Evaluating Technology Enabled Services in Perinatal Depression

Northwestern University75 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

IntelliCareBEHAVIORAL

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

COMPASS-CareOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prentice Women's Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: At 12 weeks

Secondary Outcomes

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

Time frame: 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.

Time frame: Week 6, Week 12

Data from ClinicalTrials.gov

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