Evaluating Technology Enabled Services in Perinatal Depression

NCT ID: NCT05525689

Last Updated: 2025-09-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2024-04-15

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Technology Enabled Service

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

Group Type EXPERIMENTAL

IntelliCare

Intervention Type 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

eTreatment as Usual

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

Group Type ACTIVE_COMPARATOR

COMPASS-Care

Intervention Type OTHER

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

Interventions

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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

Intervention Type BEHAVIORAL

COMPASS-Care

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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David Mohr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Mohr

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Prentice Women's Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5P50MH119029-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH119029-RP2-RCT

Identifier Type: -

Identifier Source: org_study_id

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