Rutgers University
Newark, New Jersey, 07102, United States
Location status: Recruiting
NCT Number: NCT06791356
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Newark, New Jersey, 07102, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
One session of education about behavioral strategies to optimize sleep quality
Time frame: From enrollment to the end of treatment at 8 weeks
Number of sessions completed, sleep diary completion rate
Time frame: From enrollment to the end of treatment at 8 weeks
Ratio of number of hours actually slept over total time in bed
Time frame: From enrollment to the end of treatment at 8 weeks
Performance in Rutgers Acquired Equivalence (generalization) task
Time frame: 12 weeks after end of treatment
Ratio of number of hours actually slept over total time in bed
Time frame: 12 weeks after end of treatment
Performance in Rutgers Acquired Equivalence (generalization) task
Contact information is provided by the study sponsor or research team.
Bernadette A Fausto, PhD
CONTACT
Payton White
CONTACT
Rutgers, The State University of New Jersey
Other
Cognitive Behavioral Therapy for Insomnia in Older African American Adults
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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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