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

• 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: Northwestern University
• Information provided by (Responsible Party): David Mohr, Northwestern University

Tracking Information

• First Submitted Date: July 20, 2016
• First Posted Date: July 22, 2016
• Results First Submitted Date: July 7, 2017
• Results First Posted Date: October 29, 2018
• Last Update Posted Date: October 29, 2018
• Study Start Date: December 2015
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2018)

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

Original Primary Outcome Measures (submitted: July 20, 2016)

• Depression [ Time Frame: Baseline to end of treatment (8 weeks) ]
  Change in self-reported depressive symptom severity from baseline to end of treatment
• Adherence to the program [ Time Frame: Baseline to end of treatment (8 weeks) ]
  Number of times the program is accessed from start to last use from baseline to end of treatment

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Online Peer Networked Collaborative Learning for Managing Depressive Symptoms
• Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• 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

Study Arms

• 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.)

  Intervention: 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.)

  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2018): 47
• Original Estimated Enrollment (submitted: July 20, 2016): 50
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02841787
• Other Study ID Numbers: P20MH090318-FT; P20MH090318 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: David Mohr, Northwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Northwestern University
• Verification Date: February 2018