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Completed

NCT Number: NCT02936401

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

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.

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Key information

Conditions

Impaired Cognition Blood-Borne Infections Cognition Disorders Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Neurocognitive Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Memory and Aging Center

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR

Behavioral

Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.

Primary outcomes

  1. Continuous Performance Task

    Time frame: 48 weeks after enrollment

    A neuropsychological test to assess attention and information processing and executive functioning

  2. Symbol-Digit modalities test

    Time frame: 48 weeks after enrollment

    A neuropsychological test to assess executive functioning

  3. Letter Number Sequencing

    Time frame: 48 weeks after enrollment

    A neuropsychological test to assess executive functioning

  4. Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales

    Time frame: 48 weeks after enrollment

    Questionnaires to assess everyday function

  5. Perceived Stress Scale

    Time frame: 48 weeks after enrollment

    Questionnaire to assess stress

  6. State-Trait Anxiety Inventory

    Time frame: 48 weeks after enrollment

    Questionnaire to assess anxiety

  7. Geriatric Depression Scale

    Time frame: 48 weeks after enrollment

    Questionnaire to assess depression

  8. Buss-Durkee Irritability subscale

    Time frame: 48 weeks after enrollment

    Questionnaire to assess irritability

  9. Center for Neurological Study - Lability Scale

    Time frame: 48 weeks after enrollment

    Questionnaire to assess affective lability

  10. Affective Intensity Measure

    Time frame: 48 weeks after enrollment

    Questionnaire to assess euphoria

  11. World Health Organization Quality of Life - HIV Scale

    Time frame: 48 weeks after enrollment

    Questionnaire to assess quality of life

  12. Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging

    Time frame: 16 weeks after enrollment

  13. Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging

    Time frame: 16 weeks after enrollment

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • National Institute of Nursing Research (NINR)
  • Northwestern University
  • University of Missouri, St. Louis
  • Washington University School of Medicine

Registry information

Official study title

Interventions for Symptom Management in Older Patients With HAND

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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