The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cogni… (NCT07272863) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
United States214 participantsStarted 2026-05
Plain-language 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
Who can participate
Age range
50 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insomnia Severity Index
Timeframe: From enrollment until 1-year post-intervention
2
7-day Sleep Actigraphy
Timeframe: From enrollment until 1-year post-intervention
3
Consensus Sleep Diaries
Timeframe: From enrollment until 1-year post-intervention
4
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Timeframe: From enrollment until 1-year post-intervention
5
Delis-Kaplan Executive Function System (D-KEFS)
Timeframe: From enrollment until 1-year post-intervention
6
Patient's Assessment of Own Functioning Inventory (PAOFI)
Timeframe: From enrollment until 1-year post-intervention
7
Pittsburgh Sleep Quality Index (PSQI)
Timeframe: From enrollment until 1-year post-intervention