Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
2 other identifiers
interventional
154
1 country
1
Brief Summary
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
February 22, 2023
CompletedFebruary 22, 2023
February 1, 2023
4.8 years
September 6, 2012
December 16, 2022
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diary Based Sleepiness
Diaries were based on the consensus sleep diaries but were modified to also measure patient sleepiness over the past 24 hours on a 0 "none" to 10 "highest" scale. Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
8 months
Secondary Outcomes (2)
Fatigue Severity Scale (FSS).
8 months
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
8 months
Study Arms (3)
Sleep Education
ACTIVE COMPARATORWeekly educational emails sent to participants with information about sleep science and tips for better sleep.
Cognitive Behavioral Therapy for Insomnia
EXPERIMENTALBehavioral treatment (5 component)
Sleep Restriction Therapy
EXPERIMENTALBrief sleep restriction therapy.
Interventions
Eligibility Criteria
You may qualify if:
- post-menopausal insomnia
You may not qualify if:
- unstable medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christopher Drakelead
- National Institute of Nursing Research (NINR)collaborator
- Wayne State Universitycollaborator
- University of Michigancollaborator
Study Sites (1)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Related Publications (5)
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.
PMID: 32799029DERIVEDCheng 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.
PMID: 31992407DERIVEDKalmbach 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.
PMID: 31383238DERIVEDKalmbach 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.
PMID: 30785053DERIVEDDrake 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.
PMID: 30481333DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Drake
- Organization
- Henry Ford Health
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Drake, PhD
Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Bioscientific Staff
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 2, 2013
Study Start
March 1, 2014
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 22, 2023
Results First Posted
February 22, 2023
Record last verified: 2023-02