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Electronic-Measurement Based Care (e-MBC) for Major Depressive Disorder (MDD)

18 Years
65 Years
Open (Enrolling)
Major Depressive Disorder

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Trial Information

Electronic-Measurement Based Care (e-MBC) for Major Depressive Disorder (MDD)

Major Depressive Disorder (MDD) is a serious, debilitating illness that affects persons of
all ages, races, and socioeconomic backgrounds. Despite the availability of new and
effective treatments over the last 20 years, recent evidence continues to demonstrate high
rates of inadequate antidepressant medication treatment in practice settings. Practitioners
vary widely in how they assess treatment outcomes, including symptoms, function, side-effect
frequency and burden. In contrast to other chronic medical conditions such as diabetes
mellitus, back/neck problems, or hypertension, clinicians treating patients with depression
do not routinely evaluate measurement-based care (MBC) treatment parameters. MBC provides an
essential framework for physicians to approach depression treatment consistent with their
approach for other common disorders. MBC is an effective means to provide patient-centered
care for MDD, personalizing treatment decisions based on patient progress and their ability
to tolerate the medication.

A key barrier to patient adherence with MBC treatment is that the approach requires patients
to return to the clinic for several follow-up visits. The necessity of treatment visits
varies widely among patients. Thus far, physicians using MBC for the treatment of MDD do not
have a complete set of tools that are practical to use and allow treatment to be truly
personalized patient-centered care.

One solution to this problem is to use an enhanced electronic personal health record, such
as the MyChart system. This system could be easily modified to include the central elements
of MBC for depression to allow for the systematic assessment of a patient's depressive
symptom severity, antidepressant tolerability, and adherence to treatment in a timely
fashion. This information would be available to allow the physician to provide
patient-centered care by utilizing standardized assessment to personalize treatment for
depression. The proposed electronic-MBC (e-MBC) addresses a critical gap in depression
treatment by providing regularly-scheduled drug monitoring and continuity of care, in the
face of limited patient and clinic resources.

Information technology (IT) systems have been effectively integrated into the medical
treatment of patients but have yet to have substantial impact at the point-of-care. Applying
e-MBC methods allows physicians to utilize existing information technology systems to
improve depression treatment at the point-of-care. The key features of the proposed e-MBC
approach are that it can be seamlessly integrated into standard clinical practice, and
requires no additional IT knowledge or training to be effectively utilized by physicians and
clinical staff.

In this pilot study the investigators will compare standard treatment (office based
antidepressant management) to a group receiving scheduled electronic MBC assessments via an
enhanced personal health record system (e-MBC). To date, no one has published feasibility
studies evaluating the use of personal health records for measurement-based care of
depression patients.

Inclusion Criteria:

- Patients must plan to continue living in the clinic area throughout the study

- Patients must be 18 to 65 years of age

- Patients must give written informed consent

- Patient must have clinically significant depression and/or starting an antidepressant
treatment and/or experiencing a antidepressant treatment change

- Patients must be willing and able to use MyChart to communicate with their physician

Exclusion Criteria:

- Patients with a current Axis I diagnosis of Bipolar disorder or Schizophrenia

- Patients who cannot read and understand English since all research instruments are
not yet translated and validated in Spanish or other languages

- Patients whose clinical status requires inpatient treatment at the time of baseline

- Current substance abuse or dependence

- Patients with current suicidal ideation

- Patients with general medical conditions that contraindicate antidepressant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Health Questionnaire (PHQ-9)

Outcome Description:

Depression severity assessment

Outcome Time Frame:

Every 30 days for 6 months

Safety Issue:


Principal Investigator

David W. Morris, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Data and Safety Monitoring Board

Study ID:

1 R03 MH092509-01



Start Date:

June 2011

Completion Date:

July 2013

Related Keywords:

  • Major Depressive Disorder
  • Major Depressive Disorder
  • MDD
  • Depression
  • Measurement Based Care
  • MBC
  • electronic health records
  • EHR
  • electronic medical records
  • EMR
  • Depressive Disorder
  • Depression
  • Depressive Disorder, Major



The University of Texas Southwestern Medical CenterDallas, Texas  75390