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NCT Number: NCT07272863

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

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

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Key information

Conditions

Insomnia Aging Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Dementia Dyssomnias HIV Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Tauopathies

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Insomnia Severity Index

    Time frame: From enrollment until 1-year post-intervention

    Assesses insomnia severity symptoms with scores ranging from 0 - 28. Scores of 0-7 indicate no clinically significant insomnia; scores 8-14 indicate mild insomnia; scores 15-21 indicate moderate insomnia; scores 22-28 indicate severe insomnia

  2. 7-day Sleep Actigraphy

    Time frame: From enrollment until 1-year post-intervention

    Actigraphy will be conducted at (baseline, post-intervention. and 1-year post intervention) to obtain objective sleep data including total sleep time, falling asleep time, wake-up time, sleep latency, awakenings after sleep onset, and sleep efficiency.

  3. Consensus Sleep Diaries

    Time frame: From enrollment until 1-year post-intervention

    The diaries will be completed twice a day (before going to bed at night, and then the following morning) in conjunction with the actigraphy measurement of their sleep to improve the quality of the actigraphy data.

  4. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: From enrollment until 1-year post-intervention

    Consists of 12 subtests measuring five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. RBANS has four equivalent alternate test forms. Total scores range from 40 to 160, with higher scores indicating better cognitive function

  5. Delis-Kaplan Executive Function System (D-KEFS)

    Time frame: From enrollment until 1-year post-intervention

    Three D-KEFS tests will be used for this study: Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test.

  6. Patient's Assessment of Own Functioning Inventory (PAOFI)

    Time frame: From enrollment until 1-year post-intervention

    Measures the effects of cognitive abilities on everyday activities. Scores are summed from each domain for a total score ranging from 0 to 50, with higher scores indicated worse perceived everyday functioning.

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: From enrollment until 1-year post-intervention

    An 18-item questionnaire used to assess sleep quality. Scores from 7 components are summed for a global PSQI score range from 0-21, with higher scores (> 5) indicating poorer quality of sleep.

Secondary outcomes

  1. Amyloid beta (Aβ42/40)

    Time frame: From enrollment until 1-year post-intervention

    Aβ42/40 ratio is a marker of amyloid plaque accumulation which is a hallmark of Alzheimer's Disease

  2. P-tau

    Time frame: From enrollment until 1-year post-intervention

    Biomarker for identifying individuals at risk for Alzheimer's Disease

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN

CONTACT

[email protected]

205 348 3374

Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM

CONTACT

[email protected]

205 934 3367

Sponsors and collaborators

Lead sponsor

University of Alabama, Tuscaloosa

Other

Collaborators

  • NIH Office of AIDS Research (OAR)
  • National Institute on Aging (NIA)
  • University of Alabama at Birmingham

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 9, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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