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
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: iCBT for late life depression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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.
|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||David C Mohr, PhD||Northwestern University|
|Responsible Party:||David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University|
|Other Study ID Numbers:||
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|