Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders (NCT02936401) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders
United States180 participantsStarted 2015-03-30
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 con…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Continuous Performance Task
Timeframe: 48 weeks after enrollment
2
Symbol-Digit modalities test
Timeframe: 48 weeks after enrollment
3
Letter Number Sequencing
Timeframe: 48 weeks after enrollment
4
Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales