Clinical trial NCT06791356: CBT-I in Older African American Adults
Official title: Cognitive Behavioral Therapy for Insomnia in Older African American Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults (65 Years and Older)
Keywords: insomnia
cognitive-behavioral therapy for insomnia
African Americans
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Sleep efficiency - immediate treatment effect
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Cognitive task performance - immediate treatment effect
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
measure: Sleep efficiency - longer-term treatment effect
timeFrame: 12 weeks after end of treatment
measure: Cognitive task performance - longer-term treatment effect
timeFrame: 12 weeks after end of treatment
Locations:
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Mark Gluck, PhD
role: PRINCIPAL_INVESTIGATOR
References: