Back to resultsPivotal Test: WB001
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WB001
Educational
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression
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
Sites / Locations
- Woebot Labs Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
WB001
Comparison Condition
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical Characteristic Questions
Questions assessing current and previous therapy, medication and diagnoses.
The Edinburgh Postnatal Depression Scale (EPDS)
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.
The Patient Health Questionnaire (PHQ-8)
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.
Generalized Anxiety Disorder 2-item scale (GAD-2)
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.
The Mother-to-Infant Bonding Scale (MIB)
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.
Patient-Reported Outcomes Measurement Information System (PROMIS)
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).
The Mental Health Self-Efficacy Scale (MHSES)
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.
The Client Satisfaction Questionnaire (CSQ-8)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04576754
Brief Title
Pivotal Test: WB001
Official Title
Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 :
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WB001
Arm Type
Experimental
Arm Title
Comparison Condition
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
WB001
Intervention Description
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
Intervention Name(s)
Educational
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale for Depression (HAMD)
Description
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.
Time Frame
Post-treatment at 8 weeks
Secondary Outcome Measure Information:
Title
Clinical Characteristic Questions
Description
Questions assessing current and previous therapy, medication and diagnoses.
Time Frame
Baseline, Post-treatment at 8 weeks
Title
The Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
Title
The Patient Health Questionnaire (PHQ-8)
Description
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.
Time Frame
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
Title
Generalized Anxiety Disorder 2-item scale (GAD-2)
Description
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.
Time Frame
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
Title
The Mother-to-Infant Bonding Scale (MIB)
Description
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.
Time Frame
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
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).
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
Title
The Mental Health Self-Efficacy Scale (MHSES)
Description
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.
Time Frame
Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
Title
The Client Satisfaction Questionnaire (CSQ-8)
Description
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).
Time Frame
Post-treatment at 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Woebot Labs Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
12. IPD Sharing Statement
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Pivotal Test: WB001
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