Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Conditions
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Menopause

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia
* Behavioral: Sleep Education
* Behavioral: Sleep Restriction Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post-menopausal insomnia Exclusion Criteria: unstable medical conditions

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Education<br>Weekly educational emails sent to participants with information about sleep science and tips for better sleep. | Behavioral: Sleep Education<br> <br> |
| Experimental: Cognitive Behavioral Therapy for Insomnia<br>Behavioral treatment (5 component) | Behavioral: Cognitive Behavioral Therapy for Insomnia<br> <br> |
| Experimental: Sleep Restriction Therapy<br>Brief sleep restriction therapy. | Behavioral: Sleep Restriction Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale (FSS). | Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue. Data collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline). | 8 months | 
| Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Domain scores range from 0 to 100 with higher scores indicating better quality of life. Data collected at 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment