Study of Mobile Phone Sensing and Outreach to Assist an Internet-based Behavioral Intervention for Depression (Mobilyze!)
This study will evaluate an intervention that uses multiple methods of communication to provide care for depression. The intervention, referred to as Mobilyze!, is delivered via a mobile phone, interactive website, and e-mail, and aims to help individuals with depression. The purpose of this study is to obtain preliminary information on the feasibility and effectiveness of Mobilyze! in improving symptoms of depression.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mobile Phone Sensing and Outreach as Adjuncts to Internet-based Behavioral Intervention for Depression|
- Depression, as assessed by Quick Inventory of Depressive Symptoms, the Patient Health Questionnaire-9 and the Mini-International Neuropsychiatric Interview Major Depressive Disorders Module [ Time Frame: Measured at baseline, 4, and 8 weeks ] [ Designated as safety issue: Yes ]
- Utilization - Adherence markers for the mobile phone (eg - number of responses to prompts for information) the website. [ Time Frame: Measured from baseline to 8 weeks ] [ Designated as safety issue: No ]
- Positive Affect (PANAS - Positive Affect Scale) [ Time Frame: Baseline, 4, and 8 weeks ] [ Designated as safety issue: No ]
- Anxiety (GAD-7) [ Time Frame: Baseline, 4, and 8 weeks ] [ Designated as safety issue: No ]
- Health-Related Quality of Life (SF-12) [ Time Frame: Baseline, 4, and 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.
Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the population experiencing the disorder in a given 12-month period. Symptoms of MDD include feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; excessive irritability and restlessness; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Fortunately, MDD is treatable with forms of psychotherapy and/or antidepressant medications. Several studies have found that when given a choice, about two-thirds of patients with depression prefer psychotherapy treatment over antidepressant medication. Although psychotherapy treatments are both effective and desirable, a variety of barriers exist to initiating and sustaining psychotherapy. Only about 20% of all patients referred for psychotherapy treatments ever follow up. Of those who do initiate psychotherapy, nearly half drop out before completing treatment.
We are developing an intervention that utilizes telecommunications technologies to overcome these barriers and to insert care for depression into the person's life. The intervention, referred to as Mobilyze!, uses a mobile phone and sensing system, interactive website, and e-mail. This pilot study will administer this intervention to a small group of persons with MDD, to examine whether Mobilyze! is feasible and effective. We will also gather participant feedback to determine areas of potential improvement.
Participation in the study will last 8 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of online questionnaires about mood. Eligible participants will receive 8 weeks of access to the Web-based Internet intervention, which consists of lessons and tools to help them learn skills to manage their moods. Participants will be asked to access the Web site every day to complete the modules and to practice using the tools. Participants will also receive temporary use of a mobile phone to help them practice the skills they are learning. It is suggested that participants utilize the mobile phone tools every day. Participants will also receive a 5-10 minute weekly telephone-based motivational intervention from a coach and will be able to communicate with the coach via email throughout the 8 weeks of study participation. Participants will undergo repeat assessments at Weeks 2, 4, and 8 of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107041
|Contact: Jenna Duffecy, Ph.D.||email@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Jenna Duffecy, Ph.D. 312-503-1900 firstname.lastname@example.org|
|Contact: Marya Corden, MPH 3125031849 email@example.com|
|Principal Investigator:||David C Mohr, Ph.D.||Northwestern University|