このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2020年8月5日 更新者: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.

調査の概要

状態

完了

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

180

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • San Francisco、California、アメリカ、94158
        • UCSF Memory and Aging Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

55年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Continuous Performance Task
時間枠:48 weeks after enrollment
A neuropsychological test to assess attention and information processing and executive functioning
48 weeks after enrollment
Symbol-Digit modalities test
時間枠:48 weeks after enrollment
A neuropsychological test to assess executive functioning
48 weeks after enrollment
Letter Number Sequencing
時間枠: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
時間枠:48 weeks after enrollment
Questionnaires to assess everyday function
48 weeks after enrollment
Perceived Stress Scale
時間枠:48 weeks after enrollment
Questionnaire to assess stress
48 weeks after enrollment
State-Trait Anxiety Inventory
時間枠:48 weeks after enrollment
Questionnaire to assess anxiety
48 weeks after enrollment
Geriatric Depression Scale
時間枠:48 weeks after enrollment
Questionnaire to assess depression
48 weeks after enrollment
Buss-Durkee Irritability subscale
時間枠:48 weeks after enrollment
Questionnaire to assess irritability
48 weeks after enrollment
Center for Neurological Study - Lability Scale
時間枠:48 weeks after enrollment
Questionnaire to assess affective lability
48 weeks after enrollment
Affective Intensity Measure
時間枠:48 weeks after enrollment
Questionnaire to assess euphoria
48 weeks after enrollment
World Health Organization Quality of Life - HIV Scale
時間枠: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
時間枠: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
時間枠:16 weeks after enrollment
16 weeks after enrollment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Victor Valcour, MD PhD、University of California, San Francisco
  • 主任研究者:Judith Moskowitz, PhD MPH、Northwestern University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年3月30日

一次修了 (実際)

2019年11月7日

研究の完了 (実際)

2019年11月7日

試験登録日

最初に提出

2016年7月27日

QC基準を満たした最初の提出物

2016年10月14日

最初の投稿 (見積もり)

2016年10月18日

学習記録の更新

投稿された最後の更新 (実際)

2020年8月7日

QC基準を満たした最後の更新が送信されました

2020年8月5日

最終確認日

2020年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 5R01NR015223 (米国 NIH グラント/契約)
  • R01NR015223 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

HIV感染症の臨床試験

MBSRの臨床試験

3
購読する