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Evaluating Technology Enabled Services in Perinatal Depression

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare
COMPASS-Care
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Perinatal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prentice Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technology Enabled Service

eTreatment as Usual

Arm Description

Current care plus access to a website that will provide content specific to perinatal depression

Outcomes

Primary Outcome Measures

Depression
Assessed by Patient Health Questionnaire-9

Secondary Outcome Measures

Anxiety
Assessed by General Anxiety Disorder - 7
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.

Full Information

First Posted
August 8, 2022
Last Updated
June 26, 2023
Sponsor
Northwestern University
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05525689
Brief Title
Evaluating Technology Enabled Services in Perinatal Depression
Official Title
Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Perinatal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology Enabled Service
Arm Type
Experimental
Arm Title
eTreatment as Usual
Arm Type
Active Comparator
Arm Description
Current care plus access to a website that will provide content specific to perinatal depression
Intervention Type
Behavioral
Intervention Name(s)
IntelliCare
Intervention Description
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
Intervention Type
Other
Intervention Name(s)
COMPASS-Care
Intervention Description
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
Primary Outcome Measure Information:
Title
Depression
Description
Assessed by Patient Health Questionnaire-9
Time Frame
Continuous - Up to 12 weeks
Secondary Outcome Measure Information:
Title
Anxiety
Description
Assessed by General Anxiety Disorder - 7
Time Frame
Continuous - Up to 12 weeks
Title
Satisfaction with care
Description
Assessed by Satisfaction Index - Mental Health. Items measured on a 6-point scale (72 points for entire scale) where higher scores reflect higher satisfaction.
Time Frame
Week 6, Week 12
Other Pre-specified Outcome Measures:
Title
TWente Engagement with Ehealth Technologies Scale (TWEETS)
Description
Technology engagement, usability, usefulness, and satisfaction. Items measured on 5-point scale where higher scores indicate better outcomes
Time Frame
Week 6, Week 12
Title
Execution of Stepped Care
Description
Proportion of eligible women engaged in stepped care treatment
Time Frame
through study completion, an average of 12 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David C Mohr, PhD
Phone
312-503-1403
Email
d-mohr@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily S Miller, MD
Phone
312-472-4645
Email
emily-miller-1@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mohr
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Santiago, MA
Email
joshua.santiago@northwestern.edu

12. IPD Sharing Statement

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Evaluating Technology Enabled Services in Perinatal Depression

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