Pivotal Test: WB001

NCT ID: NCT04576754

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2021-08-20

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 :

1. 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

2. a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WB001

Group Type: EXPERIMENTAL

WB001

Intervention Type: DEVICE

The WB001 treatment consists of PPD-specific psychoeducational lessons and CBT-specific skills or tools. The lessons teach PPD-specific information to normalize and contextualize postpartum experiences, as well as provide information on effective mood management and mental health promotion in the context of having recently given birth. Patients complete up to 30 psychoeducational lessons. In addition, patients access and apply core CBT-based tools upon endorsing a negative mood. These tools are core to CBT and are considered transdiagnostic. Examples include thought challenging, behavioral activation, mindfulness, and self-care.

Comparison Condition

Group Type: SHAM_COMPARATOR

Educational

Intervention Type: DEVICE

The Comparison Condition provides educational only material about various mental and physical topics, delivered in an interactive smartphone application that is accessible anytime of day.

Interventions

WB001

The WB001 treatment consists of PPD-specific psychoeducational lessons and CBT-specific skills or tools. The lessons teach PPD-specific information to normalize and contextualize postpartum experiences, as well as provide information on effective mood management and mental health promotion in the context of having recently given birth. Patients complete up to 30 psychoeducational lessons. In addition, patients access and apply core CBT-based tools upon endorsing a negative mood. These tools are core to CBT and are considered transdiagnostic. Examples include thought challenging, behavioral activation, mindfulness, and self-care.

Intervention Type: DEVICE

Educational

The Comparison Condition provides educational only material about various mental and physical topics, delivered in an interactive smartphone application that is accessible anytime of day.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woebot Labs Inc

San Francisco, California, United States

Countries

United States

Other Identifiers

Woebot Labs Inc. - 0030

Identifier Type: -

Identifier Source: org_study_id