Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001

Woebot Health1 site in 1 country83 target enrollmentNovember 12, 2020

ConditionsPostpartum Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postpartum Depression
Sponsor: Woebot Health
Enrollment: 83
Locations: 1
Primary Endpoint: Hamilton Depression Rating Scale for Depression (HAMD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to :

an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible via an iOS and Android application, or to
a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.

Registry

clinicaltrials.gov

Start Date

November 12, 2020

End Date

August 20, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Woebot Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women aged 18-45 years who had onset of a major depressive episode within the third trimester of pregnancy or within 4 weeks following delivery as measured by the MINI (Mini International Neuropsychiatric Interview).
•Current mild-moderate depression as measured by the HAM-D (HAM-D score\>13 and \<24)
•Women were \</= to 6 months postpartum at the time of screening
•Owns a smartphone (Anrdroid or iOS smartphone with a recent, supported operating system)
•Available and committed to engage with the program and complete assessments for a 3-month duration
•Able to read and write in English
•U.S. resident

Exclusion Criteria

•HAM-D score ≥ 24 (severe depression)
•Active psychosis
•Suicidal attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
•History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
•Current pregnancy or plans to become pregnant within the next 4 months
•Fetal demise within the past 24 months
•Previous Woebot user

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale for Depression (HAMD)

Time Frame: Post-treatment at 8 weeks

The HAMD is a 17-item, clinician rated measure of depression. Each item is scored from 0 to 2 and assesses the following criteria: insomnia, somatic symptoms, genital symptoms, loss of weight, and insight. The total score is calculated as a sum and ranges from 0 to 52, with higher scores indicating a greater degree of depression. The HAMD is commonly used for diagnostic purposes in research; structured clinical interviews such as this are recommended to actually diagnose clinical depression. It will be the primary outcome measure.

Secondary Outcomes

Clinical Characteristic Questions(Baseline, Post-treatment at 8 weeks)
The Patient Health Questionnaire (PHQ-8)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
Generalized Anxiety Disorder 2-item scale (GAD-2)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
The Mother-to-Infant Bonding Scale (MIB)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks)
The Edinburgh Postnatal Depression Scale (EPDS)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
The Mental Health Self-Efficacy Scale (MHSES)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
The Client Satisfaction Questionnaire (CSQ-8)(Post-treatment at 8 weeks)