Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders
Primary Purpose
Impaired Cognition, HIV Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by

About this trial
This is an interventional treatment trial for Impaired Cognition
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
Sites / Locations
- UCSF Memory and Aging Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MBSR
CONTROL
Arm Description
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
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.
Outcomes
Primary Outcome Measures
Continuous Performance Task
A neuropsychological test to assess attention and information processing and executive functioning
Symbol-Digit modalities test
A neuropsychological test to assess executive functioning
Letter Number Sequencing
A neuropsychological test to assess executive functioning
Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Questionnaires to assess everyday function
Perceived Stress Scale
Questionnaire to assess stress
State-Trait Anxiety Inventory
Questionnaire to assess anxiety
Geriatric Depression Scale
Questionnaire to assess depression
Buss-Durkee Irritability subscale
Questionnaire to assess irritability
Center for Neurological Study - Lability Scale
Questionnaire to assess affective lability
Affective Intensity Measure
Questionnaire to assess euphoria
World Health Organization Quality of Life - HIV Scale
Questionnaire to assess quality of life
Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT02936401
First Posted
July 27, 2016
Last Updated
August 5, 2020
Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR), Harvard School of Public Health (HSPH), Northwestern University, University of Missouri, St. Louis, Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02936401
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR), Harvard School of Public Health (HSPH), Northwestern University, University of Missouri, St. Louis, Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Cognition, HIV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBSR
Arm Type
Experimental
Arm Description
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
Arm Title
CONTROL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
Primary Outcome Measure Information:
Title
Continuous Performance Task
Description
A neuropsychological test to assess attention and information processing and executive functioning
Time Frame
48 weeks after enrollment
Title
Symbol-Digit modalities test
Description
A neuropsychological test to assess executive functioning
Time Frame
48 weeks after enrollment
Title
Letter Number Sequencing
Description
A neuropsychological test to assess executive functioning
Time Frame
48 weeks after enrollment
Title
Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Description
Questionnaires to assess everyday function
Time Frame
48 weeks after enrollment
Title
Perceived Stress Scale
Description
Questionnaire to assess stress
Time Frame
48 weeks after enrollment
Title
State-Trait Anxiety Inventory
Description
Questionnaire to assess anxiety
Time Frame
48 weeks after enrollment
Title
Geriatric Depression Scale
Description
Questionnaire to assess depression
Time Frame
48 weeks after enrollment
Title
Buss-Durkee Irritability subscale
Description
Questionnaire to assess irritability
Time Frame
48 weeks after enrollment
Title
Center for Neurological Study - Lability Scale
Description
Questionnaire to assess affective lability
Time Frame
48 weeks after enrollment
Title
Affective Intensity Measure
Description
Questionnaire to assess euphoria
Time Frame
48 weeks after enrollment
Title
World Health Organization Quality of Life - HIV Scale
Description
Questionnaire to assess quality of life
Time Frame
48 weeks after enrollment
Title
Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
Time Frame
16 weeks after enrollment
Title
Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
Time Frame
16 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Valcour, MD PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith Moskowitz, PhD MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Memory and Aging Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders
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