CBT-I in Older African American Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: CBT-IExperimental treatment 1 intervention
Group B: Sleep hygiene educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adherence

Number of sessions completed, sleep diary completion rate

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

Secondary outcomes

1

Sleep efficiency - immediate treatment effect

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

Time frame
From enrollment to the end of treatment at 8 weeks
2

Cognitive task performance - immediate treatment effect

Performance in Rutgers Acquired Equivalence (generalization) task

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

Other outcomes

1

Sleep efficiency - longer-term treatment effect

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

Time frame
12 weeks after end of treatment
2

Cognitive task performance - longer-term treatment effect

Performance in Rutgers Acquired Equivalence (generalization) task

Time frame
12 weeks after end of treatment

Sponsors and contacts

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Rutgers, The State University of New Jersey

Lead sponsor

National Institute on Aging (NIA)

Collaborator