The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV

University of Alabama, Tuscaloosa

Status

Not yet enrolling

Conditions

Aging

HIV

Insomnia

Cognition

Treatments

Behavioral: BMT

Behavioral: BBTI

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07272863

25-07-8836

R01AG092240 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

214 estimated patients

Sex

All

Ages

50 to 99 years old

Volunteers

No Healthy Volunteers

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