CBT-I for insomnia in older African American adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study will test the feasibility and preliminary effects of cognitive-behavioral therapy for insomnia (CBT-I) delivered in eight sessions via Zoom, compared with sleep hygiene education, among older African American participants drawn from the Pathways to Healthy Aging cohort. Participants must be age 60 or older, self-identify as African American or Black, have chronic insomnia for at least three months, meet brief sleep disturbance thresholds on the PSQI-derived components, and have a MoCA score between 20 and 26. The protocol includes pre- and post-intervention assessment visits at Rutgers University (Newark, NJ) and remote therapy sessions, with medication and cognitive-screening exclusions to reduce confounding. As a feasibility pilot, the study will generate preliminary outcome data to inform larger trials focused on this underrepresented population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rutgers University
  Newark, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Mark Gluck, PhD — Rutgers University
• Study coordinator: Payton White
• Email: pw352@newark.rutgers.edu
• Phone: (973)-353-6373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.