Prentice Women's Hospital
Chicago, Illinois, 60611, United States
NCT Number: NCT05525689
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization
Website with content specific to perinatal depression and standard EHR-based tools for patient communication
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.
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
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.
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.
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))
Northwestern University
Other
Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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