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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorUniversity of Alabama, Tuscaloosa

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BBTI
  • BMT

Treatment groups

214 Participants
are divided into 2 treatment groups

Locations

2
The University of Alabama at Birmingham35233, BirminghamAlabama, United States
The University of Alabama35401, TuscaloosaAlabama, United States

Sponsors and collaborators

University of Alabama, Tuscaloosa

Lead sponsor

University of Alabama at Birmingham

Collaborator

National Institute on Aging (NIA)

Collaborator

NIH Office of AIDS Research (OAR)

Collaborator