Pivotal Test: WB001

NCT04576754 | Completed

• 1 other identifier: Woebot Labs Inc. - 0030
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale for Depression (HAMD)

  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.

  Post-treatment at 8 weeks

Secondary Outcomes (8)

• Clinical Characteristic Questions

  Baseline, Post-treatment at 8 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 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

Study Arms (2)

WB001

EXPERIMENTAL

Device: WB001

Comparison Condition

SHAM COMPARATOR

Device: Educational

Interventions

WB001 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.

WB001

Educational 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.

Comparison Condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woebot Health: lead

Study Sites (1)

Woebot Labs Inc

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Models, Educational

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 6, 2020
• Study Start: November 12, 2020
• Primary Completion: June 14, 2021
• Study Completion: August 20, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

US (1)