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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

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


  2. Mean Number of Sessions Across the 8-week Trial [ Time Frame: 8 weeks ]
  3. 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.

  4. Average Coaching Time Per Participant by Group [ Time Frame: 8 weeks ]
    The average time spent on messages and calls and on group moderation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841787


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: David C Mohr, PhD Northwestern University
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Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02841787    
Obsolete Identifiers: NCT01912664
Other Study ID Numbers: P20MH090318-FT
P20MH090318 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2016    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by David Mohr, Northwestern University:
Depression
Web-based intervention
Aging
Geriatrics
Social network
Older adults
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders