Behavioral vs Mindfulness Treatments for Insomnia in HIV

Not yet recruiting at 1 trial location

Overseen By Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

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

Principal Investigator

The University of Alabama Capstone College of Nursing

Are You a Good Fit for This Trial?

This trial is for adults aged 50 and older who are living with HIV and suffering from insomnia. They should be willing to undergo telephone-delivered treatments and attend in-person visits for assessments, including blood collection, at the start, after treatment, and one year later.

Inclusion Criteria

STOP BANG and SCISD will be conducted at baseline to assess for insomnia, obstructive sleep apnea (OSA) risk, and other sleep disorders. Those with a high risk for moderate to severe OSA and other sleep disorders besides insomnia (e.g., narcolepsy) will be excluded from the study

I am 50 or older and have had trouble sleeping at least 3 nights a week for the last 3 months.

I have been on HIV treatment for at least 12 months.

Exclusion Criteria

Report use of a continuous positive airway pressure machine

I have been diagnosed with restless leg syndrome or narcolepsy.

Documented history of bipolar disorder or psychotic disorder

What Are the Treatments Tested in This Trial?

Interventions

• BBTI
• BMT

Trial Overview The study compares two treatments: Brief Behavioral Treatment Insomnia (BBTI) and Brief Mindfulness Treatment (BMT). It looks at how these affect sleep quality and cognitive function over a year in older adults with HIV. Participants will receive phone sessions of their assigned treatment.

How Is the Trial Designed?

Group I: Brief Behavioral Treatment for Insomnia (BBTI) Experimental Treatment 1 Intervention

Group II: Brief Mindfulness Treatment (BMT) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

NIH Office of AIDS Research (OAR)

Collaborator

Trials

8

Recruited

9,000+