Study of Mobile Phone Sensing and Outreach to Assist an Internet-based Behavioral Intervention for Depression (Mobilyze!)
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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 |
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (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 |
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| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| 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: | August 20, 2012 |
| 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 May 23, 2013