Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 45 - 65 |
| Updated: | 2/2/2019 |
| Start Date: | March 1, 2014 |
| End Date: | December 31, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- post-menopausal insomnia
Exclusion Criteria:
- unstable medical conditions
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