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NCT Number: NCT06791356

CBT-I 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

Newark, New Jersey, 07102, United States

Location status: Recruiting

Location contact

Payton White

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-Behavioral Therapy for Insomnia

Behavioral

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 Education

Behavioral

One session of education about behavioral strategies to optimize sleep quality

Primary outcomes

  1. Adherence

    Time frame: From enrollment to the end of treatment at 8 weeks

    Number of sessions completed, sleep diary completion rate

Secondary outcomes

  1. Sleep efficiency - immediate treatment effect

    Time frame: From enrollment to the end of treatment at 8 weeks

    Ratio of number of hours actually slept over total time in bed

  2. Cognitive task performance - immediate treatment effect

    Time frame: From enrollment to the end of treatment at 8 weeks

    Performance in Rutgers Acquired Equivalence (generalization) task

Other outcomes

  1. Sleep efficiency - longer-term treatment effect

    Time frame: 12 weeks after end of treatment

    Ratio of number of hours actually slept over total time in bed

  2. Cognitive task performance - longer-term treatment effect

    Time frame: 12 weeks after end of treatment

    Performance in Rutgers Acquired Equivalence (generalization) task

Study contacts

Contact information is provided by the study sponsor or research team.

Bernadette A Fausto, PhD

CONTACT

[email protected]

(973)-944-0775

Payton White

CONTACT

[email protected]

(973)-353-6373

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Cognitive Behavioral Therapy for Insomnia in Older African American Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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