Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:55 - Any
Updated:12/14/2018
Start Date:March 2015
End Date:June 2019
Contact:Shireen Javandel, BA
Email:shireen.javandel@ucsf.edu
Phone:415-476-1688

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Interventions for Symptom Management in Older Patients With HAND

The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction
(MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among
patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and
have maximized treatment options.

This study addresses symptom management for patients aged 60 and older who are living with
HIV infection, are on combination antiretroviral therapy (cART) with suppressed viral loads,
and yet continue to experience behavioral and cognitive symptoms of HIV-associated
neurocognitive disorders (HAND). It is increasingly relevant that HAND persists despite cART,
impacting between 30-50% of elders living with HIV. Patients suffer symptoms that are
pervasive in their impact on everyday functioning and quality of life; yet these patients are
currently left with a dearth of treatment options. In this study, the investigators employ a
randomized controlled evaluation of Mindfulness Based Stress Reduction (MBSR) to target
attention, stress, anxiety, and depressive symptoms among patients who have HAND and have
maximized treatment options. The investigators will employ intrinsic connectivity network
(ICN) analyses of resting state functional magnetic resonance imaging to demonstrate
increased strength of brain networks corresponding to improved symptoms. The investigators
will quantify social networks and perceived strength of social networks to determine if they
moderate the main findings. Together this work employs geriatric, neuroscience and
complementary medicine disciplines to reduce the symptom burden in aging HIV-infected
patients.

Inclusion Criteria:

- Age ≥ 55 years

- HIV-infected. For cases in which a participant has an undetectable plasma viral load
and is not currently on cART, the participant will be asked to complete HIV antibody
testing.

- Undetectable plasma viral load

- Symptomatic and sufficient neuropsychological testing abnormality to be rated as
having impairment by consensus conference, but deficits in everyday functioning that
would rate them as having no more than moderate disease. Participants with severe
deficits consistent with dementia will not be randomized unless the study team agrees
that deficits are mild enough to withstand rigors of MBSR.

Exclusion Criteria:

- Age < 55 years

- Failure to attend screening visits after two attempts and despite support offered

- Unwilling to participate in 8-week intervention

- Endorsing illicit drug use in the past 6 months

- Current or extensive previous mindfulness practitioner

- Detectable plasma HIV RNA (VL) in the previous 6 months or at enrollment. Individuals
with VL <500 copies will be allowed to enroll if they have a history of UD VL with
unchanged cART and show documentation of their past two clinical VL at UD levels (so
called "viral blips").

- Any treatable condition that may impact cognition, including:

- Neurosyphilis (cases with serum RPR positive will undergo lumbar puncture to
evaluate)

- Thyroid disorders (untreated)

- B12 deficiency (untreated)

- Cancer (requiring chemotherapy)

- Neurological or psychiatric conditions where treatment options exist, such as
multiple sclerosis, schizophrenia, uncontrolled epilepsy, recent and untreated
major depression

- HIV CNS escape (lumbar punctures will be completed in cases with clinical
scenarios worrisome for escape as done clinically; e.g. more rapid course, new
neurological symptoms, recent resistance in plasma)

- Language other than English as the main language of oral and written communication

- Inability to provide informed consent or assent with a legal surrogate to sign consent

- Major recent head injury, stroke, or major confounding cognitive factors including:

- Cognitive impairment caused primarily by alcohol or substance use

- Current active use of methamphetamine, cocaine or illicit use of narcotics
(determined at screening and enrollment visits via clinical interview of
substance abuse and dependence criteria)

- MRI demonstrating current or past CNS lesions deemed to be clinically significant
including that from past opportunistic infections but excluding white matter
injury, as can be seen with cerebrovascular disease

- Active brain infection, except for HIV

- Significant systemic medical illness such as cancer requiring chemotherapy or
end-stage cardiac or renal insufficiency

- Unstable psychiatric condition (e.g. active psychosis, suicidal ideation, homicidal
ideation) or mental health or medical condition that, in the opinion of the
investigators, will make it difficult for the potential participant to participate in
the intervention

- Cases where the investigators feel the participant won't be able to complete the study
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San Francisco, California 94143
Phone: 415-476-1688
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