Outcomes in MEasurement-Based Treatment

Study Overview
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Brief Summary
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The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.

Official Title
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Clinical Outcomes in MEasurement-Based Treatment (COMET)

Conditions
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Depressive Disorder, Major

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Diagnosis of major depressive disorder Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days Primary depression management is performed by the primary care provider Capable of self-management (i.e., taking medications and independently responding to follow-up contacts) Able to provide informed consent to participate Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English Exclusion Criteria: History psychotic disorder or bipolar disorder Diagnosis of current postpartum depression Diagnosis of bereavement less than 8 weeks duration Currently pregnant History of suicide attempts or current suicide plan Need for psychiatric hospitalization at enrollment visit History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at the intervention sites<br>The intervention sites will receive the results of the patient-reported depression severity collected during the phone interviews on a monthly basis. The patients in the intervention arm will be interviewed by phone once per month for 6 months. | |
| Patients at the usual care sites<br>The usual care sites will receive the results of the patient-reported depression severity at the end of the study. Patients in the usual care arm will be interviewed at 3 months and 6 months post study enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument |  | Measured at baseline | 
| Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument |  | Follow-up upto 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate assessed by the PHQ-9 instrument |  | 6 months | 
| The medication prescribed including refills, dose titrations, switching and augmentation |  | 6 months | 
| Health care utilizations including office visits, emergency room visits and hospitalization |  | 6 months |