Outreach to Reduce Depression Disparities

April 10, 2026 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kaiser Permanente, Hawaii Market
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
Experimental: Outreach Messaging
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Initiation of Formal Depression Treatment
Time Frame: within 60 days of randomization
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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