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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01107041

Collaborator

(none)

2,010

Enrollment

Location

Arm

Duration (Months)

105.8

Patients Per Site Per Month

Study Details

Study Description

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!	N/A

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

Study Type:

Interventional

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 participantsThis 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 :

Dec 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mobilyze!

Behavioral: Mobilyze!

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

Outcome Measures

Primary Outcome Measures

Depression, as assessed the Patient Health Questionnaire-9 [Baseline, Weeks 2-6]

Secondary Outcome Measures

Positive Affect (PANAS - Positive Affect Scale) [Baseline, Weeks 2-6]
Anxiety (GAD-7) [Baseline, Weeks 2-6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

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

First Posted:

Apr 20, 2010

Last Update Posted:

Mar 24, 2017

Last Verified:

Oct 1, 2015

Keywords provided by David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University

Depression

Technology Assisted

Mobile Phone

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Mar 24, 2017