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

Study Overview
=================
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.

Official Title
-----------------
Technology Assisted Intervention for the Treatment and Prevention of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Mobilyze!


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobilyze!<br> | Behavioral: Mobilyze!<br>* Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, as assessed the Patient Health Questionnaire-9 |  | Baseline, Weeks 2-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Affect (PANAS - Positive Affect Scale) |  | Baseline, Weeks 2-6 | 
| Anxiety (GAD-7) |  | Baseline, Weeks 2-6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Technology Assisted, Mobile Phone