CBT-I for insomnia in older African American adults
Cognitive Behavioral Therapy for Insomnia in Older African American Adults
NA · Rutgers, The State University of New Jersey · NCT06791356
This project will try an eight-session online CBT-I program to see if it helps older African American adults who have chronic insomnia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT06791356 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking African American adults age 60+ enrolled in the Pathways to Healthy Aging study with at least three months of insomnia, PSQI component scores >2 as specified, and MoCA scores of 20–26 who can attend Rutgers for assessments and join eight Zoom sessions.
Not a fit: People taking certain regular sedative or sleep-altering medications, those with MoCA scores below 20, those not enrolled in the Pathways cohort, or those unable to use Zoom or travel to Rutgers for assessments are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the program could improve sleep quality and reduce insomnia symptoms long-term without relying on sleep medications.
How similar studies have performed: CBT-I has shown consistent benefits for adults and older adults with insomnia in prior studies, but targeted evidence in older African American populations is limited, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newark, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Older Adults, insomnia, cognitive-behavioral therapy for insomnia, African Americans