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临床试验/NCT06791356
NCT06791356招募中不适用

Cognitive Behavioral Therapy for Insomnia in Older African American Adults

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Adherence

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

CBT-I

Experimental

干预措施: Cognitive-behavioral therapy for insomnia (Behavioral)

Sleep hygiene education

Active Comparator

干预措施: Sleep hygiene education (Behavioral)

结局指标

主要结局

Adherence

时间窗: From enrollment to the end of treatment at 8 weeks

Number of sessions completed, sleep diary completion rate

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark A. Gluck, PhD

Professor

Rutgers, The State University of New Jersey

研究点 (1)

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