Clinical trial · NCT07272863 · NOT_YET_RECRUITING · NA
The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
Sponsor: University of Alabama, Tuscaloosa
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
Interventions
- BBTI · BEHAVIORAL
4-week intervention delivered via telephone (once a week for 30 minutes)
- BMT · BEHAVIORAL
4-week intervention delivered via telephone (once a week for 30 minutes)
Published eligibility criteria
Verbatim from the registry. Only the site can decide how these apply to a specific patient.
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
Sites (2)
- The University of Alabama at Birmingham, Birmingham, Alabama
- The University of Alabama, Tuscaloosa, Alabama
Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-05-08.