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

August 5, 2020 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • UCSF Memory and Aging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBSR
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
Experimental: CONTROL
Participants in the waitlist control arm will receive standard of care for 16 weeks after the baseline visit, and then will be offered an identical 8-week MBSR course.
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Performance Task
Time Frame: 48 weeks after enrollment
A neuropsychological test to assess attention and information processing and executive functioning
48 weeks after enrollment
Symbol-Digit modalities test
Time Frame: 48 weeks after enrollment
A neuropsychological test to assess executive functioning
48 weeks after enrollment
Letter Number Sequencing
Time Frame: 48 weeks after enrollment
A neuropsychological test to assess executive functioning
48 weeks after enrollment
Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Time Frame: 48 weeks after enrollment
Questionnaires to assess everyday function
48 weeks after enrollment
Perceived Stress Scale
Time Frame: 48 weeks after enrollment
Questionnaire to assess stress
48 weeks after enrollment
State-Trait Anxiety Inventory
Time Frame: 48 weeks after enrollment
Questionnaire to assess anxiety
48 weeks after enrollment
Geriatric Depression Scale
Time Frame: 48 weeks after enrollment
Questionnaire to assess depression
48 weeks after enrollment
Buss-Durkee Irritability subscale
Time Frame: 48 weeks after enrollment
Questionnaire to assess irritability
48 weeks after enrollment
Center for Neurological Study - Lability Scale
Time Frame: 48 weeks after enrollment
Questionnaire to assess affective lability
48 weeks after enrollment
Affective Intensity Measure
Time Frame: 48 weeks after enrollment
Questionnaire to assess euphoria
48 weeks after enrollment
World Health Organization Quality of Life - HIV Scale
Time Frame: 48 weeks after enrollment
Questionnaire to assess quality of life
48 weeks after enrollment
Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
Time Frame: 16 weeks after enrollment
16 weeks after enrollment
Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
Time Frame: 16 weeks after enrollment
16 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Victor Valcour, MD PhD, University of California, San Francisco
  • Principal Investigator: Judith Moskowitz, PhD MPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2015

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

November 7, 2019

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 5R01NR015223 (U.S. NIH Grant/Contract)
  • R01NR015223 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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