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
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
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California
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San Francisco、California、アメリカ、94158
- UCSF Memory and Aging Center
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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 |
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実験的:MBSR
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
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Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
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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.
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Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
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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 |
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Continuous Performance Task
時間枠:48 weeks after enrollment
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A neuropsychological test to assess attention and information processing and executive functioning
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48 weeks after enrollment
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Symbol-Digit modalities test
時間枠:48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Letter Number Sequencing
時間枠:48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
時間枠:48 weeks after enrollment
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Questionnaires to assess everyday function
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48 weeks after enrollment
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Perceived Stress Scale
時間枠:48 weeks after enrollment
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Questionnaire to assess stress
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48 weeks after enrollment
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State-Trait Anxiety Inventory
時間枠:48 weeks after enrollment
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Questionnaire to assess anxiety
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48 weeks after enrollment
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Geriatric Depression Scale
時間枠:48 weeks after enrollment
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Questionnaire to assess depression
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48 weeks after enrollment
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Buss-Durkee Irritability subscale
時間枠:48 weeks after enrollment
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Questionnaire to assess irritability
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48 weeks after enrollment
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Center for Neurological Study - Lability Scale
時間枠:48 weeks after enrollment
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Questionnaire to assess affective lability
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48 weeks after enrollment
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Affective Intensity Measure
時間枠:48 weeks after enrollment
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Questionnaire to assess euphoria
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48 weeks after enrollment
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World Health Organization Quality of Life - HIV Scale
時間枠:48 weeks after enrollment
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Questionnaire to assess quality of life
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48 weeks after enrollment
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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
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16 weeks after enrollment
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Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
時間枠:16 weeks after enrollment
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16 weeks after enrollment
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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。
協力者
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
- 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.
- 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.
- 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.
- 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. Erratum In: Holist Nurs Pract. 2005 Mar-Apr;19(2):78. Kimmel, Sharon [added].
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
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
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集
MBSRの臨床試験
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)募集
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Indiana UniversityIndiana University Health完了
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University of AarhusCopenhagen University Hospital, Hvidovre完了
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Ottawa Hospital Research InstituteCanadian Cancer Society (CCS)完了
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Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Georgia Center for...完了
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California Pacific Medical Center Research InstituteNational Center for Complementary and Integrative Health (NCCIH); Kaiser Permanente; Sutter Health完了
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Henry M. Jackson Foundation for the Advancement...わからない