NCT01107041

Brief Summary

Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,010

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
4.6 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 24, 2017

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

April 19, 2010

Last Update Submit

March 21, 2017

Conditions

Keywords

DepressionTechnology AssistedMobile Phone

Outcome Measures

Primary Outcomes (1)

  • Depression, as assessed the Patient Health Questionnaire-9

    Baseline, Weeks 2-6

Secondary Outcomes (2)

  • Positive Affect (PANAS - Positive Affect Scale)

    Baseline, Weeks 2-6

  • Anxiety (GAD-7)

    Baseline, Weeks 2-6

Study Arms (1)

Mobilyze!

EXPERIMENTAL
Behavioral: Mobilyze!

Interventions

Mobilyze!BEHAVIORAL

Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.

Mobilyze!

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

March 24, 2017

Record last verified: 2015-10

Locations