NCT06791356

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

January 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

January 10, 2025

Last Update Submit

February 18, 2026

Conditions

Older Adults (65 Years and Older)

Keywords

insomniacognitive-behavioral therapy for insomniaAfrican Americans

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Number of sessions completed, sleep diary completion rate

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Sleep efficiency - immediate treatment effect

    From enrollment to the end of treatment at 8 weeks

  • Cognitive task performance - immediate treatment effect

    From enrollment to the end of treatment at 8 weeks

Other Outcomes (2)

  • Sleep efficiency - longer-term treatment effect

    12 weeks after end of treatment

  • Cognitive task performance - longer-term treatment effect

    12 weeks after end of treatment

Study Arms (2)

CBT-I

EXPERIMENTAL
Behavioral: Cognitive-behavioral therapy for insomnia

Sleep hygiene education

ACTIVE COMPARATOR
Behavioral: Sleep hygiene education

Interventions

Cognitive-behavioral therapy for insomniaBEHAVIORAL

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

CBT-I
Sleep hygiene educationBEHAVIORAL

One session of education about behavioral strategies to optimize sleep quality

Sleep hygiene education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

Newark, New Jersey, 07102, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark Gluck, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Payton White

CONTACT

(973)-353-6373pw352@newark.rutgers.edu

Bernadette A Fausto, PhD

CONTACT

(973)-944-0775bernadette.fausto@rugers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 24, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)