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Evaluating Technology Enabled Services in Perinatal Depression

Not Applicable
Completed
Conditions
Depression
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.

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
Primary Outcome Measures
NameTimeMethod
DepressionAt 12 weeks

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.

Secondary Outcome Measures
NameTimeMethod
AnxietyAt 12 weeks

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

Satisfaction Index - Mental HealthWeek 6, Week 12

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.

Trial Locations

Locations (1)

Prentice Women's Hospital

🇺🇸

Chicago, Illinois, United States

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

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