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OpenTrials
Completed

NCT Number: NCT03990389

Tracking Depression Symptoms With a Health Chatbot

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chatbot Intervention

Device

a chatbot will be used to monitor depression severity

Primary outcomes

  1. Longitudinal Change in Depression Severity

    Time frame: 3 months

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

Secondary outcomes

  1. Change in Depression Severity

    Time frame: 3 months

    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

  2. Change in Side-effect Burden

    Time frame: 3 months

    Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire

  3. Change in Maternal Function

    Time frame: 3 months

    Measured by the Barkin Index of Maternal Functioning

  4. Change in Maternal Confidence

    Time frame: 3 months

    Measured by Maternal Confidence Questionnaire

  5. Medication Adherence

    Time frame: 3 months

    Measured by 1-item medication adherence questionnaire

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Endeavor Health

Registry information

Official study title

Automated Symptom Tracking for Measurement-Based Care of Depression

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2019
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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