An interventional study of BBTI and BMT in Insomnia, Cognition and Aging, sponsored by University of Alabama, Tuscaloosa. Not yet recruiting at 2 sites in United States. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Treatment
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:
Exclusion Criteria:
Behavioral: BBTI
Behavioral: BMT
4-week intervention delivered via telephone (once a week for 30 minutes)
4-week intervention delivered via telephone (once a week for 30 minutes)
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
Time frame: From enrollment until 1-year post-intervention
7-day Sleep Actigraphy
Actigraphy will be conducted at (baseline, post-intervention. and 1-year post intervention) to obtain objective sleep data including total sleep time, falling asleep time, wake-up time, sleep latency, awakenings after sleep onset, and sleep efficiency.
Time frame: From enrollment until 1-year post-intervention
Consensus Sleep Diaries
The diaries will be completed twice a day (before going to bed at night, and then the following morning) in conjunction with the actigraphy measurement of their sleep to improve the quality of the actigraphy data.
Time frame: From enrollment until 1-year post-intervention
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Consists of 12 subtests measuring five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. RBANS has four equivalent alternate test forms. Total scores range from 40 to 160, with higher scores indicating better cognitive function
Time frame: From enrollment until 1-year post-intervention
Delis-Kaplan Executive Function System (D-KEFS)
Three D-KEFS tests will be used for this study: Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test.
Time frame: From enrollment until 1-year post-intervention
Patient's Assessment of Own Functioning Inventory (PAOFI)
Measures the effects of cognitive abilities on everyday activities. Scores are summed from each domain for a total score ranging from 0 to 50, with higher scores indicated worse perceived everyday functioning.
Time frame: From enrollment until 1-year post-intervention
Pittsburgh Sleep Quality Index (PSQI)
An 18-item questionnaire used to assess sleep quality. Scores from 7 components are summed for a global PSQI score range from 0-21, with higher scores (\> 5) indicating poorer quality of sleep.
Time frame: From enrollment until 1-year post-intervention
Amyloid beta (Aβ42/40)
Aβ42/40 ratio is a marker of amyloid plaque accumulation which is a hallmark of Alzheimer's Disease
Time frame: From enrollment until 1-year post-intervention
P-tau
Biomarker for identifying individuals at risk for Alzheimer's Disease
Time frame: From enrollment until 1-year post-intervention
Plan to share: No — The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not to identify any individual person; (2) a commitment to secure the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed. Although it is assumed that most users will want either a SAS or SPSS file, we have the ability to translate data sets into several other formats and will provide one of these if requested by a user
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
University of Alabama, Tuscaloosa