The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 214
- Locations
- 2
- Primary Endpoint
- Pittsburgh Sleep Quality Index (PSQI)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •currently undergoing radiation/chemotherapy
- •reports a history of brain trauma with loss of consciousness greater than 30 minutes
- •have a learning disability
- •have a documented diagnosis of sleep apnea (in medical records)
- •reports use of a continuous positive airway pressure machine
- •have been identified as high risk for moderate to severe sleep apnea (Snoring, Tiredness, Observed sleep apnea, Pressure, BMI, Age, Neck circumference, and Gender, STOP BANG ≥ 5) during telephone screening
- •have restless leg syndrome and/or have narcolepsy
- •have a documented history of bipolar disorder or psychotic disorder
- •not be receiving efavirenz as part of their current ART regimen
Arms & Interventions
Brief Mindfulness Treatment (BMT)
Intervention: BMT (Behavioral)
Brief Behavioral Treatment for Insomnia (BBTI)
Intervention: BBTI (Behavioral)
Outcomes
Primary Outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: From enrollment until 1-yr post-intervention
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.
Insomnia Severity Index
Time Frame: From enrollment until 1-year post-intervention
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
Time Frame: From enrollment until 1-year post-intervention
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
Time Frame: From enrollment until 1-year post-intervention
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)
Time Frame: From enrollment until 1-year post-intervention
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
Delis-Kaplan Executive Function System (D-KEFS)
Time Frame: From enrollment until 1-year post-intervention
Three D-KEFS tests will be used for this study: Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test.
Patient's Assessment of Own Functioning Inventory (PAOFI)
Time Frame: From enrollment until 1-year post-intervention
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.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: From enrollment until 1-year post-intervention
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.
Secondary Outcomes
- Amyloid beta (Aβ42/40)(From enrollment until 1-yr post-intervention)
- P-tau(From enrollment until 1-yr post-intervention)
- Amyloid beta (Aβ42/40)(From enrollment until 1-year post-intervention)
- P-tau(From enrollment until 1-year post-intervention)