Trial Outcomes & Findings for Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers (NCT NCT04986904)
NCT ID: NCT04986904
Last Updated: 2024-10-23
Results Overview
Level of SHUTi engagement: Core completion (i.e., nonuser \[no cores completed\], incomplete user \[1-3 Cores\], or complete user \[4-6 Cores\])
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
9-week Post-assessment
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
SHUTi (Sleep Healthy Using the Internet)
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
Completed Baseline Assessment
|
101
|
|
Overall Study
Completed the 9-week Intervention Period
|
100
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
SHUTi (Sleep Healthy Using the Internet)
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
Baseline characteristics by cohort
| Measure |
SHUTi (Sleep Healthy Using the Internet)
n=100 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
|---|---|
|
Age, Continuous
|
52.82 years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
87 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9-week Post-assessmentLevel of SHUTi engagement: Core completion (i.e., nonuser \[no cores completed\], incomplete user \[1-3 Cores\], or complete user \[4-6 Cores\])
Outcome measures
| Measure |
SHUTi (Sleep Healthy Using the Internet)
n=100 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
SHUTi Incomplete Users
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed one to three of the six SHUTi Cores.
|
SHUTi Complete Users
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed four or more of the six SHUTi Cores.
|
|---|---|---|---|
|
SHUTi Engagement
Non-User
|
18 Participants
|
—
|
—
|
|
SHUTi Engagement
Incomplete User
|
22 Participants
|
—
|
—
|
|
SHUTi Engagement
Complete User
|
60 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentPopulation: SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.
Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)
Outcome measures
| Measure |
SHUTi (Sleep Healthy Using the Internet)
n=18 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
SHUTi Incomplete Users
n=22 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed one to three of the six SHUTi Cores.
|
SHUTi Complete Users
n=60 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed four or more of the six SHUTi Cores.
|
|---|---|---|---|
|
Sleep-related Cognitions
Baseline
|
92.61 score on a scale
Standard Deviation 31.54
|
92.68 score on a scale
Standard Deviation 18.20
|
86.08 score on a scale
Standard Deviation 27.04
|
|
Sleep-related Cognitions
Post-Assessment
|
—
|
61.12 score on a scale
Standard Deviation 36.20
|
54.82 score on a scale
Standard Deviation 30.08
|
SECONDARY outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentPopulation: SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.
Sleep Locus of Control Scale with two subscales: 1. a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome) 2. a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)
Outcome measures
| Measure |
SHUTi (Sleep Healthy Using the Internet)
n=18 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
|
SHUTi Incomplete Users
n=22 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed one to three of the six SHUTi Cores.
|
SHUTi Complete Users
n=60 Participants
Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.
Participants were classified as users if they completed four or more of the six SHUTi Cores.
|
|---|---|---|---|
|
Sleep Self-efficacy
Baseline Sleep Locus of Control - Internal
|
17.06 score on a scale
Standard Deviation 4.49
|
14.77 score on a scale
Standard Deviation 4.06
|
15.02 score on a scale
Standard Deviation 4.85
|
|
Sleep Self-efficacy
Post-Assessment Sleep Locus of Control - Internal
|
—
|
15.94 score on a scale
Standard Deviation 6.39
|
16.93 score on a scale
Standard Deviation 5.12
|
|
Sleep Self-efficacy
Baseline Sleep Locus of Control - External
|
9.11 score on a scale
Standard Deviation 4.14
|
8.14 score on a scale
Standard Deviation 3.17
|
8.68 score on a scale
Standard Deviation 3.72
|
|
Sleep Self-efficacy
Post-Assessment Sleep Locus of Control - External
|
—
|
6.69 score on a scale
Standard Deviation 3.09
|
6.75 score on a scale
Standard Deviation 3.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9-week Post-assessmentNon-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9-week Post-assessmentItems from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentPearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentInsomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentData collected from sleep diary: Time fell asleep - Time attempting to fall asleep
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentData collected from sleep diary: Total time awake between time feel asleep and final morning waking
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Pre-assessment and 9-week Post-assessmentData collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good
Outcome measures
Outcome data not reported
Adverse Events
SHUTi (Sleep Healthy Using the Internet)
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