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| Name | Class |
|---|---|
| Endeavor Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | 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. | |
| Chabot Care Group | Experimental | 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. |
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| Provider Subject Cohort | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chatbot Intervention | Device | a chatbot will be used to monitor depression severity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.
Patient Subject Cohort:
Exclusion Criteria:
Provider Subject Cohort: None
Patient Subject Cohort:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| NorthShore University HealthSystem |
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Excluded Patient Subjects (n = 35)
No data was collected for the providers as no results related to the providers were reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Experimental: Chabot Care Group | Subjects will undergo screening including REALM-R and EPDS and a few additional questions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Experimental: Chabot Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | missing values at month 1, month 2, and month 3 | Posted | Mean | Standard Error | score on a scale | 3 months |
|
3 months]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Beiser | The University of Chicago | 773-702-0307 | dbeiser@medicine.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2019 | Feb 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Change in Side-effect Burden |
Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire |
| 3 months |
| Change in Maternal Function | Measured by the Barkin Index of Maternal Functioning | 3 months |
| Change in Maternal Confidence | Measured by Maternal Confidence Questionnaire | 3 months |
| Medication Adherence | Measured by 1-item medication adherence questionnaire | 3 months |
| Skokie |
| Illinois |
| 60076 |
| United States |
Subjects will undergo screening including REALM-R and EPDS and a few additional questions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| 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 | Four missing values in the Usual Care Group and one missing value in the Chabot Care Group | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
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|
|
| Secondary | Change in Side-effect Burden | Measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) questionnaire | No data collected | Posted | 3 months |
|
|
| Secondary | Change in Maternal Function | Measured by the Barkin Index of Maternal Functioning | No data collected | Posted | 3 months |
|
|
| Secondary | Change in Maternal Confidence | Measured by Maternal Confidence Questionnaire | No data collected | Posted | 3 months |
|
|
| Secondary | Medication Adherence | Measured by 1-item medication adherence questionnaire | No data collected | Posted | 3 months |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Experimental: Chabot Care Group | Subjects will undergo screening including REALM-R and EPDS and a few additional questions. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |