Clinical trial NCT02936401: Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders
Official title: Interventions for Symptom Management in Older Patients With HAND
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Cognition
HIV Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Harvard School of Public Health (HSPH)
name: Northwestern University
name: University of Missouri, St. Louis
name: Washington University School of Medicine
First posted: 2016-10-18
Enrollment: 180
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous Performance Task
timeFrame: 48 weeks after enrollment
measure: Symbol-Digit modalities test
timeFrame: 48 weeks after enrollment
measure: Letter Number Sequencing
timeFrame: 48 weeks after enrollment
measure: Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
timeFrame: 48 weeks after enrollment
measure: Perceived Stress Scale
timeFrame: 48 weeks after enrollment
measure: State-Trait Anxiety Inventory
timeFrame: 48 weeks after enrollment
measure: Geriatric Depression Scale
timeFrame: 48 weeks after enrollment
measure: Buss-Durkee Irritability subscale
timeFrame: 48 weeks after enrollment
measure: Center for Neurological Study - Lability Scale
timeFrame: 48 weeks after enrollment
measure: Affective Intensity Measure
timeFrame: 48 weeks after enrollment
measure: World Health Organization Quality of Life - HIV Scale
timeFrame: 48 weeks after enrollment
measure: Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
timeFrame: 16 weeks after enrollment
measure: Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
timeFrame: 16 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Memory and Aging Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Victor Valcour, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Judith Moskowitz, PhD MPH
role: PRINCIPAL_INVESTIGATOR
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