Trial Outcomes & Findings for Online Peer Networked Collaborative Learning for Managing Depressive Symptoms (NCT NCT02841787)
NCT ID: NCT02841787
Last Updated: 2018-10-29
Results Overview
The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe. The data table below shows PHQ-9 pre- and post- intervention score differences by group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Baseline and Week 8 - Difference in PHQ-9 score
Results posted on
2018-10-29
Participant Flow
Participant milestones
| Measure |
Individual Internet Intervention (III)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
23
|
12
|
|
Overall Study
COMPLETED
|
9
|
19
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
Reasons for withdrawal
| Measure |
Individual Internet Intervention (III)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Symptoms dropped below threshold
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
0
|
Baseline Characteristics
Online Peer Networked Collaborative Learning for Managing Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Individual Internet Intervention (III)
n=12 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
n=23 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
n=12 Participants
WLC participants received access to the III following the 8-week waiting period.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Education
Some High School
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Education
Some College
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
70 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Annual gross household income (x1000)
|
37.5 USD
n=5 Participants
|
37 USD
n=7 Participants
|
50 USD
n=5 Participants
|
41 USD
n=4 Participants
|
|
Marital Status
No Partner
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Marital Status
Partner
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Education
2-yr College (Associate's)
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Education
4-yr College (Bachelor's)
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Education
Master's Degree
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Education
Doctoral Degree (PhD, MD, JD)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Employment Status
Employed
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Employment Status
Retired
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Employment Status
Unemployed/Disability
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Health Insurance
Insured
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Health Insurance
Medicare
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Health Insurance
Medicaid
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Taking antidepressant medication
No
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Taking antidepressant medication
Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8 - Difference in PHQ-9 scoreThe PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe. The data table below shows PHQ-9 pre- and post- intervention score differences by group.
Outcome measures
| Measure |
Individual Internet Intervention (III)
n=9 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
n=19 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
n=12 Participants
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
|
-5.4 units on a scale
Standard Deviation 2.4
|
-4.8 units on a scale
Standard Deviation 4.4
|
-1.1 units on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Out of the 12 participants who started Individual Internet Intervention, one participant was administratively dropped (no longer eligible for the study) before treatment started; only 11 participants were analyzed.
Outcome measures
| Measure |
Individual Internet Intervention (III)
n=11 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
n=23 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
Mean Number of Sessions Across the 8-week Trial
|
45.6 number of sessions
Standard Deviation 24.9
|
49.1 number of sessions
Standard Deviation 35.8
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 21 participants met this criterion.
The System Usability Scale (SUS) is a usability scale that can be used for global assessments of systems usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Outcome measures
| Measure |
Individual Internet Intervention (III)
n=9 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
n=21 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
System Usability Scale (SUS)
|
68.75 units on a scale
Standard Deviation 16.09
|
60.5 units on a scale
Standard Deviation 16.69
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 19 participants met this criterion.
The average time spent on messages and calls and on group moderation.
Outcome measures
| Measure |
Individual Internet Intervention (III)
n=9 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
|
Internet Intervention With Peer Support (II+PS)
n=19 Participants
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
|
Waitlist Control (WLC)
WLC participants received access to the III following the 8-week waiting period.
|
|---|---|---|---|
|
Average Coaching Time Per Participant by Group
|
134.33 Minutes
Standard Deviation 28.43
|
92.43 Minutes
Standard Deviation 32.36
|
—
|
Adverse Events
Individual Internet Intervention (III)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Internet Intervention With Peer Support (II+PS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control (WLC)
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