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Clinical Trials/NCT05525689
NCT05525689
Completed
Not Applicable

Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression

Northwestern University1 site in 1 country75 target enrollmentJune 16, 2022
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Northwestern University
Enrollment
75
Locations
1
Primary Endpoint
Depression
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.

Detailed Description

Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.

Registry
clinicaltrials.gov
Start Date
June 16, 2022
End Date
April 15, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Mohr

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • 18 years or older
  • Referred to Northwestern Medicine COMPASS program for mental health care
  • Currently pregnant or within 3 months of delivery
  • Moderate to severe perinatal depression (defined as a PHQ-9 screen greater than or equal to 10)
  • Owns a smartphone, has used smartphone in last 7 days

Exclusion Criteria

  • Experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index pregnancy)
  • Severe suicidality (as defined by the presence of a plan and intent to act on that plan)
  • Not meeting the inclusion criteria described above

Outcomes

Primary Outcomes

Depression

Time Frame: At 12 weeks

Assessed by Patient Health Questionnaire-9 Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

Secondary Outcomes

  • Anxiety(At 12 weeks)
  • Satisfaction Index - Mental Health(Week 6, Week 12)

Study Sites (1)

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