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

HIV Infection Clinical Trial

Official title:

Interventions for Symptom Management in Older Patients With HAND

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936401
• Other study ID #: 5R01NR015223
• Secondary ID: R01NR015223
• Status: Completed
• Phase: N/A
• Start date: March 30, 2015
• Est. completion date: November 7, 2019

Study information

• Verified date: August 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• HIV Infection
• Impaired Cognition

Intervention

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

Locations

Country	Name	City	State
United States	UCSF Memory and Aging Center	San Francisco	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Harvard School of Public Health, National Institute of Nursing Research (NINR), Northwestern University, University of Missouri, St. Louis, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. Epub 2007 Sep 25. — View Citation

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. — View Citation

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. Erratum in: Holist Nurs Pract. 2005 Mar-Apr;19(2):78. Kimmel, Sharon [added]. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

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