N/A
N=31
Tracking Depression Symptoms With a Health Chatbot
Depression, Postpartum · Depression, Unipolar
Bottom Line
View on ClinicalTrials.gov: NCT03990389 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Longitudinal Change in Depression Severity — 16.13; 14.06; 10.47; 10.69 score on a scale — p=0.0618
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chatbot Intervention (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Longitudinal Change in Depression Severity |
16.13; 14.06; 10.47; 10.69; 8.23; 11.35 | 0.0618 |
| SECONDARY Change in Depression Severity |
-6.2; -3.1 | 0.116 |
| SECONDARY Change in Side-effect Burden |
— | — |
| SECONDARY Change in Maternal Function |
— | — |
| SECONDARY Change in Maternal Confidence |
— | — |
| SECONDARY Medication Adherence |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03990389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.