Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression

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: NCT01107041
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Mobilyze! Not Applicable

Detailed Description:
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. Participants will include people who are high on depression, high on anxiety, hight on both depression and anxiety, and health controls. Particpants will load software on their phones that collects phone sensor data, and obtains self report on sleep, mood, and social contacts. Data will be collected for at least 6 weeks.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2010 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is collecting phone sensor data and ecological momentary assessment data to try to develop algorithms that can passively detect behavioral patterns in participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Mobilyze! Behavioral: Mobilyze!
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Depression, as assessed the Patient Health Questionnaire-9 [ Time Frame: Baseline, Weeks 2-6 ]

Secondary Outcome Measures :
  1. Positive Affect (PANAS - Positive Affect Scale) [ Time Frame: Baseline, Weeks 2-6 ]
  2. Anxiety (GAD-7) [ Time Frame: Baseline, Weeks 2-6 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PHQ-9 score 10 or higher
  • Has an e-mail account, computer, and broadband access to the Internet
  • Familiarity with mobile phones and is within a cellular network range the majority of the day.
  • Is able to speak and read English.
  • Is at least 19 years of age.

Exclusion Criteria:

  • Hearing or voice impairment preventing participation in psychotherapy.
  • Visual impairment that would prevent use of the website, mobile phone application, and assessment materials.
  • Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.).
  • Planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation.
  • Exhibits severe suicidality, including ideation, plan, and intent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01107041


Locations
Layout table for location information
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01107041    
Other Study ID Numbers: P20MH090318 STU00021825
P20MH090318 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: October 2015
Keywords provided by David Mohr, Northwestern University:
Depression
Technology Assisted
Mobile Phone
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders