Tracking Depression Symptoms With a Health Chatbot

NCT ID: NCT03990389

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2020-02-29

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.

Conditions

Depression, Postpartum; Depression, Unipolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chabot Care Group

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.

Group Type: EXPERIMENTAL

Chatbot Intervention

Intervention Type: DEVICE

a chatbot will be used to monitor depression severity

Provider Subject Cohort

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chatbot Intervention

a chatbot will be used to monitor depression severity

Intervention Type: DEVICE

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Chicago

Chicago, Illinois, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB16-1802

Identifier Type: -

Identifier Source: org_study_id