Older Adults (65 Years and Older)NCT06791356
CBT-I in Older African American Adults
A study testing Cognitive-behavioral therapy for insomnia and Sleep hygiene education in people with Older Adults (65 Years and Older), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older Adults (65 Years and Older)
- What is being tested?
- Cognitive-behavioral therapy for insomnia and Sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to Jun 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reading level 6th grade or better and can speak and understand English well.
- Self-identify as African American or Black.
- Ages 60 and over.
- Score of >2 in PSQI sleep duration, sleep disturbance, or overall sleep quality calculated components.
- Participating in the "Pathways to Healthy Aging in African Americans" study.
- Has established chronic insomnia issues for at least three months.
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- Subjects must be willing to participate in 8 sessions of CBT-I via Zoom for the CBT-I group.
- Subjects must be willing to come for pre/post assessment visits.
- MoCA score of between 20-26.
Who cannot join
- Currently taking any of the following medications consistently: Benzodiazepines (ProSom, Restoril, Ativan and Xanax); Z Drugs (eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist); antidepressants that affect sleep (doxepin, mirtazapine, trazodone); antihistamines (diphenhydramine and doxylamine succinate); barbiturates (methohexital, pentobarbital, primidone, secobarbital).
- Diagnosed with any sleep disorder other than insomnia (i.e. obstructive sleep apnea using STOP-BANG, restless leg syndrome, REM sleep behavior disorder, etc.).
- Classified as high fall risk.
- Primary causes for frequent awakenings are due to a medical condition that is not related to insomnia, such as chronic pain, urinary frequency, upper respiratory infection.
- Previous experience with CBT-I.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
Newark, New Jersey, 07102
Payton White, pw352@newark.rutgers.edu
About this study
Official title: Cognitive Behavioral Therapy for Insomnia in Older African American Adults
Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population.
For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.
- Conditions
- Older Adults (65 Years and Older)
- Being tested
- Cognitive-behavioral therapy for insomnia, Sleep hygiene education
- Keywords
- insomnia, cognitive-behavioral therapy for insomnia, African Americans
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy for insomniaBehavioural
8 sessions of therapy that focus on psychoeducation about sleep hygiene, cognitive restructuring of dysfunctional beliefs that reinforce insomnia, stimulus control to eliminate the association between the bed and wakefulness, sleep restriction in order to establish a consistent sleep schedule, and relaxation training to reduce anxiety that interferes with sleep
Sleep hygiene educationBehavioural
One session of education about behavioral strategies to optimize sleep quality
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Not described Receives: Behavioral: Cognitive-behavioral therapy for insomnia |
| Sleep hygiene education | Active comparator | Not described Receives: Behavioral: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of sessions completed, sleep diary completion rate
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Sleep efficiency - immediate treatment effect
Ratio of number of hours actually slept over total time in bed
Measured: From enrollment to the end of treatment at 8 weeks
Cognitive task performance - immediate treatment effect
Performance in Rutgers Acquired Equivalence (generalization) task
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start2 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mark A. Gluck, PhD, Rutgers, The State University of New Jersey
- Investigators
- Mark Gluck, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791356
- Sponsor's protocol ID
- Pro2024000293
- Other IDs
- 1R01AG078211
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Older African American Adults
- ClinicalTrials.gov ID
- NCT06791356
- Acronym / sponsor ID
- Pro2024000293
- Conditions
- Older Adults (65 Years and Older)
- Keywords
- insomnia, cognitive-behavioral therapy for insomnia, African Americans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jan 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.
Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population.
For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive-behavioral therapy for insomnia |
| Sleep hygiene education | Active comparator | Behavioral: Sleep hygiene education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Reading level 6th grade or better and can speak and understand English well.
- Self-identify as African American or Black.
- Ages 60 and over.
- Score of >2 in PSQI sleep duration, sleep disturbance, or overall sleep quality calculated components.
- Participating in the "Pathways to Healthy Aging in African Americans" study.
Key exclusion criteria (5 listed)
- Currently taking any of the following medications consistently: Benzodiazepines (ProSom, Restoril, Ativan and Xanax); Z Drugs (eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist); antidepressants that affect sleep (doxepin, mirtazapine, trazodone); antihistamines (diphenhydramine and doxylamine succinate); barbiturates (methohexital, pentobarbital, primidone, secobarbital).
- Diagnosed with any sleep disorder other than insomnia (i.e. obstructive sleep apnea using STOP-BANG, restless leg syndrome, REM sleep behavior disorder, etc.).
- Classified as high fall risk.
- Primary causes for frequent awakenings are due to a medical condition that is not related to insomnia, such as chronic pain, urinary frequency, upper respiratory infection.
- Previous experience with CBT-I.
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 |
|---|---|---|
| Cognitive-behavioral therapy for insomnia8 sessions of therapy that focus on psychoeducation about sleep hygiene, cognitive restructuring of dysfunctional beliefs that reinforce insomnia, stimulus control to eliminate the association between the bed and wakefulness, sleep restriction in order to establish a consistent sleep schedule, and relaxation training to reduce anxiety that interferes with sleep | Behavioural | CBT-I |
| Sleep hygiene educationOne session of education about behavioral strategies to optimize sleep quality | Behavioural | Sleep hygiene education |
Primary outcome
Adherence
Time frame: From enrollment to the end of treatment at 8 weeks
Number of sessions completed, sleep diary completion rate
2 secondary outcomes
Sleep efficiency - immediate treatment effect
Time frame: From enrollment to the end of treatment at 8 weeks
Cognitive task performance - immediate treatment effect
Time frame: From enrollment to the end of treatment at 8 weeks
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 20 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Mark Gluck, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy for insomnia and Sleep hygiene education in people with Older Adults (65 Years and Older), run by Rutgers, The State University of New Jersey at 1 site 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Payton White ((973)-353-6373, pw352@newark.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.