Evaluating Technology Enabled Services in Perinatal Depression
- 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
- 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
- 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
Name Time Method Depression At 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
Name Time Method Anxiety At 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 AnxietySatisfaction Index - Mental Health Week 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