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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG092240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| National Institute on Aging (NIA) | NIH |
| NIH Office of AIDS Research (OAR) | NIH |
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The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are:
What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental |
| |
| Brief Mindfulness Treatment (BMT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBTI | Behavioral | 4-week intervention delivered via telephone (once a week for 30 minutes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Assesses insomnia severity symptoms with scores ranging from 0 - 28. Scores of 0-7 indicate no clinically significant insomnia; scores 8-14 indicate mild insomnia; scores 15-21 indicate moderate insomnia; scores 22-28 indicate severe insomnia | From enrollment until 1-year post-intervention |
| 7-day Sleep Actigraphy | Actigraphy will be conducted at (baseline, post-intervention. and 1-year post intervention) to obtain objective sleep data including total sleep time, falling asleep time, wake-up time, sleep latency, awakenings after sleep onset, and sleep efficiency. | From enrollment until 1-year post-intervention |
| Consensus Sleep Diaries | The diaries will be completed twice a day (before going to bed at night, and then the following morning) in conjunction with the actigraphy measurement of their sleep to improve the quality of the actigraphy data. | From enrollment until 1-year post-intervention |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Consists of 12 subtests measuring five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. RBANS has four equivalent alternate test forms. Total scores range from 40 to 160, with higher scores indicating better cognitive function | From enrollment until 1-year post-intervention |
| Delis-Kaplan Executive Function System (D-KEFS) | Three D-KEFS tests will be used for this study: Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. | From enrollment until 1-year post-intervention |
| Patient's Assessment of Own Functioning Inventory (PAOFI) |
| Measure | Description | Time Frame |
|---|---|---|
| Amyloid beta (Aβ42/40) | Aβ42/40 ratio is a marker of amyloid plaque accumulation which is a hallmark of Alzheimer's Disease | From enrollment until 1-year post-intervention |
| P-tau | Biomarker for identifying individuals at risk for Alzheimer's Disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN | Contact | 205 348 3374 | slcody@ua.edu | |
| Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM | Contact | 205 934 3367 | sjthoma@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN | The University of Alabama Capstone College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39244666 | Background | Cody SL, Kusko DA, Gonzalez CE, Owens MA, Hobson JM, Gilstrap SR, Thomas SJ, Goodin BR. Improving Sleep in People with HIV and Chronic Pain: A Pilot Study of Brief Behavioral Treatment for Insomnia. Behav Sleep Med. 2024 Nov-Dec;22(6):949-959. doi: 10.1080/15402002.2024.2396820. Epub 2024 Sep 8. |
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The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not to identify any individual person; (2) a commitment to secure the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed. Although it is assumed that most users will want either a SAS or SPSS file, we have the ability to translate data sets into several other formats and will provide one of these if requested by a user
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| BMT | Behavioral | 4-week intervention delivered via telephone (once a week for 30 minutes) |
|
Measures the effects of cognitive abilities on everyday activities. Scores are summed from each domain for a total score ranging from 0 to 50, with higher scores indicated worse perceived everyday functioning. |
| From enrollment until 1-year post-intervention |
| Pittsburgh Sleep Quality Index (PSQI) | An 18-item questionnaire used to assess sleep quality. Scores from 7 components are summed for a global PSQI score range from 0-21, with higher scores (> 5) indicating poorer quality of sleep. | From enrollment until 1-year post-intervention |
| From enrollment until 1-year post-intervention |
| The University of Alabama | Tuscaloosa | Alabama | 35401 | United States |
|
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
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