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

May 7, 2026 updated by: University of Alabama, Tuscaloosa

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN
  • Phone Number: 205 348 3374
  • Email: slcody@ua.edu

Study Contact Backup

  • Name: Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM
  • Phone Number: 205 934 3367
  • Email: sjthoma@uabmc.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The University of Alabama at Birmingham
        • Contact:
          • Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM
          • Phone Number: 205 934 3367
          • Email: sjthoma@uabmc.edu
        • Contact:
          • Dr. David E. Vance, PhD, MGS, FAAN
          • Phone Number: 205 934 7589
          • Email: devance@uab.edu
        • Sub-Investigator:
          • Dr. Shu Chen, PhD
      • Tuscaloosa, Alabama, United States, 35401
        • The University of Alabama
        • Contact:
          • Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN
          • Phone Number: 205 348 3374
          • Email: slcody@ua.edu
        • Contact:
        • Sub-Investigator:
          • Dr. Chuong Bui, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief Behavioral Treatment for Insomnia (BBTI)
Behavioral: BBTI
4-week intervention delivered via telephone (once a week for 30 minutes)
Active Comparator: Brief Mindfulness Treatment (BMT)
Behavioral: BMT
4-week intervention delivered via telephone (once a week for 30 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment until 1-year post-intervention
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.
From enrollment until 1-year post-intervention
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.
From enrollment until 1-year post-intervention
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
From enrollment until 1-year post-intervention
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.
From enrollment until 1-year post-intervention
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.
From enrollment until 1-year post-intervention
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.
From enrollment until 1-year post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment until 1-year post-intervention
P-tau
Time Frame: From enrollment until 1-year post-intervention
Biomarker for identifying individuals at risk for Alzheimer's Disease
From enrollment until 1-year post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama, Tuscaloosa

Collaborators

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

Investigators

  • Principal Investigator: Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN, The University of Alabama Capstone College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-07-8836
  • R01AG092240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not to identify any individual person; (2) a commitment to secure the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed. Although it is assumed that most users will want either a SAS or SPSS file, we have the ability to translate data sets into several other formats and will provide one of these if requested by a user

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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