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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCBT for late life depression
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Individual Internet Intervention (III)

Internet Intervention+Peer Supp.(II+PS)

Waitlist Control (WLC)

Arm Description

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.)

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.)

Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
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.
Mean Number of Sessions Across the 8-week Trial
System Usability Scale (SUS)
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.
Average Coaching Time Per Participant by Group
The average time spent on messages and calls and on group moderation.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2016
Last Updated
February 14, 2018
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02841787
Brief Title
Online Peer Networked Collaborative Learning for Managing Depressive Symptoms
Acronym
MoodTech
Official Title
Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Web-based intervention, Aging, Geriatrics, Social network, Older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Internet Intervention (III)
Arm Type
Experimental
Arm Description
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.)
Arm Title
Internet Intervention+Peer Supp.(II+PS)
Arm Type
Experimental
Arm Description
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.)
Arm Title
Waitlist Control (WLC)
Arm Type
No Intervention
Arm Description
Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period.
Intervention Type
Behavioral
Intervention Name(s)
iCBT for late life depression
Primary Outcome Measure Information:
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
Title
Mean Number of Sessions Across the 8-week Trial
Time Frame
8 weeks
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Mohr, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

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