Evaluating Technology Enabled Services in Perinatal Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05525689
• Other study ID #: MH119029-RP2-RCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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

Other:
• COMPASS-Care
Website with content specific to perinatal depression and standard EHR-based tools for patient communication

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TWente Engagement with Ehealth Technologies Scale (TWEETS)	Technology engagement, usability, usefulness, and satisfaction. Items measured on 5-point scale where higher scores indicate better outcomes	Week 6, Week 12
Other	Execution of Stepped Care	Proportion of eligible women engaged in stepped care treatment	through study completion, an average of 12 weeks.
Primary	Depression	Assessed by Patient Health Questionnaire-9	Continuous - Up to 12 weeks
Secondary	Anxiety	Assessed by General Anxiety Disorder - 7	Continuous - Up to 12 weeks
Secondary	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