Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
NCT ID: NCT01933295
Last Updated: 2023-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2014-03-01
2018-12-31
Brief Summary
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Detailed Description
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Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.
Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).
Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sleep Education
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
Cognitive Behavioral Therapy for Insomnia
Behavioral treatment (5 component)
Cognitive Behavioral Therapy for Insomnia
Sleep Restriction Therapy
Brief sleep restriction therapy.
Sleep Restriction Therapy
Interventions
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Cognitive Behavioral Therapy for Insomnia
Sleep Education
Sleep Restriction Therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
65 Years
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Wayne State University
OTHER
University of Michigan
OTHER
Christopher Drake
OTHER
Responsible Party
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Christopher Drake
Bioscientific Staff
Principal Investigators
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Christopher Drake, PhD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Hospital
Detroit, Michigan, United States
Countries
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References
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Kalmbach DA, Cheng P, Roth T, Sagong C, Drake CL. Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women. Sleep Med. 2020 Sep;73:82-92. doi: 10.1016/j.sleep.2020.04.024. Epub 2020 May 7.
Cheng P, Kalmbach D, Fellman-Couture C, Arnedt JT, Cuamatzi-Castelan A, Drake CL. Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial. J Clin Sleep Med. 2020 Feb 15;16(2):193-198. doi: 10.5664/jcsm.8164. Epub 2020 Jan 13.
Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.
Kalmbach DA, Cheng P, Arnedt JT, Anderson JR, Roth T, Fellman-Couture C, Williams RA, Drake CL. Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep Med. 2019 Mar;55:124-134. doi: 10.1016/j.sleep.2018.11.019. Epub 2018 Dec 28.
Drake CL, Kalmbach DA, Arnedt JT, Cheng P, Tonnu CV, Cuamatzi-Castelan A, Fellman-Couture C. Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. Sleep. 2019 Feb 1;42(2):zsy217. doi: 10.1093/sleep/zsy217.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NR013959
Identifier Type: -
Identifier Source: org_study_id
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