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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama, Tuscaloosa
Study ID
NCT07272863
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Behavioral Treatment for Insomnia (BBTI)
  • Active Comparator: Brief Mindfulness Treatment (BMT)

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: From enrollment until 1-year post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233
Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM
205 934 3367
Dr. David E. Vance, PhD, MGS, FAAN
205 934 7589
Dr. Shu Chen, PhD (SUB_INVESTIGATOR)
The University of AlabamaTuscaloosaAlabama35401
Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN
205 348 3374
Dr. Mary L. Jacobs, PhD, MSPH, ABPP
Dr. Chuong Bui, PhD (SUB_INVESTIGATOR)

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