Evaluating Technology Enabled Services in Perinatal Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: IntelliCare; Other: COMPASS-Care

• Registration Number: NCT05525689
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology Enabled Service	IntelliCare	Access to the Intellicare suite of digital mental health self-management tools and coaching
eTreatment as Usual	COMPASS-Care	Current care plus access to a website that will provide content specific to perinatal depression

Primary Outcome Measures

Name	Time	Method
Depression	Continuous - Up to 12 weeks	Assessed by Patient Health Questionnaire-9

Secondary Outcome Measures

Name	Time	Method
Anxiety	Continuous - Up to 12 weeks	Assessed by General Anxiety Disorder - 7
Satisfaction with care	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.

Trial Locations

Locations (1)

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States