We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Online Peer Networked Collaborative Learning for Managing Depressive Symptoms (MoodTech)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841787
Recruitment Status : Completed
First Posted : July 22, 2016
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Behavioral: iCBT for late life depression
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Hide Arm/Group Description Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. 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. WLC participants received access to the III following the 8-week waiting period.
Period Title: Overall Study
Started 12 23 12
Completed 9 19 12
Not Completed 3 4 0
Reason Not Completed
Lost to Follow-up             1             0             0
Symptoms dropped below threshold             1             0             0
Withdrawal by Subject             1             4             0
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC) Total
Hide Arm/Group Description Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. 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. WLC participants received access to the III following the 8-week waiting period. Total of all reporting groups
Overall Number of Baseline Participants 12 23 12 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 23 participants 12 participants 47 participants
69.2  (3.4) 69.5  (4.3) 70  (4.7) 69.6  (4.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
Female
8
  66.7%
16
  69.6%
8
  66.7%
32
  68.1%
Male
4
  33.3%
7
  30.4%
4
  33.3%
15
  31.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
Hispanic or Latino
0
   0.0%
1
   4.3%
0
   0.0%
1
   2.1%
Not Hispanic or Latino
12
 100.0%
22
  95.7%
12
 100.0%
46
  97.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.3%
1
   8.3%
2
   4.3%
White
11
  91.7%
19
  82.6%
11
  91.7%
41
  87.2%
More than one race
1
   8.3%
2
   8.7%
0
   0.0%
3
   6.4%
Unknown or Not Reported
0
   0.0%
1
   4.3%
0
   0.0%
1
   2.1%
Annual gross household income (x1000)  
Median (Inter-Quartile Range)
Unit of measure:  USD
Number Analyzed 12 participants 23 participants 12 participants 47 participants
37.5
(33 to 45)
37
(22.2 to 50)
50
(34 to 115)
41
(29 to 50)
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
No Partner
8
  66.7%
16
  69.6%
5
  41.7%
29
  61.7%
Partner
4
  33.3%
7
  30.4%
7
  58.3%
18
  38.3%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
Some High School
0
   0.0%
0
   0.0%
1
   8.3%
1
   2.1%
Some College
1
   8.3%
5
  21.7%
1
   8.3%
7
  14.9%
2-yr College (Associate's)
0
   0.0%
5
  21.7%
2
  16.7%
7
  14.9%
4-yr College (Bachelor's)
3
  25.0%
6
  26.1%
4
  33.3%
13
  27.7%
Master's Degree
5
  41.7%
5
  21.7%
2
  16.7%
12
  25.5%
Doctoral Degree (PhD, MD, JD)
3
  25.0%
2
   8.7%
2
  16.7%
7
  14.9%
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
Employed
3
  25.0%
4
  17.4%
3
  25.0%
10
  21.3%
Retired
9
  75.0%
18
  78.3%
7
  58.3%
34
  72.3%
Unemployed/Disability
0
   0.0%
1
   4.3%
2
  16.7%
3
   6.4%
Health Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 12 participants 23 participants 12 participants 47 participants
Insured
12
 100.0%
22
  95.7%
12
 100.0%
46
  97.9%
Medicare
10
  83.3%
19
  82.6%
11
  91.7%
40
  85.1%
Medicaid
1
   8.3%
3
  13.0%
0
   0.0%
4
   8.5%
Taking antidepressant medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 12 participants 47 participants
No
7
  58.3%
18
  78.3%
7
  58.3%
32
  68.1%
Yes
5
  41.7%
5
  21.7%
5
  41.7%
15
  31.9%
1.Primary Outcome
Title Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Hide Description

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.
Time Frame Baseline and Week 8 - Difference in PHQ-9 score
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Hide Arm/Group Description:
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
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.
WLC participants received access to the III following the 8-week waiting period.
Overall Number of Participants Analyzed 9 19 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.4  (2.4) -4.8  (4.4) -1.1  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individual Internet Intervention (III)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .001
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet Intervention With Peer Support (II+PS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Waitlist Control (WLC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS), Waitlist Control (WLC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments The threshold for significance was alpha=0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Individual Internet Intervention (III), Waitlist Control (WLC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Internet Intervention With Peer Support (II+PS), Waitlist Control (WLC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Mean Number of Sessions Across the 8-week Trial
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS)
Hide Arm/Group Description:
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
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.
Overall Number of Participants Analyzed 11 23
Mean (Standard Deviation)
Unit of Measure: number of sessions
45.6  (24.9) 49.1  (35.8)
3.Primary Outcome
Title System Usability Scale (SUS)
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS)
Hide Arm/Group Description:
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
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.
Overall Number of Participants Analyzed 9 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
68.75  (16.09) 60.5  (16.69)
4.Primary Outcome
Title Average Coaching Time Per Participant by Group
Hide Description The average time spent on messages and calls and on group moderation.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS)
Hide Arm/Group Description:
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
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.
Overall Number of Participants Analyzed 9 19
Mean (Standard Deviation)
Unit of Measure: Minutes
134.33  (28.43) 92.43  (32.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The threshold for significance was alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 8 months (January 2016 through September 2016)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Hide Arm/Group Description Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists. 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. WLC participants received access to the III following the 8-week waiting period.
All-Cause Mortality
Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/23 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/23 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Individual Internet Intervention (III) Internet Intervention With Peer Support (II+PS) Waitlist Control (WLC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/23 (0.00%)   0/12 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David C. Mohr, PhD
Organization: Northwestern University
Phone: 312-503-1403
EMail: d-mohr@northwestern.edu
Layout table for additonal information
Responsible Party: David Mohr, Northwestern University
ClinicalTrials.gov Identifier: NCT02841787    
Obsolete Identifiers: NCT01912664
Other Study ID Numbers: P20MH090318-FT
P20MH090318 ( U.S. NIH Grant/Contract )
First Submitted: July 20, 2016
First Posted: July 22, 2016
Results First Submitted: July 7, 2017
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018