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Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.

ABSTRACT: The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist control arm that receives MBSR following a 16-week period of standard care. Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness) are assessed at baseline and weeks 8, 16, and 48 in both groups, with an additional assessment at week 24 (post-MBSR) in the crossover control group. Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs). In addition, a subset of participants (n = 30 per group) are randomly selected to undergo fMRI to evaluate changes in functional connectivity networks and their relationship to changes in neuropsychological outcomes. Forthcoming findings from this randomized controlled trial have the potential to contribute to a growing public health need as the number of older adults with HAND is expected to rise.

SUBMITTER: Addington EL

PROVIDER: S-EPMC7686285 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.

Addington Elizabeth L EL Javandel Shireen S De Gruttola Victor V Paul Robert R Milanini Benedetta B Ances Beau M BM Moskowitz Judith T JT Valcour Victor V

Contemporary clinical trials 20200915

The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed vir ...[more]

PMID: 32942053

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Project description:BackgroundHIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV.ObjectiveThis article reports and discusses the overall rationale and development of speed of processing training, a computerized Internet cognitive training program, to improve this specific neurocognitive ability as well as everyday functioning and quality of life in adults aging with HIV. Although this protocol has been shown to improve speed of processing, everyday functioning, and quality of life in healthy, community-dwelling older adults in the advanced cognitive training in vital elderly (ACTIVE) study, its efficacy in adults aging with HIV has not been established. Nevertheless, such a cognitive intervention is particularly germane as 52%-59% of adults with HIV experience HIV-associated neurocognitive disorders (HAND), and both the frequency and severity of such disorders may increase with advancing age.MethodsThe description of this longitudinal randomized controlled trial covers the following: (1) rationale for speed of processing training in this clinical population, (2) overview of overall study design, (3) eligibility criteria and HAND, (4) intervention dosage, (5) assessment battery, and (6) examination of biomarkers.ResultsThe project was funded in April 2016 and enrolment is on-going. The first results are expected to be submitted for publication in 2020.ConclusionsSimilar novel cognitive intervention approaches are suggested as they may be of value to those with HAND and may utilize similar features of this current randomized controlled trial (RCT) protocol to examine their therapeutic efficacy.Trial registrationClinicalTrials.gov NCT02758093; https://clinicaltrials.gov/ct2/show/NCT02758093 (Archived by Webcite at http://www.webcitation.org/6p8C5fBCX).

Project description:ObjectiveEvidence links depression and stress to more rapid progression of HIV-1 disease. We conducted a randomized controlled trial to test whether an intervention aimed at improving stress management and emotion regulation, mindfulness-based stress reduction (MBSR), would improve immunological (i.e. CD4+ T-cell counts) and psychological outcomes in persons with HIV-1 infection.MethodsWe randomly assigned participants with HIV-1 infection and CD4 T-cell counts >350 cells/μl who were not on antiretroviral therapy in a 1:1 ratio to either an MBSR group (n = 89) or an HIV disease self-management skills group (n = 88). The study was conducted at the University of California at San Francisco. We assessed immunologic (CD4, c-reactive protein, IL-6, and d-dimer) and psychological measures (Beck Depression Inventory for depression, modified Differential Emotions Scale for positive and negative affect, Perceived stress-scale, and mindfulness) at 3, 6 and 12 months after initiation of the intervention; we used multiple imputation to address missing values.ResultsWe observed statistically significant improvements from baseline to 3-months within the MBSR group in depression, positive and negative affect, perceived stress, and mindfulness; between group differences in change were significantly greater in the MBSR group only for positive affect (per item difference on DES-positive 0.25, 95% CI 0.049, 0.44, p = .015). By 12 months the between group difference in positive affect was not statistically significant, although both groups had trends toward improvements compared to baseline in several psychological outcomes that were maintained at 12-months; these improvements were only statistically significant for depression and negative affect in the MBSR group and perceived stress for the control group. The groups did not differ significantly on rates of antiretroviral therapy initiation (MBSR = 39%, control = 29%, p = .22). After 12 months, the mean decrease in CD4+ T-cell count was 49.6 cells/μl in participants in the MBSR arm, compared to 54.2 cells/μl in the control group, a difference of 4.6 cells favoring the MBSR group (95% CI, -44.6, 53.7, p = .85). The between group differences in other immunologic-related outcomes (c-reactive protein, IL-6, HIV-1 viral load, and d-dimer) were not statistically significant at any time point.ConclusionsMBSR improved positive affect more than an active control arm in the 3 months following the start of the intervention. However, this difference was not maintained over the 12-month follow-up and there were no significant differences in immunologic outcomes between intervention groups. These results emphasize the need for further carefully designed research if we are to translate evidence linking psychological states to immunological outcomes into evidence-based clinical practices.

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Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.

Publications

Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.

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