N/A
N=154
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Menopause
Bottom Line
View on ClinicalTrials.gov: NCT01933295 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (Behavioral); Sleep Education (Behavioral); Sleep Restriction Therapy (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Christopher Drake
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diary Based Sleepiness |
5.01; 5.13; 4.87; 4.72; 4.36; 4.09 | — |
| SECONDARY Fatigue Severity Scale (FSS). |
32.50; 31.78; 33.28; 32.32; 28.20; 29.90 | — |
| SECONDARY Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale |
52.70; 52.50; 52.76; 52.10; 61.90; 61.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- post-menopausal insomnia
Exclusion Criteria
- unstable medical conditions
Data sourced from ClinicalTrials.gov (NCT01933295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.