Outreach to Reduce Depression Disparities

Study Overview
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Brief Summary
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Previous research by Mental Health Research Network (MHRN) investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently address premature discontinuation of depression treatment. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white populations. Less is known about the acceptability and effectiveness of different communication modalities (online messaging, mailed letters, telephone) among racial and ethnic minority populations. Implementation of electronic-Health (eHealth) technologies must take care not to exacerbate health disparities. This clinical trial involves a pilot trial to evaluate a population-based outreach program to improve rates of depression treatment initiation among traditionally underserved racial and ethnic groups. This pilot work intends to inform a subsequent full-scale pragmatic trial to examine impact on health disparities.

Official Title
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Outreach to Reduce Depression Disparities

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Outreach messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New diagnosis of major depressive disorder or dysthymic disorder at a primary care visit (new defined as no depression diagnosis, psychotherapy visit or filled antidepressant prescription in the prior year) Continuously enrolled in the participating health system for 365 days prior to the eligible diagnosis (to assure capture of prior diagnoses or treatments) Patients Health Questionnaire-9 (PHQ-9) depression score of 10 or more within 14 days before to 7 days after the eligible diagnosis No filled prescription for any antidepressant medication OR psychotherapy visit attended within 30 days of the eligible diagnosis* No recorded PHQ-9 depression score less than 5 since the eligible diagnosis At least 18 years of age or older Exclusion Criteria: Diagnosis of schizophrenia or bipolar disorder in the prior 2 years Not registered to use Electronic Health Record (EHR) patient portal Previously requested to not be contacted for research

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff. | |
| Experimental: Outreach Messaging<br>Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone. | Behavioral: Outreach messaging<br>* Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of formal depression treatment | Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit. | within 60 days of randomization |