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

NCT07272863 | Not Yet Recruiting

• 2 other identifiers: 25-07-8836R01AG092240
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Insomnia; Cognition; Aging; HIV

Keywords

insomnia; cognition; older adults; HIV; Alzheimer's Disease; brief behavioral treatment; randomized control trial

Outcome Measures

Primary Outcomes (7)

• Insomnia Severity Index

  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

  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

  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)

  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)

  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)

  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)

  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 Outcomes (2)

• Amyloid beta (Aβ42/40)

  From enrollment until 1-year post-intervention

• P-tau

  From enrollment until 1-year post-intervention

Study Arms (2)

Brief Behavioral Treatment for Insomnia (BBTI)

EXPERIMENTAL

Behavioral: BBTI

Brief Mindfulness Treatment (BMT)

ACTIVE COMPARATOR

Behavioral: BMT

Interventions

BBTI BEHAVIORAL

4-week intervention delivered via telephone (once a week for 30 minutes)

Brief Behavioral Treatment for Insomnia (BBTI)

BMT BEHAVIORAL

4-week intervention delivered via telephone (once a week for 30 minutes)

Brief Mindfulness Treatment (BMT)

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: collaborator
• National Institute on Aging (NIA): collaborator
• NIH Office of AIDS Research (OAR): collaborator
• University of Alabama, Tuscaloosa: lead

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

The University of Alabama

Tuscaloosa, Alabama, 35401, United States

Location

Related Publications (1)

• Cody SL, Kusko DA, Gonzalez CE, Owens MA, Hobson JM, Gilstrap SR, Thomas SJ, Goodin BR. Improving Sleep in People with HIV and Chronic Pain: A Pilot Study of Brief Behavioral Treatment for Insomnia. Behav Sleep Med. 2024 Nov-Dec;22(6):949-959. doi: 10.1080/15402002.2024.2396820. Epub 2024 Sep 8.

  PMID: 39244666 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

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

  The University of Alabama Capstone College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

205 348 3374; slcody@ua.edu

Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM

CONTACT

205 934 3367; sjthoma@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)