Sleep and thinking treatments for older adults with HIV and insomnia
Compares phone-delivered insomnia therapy with mindfulness training in adults aged 50 and older with HIV.
Key facts
- Who runs it
- University of Alabama, Tuscaloosa
- Where
- Birmingham and Tuscaloosa, United StatesSee the 2 sites
- Trial code
- Registry title
- The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
- Status
- Not yet recruiting
- People taking part
- 214 people, planned
- Started
- May 2026
- Expected to end
- Sept 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BBTI
- BMT
- Record updated
- 8 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older who live with HIV and have insomnia. It compares two 4-week telephone programs for sleep and thinking.
- Age
- 50 years or older (up to 99 years)
- Sex
- All sexes can join
- Disease stage
- Insomnia (sleep trouble at least 3 times per week for at least 3 months in a row) in a person with a confirmed HIV diagnosis
- Earlier treatment
- Must have been prescribed antiretroviral therapy (ART) for at least 12 months
Main reasons for not taking part
- Cannot speak English
- Diagnosis of Alzheimer's disease or dementia, or severe memory and thinking problems at screening
- History of stroke
- Sleep apnea, CPAP use, or high risk of moderate to severe sleep apnea
- Taking efavirenz as part of the current ART regimen
This trial only enrols participants living with HIV. The registry sentence this rests on: have a confirmed HIV diagnosis and a prescribed ART regimen for at least 12 months.
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- currently undergoing radiation/chemotherapy
- not be receiving efavirenz as part of their current ART regimen
- 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
- reports a history of brain trauma with loss of consciousness greater than 30 minutes
- have restless leg syndrome and/or have narcolepsy
- have a documented history of bipolar disorder or psychotic disorder
- 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
- unable to speak English
- have a learning disability
- have a documented diagnosis of sleep apnea (in medical records)
- reports use of a continuous positive airway pressure machine
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 99 years old?
Where in United States
- The University of Alabama at BirminghamBirmingham, United StatesContact: Dr. Stephen Justin Thomas, PhD, DBSM, FSBSMNot yet recruiting
- The University of AlabamaTuscaloosa, United StatesContact: Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAANNot yet recruiting
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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
The 2 groups in the trial
- Brief Behavioral Treatment for Insomnia (BBTI)Treatment being tested
Treatment: BBTI
- Brief Mindfulness Treatment (BMT)Existing treatment, for comparison
Treatment: BMT
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV
- Plain-language title
- Sleep and thinking treatments for older adults with HIV and insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07272863, who can take part
- Record updated
- 8 May 2026