Outreach to Reduce Depression Disparities

NCT05580406 | Completed Results DMC

• 1 other identifier: 12874
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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

Study Arms (2)

Usual Care

NO INTERVENTION

Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.

Outreach Messaging

EXPERIMENTAL

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

Interventions

Outreach messaging BEHAVIORAL

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.

Outreach Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Henry Ford Health System: collaborator

Study Sites (2)

Kaiser Permanente, Hawaii Market

Honolulu, Hawaii, 96817, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Vanessa Simiola
• Organization: Kaiser Permanente, Center for Integrated Health Care Research

vanessa.l.simiola@kp.org

808-432-7777

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: April 13, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)