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

5. august 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • San Francisco, California, Forente stater, 94158
        • UCSF Memory and Aging Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Victor Valcour, MD PhD, University of California, San Francisco
  • Hovedetterforsker: Judith Moskowitz, PhD MPH, Northwestern University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. mars 2015

Primær fullføring (Faktiske)

7. november 2019

Studiet fullført (Faktiske)

7. november 2019

Datoer for studieregistrering

Først innsendt

27. juli 2016

Først innsendt som oppfylte QC-kriteriene

14. oktober 2016

Først lagt ut (Anslag)

18. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2020

Sist bekreftet

1. august 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 5R01NR015223 (U.S. NIH-stipend/kontrakt)
  • R01NR015223 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på HIV-infeksjon

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