Outreach to Reduce Depression Disparities

Depression Clinical Trial

Official title:

Outreach to Reduce Depression Disparities

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05580406
• Other study ID #: 12874
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health	Detroit	Michigan
United States	Kaiser Permanente, Hawaii Market	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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