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Pivotal Test: WB001

NCT04576754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Woebot Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2021-06-14
Completion
2021-08-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576754 on ClinicalTrials.gov