Back to resultsMobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilyze!
Sponsored by
About this trial
This is an interventional other trial for Depression focused on measuring Depression, Technology Assisted, Mobile Phone
Eligibility 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.
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobilyze!
Arm Description
Outcomes
Primary Outcome Measures
Depression, as assessed the Patient Health Questionnaire-9
Secondary Outcome Measures
Positive Affect (PANAS - Positive Affect Scale)
Anxiety (GAD-7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01107041
Brief Title
Mobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression
Official Title
Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Technology Assisted, Mobile Phone
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
2010 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobilyze!
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mobilyze!
Intervention Description
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.
Primary Outcome Measure Information:
Title
Depression, as assessed the Patient Health Questionnaire-9
Time Frame
Baseline, Weeks 2-6
Secondary Outcome Measure Information:
Title
Positive Affect (PANAS - Positive Affect Scale)
Time Frame
Baseline, Weeks 2-6
Title
Anxiety (GAD-7)
Time Frame
Baseline, Weeks 2-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21840837
Citation
Burns MN, Begale M, Duffecy J, Gergle D, Karr CJ, Giangrande E, Mohr DC. Harnessing context sensing to develop a mobile intervention for depression. J Med Internet Res. 2011 Aug 12;13(3):e55. doi: 10.2196/jmir.1838.
Results Reference
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
MedlinePlus
URL
http://www.nlm.nih.gov/medlineplus/depression.html
Description
Depression at MedlinePlus Site
URL
http://www.nlm.nih.gov/medlineplus/mentalhealth.html
Description
Mental Health at MedlinePlus Site
Learn more about this trial
Mobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression
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