Trial Outcomes & Findings for Tracking Depression Symptoms With a Health Chatbot (NCT NCT03990389)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3 months

Results posted on

2022-05-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Experimental: Chabot Care Group Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
Overall Study STARTED	15	16
Overall Study COMPLETED	12	16
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Experimental: Chabot Care Group Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention: Usual Care Group n=15 Participants 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.	Experimental: Chabot Care Group n=16 Participants Subjects will undergo screening including REALM-R and EPDS and a few additional questions.	Total n=31 Participants Total of all reporting groups
Age, Continuous	31.3 years STANDARD_DEVIATION 4.4 • n=15 Participants	33.1 years STANDARD_DEVIATION 2.7 • n=16 Participants	32.2 years STANDARD_DEVIATION 3.7 • n=31 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	16 Participants n=16 Participants	31 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 months

Population: missing values at month 1, month 2, and month 3

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

Outcome measures

Outcome measures
Measure	No Intervention: Usual Care Group n=15 Participants 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.	Experimental: Chabot Care Group n=16 Participants Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
Longitudinal Change in Depression Severity baseline	16.13 score on a scale Standard Error 1.17	14.06 score on a scale Standard Error 1.13
Longitudinal Change in Depression Severity month 1	10.47 score on a scale Standard Error 1.29	10.69 score on a scale Standard Error 1.13
Longitudinal Change in Depression Severity month 2	8.23 score on a scale Standard Error 1.33	11.35 score on a scale Standard Error 1.19
Longitudinal Change in Depression Severity month 3	9.64 score on a scale Standard Error 1.33	10.87 score on a scale Standard Error 1.16

SECONDARY outcome

Timeframe: 3 months

Population: Four missing values in the Usual Care Group and one missing value in the Chabot Care Group

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

Outcome measures

Outcome measures
Measure	No Intervention: Usual Care Group n=11 Participants 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.	Experimental: Chabot Care Group n=15 Participants Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
Change in Depression Severity	-6.2 score on a scale Standard Deviation 4.3	-3.1 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 3 months

Population: No data collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: No data collected

Measured by the Barkin Index of Maternal Functioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: No data collected

Measured by Maternal Confidence Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: No data collected

Measured by 1-item medication adherence questionnaire

Outcome measures

Outcome data not reported

Adverse Events

No Intervention: Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: Chabot Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Beiser

The University of Chicago

Phone: 773-702-0307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place