Pivotal Test: WB001

Woebot Health

Status

Completed

Conditions

Postpartum Depression

Treatments

Device: WB001

Device: Educational

Study type

Interventional

Funder types

Industry

Identifiers

NCT04576754

Woebot Labs Inc. - 0030

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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