Evaluating Technology Enabled Services in Perinatal Depression

Study Overview
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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.

Official Title
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Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: IntelliCare
* Other: COMPASS-Care


Participation Criteria
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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) Not meeting the inclusion criteria described above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology Enabled Service<br> | Behavioral: IntelliCare<br>* Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization<br>|
| Active Comparator: eTreatment as Usual<br>Current care plus access to a website that will provide content specific to perinatal depression | Other: COMPASS-Care<br>* Website with content specific to perinatal depression and standard EHR-based tools for patient communication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Assessed by Patient Health Questionnaire-9 | Continuous - Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Assessed by General Anxiety Disorder - 7 | Continuous - Up to 12 weeks | 
| Satisfaction with care | Assessed by Satisfaction Index - Mental Health. Items measured on a 6-point scale (72 points for entire scale) where higher scores reflect higher satisfaction. | Week 6, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal