Trial Outcomes & Findings for Sleep to Prevent Evolving Affecting Disorders (NCT NCT02988375)
NCT ID: NCT02988375
Last Updated: 2024-01-12
Results Overview
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1385 participants
Primary outcome timeframe
Pre-treatment (Day 1)
Results posted on
2024-01-12
Participant Flow
Participant milestones
| Measure |
dCBTI
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Overall Study
STARTED
|
946
|
439
|
|
Overall Study
COMPLETED
|
358
|
300
|
|
Overall Study
NOT COMPLETED
|
588
|
139
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep to Prevent Evolving Affecting Disorders
Baseline characteristics by cohort
| Measure |
dCBTI
n=946 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=439 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
Total
n=1385 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
853 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
1229 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
45 years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
737 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
1088 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
171 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
710 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
1004 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment (Day 1)Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Outcome measures
| Measure |
dCBTI
n=358 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=300 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment
|
10.8 score on a scale
Standard Deviation 4.5
|
10.8 score on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Post-treatment (~6 week after Screening)Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Outcome measures
| Measure |
dCBTI
n=358 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=300 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment
|
3.9 score on a scale
Standard Deviation 4.0
|
6.4 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: 1-year follow-up (58 week after screening)Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Outcome measures
| Measure |
dCBTI
n=326 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=283 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up
|
4.7 score on a scale
Standard Deviation 4.3
|
6.5 score on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Pre-treatment (Day 1)Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Outcome measures
| Measure |
dCBTI
n=358 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=300 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
|
17.8 score on a scale
Standard Deviation 4.2
|
17.7 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Post-treatment (~6 week after Screening)Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Outcome measures
| Measure |
dCBTI
n=358 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=300 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Symptoms of Insomnia - Post Treatment
|
17.9 score on a scale
Standard Deviation 4.3
|
17.7 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 1-year follow-up (58 week after screening)Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Outcome measures
| Measure |
dCBTI
n=326 Participants
Online access to the digital CBTI program Sleepio
dCBTI
|
Sleep Education
n=283 Participants
Weekly email messages with sleep hygiene recommendations
Sleep Education
|
|---|---|---|
|
Severity of Symptoms of Insomnia - 1 Year Post Treatment
|
8.2 score on a scale
Standard Deviation 6.2
|
12.8 score on a scale
Standard Deviation 5.6
|
Adverse Events
dCBTI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Education
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