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

Technology Assisted Intervention for the Treatment and Prevention of Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: iCBT for late life depression

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8 - Difference in PHQ-9 score
Mean Number of Sessions Across the 8-week Trial		8 weeks
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.	Week 8
Average Coaching Time Per Participant by Group	The average time spent on messages and calls and on group moderation.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Web-based intervention; Aging; Older adults; Social network; Geriatrics
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: P20MH090318-FT; P20MH090318 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED