Outreach to Reduce Depression Disparities

NCT ID: NCT05580406

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2024-12-10

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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Outreach messaging

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaiser Permanente, Hawaii Market

Honolulu, Hawaii, United States

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

Other Identifiers

12874

Identifier Type: -

Identifier Source: org_study_id