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CBT-I in Older African American Adults

Cognitive Behavioral Therapy for Insomnia in Older African American Adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06791356
Enrollment
20
Registered
2025-01-24
Start date
2025-06-02
Completion date
2027-06-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Adults (65 Years and Older)

Keywords

insomnia, cognitive-behavioral therapy for insomnia, African Americans

Brief 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. 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.

Interventions

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

BEHAVIORALSleep hygiene education

One session of education about behavioral strategies to optimize sleep quality

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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. * 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
AdherenceFrom enrollment to the end of treatment at 8 weeksNumber of sessions completed, sleep diary completion rate

Secondary

MeasureTime frameDescription
Sleep efficiency - immediate treatment effectFrom enrollment to the end of treatment at 8 weeksRatio of number of hours actually slept over total time in bed
Cognitive task performance - immediate treatment effectFrom enrollment to the end of treatment at 8 weeksPerformance in Rutgers Acquired Equivalence (generalization) task

Countries

United States

Contacts

CONTACTPayton White
pw352@newark.rutgers.edu(973)-353-6373
CONTACTBernadette A Fausto, PhD
bernadette.fausto@rugers.edu(973)-944-0775
PRINCIPAL_INVESTIGATORMark Gluck, PhD

Rutgers University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026