Menu
Not yet recruiting NCT07272863

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

No phase Interventional Insomnia Cognition Aging HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BBTI, BMT.
Who it may be relevant to
Registry conditions: Insomnia, Cognition, Aging, HIV. Basic parameters: 50 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral BBTI
    4-week intervention delivered via telephone (once a week for 30 minutes)
  • Behavioral BMT
    4-week intervention delivered via telephone (once a week for 30 minutes)

Primary outcome measures

  • Insomnia Severity Index [Time frame: From enrollment until 1-year post-intervention]
  • 7-day Sleep Actigraphy [Time frame: From enrollment until 1-year post-intervention]
  • Consensus Sleep Diaries [Time frame: 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]
  • Delis-Kaplan Executive Function System (D-KEFS) [Time frame: From enrollment until 1-year post-intervention]
  • Patient's Assessment of Own Functioning Inventory (PAOFI) [Time frame: From enrollment until 1-year post-intervention]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: From enrollment until 1-year post-intervention]
Secondary outcome measures (2)
  • Amyloid beta (Aβ42/40) [Time frame: From enrollment until 1-year post-intervention]
  • P-tau [Time frame: From enrollment until 1-year post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • The University of Alabama at Birmingham — Birmingham
  • The University of Alabama — Tuscaloosa

Publications

  • 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

Identifiers

NCT: NCT07272863 · 25-07-8836 · R01AG092240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗