Trial Outcomes & Findings for Reducing Health Disparities for Black Women in the Treatment of Insomnia (NCT NCT03613519)
NCT ID: NCT03613519
Last Updated: 2022-10-25
Results Overview
A change in sleep difficulties will be assessed by the change in the ISI (Insomnia Severity Index) score. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by sleep difficulties. A 5-point Likert scale (0 = none; 4 = very severe) is used to rate each item, with total scores ranging from 0 to 28. A higher total score indicates more severe sleep difficulties.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
Time 1 (baseline), Time 3 (6 months after expected completion of program)
Results posted on
2022-10-25
Participant Flow
1010 completed the eligibility questionnaire. 490 were excluded for not meeting criteria and 187 declined to participate. The remaining 333 were randomized into one of the three trial arms.
Participant milestones
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient education: A woman assigned to patient education receive access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
SHUTi (Sleep Healthy Using the Internet) is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Baseline
STARTED
|
115
|
108
|
110
|
|
Baseline
COMPLETED
|
113
|
85
|
100
|
|
Baseline
NOT COMPLETED
|
2
|
23
|
10
|
|
Post -Intervention (9 Weeks)
STARTED
|
113
|
85
|
100
|
|
Post -Intervention (9 Weeks)
COMPLETED
|
112
|
79
|
93
|
|
Post -Intervention (9 Weeks)
NOT COMPLETED
|
1
|
6
|
7
|
|
Long-term Follow-up (6 Months)
STARTED
|
112
|
79
|
93
|
|
Long-term Follow-up (6 Months)
COMPLETED
|
112
|
79
|
93
|
|
Long-term Follow-up (6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Health Disparities for Black Women in the Treatment of Insomnia
Baseline characteristics by cohort
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=115 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receive access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=108 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=110 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
333 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/Ethnicity, Customized
Black/African American
|
115 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
108 participants
n=7 Participants
|
110 participants
n=5 Participants
|
333 participants
n=4 Participants
|
|
Weekly alcohol consumption
|
1.2 drinks per week
STANDARD_DEVIATION 2.1 • n=5 Participants
|
1.8 drinks per week
STANDARD_DEVIATION 2.6 • n=7 Participants
|
1.1 drinks per week
STANDARD_DEVIATION 1.9 • n=5 Participants
|
1.4 drinks per week
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Smoking history
Current
|
4 percent of participants
n=5 Participants
|
9 percent of participants
n=7 Participants
|
5 percent of participants
n=5 Participants
|
6 percent of participants
n=4 Participants
|
|
Smoking history
Past
|
24 percent of participants
n=5 Participants
|
17 percent of participants
n=7 Participants
|
29 percent of participants
n=5 Participants
|
23 percent of participants
n=4 Participants
|
|
Smoking history
Never
|
71 percent of participants
n=5 Participants
|
74 percent of participants
n=7 Participants
|
66 percent of participants
n=5 Participants
|
71 percent of participants
n=4 Participants
|
|
Body Mass Index (BMI= kg/m^2)
<25
|
16 percent of participants
n=5 Participants
|
23 percent of participants
n=7 Participants
|
30 percent of participants
n=5 Participants
|
23 percent of participants
n=4 Participants
|
|
Body Mass Index (BMI= kg/m^2)
25-29
|
27 percent of participants
n=5 Participants
|
26 percent of participants
n=7 Participants
|
23 percent of participants
n=5 Participants
|
25 percent of participants
n=4 Participants
|
|
Body Mass Index (BMI= kg/m^2)
30 or greater
|
51 percent of participants
n=5 Participants
|
47 percent of participants
n=7 Participants
|
40 percent of participants
n=5 Participants
|
46 percent of participants
n=4 Participants
|
|
Body Mass Index (BMI= kg/m^2)
Unknown
|
6 percent of participants
n=5 Participants
|
4 percent of participants
n=7 Participants
|
7 percent of participants
n=5 Participants
|
6 percent of participants
n=4 Participants
|
|
Insomnia Severity Index
|
19.2 score on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
18.3 score on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
18.7 score on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
18.8 score on a scale
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Sleep Onset Latency
|
41.6 minutes
STANDARD_DEVIATION 2.6 • n=5 Participants
|
47.5 minutes
STANDARD_DEVIATION 2.7 • n=7 Participants
|
38.0 minutes
STANDARD_DEVIATION 2.7 • n=5 Participants
|
42.3 minutes
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
Total Sleep Time
|
5.7 hours
STANDARD_DEVIATION 0.1 • n=5 Participants
|
5.7 hours
STANDARD_DEVIATION 0.1 • n=7 Participants
|
6.0 hours
STANDARD_DEVIATION 0.1 • n=5 Participants
|
5.8 hours
STANDARD_DEVIATION 0.1 • n=4 Participants
|
|
Sleep Efficiency
|
72.7 percent
STANDARD_DEVIATION 1.1 • n=5 Participants
|
70.9 percent
STANDARD_DEVIATION 1.1 • n=7 Participants
|
73.1 percent
STANDARD_DEVIATION 1.1 • n=5 Participants
|
72.2 percent
STANDARD_DEVIATION 0.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Time 1 (baseline), Time 3 (6 months after expected completion of program)A change in sleep difficulties will be assessed by the change in the ISI (Insomnia Severity Index) score. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by sleep difficulties. A 5-point Likert scale (0 = none; 4 = very severe) is used to rate each item, with total scores ranging from 0 to 28. A higher total score indicates more severe sleep difficulties.
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=112 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=79 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=93 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Change in Sleep Difficulties Assessed by the Insomnia Severity Index
|
-3.6 score on a scale
Standard Error 0.5
|
-10.0 score on a scale
Standard Error 0.6
|
-9.3 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 3 (6 months after expected completion of program)SOL is the amount of time it takes to fall asleep measured in minutes.
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=112 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=79 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=93 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Change in Sleep Onset Latency (SOL)
|
-7.0 Minutes
Standard Error 2.7
|
-20.2 Minutes
Standard Error 3.0
|
-17.7 Minutes
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 3 (6 months after expected completion of program)WASO measures time awake after falling asleep measured in minutes.
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=112 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=79 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=93 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Change in Wake After Sleep Onset (WASO)
|
-7.2 minutes
Standard Error 2.9
|
-17.6 minutes
Standard Error 3.3
|
-19.7 minutes
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 3 (6 months after expected completion of program)TST is the amount of time spent asleep in bed, measured in minutes and then converted to hours. Total sleep time is calculated by subtracting SOL (Sleep Onset Latency, WASO (Wake After Sleep Onset) and EMA (Early Morning Arise) from total time in bed (TIB).
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=112 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=79 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=93 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Change in Total Sleep Time (TST)
|
0.5 hours
Standard Error 0.1
|
0.8 hours
Standard Error 0.1
|
0.3 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 3 (6 months after expected completion of program)Change in Sleep Efficiency (SE). SE is the change in the percentage of time spent asleep while in bed. SE is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes) times 100.
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=112 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=79 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
n=93 Participants
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Change in Sleep Efficiency (SE)
|
4.3 percent
Standard Error 1.1
|
12.3 percent
Standard Error 1.2
|
11.4 percent
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Time 3 (6 months after expected completion of program)Population: Only participants in the SHUti and the modified SHUTi arms used the cores/modules, so this outcome was not measured in the usual care arm.
The percentage of participants in the SHUTi and modified SHUTI arms who completed all six cores/modules during the study
Outcome measures
| Measure |
Patient Education (Sleep Hygiene, Usual Care)
n=70 Participants
A web-based program that presents ways to improve behaviors and environments that can affect sleep.
Patient Education: A woman assigned to Patient Education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
|
SHUTi (Sleep Healthy Using the Internet)
n=86 Participants
SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)
SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
Modified SHUTi (SHUTi Modified for Black Women)
The CBT-I instrument tailored for Black women.
Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
|
|---|---|---|---|
|
Completion of All 6 Cores/Modules
|
64.8 percentage of participants
|
78.2 percentage of participants
|
—
|
Adverse Events
Patient Education (Sleep Hygiene, Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SHUTi (Sleep Healthy Using the Internet)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Modified SHUTi (SHUTi Modified for Black Women)
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
Lynn Rosenberg, ScD
Boston University School of Public Health
Phone: 617.734.6006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place