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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University
ClinicalTrials.gov Identifier:
NCT01107041
First received: April 19, 2010
Last updated: March 21, 2016
Last verified: October 2015
  Purpose
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.

Condition Intervention
Depression
Behavioral: Mobilyze!

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Depression, as assessed the Patient Health Questionnaire-9 [ Time Frame: Baseline, Weeks 2-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive Affect (PANAS - Positive Affect Scale) [ Time Frame: Baseline, Weeks 2-6 ] [ Designated as safety issue: No ]
  • Anxiety (GAD-7) [ Time Frame: Baseline, Weeks 2-6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2014
Estimated Study Completion Date: July 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobilyze! Behavioral: Mobilyze!
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.

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.
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107041

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01107041     History of Changes
Other Study ID Numbers: P20MH090318 STU00021825 
Study First Received: April 19, 2010
Last Updated: March 21, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northwestern University:
Depression
Technology Assisted
Mobile Phone

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016