Depression, Postpartum, Depression, Unipolar
Conditions
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.
Interventions
DEVICEChatbot Intervention
a chatbot will be used to monitor depression severity
Sponsors
Endeavor Health
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Change in Depression Severity | 3 months | Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity | 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 |
| Change in Side-effect Burden | 3 months | Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire |
| Change in Maternal Function | 3 months | Measured by the Barkin Index of Maternal Functioning |
| Change in Maternal Confidence | 3 months | Measured by Maternal Confidence Questionnaire |
| Medication Adherence | 3 months | Measured by 1-item medication adherence questionnaire |
Countries
United States
Participant flow
Pre-assignment details
Excluded Patient Subjects (n = 35) * EPDS \< 12 (n = 12) * Spanish speaking only (n = 2) * No Facebook account (n=1) * Consent not returned (n=18) * Refused (n = 2) No data was collected for the providers as no results related to the providers were reported.
Participants by arm
| Arm | Count |
|---|---|
| No Intervention: 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. | 15 |
| Experimental: Chabot Care Group Subjects will undergo screening including REALM-R and EPDS and a few additional questions. | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | No Intervention: Usual Care Group | Experimental: Chabot Care Group | Total |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 4.4 | 33.1 years STANDARD_DEVIATION 2.7 | 32.2 years STANDARD_DEVIATION 3.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
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
Time frame: 3 months
Population: missing values at month 1, month 2, and month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Intervention: Usual Care Group | Longitudinal Change in Depression Severity | baseline | 16.13 score on a scale | Standard Error 1.17 |
| No Intervention: Usual Care Group | Longitudinal Change in Depression Severity | month 1 | 10.47 score on a scale | Standard Error 1.29 |
| No Intervention: Usual Care Group | Longitudinal Change in Depression Severity | month 2 | 8.23 score on a scale | Standard Error 1.33 |
| No Intervention: Usual Care Group | Longitudinal Change in Depression Severity | month 3 | 9.64 score on a scale | Standard Error 1.33 |
| Experimental: Chabot Care Group | Longitudinal Change in Depression Severity | month 3 | 10.87 score on a scale | Standard Error 1.16 |
| Experimental: Chabot Care Group | Longitudinal Change in Depression Severity | baseline | 14.06 score on a scale | Standard Error 1.13 |
| Experimental: Chabot Care Group | Longitudinal Change in Depression Severity | month 2 | 11.35 score on a scale | Standard Error 1.19 |
| Experimental: Chabot Care Group | Longitudinal Change in Depression Severity | month 1 | 10.69 score on a scale | Standard Error 1.13 |
p-value: 0.0618Mixed Models Analysis
p-value: 0.63Mixed Models Analysis
p-value: 0.018Mixed Models Analysis
p-value: 0.234Mixed Models Analysis
Secondary
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
Time frame: 3 months
Population: Four missing values in the Usual Care Group and one missing value in the Chabot Care Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention: Usual Care Group | Change in Depression Severity | -6.2 score on a scale | Standard Deviation 4.3 |
| Experimental: Chabot Care Group | Change in Depression Severity | -3.1 score on a scale | Standard Deviation 5.4 |
p-value: 0.116t-test, 2 sided
Secondary
Change in Maternal Confidence
Measured by Maternal Confidence Questionnaire
Time frame: 3 months
Population: No data collected
Secondary
Change in Maternal Function
Measured by the Barkin Index of Maternal Functioning
Time frame: 3 months
Population: No data collected
Secondary
Change in Side-effect Burden
Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire
Time frame: 3 months
Population: No data collected
Secondary
Medication Adherence
Measured by 1-item medication adherence questionnaire
Time frame: 3 months
Population: No data collected