Clinical trial NCT03990389: Tracking Depression Symptoms With a Health Chatbot
Official title: Automated Symptom Tracking for Measurement-Based Care of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Depression, Unipolar
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Endeavor Health
First posted: 2019-06-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Longitudinal Change in Depression Severity
timeFrame: 3 months
Secondary outcomes:
measure: Change in Depression Severity
timeFrame: 3 months
measure: Change in Side-effect Burden
timeFrame: 3 months
measure: Change in Maternal Function
timeFrame: 3 months
measure: Change in Maternal Confidence
timeFrame: 3 months
measure: Medication Adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
References: