Trial Outcomes & Findings for Mobile Sleep Intervention for OEF, OIF and OND Veterans (NCT NCT02392000)
NCT ID: NCT02392000
Last Updated: 2018-04-20
Results Overview
Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.
COMPLETED
NA
38 participants
Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
2018-04-20
Participant Flow
Participant milestones
| Measure |
WatchPAT and CBT-i Coach App
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
WatchPAT and CBT-i Coach App
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Overall Study
Greater than mild sleep apnea exclusion
|
18
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
Baseline Characteristics
Mobile Sleep Intervention for OEF, OIF and OND Veterans
Baseline characteristics by cohort
| Measure |
WatchPAT and CBT-i Coach App
n=38 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=99 Participants
|
|
Height
|
68.6 inches
STANDARD_DEVIATION 3.8 • n=99 Participants
|
|
Weight
|
195.9 pounds
STANDARD_DEVIATION 40.5 • n=99 Participants
|
|
Usability Satisfaction with Care
|
14.6 units on a scale
STANDARD_DEVIATION 3.1 • n=99 Participants
|
|
Usability Health Knowledge
|
8.0 units on a scale
STANDARD_DEVIATION 2.4 • n=99 Participants
|
|
Usability Internet Dependence
|
19.5 units on a scale
STANDARD_DEVIATION 5.6 • n=99 Participants
|
|
Usability Information Seeking Preferences
|
21.8 units on a scale
STANDARD_DEVIATION 4.4 • n=99 Participants
|
|
Usability Healthcare Need
|
1.3 units on a scale
STANDARD_DEVIATION 1.0 • n=99 Participants
|
|
CBT-i Coach App Intrinsic Motivation
|
14.7 units on a scale
STANDARD_DEVIATION 3.2 • n=99 Participants
|
|
CBT-i Coach Perceived Ease of Use
|
16.1 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
|
CBT-i Coach Perceived Usefulness
|
15.9 units on a scale
STANDARD_DEVIATION 3.0 • n=99 Participants
|
|
CBT-i Coach Behavioral Intention
|
12.5 units on a scale
STANDARD_DEVIATION 2.1 • n=99 Participants
|
|
WatchPAT Intrinsic Motivation
|
13.9 units on a scale
STANDARD_DEVIATION 3.8 • n=99 Participants
|
|
WatchPAT Perceived Ease of Use
|
16.7 units on a scale
STANDARD_DEVIATION 3.4 • n=99 Participants
|
|
WatchPAT Perceived Usefulness
|
16.3 units on a scale
STANDARD_DEVIATION 3.3 • n=99 Participants
|
|
WatchPAT Behavioral Intention
|
12.6 units on a scale
STANDARD_DEVIATION 2.2 • n=99 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are those whose data are used for Week 0.
Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.
Outcome measures
| Measure |
WatchPAT and CBT-i Coach Mobile App
n=11 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Number of Participants Using WatchPAT
Number of Participants using WatchPAT at Baseline
|
11 Participants
|
|
Number of Participants Using WatchPAT
Number of Participants using WatchPAT at Week 6
|
11 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)Population: Those completing enrollment and not withdrawn by study personnel for insomnia were counted at Week 0. The Week 0 outcome measure is the number of participants who used sleep diaries in the CBT-I Coach for 5 or more nights of Week 0. In Week 6 it is the number of participants who used the CBT-I Coach for 5 or more nights during the sixth week.
CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.
Outcome measures
| Measure |
WatchPAT and CBT-i Coach Mobile App
n=11 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Number of Participants Using CBT-I Coach
Participants using CBT-I Coach at Baseline
|
11 Participants
|
|
Number of Participants Using CBT-I Coach
Participants using CBT-I Coach Week 6
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.
Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Outcome measures
| Measure |
WatchPAT and CBT-i Coach Mobile App
n=11 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Insomnia Severity Index Score
Insomnia Severity Score at Week 6
|
12.8 units on a scale
Standard Deviation 3.7
|
|
Insomnia Severity Index Score
Insomnia Severity Score at Baseline
|
16.6 units on a scale
Standard Deviation 5.6
|
|
Insomnia Severity Index Score
Insomnia Severity Score at Week 4
|
12.4 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.
Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Outcome measures
| Measure |
WatchPAT and CBT-i Coach Mobile App
n=11 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Total Score
PSQI Total Score at Baseline
|
12.8 units on a scale
Standard Deviation 4.6
|
|
Pittsburgh Sleep Quality Index (PSQI) Total Score
PSQI Total Score at Week 4
|
10.4 units on a scale
Standard Deviation 2.7
|
|
Pittsburgh Sleep Quality Index (PSQI) Total Score
PSQI Total Score at Week 6
|
10.7 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.
Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Outcome measures
| Measure |
WatchPAT and CBT-i Coach Mobile App
n=11 Participants
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
|
|---|---|
|
Functional Outcomes of Sleep Score
FOSQ Score at Baseline
|
13.9 units on a scale
Standard Deviation 3.7
|
|
Functional Outcomes of Sleep Score
FOSQ Score at Week 4
|
15.2 units on a scale
Standard Deviation 3.8
|
|
Functional Outcomes of Sleep Score
FOSQ Score at Week 6
|
15.4 units on a scale
Standard Deviation 2.9
|
Adverse Events
WatchPAT and CBT-i Coach App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen S. Quigley
Edith Nourse Rogers Memorial VA Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place