Evaluating Technology Enabled Services in Perinatal Depression

NCT05525689 | Completed Results DMC

• 2 other identifiers: MH119029-RP2-RCT5P50MH119029-04
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Perinatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety

  At 12 weeks

• Satisfaction Index - Mental Health

  Week 6, Week 12

Other Outcomes (2)

• TWente Engagement With Ehealth Technologies Scale (TWEETS)

  Week 6, Week 12

• Execution of Stepped Care

  Up to 12 weeks

Study Arms (2)

Technology Enabled Service

EXPERIMENTAL

Access to the Intellicare suite of digital mental health self-management tools and coaching

Behavioral: IntelliCare

eTreatment as Usual

ACTIVE COMPARATOR

Current care plus access to a website that will provide content specific to perinatal depression

Other: COMPASS-Care

Interventions

IntelliCare BEHAVIORAL

Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization

Technology Enabled Service

COMPASS-Care OTHER

Website with content specific to perinatal depression and standard EHR-based tools for patient communication

eTreatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• Brown University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. David Mohr
• Organization: Northwestern University

d-mohr@northwestern.edu

312-503-1403

Study Officials

• David Mohr

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 1, 2022
• Study Start: June 16, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-09

Locations

US (1)