Trial Outcomes & Findings for Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes (NCT NCT01933295)
NCT ID: NCT01933295
Last Updated: 2023-02-22
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
8 months
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
Sleep Education
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
52
|
|
Overall Study
COMPLETED
|
43
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Baseline characteristics by cohort
| Measure |
Sleep Education
n=50 Participants
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
|
Cognitive Behavioral Therapy for Insomnia
n=52 Participants
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.
|
Sleep Restriction Therapy
n=52 Participants
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.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.24 years
STANDARD_DEVIATION 5.55 • n=5 Participants
|
55.32 years
STANDARD_DEVIATION 5.90 • n=7 Participants
|
56.76 years
STANDARD_DEVIATION 5.39 • n=5 Participants
|
56.44 years
STANDARD_DEVIATION 5.64 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: Lost to follow-up at 6 months follow-up assessment
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)
Outcome measures
| Measure |
Sleep Education
n=50 Participants
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
|
Cognitive Behavioral Therapy for Insomnia
n=52 Participants
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.
|
Sleep Restriction Therapy
n=52 Participants
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.
|
|---|---|---|---|
|
Diary Based Sleepiness
Pre Treatment
|
5.01 score on a scale
Standard Deviation 1.65
|
5.13 score on a scale
Standard Deviation 1.68
|
4.87 score on a scale
Standard Deviation 1.70
|
|
Diary Based Sleepiness
Post Treatment
|
4.72 score on a scale
Standard Deviation 2.06
|
4.36 score on a scale
Standard Deviation 2.16
|
4.09 score on a scale
Standard Deviation 2.07
|
|
Diary Based Sleepiness
6 months follow up
|
4.73 score on a scale
Standard Deviation 1.97
|
3.43 score on a scale
Standard Deviation 1.90
|
3.47 score on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Lost to follow-up at 6 months follow-up assessment
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).
Outcome measures
| Measure |
Sleep Education
n=50 Participants
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
|
Cognitive Behavioral Therapy for Insomnia
n=52 Participants
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.
|
Sleep Restriction Therapy
n=52 Participants
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.
|
|---|---|---|---|
|
Fatigue Severity Scale (FSS).
Pre Treatment
|
32.50 score on a scale
Standard Deviation 11.68
|
31.78 score on a scale
Standard Deviation 10.89
|
33.28 score on a scale
Standard Deviation 11.68
|
|
Fatigue Severity Scale (FSS).
Post Treatment
|
32.32 score on a scale
Standard Deviation 11.95
|
28.20 score on a scale
Standard Deviation 10.32
|
29.90 score on a scale
Standard Deviation 12.08
|
|
Fatigue Severity Scale (FSS).
6 months follow-up
|
32.31 score on a scale
Standard Deviation 10.95
|
25.35 score on a scale
Standard Deviation 10.41
|
28.49 score on a scale
Standard Deviation 10.74
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Lost to follow-up at 6 months follow-up assessment
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)
Outcome measures
| Measure |
Sleep Education
n=50 Participants
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Sleep Education
|
Cognitive Behavioral Therapy for Insomnia
n=52 Participants
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.
|
Sleep Restriction Therapy
n=52 Participants
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.
|
|---|---|---|---|
|
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
Post-Treatment
|
52.10 score on a scale
Standard Deviation 19.77
|
61.90 score on a scale
Standard Deviation 18.07
|
61.33 score on a scale
Standard Deviation 17.76
|
|
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
Pre-Treatment
|
52.70 score on a scale
Standard Deviation 19.51
|
52.50 score on a scale
Standard Deviation 18.11
|
52.76 score on a scale
Standard Deviation 21.02
|
|
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
6 months follow-up
|
54.55 score on a scale
Standard Deviation 19.10
|
67.79 score on a scale
Standard Deviation 16.49
|
65.70 score on a scale
Standard Deviation 17.48
|
Adverse Events
Sleep Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy for Insomnia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Restriction Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place