Trial Outcomes & Findings for Online Insomnia Intervention to Reduce Alcohol Use (NCT NCT05630118)
NCT ID: NCT05630118
Last Updated: 2026-07-15
Results Overview
Participants reported daily alcohol use on a daily alcohol diary, including whether alcohol was consumed each day. Daily responses were used to calculate the total number of drinking days during the assessment period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Results posted on
2026-07-15
Participant Flow
Participant milestones
| Measure |
SHUTi Intervention
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
52
|
|
Overall Study
COMPLETED
|
29
|
45
|
|
Overall Study
NOT COMPLETED
|
32
|
7
|
Reasons for withdrawal
| Measure |
SHUTi Intervention
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
28
|
5
|
Baseline Characteristics
Online Insomnia Intervention to Reduce Alcohol Use
Baseline characteristics by cohort
| Measure |
SHUTi Intervention
n=61 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=52 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
41 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
113 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=20 Participants
|
45 Participants
n=20 Participants
|
92 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=20 Participants
|
52 participants
n=20 Participants
|
113 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Participants reported daily alcohol use on a daily alcohol diary, including whether alcohol was consumed each day. Daily responses were used to calculate the total number of drinking days during the assessment period.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
Baseline
|
6.7 number of drinking days
Standard Deviation 3.0
|
6.4 number of drinking days
Standard Deviation 2.7
|
|
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
Post-Intervention
|
4.4 number of drinking days
Standard Deviation 3.6
|
5.5 number of drinking days
Standard Deviation 3.4
|
|
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
6-Month Post-Intervention
|
3.9 number of drinking days
Standard Deviation 3.2
|
4.4 number of drinking days
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Participants will report the number of drinks consumed each day on a daily alcohol diary.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
Baseline
|
5.2 drinks/drinking day
Standard Deviation 2.7
|
5.3 drinks/drinking day
Standard Deviation 3.3
|
|
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
Post-Intervention
|
4.4 drinks/drinking day
Standard Deviation 3.1
|
4.0 drinks/drinking day
Standard Deviation 2.6
|
|
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
6-Month Post-Intervention
|
2.8 drinks/drinking day
Standard Deviation 2.4
|
3.0 drinks/drinking day
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Participants will report the number of drinks consumed each day on a daily alcohol diary.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Alcohol Use: 3) Total Number of Drinks (TD).
Baseline
|
35.8 drinks/day
Standard Deviation 24.2
|
31.5 drinks/day
Standard Deviation 17.1
|
|
Change In Alcohol Use: 3) Total Number of Drinks (TD).
Post-Intervention
|
21.8 drinks/day
Standard Deviation 25.9
|
24.1 drinks/day
Standard Deviation 15.5
|
|
Change In Alcohol Use: 3) Total Number of Drinks (TD).
6-Month Post-Intervention
|
14.7 drinks/day
Standard Deviation 18.3
|
17.8 drinks/day
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Participants will report the number of drinks consumed each day on a daily alcohol diary. Summary measures will include total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
Baseline
|
4.3 total number of binge episodes
Standard Deviation 3.2
|
3.7 total number of binge episodes
Standard Deviation 2.5
|
|
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
Post-Intervention
|
2.3 total number of binge episodes
Standard Deviation 3.0
|
2.4 total number of binge episodes
Standard Deviation 2.2
|
|
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
6-Month Post-Intervention
|
1.3 total number of binge episodes
Standard Deviation 2.2
|
2.1 total number of binge episodes
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)The ISI uses a 7-item scale to asses insomnia impact over the previous two weeks. Items scores range from 0-28. Scores indicate moderate to severe insomnia. Moderate or marked clinical improvement is indicated by a change score of \>7 or \>8 respectively. Higher scores on the ISI mean worse sleep (more severe insomnia).
Outcome measures
| Measure |
SHUTi Intervention
n=61 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=52 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Sleep: Insomnia Severity Index (ISI)
Baseline
|
20.3 score on a scale
Standard Deviation 3.5
|
20.1 score on a scale
Standard Deviation 3.4
|
|
Change In Sleep: Insomnia Severity Index (ISI)
Post-Intervention
|
9.8 score on a scale
Standard Deviation 4.4
|
13.9 score on a scale
Standard Deviation 5.2
|
|
Change In Sleep: Insomnia Severity Index (ISI)
3-Month Post-Intervention
|
9.6 score on a scale
Standard Deviation 5.1
|
12.5 score on a scale
Standard Deviation 5.0
|
|
Change In Sleep: Insomnia Severity Index (ISI)
6-Month Post-Intervention
|
8.3 score on a scale
Standard Deviation 5.3
|
11.6 score on a scale
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. On the PSQI, higher scores mean worse sleep quality.
Outcome measures
| Measure |
SHUTi Intervention
n=61 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=52 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
13.8 score on a scale
Standard Deviation 2.9
|
13.7 score on a scale
Standard Deviation 2.6
|
|
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
Post-Intervention
|
8.4 score on a scale
Standard Deviation 3.7
|
10.9 score on a scale
Standard Deviation 4.1
|
|
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
3-Month Post-Intervention
|
7.2 score on a scale
Standard Deviation 3.5
|
9.9 score on a scale
Standard Deviation 4.5
|
|
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
6-Month Post Intervention
|
6.2 score on a scale
Standard Deviation 3.4
|
9.4 score on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Sleep: 3) Daily Sleep Diaries
Baseline
|
52.1 minutes/night
Standard Deviation 36.6
|
55.5 minutes/night
Standard Deviation 39.2
|
|
Change In Sleep: 3) Daily Sleep Diaries
Post-Intervention
|
26.5 minutes/night
Standard Deviation 19.7
|
47.3 minutes/night
Standard Deviation 35.5
|
|
Change In Sleep: 3) Daily Sleep Diaries
6-Month Post-Intervention
|
26.6 minutes/night
Standard Deviation 24.3
|
42.1 minutes/night
Standard Deviation 32.1
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Sleep: 4) Daily Sleep Diaries
6-Month Post-Intervention
|
38.9 minutes/night
Standard Deviation 35.2
|
49.7 minutes/night
Standard Deviation 26.1
|
|
Change In Sleep: 4) Daily Sleep Diaries
Baseline
|
71.3 minutes/night
Standard Deviation 53.8
|
69.2 minutes/night
Standard Deviation 41.7
|
|
Change In Sleep: 4) Daily Sleep Diaries
Post-Intervention
|
39.6 minutes/night
Standard Deviation 35.9
|
49.4 minutes/night
Standard Deviation 27.8
|
PRIMARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)Participants will report the amount of sleep medication used each day.
Outcome measures
| Measure |
SHUTi Intervention
n=50 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=43 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change in Medication Use: 5) Daily Sleep Diaries
Baseline
|
3.0 medication/day
Standard Deviation 3.5
|
2.0 medication/day
Standard Deviation 2.8
|
|
Change in Medication Use: 5) Daily Sleep Diaries
Post-Intervention
|
2.2 medication/day
Standard Deviation 3.4
|
1.8 medication/day
Standard Deviation 2.5
|
|
Change in Medication Use: 5) Daily Sleep Diaries
6-Month Post-Intervention
|
1.1 medication/day
Standard Deviation 2.8
|
2.1 medication/day
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)The PSS will assess perceived stress over the prior month. Scores range from 0-40. The PSS demonstrates strong concurrent and predictive validity for various health behaviors and outcomes with higher scores indicating greater psychological distress.
Outcome measures
| Measure |
SHUTi Intervention
n=61 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=52 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Mood: 1) Perceived Stress Scale (PSS)
Baseline
|
22.3 score on a scale
Standard Deviation 6.5
|
24.4 score on a scale
Standard Deviation 6.6
|
|
Change In Mood: 1) Perceived Stress Scale (PSS)
Post-Intervention
|
18.9 score on a scale
Standard Deviation 6.4
|
21.9 score on a scale
Standard Deviation 7.5
|
|
Change In Mood: 1) Perceived Stress Scale (PSS)
3-Month Post-Intervention
|
17.5 score on a scale
Standard Deviation 6.3
|
20.9 score on a scale
Standard Deviation 6.4
|
|
Change In Mood: 1) Perceived Stress Scale (PSS)
6-Month Post-Intervention
|
17.0 score on a scale
Standard Deviation 6.7
|
20.5 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.
Outcome measures
| Measure |
SHUTi Intervention
n=61 Participants
Adult heavy drinkers with insomnia
SHUTi Intervention: Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
|
Web-Based Insomnia Education Program
n=52 Participants
Adult heavy drinkers with insomnia
Web-Based Insomnia Education Program: Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
|
|---|---|---|
|
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
Baseline
|
15.1 score on a scale
Standard Deviation 5.2
|
15.9 score on a scale
Standard Deviation 5.3
|
|
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
Post-Intervention
|
11.1 score on a scale
Standard Deviation 5.8
|
13.5 score on a scale
Standard Deviation 6.1
|
|
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
3-Month Post-Intervention
|
10.5 score on a scale
Standard Deviation 5.0
|
12.1 score on a scale
Standard Deviation 5.1
|
|
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)
6-Month Post-Intervention
|
9.0 score on a scale
Standard Deviation 6.1
|
12.4 score on a scale
Standard Deviation 6.0
|
Adverse Events
SHUTi Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Web-Based Insomnia Education Program
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