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:
* Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points
must be age 50 or older
have a DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months (indicated on the Structured Clinical Interview for Sleep Disorders, SCISD) during telephone screening
have a confirmed HIV diagnosis and a prescribed ART regimen for at least 12 months.
unable to speak English
have a reported or documented (in medical records) diagnosis of AD or dementia
have severe neurocognitive impairment (>7 errors on the Short Portable Mental Status Questionnaire, SPMSQ) during telephone screening
have a history of a stroke
Parallel
BBTI
Behavioral4-week intervention delivered via telephone (once a week for 30 minutes)
BMT
Behavioral4-week intervention delivered via telephone (once a week for 30 minutes)
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
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.
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.
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
Amyloid beta (Aβ42/40)
Aβ42/40 ratio is a marker of amyloid plaque accumulation which is a hallmark of Alzheimer's Disease
P-tau
Biomarker for identifying individuals at risk for Alzheimer's Disease
Click on the lead sponsor to view all of their trials.
University of Alabama, Tuscaloosa
Lead sponsor
University of Alabama at Birmingham
Collaborator
National Institute on Aging (NIA)
Collaborator
NIH Office of AIDS Research (OAR)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
