Outreach to Reduce Depression Disparities

Sponsor
Kaiser Permanente (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05580406
Collaborator
Henry Ford Health System (Other)
400
2
13

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Outreach messaging
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Outreach to Reduce Depression Disparities
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Initiation of formal depression treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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)

  • 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 EHR patient portal

  • Previously requested to not be contacted for research

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kaiser Permanente
  • Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT05580406
Other Study ID Numbers:
  • 12874
First Posted:
Oct 14, 2022
Last Update Posted:
Oct 14, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2022