InsomniaNCT07272863
The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
A study testing BBTI and BMT in people with Insomnia and Cognition, run by University of Alabama, Tuscaloosa at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- What is being tested?
- BBTI and BMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dr. Stephen Justin Thomas, PhD, DBSM, FSBSM, 205 934 3367, sjthoma@uabmc.edu
Dr. David E. Vance, PhD, MGS, FAAN, 205 934 7589, devance@uab.edu
The University of Alabama
Tuscaloosa, Alabama, 35401
Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN, 205 348 3374, slcody@ua.edu
Dr. Mary L. Jacobs, PhD, MSPH, ABPP, jacob008@ua.edu
About this study
Official title: The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV
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?
Read more
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
- Being tested
- BBTI, BMT
- Keywords
- insomnia, cognition, older adults, HIV, Alzheimer's Disease, brief behavioral treatment, randomized control trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBTIBehavioural
4-week intervention delivered via telephone (once a week for 30 minutes)
BMTBehavioural
4-week intervention delivered via telephone (once a week for 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | Not described Receives: Behavioral: BBTI |
| Brief Mindfulness Treatment (BMT) | Active comparator | Not described Receives: Behavioral: BMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until 1-year post-intervention
Secondary outcomes (2)
Amyloid beta (Aβ42/40)
Aβ42/40 ratio is a marker of amyloid plaque accumulation which is a hallmark of Alzheimer's Disease
Measured: From enrollment until 1-year post-intervention
P-tau
Biomarker for identifying individuals at risk for Alzheimer's Disease
Measured: From enrollment until 1-year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute on Aging (NIA), NIH Office of AIDS Research (OAR)
- Responsible party
- Sponsor
- Investigators
- Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN, Principal investigator, The University of Alabama Capstone College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272863
- Sponsor's protocol ID
- 25-07-8836
- Other IDs
- R01AG092240
- Status last verified
- May 2026
- First submitted
- 26 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Cody SL, Kusko DA, Gonzalez CE, Owens MA, Hobson JM, Gilstrap SR, Thomas SJ, Goodin BR. Improving Sleep in People with HIV and Chronic Pain: A Pilot Study of Brief Behavioral Treatment for Insomnia. Behav Sleep Med. 2024 Nov-Dec;22(6):949-959. doi: 10.1080/15402002.2024.2396820. Epub 2024 Sep 8.
PubMed 39244666
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV
- ClinicalTrials.gov ID
- NCT07272863
- Acronym / sponsor ID
- 25-07-8836
- Keywords
- insomnia, cognition, older adults, HIV, Alzheimer's Disease, brief behavioral treatment, randomized control trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute on Aging (NIA), NIH Office of AIDS Research (OAR)
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | Behavioral: BBTI |
| Brief Mindfulness Treatment (BMT) | Active comparator | Behavioral: BMT |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBTI4-week intervention delivered via telephone (once a week for 30 minutes) | Behavioural | Brief Behavioral Treatment for Insomnia (BBTI) |
| BMT4-week intervention delivered via telephone (once a week for 30 minutes) | Behavioural | Brief Mindfulness Treatment (BMT) |
Primary outcome
Insomnia Severity Index
Time frame: From enrollment until 1-year post-intervention
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
7-day Sleep Actigraphy
Time frame: From enrollment until 1-year post-intervention
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.
Consensus Sleep Diaries
Time frame: From enrollment until 1-year post-intervention
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.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: From enrollment until 1-year post-intervention
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
Delis-Kaplan Executive Function System (D-KEFS)
Time frame: From enrollment until 1-year post-intervention
Three D-KEFS tests will be used for this study: Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test.
Patient's Assessment of Own Functioning Inventory (PAOFI)
Time frame: From enrollment until 1-year post-intervention
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment until 1-year post-intervention
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.
2 secondary outcomes
Amyloid beta (Aβ42/40)
Time frame: From enrollment until 1-year post-intervention
P-tau
Time frame: From enrollment until 1-year post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 39244666Cody SL, Kusko DA, Gonzalez CE, Owens MA, Hobson JM, Gilstrap SR, Thomas SJ, Goodin BR. Improving Sleep in People with HIV and Chronic Pain: A Pilot Study of Brief Behavioral Treatment for Insomnia. Behav Sleep Med. 2024 Nov-Dec;22(6):949-959. doi: 10.1080/15402002.2024.2396820. Epub 2024 Sep 8.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN principal investigator
The University of Alabama Capstone College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBTI and BMT in people with Insomnia and Cognition, run by University of Alabama, Tuscaloosa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shameka L. Cody, PhD, AGNP-C, PMHNP-BC, FAAN (205 348 3374, slcody@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: From enrollment until 1-year post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.