Evaluating Technology Enabled Services in Perinatal Depression

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: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: IntelliCare; Other: COMPASS-Care

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	At 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Assessed by General Anxiety Disorder - 7 Scores range from 0-21. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety	At 12 weeks
Satisfaction Index - Mental Health	The Satisfaction Index - Mental Health measures satisfaction with mental health treatment. The measure includes 12 items, each rated on a 1-6 point likert scale (range of 6-72 points for total score) where higher scores reflect higher satisfaction. Scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups.	Week 6, Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TWente Engagement With Ehealth Technologies Scale (TWEETS)	The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups.	Week 6, Week 12
Execution of Stepped Care	Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 >=10))	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH); Brown University
• Investigators: Principal Investigator: David Mohr, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 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 (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Perinatal
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: MH119029-RP2-RCT; 5P50MH119029-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No