MoodTech: Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02841787
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

The goal of this field trial is to tailor and test a web-based intervention in adults 65 years of age or older. Two versions of the web-based intervention have been created and will be tested--one with an online social network and one without an online social network. The purpose of this study is to: pilot a novel intervention, examine methods to improve adherence to web-based interventions (e.g., peer network); collect data on feasibility, acceptability, and efficacy of an web-based intervention for late life depression; and ultimately, to overcome the numerous barriers to treating depression in later life.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: iCBT for late life depression	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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. (iCBT for late life depression without social network included.)	Behavioral: iCBT for late life depression
Experimental: Internet Intervention+Peer Supp.(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. (iCBT for late life depression with social network included.)	Behavioral: iCBT for late life depression
No Intervention: Waitlist Control (WLC) Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period.

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module [Baseline and Week 8 - Difference in PHQ-9 score]

   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.

2. Mean Number of Sessions Across the 8-week Trial [8 weeks]

3. System Usability Scale (SUS) [Week 8]

   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.

4. Average Coaching Time Per Participant by Group [8 weeks]

   The average time spent on messages and calls and on group moderation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has elevated depressive symptoms

• Has a telephone, e-mail account, computer, and broadband access to the Internet.

• Has basic internet skills and is able to access the internet independently

• Is able to speak and read English.

• Is at least 65 years of age.

• Is able to give informed consent.

Exclusion Criteria:

• Has hearing or voice impairment that would prevent participation in psychotherapy

• Has visual impairment that would prevent completion of assessment materials.

• Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous.

• Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study

• Is planning to be out of town or unavailable for an extended period of time during the study without access to the Internet

• Exhibits severe suicidality, including ideation, plan, and intent.

• Has initiated treatment with an antidepressant in past 14 days. Once patients have been on a stable dose for 14 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: David C Mohr, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT02841787
• Other Study ID Numbers: P20MH090318-FT; P20MH090318; NCT01912664
• First Posted: Jul 22, 2016
• Last Update Posted: Oct 29, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University: Depression; Web-based intervention; Aging; Geriatrics; Social network; Older adults
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Individual Internet Intervention (III)	Internet Intervention With Peer Support (II+PS)	Waitlist Control (WLC)
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

Baseline Characteristics

Arm/Group Title	Individual Internet Intervention (III)	Internet Intervention With Peer Support (II+PS)	Waitlist Control (WLC)	Total
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 Participants	12	23	12	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (3.4)	69.5 (4.3)	70 (4.7)	69.6 (4.1)
Sex: Female, Male (Count of 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) (Count of Participants)
Hispanic or Latino	0 0%	1 4.3%	0 0%	1 2.1%
Not Hispanic or Latino	12 100%	22 95.7%	12 100%	46 97.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	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%	3 6.4%
Unknown or Not Reported	0 0%	1 4.3%	0 0%	1 2.1%
Annual gross household income (x1000) (USD) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [USD]	37.5	37	50	41
Marital Status (Count of 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 (Count of Participants)
Some High School	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%	5 21.7%	2 16.7%	7 14.9%
4-yr College (Bachelor's)	3 25%	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%	2 8.7%	2 16.7%	7 14.9%
Employment Status (Count of Participants)
Employed	3 25%	4 17.4%	3 25%	10 21.3%
Retired	9 75%	18 78.3%	7 58.3%	34 72.3%
Unemployed/Disability	0 0%	1 4.3%	2 16.7%	3 6.4%
Health Insurance (Count of Participants)
Insured	12 100%	22 95.7%	12 100%	46 97.9%
Medicare	10 83.3%	19 82.6%	11 91.7%	40 85.1%
Medicaid	1 8.3%	3 13%	0 0%	4 8.5%
Taking antidepressant medication (Count of 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%

Outcome Measures

1. Primary Outcome

Title	Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individual Internet Intervention (III)	Internet Intervention With Peer Support (II+PS)	Waitlist Control (WLC)
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.
Measure Participants	9	19	12
Mean (Standard Deviation) [units on a scale]	-5.4 (2.4)	-4.8 (4.4)	-1.1 (4.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individual Internet Intervention (III)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Internet Intervention With Peer Support (II+PS)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Waitlist Control (WLC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS), Waitlist Control (WLC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	The threshold for significance was alpha=0.05.
	Method	ANOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Individual Internet Intervention (III), Waitlist Control (WLC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Internet Intervention With Peer Support (II+PS), Waitlist Control (WLC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Mean Number of Sessions Across the 8-week Trial
Time Frame	8 weeks

Outcome Measure Data

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)
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.
Measure Participants	11	23
Mean (Standard Deviation) [number of sessions]	45.6 (24.9)	49.1 (35.8)

3. Primary Outcome

Title	System Usability Scale (SUS)
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

Outcome Measure Data

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)
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.
Measure Participants	9	21
Mean (Standard Deviation) [units on a scale]	68.75 (16.09)	60.5 (16.69)

4. Primary Outcome

Title	Average Coaching Time Per Participant by Group
Description	The average time spent on messages and calls and on group moderation.
Time Frame	8 weeks

Outcome Measure Data

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)
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.
Measure Participants	9	19
Mean (Standard Deviation) [Minutes]	134.33 (28.43)	92.43 (32.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individual Internet Intervention (III), Internet Intervention With Peer Support (II+PS)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	The threshold for significance was alpha=0.05.
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	8 months (January 2016 through September 2016)
Arm/Group Title	Individual Internet Intervention (III)		Internet Intervention With Peer Support (II+PS)		Waitlist Control (WLC)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/23 (0%)		0/12 (0%)
Serious Adverse Events
	Individual Internet Intervention (III)		Internet Intervention With Peer Support (II+PS)		Waitlist Control (WLC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/23 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Individual Internet Intervention (III)		Internet Intervention With Peer Support (II+PS)		Waitlist Control (WLC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/23 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.