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Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

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ClinicalTrials.gov Identifier: NCT01933295
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Wayne State University
University of Michigan
Information provided by (Responsible Party):
Christopher Drake, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE September 6, 2012
First Posted Date  ICMJE September 2, 2013
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE March 1, 2014
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
Sleep [ Time Frame: 8 months ]
Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. A total of 4 standarized nocturnal PSGs will be performed for each participant (screening night, baseline assessment, and post-treatment night 1 and post treatment night 2. For each participant, self report sleep diaries will be measured in the home nightly throughout the 2-week baseline, treatment protocols, during the 2 weeks immediately post-treatment and for 2 weeks during follow up assessment at 6 months post treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01933295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
  • Depression [ Time Frame: 8 months ]
    Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. Depression will be measured by the administration of the Beck Depression Inventory questionnaire(BDI-II).
  • Quality of life [ Time Frame: 8 months ]
    Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2013)
Self-Reported Sleep (Diary) [ Time Frame: 8 months ]
Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. For each participant, self report sleep diaries will be measured in the home nightly throughout the 2-week baseline, treatment protocols, during the 2 weeks immediately post-treatment and for 2 weeks during follow up assessment at 6 months post treatment. Home based measures (Diary): Wake after sleep onset; sleep efficiency; total sleep time; sleep latency; number of awakenings
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Official Title  ICMJE Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
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.
Detailed Description

Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Behavioral: Sleep Education
  • Behavioral: Sleep Restriction Therapy
Study Arms  ICMJE
  • Active Comparator: Sleep Education
    Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
    Intervention: Behavioral: Sleep Education
  • Experimental: Cognitive Behavioral Therapy for Insomnia
    Behavioral treatment (5 component)
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Experimental: Sleep Restriction Therapy
    Brief sleep restriction therapy.
    Intervention: Behavioral: Sleep Restriction Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • post-menopausal insomnia

Exclusion Criteria:

  • unstable medical conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01933295
Other Study ID Numbers  ICMJE NR013959
R01NR013959-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Drake, Henry Ford Health System
Study Sponsor  ICMJE Christopher Drake
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • Wayne State University
  • University of Michigan
Investigators  ICMJE
Principal Investigator: Christopher Drake, PhD Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP