Pivotal Test: WB001

Study Overview
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Brief Summary
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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.

Official Title
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Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001

Conditions
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Postpartum Depression

Intervention / Treatment
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* Device: WB001
* Device: Educational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WB001<br> | Device: WB001<br>* 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.<br>|
| Sham Comparator: Comparison Condition<br> | Device: Educational<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Characteristic Questions | Questions assessing current and previous therapy, medication and diagnoses. | Baseline, Post-treatment at 8 weeks | 
| 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. | Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks | 
| 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. | 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) | 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) | 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) | 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) | 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) | 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 |