Tracking Depression Symptoms With a Health Chatbot

NCT03990389 | Completed Results FDA Device

• 1 other identifier: IRB16-1802
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators have developed a chatbot which will assist in performing measurement-based care (MBC) via Facebook Messenger. Participants will be randomized to either Usual Care or Usual Care with additional Chatbot Care.

Conditions

Depression, Postpartum; Depression, Unipolar

Outcome Measures

Primary Outcomes (1)

• Longitudinal Change in Depression Severity

  Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score

  3 months

Secondary Outcomes (5)

• Change in Depression Severity

  3 months

• Change in Side-effect Burden

  3 months

• Change in Maternal Function

  3 months

• Change in Maternal Confidence

  3 months

• Medication Adherence

  3 months

Study Arms (3)

Usual Care Group

NO INTERVENTION

Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions. Eligible subjects randomized to usual care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning. All participants will be asked to participate in a semi-structured debrief interview upon study completion.

Chabot Care Group

EXPERIMENTAL

Subjects will undergo screening including REALM-R and EPDS and a few additional questions. Eligible subjects randomized to chatbot care will receive monthly reminder phone calls from a research coordinator. Subjects will receive an email with a link to surveys for the purpose of collecting information on depression severity, medication adherence, self-efficacy, side-effect burden, and maternal functioning. In addition to the above procedures, eligible subjects randomized to chatbot care will receive weekly messages from the chatbot asking them to complete a depression severity measure and side-effect burden assessments. Within week 1 subjects will receive a check-in call from a study coordinator to answer any questions regarding use of the chatbot. All participants will be asked to participate in a semi-structured debrief interview upon study completion.

Device: Chatbot Intervention

Provider Subject Cohort

NO INTERVENTION

20 provider subjects from each study site will be enrolled to ensure they understand the study and consent to have their patients enrolled in the study

Interventions

Chatbot Intervention DEVICE

a chatbot will be used to monitor depression severity

Chabot Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.
• Patient Subject Cohort:
• Age ≥ 18 years and able to and demonstrate English reading literacy of at least 8th-grade level (REALM-R ≥ 6)
• Postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (EPDS ≥ 12)
• Willing to participate and able to give written informed consent
• Must own a smart phone with a data plan
• Must have a Facebook account and Facebook Messaging app on phone (or willing to create account/download app today)
• Sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance

You may not qualify if:

• Provider Subject Cohort: None
• Patient Subject Cohort:
• Subjects with documented dysthymia or Axis II diagnoses
• Subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation
• Active suicidality as determined by clinician
• Non-English speakers

Sponsors & Collaborators

• University of Chicago: lead
• Endeavor Health: collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depressive Disorder

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. David Beiser
• Organization: The University of Chicago

dbeiser@medicine.bsd.uchicago.edu

773-702-0307

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: June 19, 2019
• Study Start: February 20, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: May 12, 2022
• Results First Posted: May 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)