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

Starting soon · Not applicable

Conditions studied: Insomnia, Cognition, Aging, HIV

In brief

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

Key facts

Study ID

NCT07272863

Run by

University of Alabama, Tuscaloosa

People needed

214

Starts

2026-05-01

Expected to finish

2030-09-01

Last updated by the study team

2026-05-08

Who can join

Age: 50 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• The University of Alabama — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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