Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Henry Ford Health System
Sponsor:
Collaborators:
Wayne State University
University of Michigan
Information provided by (Responsible Party):
Christopher Drake, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01933295
First received: September 6, 2012
Last updated: August 24, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Menopause
Behavioral: Cognitive Behavioral Therapy for Insomnia
Behavioral: Sleep Education
Behavioral: Sleep Restriction Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Sleep [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Depression [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up


Other Outcome Measures:
  • Self-Reported Sleep (Diary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sleep Education
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Behavioral: Sleep Education
Experimental: Cognitive Behavioral Therapy for Insomnia
Behavioral treatment (5 component)
Behavioral: Cognitive Behavioral Therapy for Insomnia
Experimental: Sleep Restriction Therapy
Brief sleep restriction therapy.
Behavioral: Sleep Restriction Therapy

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-menopausal insomnia

Exclusion Criteria:

  • unstable medical conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933295

Contacts
Contact: Cynthia Fellman-Couture, RN 313-916-4150 cfellma1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Christopher Drake
Wayne State University
University of Michigan
  More Information

No publications provided

Responsible Party: Christopher Drake, Bioscientific Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01933295     History of Changes
Other Study ID Numbers: NR013959, R01NR013959-01
Study First Received: September 6, 2012
Last Updated: August 24, 2015
Health Authority: USA: National Institute of Nursing Research

Keywords provided by Henry Ford Health System:
treatment

ClinicalTrials.gov processed this record on August 27, 2015