Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02936401
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Harvard School of Public Health
Northwestern University
University of Missouri, St. Louis
Washington University School of Medicine
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Impaired Cognition HIV Infection Behavioral: MBSR Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Interventions for Symptom Management in Older Patients With HAND
Study Start Date : March 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: MBSR
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
Behavioral: MBSR
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.
Behavioral: MBSR
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936401


Contacts
Layout table for location contacts
Contact: Shireen Javandel, BA 415-476-1688 shireen.javandel@ucsf.edu
Contact: Benedetta Milanini, PhD 415-476-9306 benedetta.milanini@ucsf.edu

Locations
Layout table for location information
United States, California
UCSF Memory and Aging Center Recruiting
San Francisco, California, United States, 94158
Contact: Shireen Javandel, BA    415-476-1688    shireen.javandel@ucsf.edu   
Contact: Benedetta Milanini, PhD    415-476-9306    benedetta.milanini@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute of Nursing Research (NINR)
Harvard School of Public Health
Northwestern University
University of Missouri, St. Louis
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Victor Valcour, MD PhD University of California, San Francisco
Principal Investigator: Judith Moskowitz, PhD MPH Northwestern University

Publications:

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02936401     History of Changes
Other Study ID Numbers: 5R01NR015223 ( U.S. NIH Grant/Contract )
R01NR015223 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Neurocognitive Disorders
Cognitive Dysfunction
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mental Disorders
Cognition Disorders