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Tracking Depression Symptoms With a Health Chatbot

Primary Purpose

Depression, Postpartum, Depression, Unipolar

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chatbot Intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago
  • NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Usual Care Group

Chabot Care Group

Provider Subject Cohort

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in Side-effect Burden
Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire
Change in Maternal Function
Measured by the Barkin Index of Maternal Functioning
Change in Maternal Confidence
Measured by Maternal Confidence Questionnaire
Medication Adherence
Measured by 1-item medication adherence questionnaire

Full Information

First Posted
March 13, 2019
Last Updated
April 19, 2022
Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT03990389
Brief Title
Tracking Depression Symptoms With a Health Chatbot
Official Title
Automated Symptom Tracking for Measurement-Based Care of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Depression, Unipolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Chabot Care Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Provider Subject Cohort
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Chatbot Intervention
Intervention Description
a chatbot will be used to monitor depression severity
Primary Outcome Measure Information:
Title
Longitudinal Change in Depression Severity
Description
Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Depression Severity
Description
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
Time Frame
3 months
Title
Change in Side-effect Burden
Description
Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire
Time Frame
3 months
Title
Change in Maternal Function
Description
Measured by the Barkin Index of Maternal Functioning
Time Frame
3 months
Title
Change in Maternal Confidence
Description
Measured by Maternal Confidence Questionnaire
Time Frame
3 months
Title
Medication Adherence
Description
Measured by 1-item medication adherence questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tracking Depression Symptoms With a Health Chatbot

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