Pivotal Test: WB001

November 8, 2022 updated by: Woebot Health

Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Woebot Labs Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: WB001
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.
SHAM_COMPARATOR: Comparison Condition
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Post-treatment at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Characteristic Questions
Time Frame: Baseline, Post-treatment at 8 weeks
Questions assessing current and previous therapy, medication and diagnoses.
Baseline, Post-treatment at 8 weeks
The Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a validated screening for depressive symptomatology among women who have recently given birth. The instrument is recommended by the American College of Obstetricians and Gynecologists for postnatal depression screening for all postpartum individuals. It has 10 items that are scored on a 0-3 basis. For the purpose of this study item number 10 that inquires about suicidal ideation, was omitted. A total EPDS score will be utilized. A total score of 10 indicates possible depression and the maximum achievable is 30.
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The Patient Health Questionnaire (PHQ-8)
Time Frame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The 8-item PHQ is an abbreviated version of the PHQ-9, will be used to assess mood and anxiety symptoms respectively. The PHQ-9 is a widely used self-report measure, with demonstrated reliability and sensitivity to clinical change. The PHQ-8 excludes an item assessing suicidality.
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)
Time Frame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The Generalized Anxiety Disorder 2-item scale (GAD-2) is a 2-item version of the GAD-7, a brief self-report tool to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. The correlation coefficient between the two measures was r=.75.
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)
Time Frame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The MIB consists of 8 one-word items describing an emotional response, such as ''loving'' or ''disappointed." Mothers rate the degree they feel the emotional response with their infant using a 4-point Likert scale from very much=0 to not at all=3. Five items describe negative emotional responses and are reverse scored. Total scores can range from 0 to 24, with lower scores indicating good bonding. Mother-infant bonding has been shown to be positively correlated with postpartum depression scores, where lower MIB are associated with lower depression scores.
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)
Time Frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks
The PROMIS is a measure that evaluates and monitors physical, mental, and social health in adults and/or children. It can be used with the general population as well as with those living with chronic conditions. Each question has five response options ranging in value from 1-5. The total score is calculated by summing all items. Higher scores equal more of the concept being measured (e.g., more Fatigue, more Physical Function).
Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks
The Mental Health Self-Efficacy Scale (MHSES)
Time Frame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The MHSES was developed following Bandura's guidelines for constructing self-efficacy scales24. The six items assess confidence in managing stress, depression and anxiety, and are scored on a 10 point Likert scale (from 1, not at all confident to 10, very confident). Ratings across the 6 items are summed for an overall measure of MHSE (range 10 to 60), with higher scores indicating more self-efficacy. This measure is included as a way to capture an individual's confidence that they can successfully manage their mental health concerns.
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
The Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Post-treatment at 8 weeks
The CSQ-8 is an 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1= "very dissatisfied" to 4= "very satisfied") [15, 22] will be utilized starting at week 2 and continuing biweekly thereafter. Example questions include, "how would you rate the quality of service you received?" and "did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with Woebot. The CSQ-8 has been widely disseminated and considered both valid and reliable (α ranges= .83-.93).
Post-treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Woebot Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Woebot Labs Inc. - 0030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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