Major Depressive Disordere-MBCNCT01583998
Electronic-Measurement Based Care for Major Depressive Disorder
A study testing e-MBC in people with Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT Southwestern MyChart personal health record is feasible, associated with patient and health care team satisfaction, and improves treatment outcomes compared to a standard treatment model. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- e-MBC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 interview.
- Current substance abuse or dependence
- Patients with current suicidal ideation
- Patients with general medical conditions that contraindicate antidepressant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Electronic-Measurement Based Care (e-MBC) for Major Depressive Disorder (MDD)
The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT Southwestern MyChart personal health record is feasible, associated with patient and health care team satisfaction, and improves treatment outcomes compared to a standard treatment model. The project will be conducted in the Simmons Cancer Center Clinic at the University of Texas Southwestern Medical Center, Dallas as a collaborative effort between the Departments of Psychiatry, Oncology, and Family and Community Medicine. The primary patient population will include adults with significant depression and/or starting an antidepressant treatment and/or experiencing a treatment change. The study will compare two groups, an e-MBC group and an office-based standard care MBC group. Study staff will explain the study to the patients, specifically explaining that study participants will receive either office-based MBC or e-MBC. Eligible participants must be willing to receive either form of treatment monitoring. Participating patients will be randomly assigned to receive either e-MBC or office-based MBC. In the e-MBC group once a month the study nurse will send a prompt from the participating patients treating physician requesting the patient to use the MyChart system to fill-out the MBC scales. Beyond these monthly assessments, patients will be encouraged to utilize the MyChart MBC assessments (e-MBC) at any time to communicate with their physician. Patients experiencing difficulties using the e-MBC system will be given additional instruction by the study nurse. Patients and physicians will be trained in the use of the eMBC system. In the office-based MBC group the study nurse will schedule monthly treatment visits and request the patient call as needed to report symptoms. The evaluation period will be 6 months.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- e-MBC
- Keywords
- Major Depressive Disorder, MDD, Depression, Measurement Based Care, MBC, electronic health records, EHR, electronic medical records, EMR
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-MBCBehavioural
Also called e-MBC for MDD
antidepressant treatment
| Study group | Role | What they receive |
|---|---|---|
| e-MBC | Active comparator | Patients will receive e-MBC Receives: Behavioral: e-MBC |
| Treatment as Usual Control | No intervention | Patients receive standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
Depression severity assessment
Measured: Every 30 days for 6 months
Secondary outcomes (4)
Frequency, Intensity, and Burden of Side Effect Rating (FIBSER)
Antidepressant side effects
Measured: Every 30 days for 6 months
Patient Satisfaction Questionnaire (PSQ)
Assesses satisfaction with care
Measured: At the end of study treament (6 months from the first assessment)
Physician Evaluation of Ease of Use Survey (EEUS)
Physicians' perception of the ease of use of the e-MBC system
Measured: At the end of study treament (6 months from the first assessment)
Physician Evaluation of Usefulness Survey (EUS)
Physicians' perception of the usefulness of the e-MBC system
Measured: At the end of study treament (6 months from the first assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: UTSW Family Medicine refused to comply with agreement to implement study after department head left university. Attempts to implement elsewhere failed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Morris, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583998
- Sponsor's protocol ID
- 1R03MH092509-01
- Acronym
- e-MBC
- Status last verified
- Feb 2019
- First submitted
- 19 Apr 2012
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic-Measurement Based Care (e-MBC) for Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT01583998
- Acronym / sponsor ID
- e-MBC / 1R03MH092509-01
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, Depression, Measurement Based Care, MBC, electronic health records, EHR, electronic medical records
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: UTSW Family Medicine refused to comply with agreement to implement study after department head left university. Attempts to implement elsewhere failed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT Southwestern MyChart personal health record is feasible, associated with patient and health care team satisfaction, and improves treatment outcomes compared to a standard treatment model. The project will be conducted in the Simmons Cancer Center Clinic at the University of Texas Southwestern Medical Center, Dallas as a collaborative effort between the Departments of Psychiatry, Oncology, and Family and Community Medicine. The primary patient population will include adults with significant depression and/or starting an antidepressant treatment and/or experiencing a treatment change. The study will compare two groups, an e-MBC group and an office-based standard care MBC group. Study staff will explain the study to the patients, specifically explaining that study participants will receive either office-based MBC or e-MBC. Eligible participants must be willing to receive either form of treatment monitoring. Participating patients will be randomly assigned to receive either e-MBC or office-based MBC. In the e-MBC group once a month the study nurse will send a prompt from the participating patients treating physician requesting the patient to use the MyChart system to fill-out the MBC scales. Beyond these monthly assessments, patients will be encouraged to utilize the MyChart MBC assessments (e-MBC) at any time to communicate with their physician. Patients experiencing difficulties using the e-MBC system will be given additional instruction by the study nurse. Patients and physicians will be trained in the use of the eMBC system. In the office-based MBC group the study nurse will schedule monthly treatment visits and request the patient call as needed to report symptoms. The evaluation period will be 6 months.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-MBC | Active comparator | Behavioral: e-MBCPatients will receive e-MBC |
| Treatment as Usual Control | No intervention | –Patients receive standard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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 interview.
- Current substance abuse or dependence
- Patients with current suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-MBCAlso: e-MBC for MDDantidepressant treatment | Behavioural | e-MBC |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Every 30 days for 6 months
Depression severity assessment
4 secondary outcomes
Frequency, Intensity, and Burden of Side Effect Rating (FIBSER)
Time frame: Every 30 days for 6 months
Patient Satisfaction Questionnaire (PSQ)
Time frame: At the end of study treament (6 months from the first assessment)
Physician Evaluation of Ease of Use Survey (EEUS)
Time frame: At the end of study treament (6 months from the first assessment)
Physician Evaluation of Usefulness Survey (EUS)
Time frame: At the end of study treament (6 months from the first assessment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Related trials for Major Depressive Disorder
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-MBC in people with Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Every 30 days for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.