Evaluating Technology Enabled Services in Perinatal Depression

February 6, 2024 updated by: Emily Miller, Northwestern University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Prentice Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: eTreatment as Usual
Current care plus access to a website that will provide content specific to perinatal depression
Other: COMPASS-Care
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
Experimental: Technology Enabled Service
Access to the Intellicare suite of digital mental health self-management tools and coaching
Behavioral: IntelliCare
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Continuous - Up to 12 weeks
Assessed by Patient Health Questionnaire-9
Continuous - Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Continuous - Up to 12 weeks
Assessed by General Anxiety Disorder - 7
Continuous - Up to 12 weeks
Satisfaction with care
Time Frame: Week 6, Week 12
Assessed by Satisfaction Index - Mental Health. Items measured on a 6-point scale (72 points for entire scale) where higher scores reflect higher satisfaction.
Week 6, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TWente Engagement with Ehealth Technologies Scale (TWEETS)
Time Frame: Week 6, Week 12
Technology engagement, usability, usefulness, and satisfaction. Items measured on 5-point scale where higher scores indicate better outcomes
Week 6, Week 12
Execution of Stepped Care
Time Frame: through study completion, an average of 12 weeks.
Proportion of eligible women engaged in stepped care treatment
through study completion, an average of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Brown University

Investigators

  • Principal Investigator: David Mohr, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH119029-RP2-RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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