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

N/ANot Yet RecruitingNCT07272863

University of Alabama, Tuscaloosa214 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

214

Conditions

Insomnia Cognition Aging HIV

Eligibility

Sex: ALLMin age: 50 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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