) to determine if there was a significant between-group difference for change in outcomes relative to preintervention. Lacking a standardized scale to assess BTA use at the time of study design, progress reports from PositScience by BrainHQ were used for the novel arm, and self-reported use of BTA was used for the control arm.

Participant flow

Figure 1 displays participant flow throughout the study. There were 100 individuals diagnosed with HAND at the recruiting clinic since 1 January 2016, of which 40 were diagnosed with the mild-to-moderate form that constituted the study’s sampling frame.

Figure 1. Participant flowchart.

Display full size

Recruitment

From 1 April to 30 September 2018, a clinical psychologist from the recruiting site made three distinct contact attempts to all participants in the sampling frame (n = 40) at the phone number and e-mail address that they provided at their last clinic visit. These contacts briefly detailed the study and eligibility criteria, and asked participants whether they would like to be contacted by the research coordinator to schedule a meeting to confirm eligibility and review the consent form. Twelve people consented to participate, on the lower end of our target sample. Because the sampling frame’s contact attempts had been exhausted and some people had been waiting approximately 4 months for the trial to begin, the trial was initiated with 12 participants on 1 October 2018. Both groups were held on Wednesdays, the novel arm in afternoons and the control in the evening. Preintervention assessments were conducted on 10 October 2018. Group series ran from 17 October 2018 to 12 December 2018. Postintervention outcomes were assessed on 19 December 2018, and the 3-month follow-up was conducted on 19 March 2019. Participants received $20 Canadian honorarium for each study visit.

Baseline data

Participants (n = 12) all identified as gay, cisgender males. All participants also had a family doctor and an HIV specialist, were taking daily antiretroviral HIV medication, and identified prescription substance misuse. Refer to Table 1 for further participant characteristics.

Feasibility results are presented against a denominator of 40, which is the sampling frame and is the number of people that the recruiting psychologist attempted to contact. For all other outcomes, the denominator is 10 per who completed the study and all assessments.

Feasibility

Overall, 30% (n = 12) of the sampling frame agreed to participate, completed the preintervention assessment, and attended the first orientation session of their arm’s intervention. Two participants (one from each arm) withdrew, leaving 25% (n = 10) completing the study.

Acceptability

On the standardized satisfaction scale at postintervention, the novel arm averaged 90% acceptability compared to 85% in the control. Open-ended acceptability responses were brief but positive in both arms, as participants felt session and series length was appropriate, the facilitators were skilled and non-judgmental, and the groups’ activities were helpful.

Fidelity

Facilitators self-reported use of intervention components via checklists and added additional qualitative detail to support their claims. Two independent coders found that both arms were delivered with satisfactory fidelity.

Exploratory outcomes

Exploratory outcome assessments of anxiety, stress, coping, and use of mindfulness activities were assessed at preintervention (T1), postintervention (T2), and 3-month follow-up (T3). Anxiety decreased for all participants in the CRGT novel arm and for half of the mutual aid control, although a change was not significantly different between the two groups at T3 relative to T1 (p = .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 < .01). Coping also improved for about half of each group, with an insignificant difference between the novel arm and control at T3 compared to T1 (p = .75). Half of each group’s participants increased in use of mindfulness activities with the novel arm’s increase being significantly greater than the control’s at T3 compared to T1 (p = .035). Based on usage data from PositScience by BrainHQ, the novel arm’s six participants sustained more than 3 hours of BTA practice per week for the 21-week duration of the study. The control arm’s six participants self-reported BTA use of 1–3 hours per week during the study’s timeline.

Limitations

This trial has several limitations. A small sample size limits outcome assessment and interpretation. This small sample may be the result of limiting recruitment to a single site and/or a formal diagnosis of mild-to-moderate HAND, which requires intensive neuropsychological screening. The lack of participant masking poses a risk to performance bias whereby participant responses may have been affected by allocation to the novel or control arm. Assessing fidelity from facilitator reports risks reporting bias, where the facilitators may have exaggerated the groups’ progress. Recording sessions may be a more rigorous measure of fidelity, although this method raises privacy concerns in a stigmatized population.