Skip to main content
Clinical Trials/NCT05580406
NCT05580406CompletedNot Applicable

Outreach to Reduce Depression Disparities

Kaiser Permanente4 sites in 1 country309 target enrollmentStarted: April 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
309
Locations
4
Primary Endpoint
Initiation of formal depression treatment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Outreach messaging (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Outreach to Reduce Depression Disparities | Clinical Trial