Study of Mobile Phone Sensing and Outreach to Assist an Internet-based Behavioral Intervention for Depression (Mobilyze!)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University
ClinicalTrials.gov Identifier:
NCT01107041
First received: April 19, 2010
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Mobilyze!
Phase 1

Study Type: Interventional
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

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
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)
Arms Assigned Interventions
Experimental: Mobilyze! Behavioral: Mobilyze!
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of MDD as assessed using the Mini-International Neuropsychiatric Interview plus a score of 11 or greater on the Quick Inventory of Depression Symptoms - Clinician Rated and a score of 10 or greater on the Patient Health Questionnaire-8
  • 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.
  • Is able to give informed consent.
  • Lives in the United States

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.
  • Meets criteria for dementia.
  • 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.).
  • Currently receiving psychotherapy or planning to receive psychotherapy during the 8 weeks of the study.
  • 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.
  • Has initiated treatment with an antidepressant in past 10 days or has an appointment with a physician or psychiatrist to change this dose.
  • Has a pre-existing mobile phone or wireless service carrier that prohibits transfer of the participant's existing mobile phone number, settings, and contact lists to the mobile phone provided for the study. As portability fluctuates with changes in the mobile phone service market, the particulars of this requirement are subject to change.
  • Minimal levels of knowledge and comfort with computer, internet, and/or mobile phone technologies, or does not regularly use computers, or has never had regular use of a mobile phone.
  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

Contacts
Contact: Jenna Duffecy, Ph.D. 312-503-1900 j-duffecy@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jenna Duffecy, Ph.D.    312-503-1900    jduffecy@hotmail.com   
Contact: Marya Corden, MPH    3125031849    m-corden@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David C Mohr, Ph.D. Northwestern University
  More Information

Additional Information:
No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Mohr, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01107041     History of Changes
Other Study ID Numbers: STU00021825
Study First Received: April 19, 2010
Last Updated: March 24, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northwestern University:
Major Depressive Disorder
Behavior Therapy
Technology Assisted
Internet
World Wide Web
Mobile Phone
Cellular Phone
Motivational Interviewing

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

ClinicalTrials.gov processed this record on September 30, 2014