CBT-I in Older African American Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults (65 Years and Older)
• Intervention / Treatment: Behavioral: Cognitive-behavioral therapy for insomnia; Behavioral: Sleep hygiene education

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Payton White; Phone Number: (973)-353-6373; Email: pw352@newark.rutgers.edu
• Study Contact Backup: Name: Bernadette A Fausto, PhD; Phone Number: (973)-944-0775; Email: bernadette.fausto@rugers.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Recruiting
      • Rutgers University
      • Contact: Payton White; Email: pw352@newark.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-I	Behavioral: Cognitive-behavioral therapy for insomnia; 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
Active Comparator: Sleep hygiene education	Behavioral: Sleep hygiene education; One session of education about behavioral strategies to optimize sleep quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Number of sessions completed, sleep diary completion rate	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency - immediate treatment effect	Ratio of number of hours actually slept over total time in bed	From enrollment to the end of treatment at 8 weeks
Cognitive task performance - immediate treatment effect	Performance in Rutgers Acquired Equivalence (generalization) task	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency - longer-term treatment effect	Ratio of number of hours actually slept over total time in bed	12 weeks after end of treatment
Cognitive task performance - longer-term treatment effect	Performance in Rutgers Acquired Equivalence (generalization) task	12 weeks after end of treatment

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mark Gluck, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; African Americans; cognitive-behavioral therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: Pro2024000293; 1R01AG078211 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No