- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936401
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
Conditions
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
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California
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San Francisco, California, United States, 94158
- UCSF Memory and Aging Center
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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.
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Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
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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
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A neuropsychological test to assess attention and information processing and executive functioning
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48 weeks after enrollment
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Symbol-Digit modalities test
Time Frame: 48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Letter Number Sequencing
Time Frame: 48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Time Frame: 48 weeks after enrollment
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Questionnaires to assess everyday function
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48 weeks after enrollment
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Perceived Stress Scale
Time Frame: 48 weeks after enrollment
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Questionnaire to assess stress
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48 weeks after enrollment
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State-Trait Anxiety Inventory
Time Frame: 48 weeks after enrollment
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Questionnaire to assess anxiety
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48 weeks after enrollment
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Geriatric Depression Scale
Time Frame: 48 weeks after enrollment
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Questionnaire to assess depression
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48 weeks after enrollment
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Buss-Durkee Irritability subscale
Time Frame: 48 weeks after enrollment
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Questionnaire to assess irritability
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48 weeks after enrollment
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Center for Neurological Study - Lability Scale
Time Frame: 48 weeks after enrollment
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Questionnaire to assess affective lability
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48 weeks after enrollment
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Affective Intensity Measure
Time Frame: 48 weeks after enrollment
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Questionnaire to assess euphoria
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48 weeks after enrollment
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World Health Organization Quality of Life - HIV Scale
Time Frame: 48 weeks after enrollment
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Questionnaire to assess quality of life
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48 weeks after enrollment
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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
|
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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.
Collaborators
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
- Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
- Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. doi: 10.1080/13550280290049615.
- Lau MA, Bishop SR, Segal ZV, Buis T, Anderson ND, Carlson L, Shapiro S, Carmody J, Abbey S, Devins G. The Toronto Mindfulness Scale: development and validation. J Clin Psychol. 2006 Dec;62(12):1445-67. doi: 10.1002/jclp.20326.
- Cohen-Katz J, Wiley SD, Capuano T, Baker DM, Kimmel S, Shapiro S. The effects of mindfulness-based stress reduction on nurse stress and burnout, Part II: A quantitative and qualitative study. Holist Nurs Pract. 2005 Jan-Feb;19(1):26-35. doi: 10.1097/00004650-200501000-00008. Erratum In: Holist Nurs Pract. 2005 Mar-Apr;19(2):78. Kimmel, Sharon [added].
- Jain S, Shapiro SL, Swanick S, Roesch SC, Mills PJ, Bell I, Schwartz GE. A randomized controlled trial of mindfulness meditation versus relaxation training: effects on distress, positive states of mind, rumination, and distraction. Ann Behav Med. 2007 Feb;33(1):11-21. doi: 10.1207/s15324796abm3301_2.
- Gayner B, Esplen MJ, DeRoche P, Wong J, Bishop S, Kavanagh L, Butler K. A randomized controlled trial of mindfulness-based stress reduction to manage affective symptoms and improve quality of life in gay men living with HIV. J Behav Med. 2012 Jun;35(3):272-85. doi: 10.1007/s10865-011-9350-8. Epub 2011 May 20.
- Cysique LA, Brew BJ. Neuropsychological functioning and antiretroviral treatment in HIV/AIDS: a review. Neuropsychol Rev. 2009 Jun;19(2):169-85. doi: 10.1007/s11065-009-9092-3. Epub 2009 May 9.
- Cysique LA, Maruff P, Brew BJ. Variable benefit in neuropsychological function in HIV-infected HAART-treated patients. Neurology. 2006 May 9;66(9):1447-50. doi: 10.1212/01.wnl.0000210477.63851.d3.
- Robertson KR, Smurzynski M, Parsons TD, Wu K, Bosch RJ, Wu J, McArthur JC, Collier AC, Evans SR, Ellis RJ. The prevalence and incidence of neurocognitive impairment in the HAART era. AIDS. 2007 Sep 12;21(14):1915-21. doi: 10.1097/QAD.0b013e32828e4e27.
- Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7. doi: 10.1212/01.wnl.0000134665.58343.8d.
- Kanmogne GD, Kuate CT, Cysique LA, Fonsah JY, Eta S, Doh R, Njamnshi DM, Nchindap E, Franklin DR Jr, Ellis RJ, McCutchan JA, Binam F, Mbanya D, Heaton RK, Njamnshi AK. HIV-associated neurocognitive disorders in sub-Saharan Africa: a pilot study in Cameroon. BMC Neurol. 2010 Jul 13;10:60. doi: 10.1186/1471-2377-10-60.
- Tozzi V, Balestra P, Bellagamba R, Corpolongo A, Salvatori MF, Visco-Comandini U, Vlassi C, Giulianelli M, Galgani S, Antinori A, Narciso P. Persistence of neuropsychologic deficits despite long-term highly active antiretroviral therapy in patients with HIV-related neurocognitive impairment: prevalence and risk factors. J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):174-82. doi: 10.1097/QAI.0b013e318042e1ee.
- Vance DE, Fazeli PL, Grant JS, Slater LZ, Raper JL. The role of neuroplasticity and cognitive reserve in aging with HIV: recommendations for cognitive protection and rehabilitation. J Neurosci Nurs. 2013 Oct;45(5):306-16. doi: 10.1097/JNN.0b013e31829d8b29.
- Cohen-Katz J, Wiley S, Capuano T, Baker DM, Deitrick L, Shapiro S. The effects of mindfulness-based stress reduction on nurse stress and burnout: a qualitative and quantitative study, part III. Holist Nurs Pract. 2005 Mar-Apr;19(2):78-86. doi: 10.1097/00004650-200503000-00009.
- Moynihan JA, Chapman BP, Klorman R, Krasner MS, Duberstein PR, Brown KW, Talbot NL. Mindfulness-based stress reduction for older adults: effects on executive function, frontal alpha asymmetry and immune function. Neuropsychobiology. 2013;68(1):34-43. doi: 10.1159/000350949. Epub 2013 Jun 15.
- Shapiro SL, Oman D, Thoresen CE, Plante TG, Flinders T. Cultivating mindfulness: effects on well-being. J Clin Psychol. 2008 Jul;64(7):840-62. doi: 10.1002/jclp.20491.
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
Additional Relevant MeSH Terms
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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