Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05525689
Other study ID # MH119029-RP2-RCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A