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

The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two 4-week phone treatments: one that changes sleep habits and one that teaches mindfulness. It is for adults age 50 or older who have HIV and insomnia, or trouble sleeping. Researchers will check sleep, memory, and thinking for up to 1 year and study blood markers linked to Alzheimer’s disease.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 50 or older.
  • Have insomnia confirmed during phone screening, with trouble sleeping at least 3 times a week for at least 3 months in a row.
  • Have a confirmed HIV diagnosis and have been prescribed HIV medicines, called ART, for at least 12 months.

Who can't join

  • Cannot speak English.
  • Have Alzheimer’s disease, dementia, or severe trouble with memory and thinking on the phone screening test.
  • Have had a stroke, have a learning disability, or had a brain injury that left you unconscious for more than 30 minutes.
  • Are currently getting radiation or chemotherapy.
  • Have diagnosed sleep apnea (breathing that stops and starts during sleep), use a CPAP breathing machine, or screen as high risk for moderate to severe sleep apnea.
  • Have restless legs syndrome (an urge to move your legs) or narcolepsy (a condition that causes strong daytime sleepiness).
  • Have a documented history of bipolar disorder or a psychotic disorder, which can affect a person’s sense of what is real.
  • Are not taking efavirenz as part of your current HIV medicines. This is listed as an exclusion in the study text.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

AL