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

NCT02936401 | Completed

• 2 other identifiers: 5R01NR015223R01NR015223
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Cognition; HIV Infection

Outcome Measures

Primary Outcomes (13)

• Continuous Performance Task

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

  48 weeks after enrollment

• Symbol-Digit modalities test

  A neuropsychological test to assess executive functioning

  48 weeks after enrollment

• Letter Number Sequencing

  A neuropsychological test to assess executive functioning

  48 weeks after enrollment

• Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales

  Questionnaires to assess everyday function

  48 weeks after enrollment

• Perceived Stress Scale

  Questionnaire to assess stress

  48 weeks after enrollment

• State-Trait Anxiety Inventory

  Questionnaire to assess anxiety

  48 weeks after enrollment

• Geriatric Depression Scale

  Questionnaire to assess depression

  48 weeks after enrollment

• Buss-Durkee Irritability subscale

  Questionnaire to assess irritability

  48 weeks after enrollment

• Center for Neurological Study - Lability Scale

  Questionnaire to assess affective lability

  48 weeks after enrollment

• Affective Intensity Measure

  Questionnaire to assess euphoria

  48 weeks after enrollment

• World Health Organization Quality of Life - HIV Scale

  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

  16 weeks after enrollment

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

  16 weeks after enrollment

Study Arms (2)

MBSR

EXPERIMENTAL

Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.

Behavioral: MBSR

CONTROL

EXPERIMENTAL

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

Interventions

MBSR BEHAVIORAL

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

CONTROL; MBSR

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Nursing Research (NINR): collaborator
• Harvard School of Public Health (HSPH): collaborator
• Northwestern University: collaborator
• University of Missouri, St. Louis: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

UCSF Memory and Aging Center

San Francisco, California, 94158, United States

Location

Related Publications (16)

• 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.

  PMID: 17721099 BACKGROUND

• 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.

  PMID: 20626870 BACKGROUND

• 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.

  PMID: 15365130 BACKGROUND

• 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.

  PMID: 17356465 BACKGROUND

• 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.

  PMID: 11935465 BACKGROUND

• 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.

  PMID: 19424802 BACKGROUND

• 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.

  PMID: 16682686 BACKGROUND

• 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.

  PMID: 24025470 BACKGROUND

• 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.

  PMID: 15871591 BACKGROUND

• 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.

  PMID: 23774986 BACKGROUND

• 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.

  PMID: 21597980 BACKGROUND

• 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.

  PMID: 17019673 BACKGROUND

• 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.

  PMID: 17899351 BACKGROUND

• 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.

  PMID: 17291166 BACKGROUND

• 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.

  PMID: 18484600 BACKGROUND

• 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.

  PMID: 15736727 BACKGROUND

MeSH Terms

Conditions

Cognition Disorders; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Victor Valcour, MD PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Judith Moskowitz, PhD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: October 18, 2016
• Study Start: March 30, 2015
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)