Menopause
Conditions
Keywords
treatment
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
BEHAVIORALSleep Education
BEHAVIORALSleep Restriction Therapy
Sponsors
National Institute of Nursing Research (NINR)
Wayne State University
University of Michigan
Christopher Drake
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* post-menopausal insomnia
Exclusion criteria
* unstable medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diary Based Sleepiness | 8 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale (FSS). | 8 months | 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). |
| Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | 8 months | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Education Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education | 50 |
| Cognitive Behavioral Therapy for Insomnia Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation strategies (eg, progressive muscle relaxation and autogenic training) and sleep hygiene education. | 52 |
| Sleep Restriction Therapy 2-week intervention. Specifically, the initial face-to-face session consisted of reviewing patient sleep history, education and rationale for sleep restriction practices, and behavioral homework. Then four follow-up sessions (three phone contacts, each 3-4 days apart, followed by a second face-to-face session) were delivered across the following 2 weeks and were used to titrate sleep schedules based on sleep diary data. | 52 |
| Total | 154 |
Baseline characteristics
| Characteristic | Sleep Education | Cognitive Behavioral Therapy for Insomnia | Sleep Restriction Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 57.24 years STANDARD_DEVIATION 5.55 | 55.32 years STANDARD_DEVIATION 5.9 | 56.76 years STANDARD_DEVIATION 5.39 | 56.44 years STANDARD_DEVIATION 5.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 22 Participants | 17 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) White | 26 Participants | 24 Participants | 28 Participants | 78 Participants |
| Sex: Female, Male Female | 50 Participants | 52 Participants | 52 Participants | 154 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 50 | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 50 | 0 / 52 | 0 / 52 |
Outcome results
Primary
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)
Time frame: 8 months
Population: Lost to follow-up at 6 months follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Education | Diary Based Sleepiness | Post Treatment | 4.72 score on a scale | Standard Deviation 2.06 |
| Sleep Education | Diary Based Sleepiness | Pre Treatment | 5.01 score on a scale | Standard Deviation 1.65 |
| Sleep Education | Diary Based Sleepiness | 6 months follow up | 4.73 score on a scale | Standard Deviation 1.97 |
| Cognitive Behavioral Therapy for Insomnia | Diary Based Sleepiness | Post Treatment | 4.36 score on a scale | Standard Deviation 2.16 |
| Cognitive Behavioral Therapy for Insomnia | Diary Based Sleepiness | Pre Treatment | 5.13 score on a scale | Standard Deviation 1.68 |
| Cognitive Behavioral Therapy for Insomnia | Diary Based Sleepiness | 6 months follow up | 3.43 score on a scale | Standard Deviation 1.9 |
| Sleep Restriction Therapy | Diary Based Sleepiness | Pre Treatment | 4.87 score on a scale | Standard Deviation 1.7 |
| Sleep Restriction Therapy | Diary Based Sleepiness | 6 months follow up | 3.47 score on a scale | Standard Deviation 2.04 |
| Sleep Restriction Therapy | Diary Based Sleepiness | Post Treatment | 4.09 score on a scale | Standard Deviation 2.07 |
Secondary
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).
Time frame: 8 months
Population: Lost to follow-up at 6 months follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Education | Fatigue Severity Scale (FSS). | 6 months follow-up | 32.31 score on a scale | Standard Deviation 10.95 |
| Sleep Education | Fatigue Severity Scale (FSS). | Post Treatment | 32.32 score on a scale | Standard Deviation 11.95 |
| Sleep Education | Fatigue Severity Scale (FSS). | Pre Treatment | 32.50 score on a scale | Standard Deviation 11.68 |
| Cognitive Behavioral Therapy for Insomnia | Fatigue Severity Scale (FSS). | Post Treatment | 28.20 score on a scale | Standard Deviation 10.32 |
| Cognitive Behavioral Therapy for Insomnia | Fatigue Severity Scale (FSS). | Pre Treatment | 31.78 score on a scale | Standard Deviation 10.89 |
| Cognitive Behavioral Therapy for Insomnia | Fatigue Severity Scale (FSS). | 6 months follow-up | 25.35 score on a scale | Standard Deviation 10.41 |
| Sleep Restriction Therapy | Fatigue Severity Scale (FSS). | Pre Treatment | 33.28 score on a scale | Standard Deviation 11.68 |
| Sleep Restriction Therapy | Fatigue Severity Scale (FSS). | 6 months follow-up | 28.49 score on a scale | Standard Deviation 10.74 |
| Sleep Restriction Therapy | Fatigue Severity Scale (FSS). | Post Treatment | 29.90 score on a scale | Standard Deviation 12.08 |
Secondary
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)
Time frame: 8 months
Population: Lost to follow-up at 6 months follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Education | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Post-Treatment | 52.10 score on a scale | Standard Deviation 19.77 |
| Sleep Education | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Pre-Treatment | 52.70 score on a scale | Standard Deviation 19.51 |
| Sleep Education | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | 6 months follow-up | 54.55 score on a scale | Standard Deviation 19.1 |
| Cognitive Behavioral Therapy for Insomnia | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Post-Treatment | 61.90 score on a scale | Standard Deviation 18.07 |
| Cognitive Behavioral Therapy for Insomnia | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Pre-Treatment | 52.50 score on a scale | Standard Deviation 18.11 |
| Cognitive Behavioral Therapy for Insomnia | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | 6 months follow-up | 67.79 score on a scale | Standard Deviation 16.49 |
| Sleep Restriction Therapy | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Pre-Treatment | 52.76 score on a scale | Standard Deviation 21.02 |
| Sleep Restriction Therapy | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | 6 months follow-up | 65.70 score on a scale | Standard Deviation 17.48 |
| Sleep Restriction Therapy | Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale | Post-Treatment | 61.33 score on a scale | Standard Deviation 17.76 |