Tracking Depression Symptoms With a Health Chatbot

Depression, Postpartum Clinical Trial

Official title:

Automated Symptom Tracking for Measurement-Based Care of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990389
• Other study ID #: IRB16-1802
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators will be looking specifically at depressed women soon after they give birth, otherwise known as known as perinatal depression. Measurement-based care (MBC) which involves the use of quantitative assessments for depression screening, diagnosis, and symptom monitoring is recognized as one of the keys to depression management. MBC can be difficult to implement within the clinical setting due to the administrative overhead and close follow-up required. It is reasonable to hypothesize that low rates of MBC adoption are responsible for low rates of adequate depression care.

The investigators have developed an automated conversational agent or "chatbot" (CB) for delivering MBC via Facebook Messenger. The investigators hypothesize that the use of CB-MBC, which combines a conversational interface with state-of-the-art quantitative assessments, will improve depression symptom severity for patients with perinatal depression. If successful, this project will provide primary care physicians with a new and inexpensive method for delivering better and safer care to their patients with depression. This study works to determine the impact of the chatbot in improving depression outcomes for patients under treatment for perinatal depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.

• Patient Subject Cohort:

1. Age = 18 years and able to and demonstrate English reading literacy of at least 8th-grade level (REALM-R = 6)

2. Postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (EPDS = 12)

3. Willing to participate and able to give written informed consent

4. Must own a smart phone with a data plan

5. Must have a Facebook account and Facebook Messaging app on phone (or willing to create account/download app today)

6. Sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance

Exclusion Criteria:

• Provider Subject Cohort: None

• Patient Subject Cohort:

1. Subjects with documented dysthymia or Axis II diagnoses

2. Subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation

3. Active suicidality as determined by clinician

4. Non-English speakers

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depression, Unipolar
• Depressive Disorder

Intervention

Device:
• Chatbot Intervention
a chatbot will be used to monitor depression severity

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	NorthShore University HealthSystem	Skokie	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Depression Severity	Measured by the Computerized Adaptive Test-Depression Inventory (CAT-DI) and calculated change in Edinburgh Postnatal Depression Scale (EPDS) between Baseline and 3 months.; Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score	3 months
Secondary	Change in Side-effect Burden	Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire	3 months
Secondary	Change in Maternal Function	Measured by the Barkin Index of Maternal Functioning	3 months
Secondary	Change in Maternal Confidence	Measured by Maternal Confidence Questionnaire	3 months
Secondary	Medication Adherence	Measured by 1-item medication adherence questionnaire	3 months