Evaluating Technology Enabled Services in Perinatal Depression
Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Prentice Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: eTreatment as Usual
Current care plus access to a website that will provide content specific to perinatal depression
|
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|
Experimental: Technology Enabled Service
Access to the Intellicare suite of digital mental health self-management tools and coaching
|
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: 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. |
At 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: 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 Anxiety |
At 12 weeks
|
|
Satisfaction Index - Mental Health
Time Frame: 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. |
Week 6, Week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TWente Engagement With Ehealth Technologies Scale (TWEETS)
Time Frame: Week 6, Week 12
|
The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS 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. |
Week 6, Week 12
|
|
Execution of Stepped Care
Time Frame: Up to 12 weeks
|
Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 >=10))
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Mohr, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH119029-RP2-RCT
- 5P50MH119029-04 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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