[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

Study Overview
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Brief Summary
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This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.

Detailed Description
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This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).

Official Title
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A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression

Conditions
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Postpartum Depression

Intervention / Treatment
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* Device: WB001
* Device: ED001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have primary residence in the United States Must be ≤ 92 days postpartum Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study Participants must have current mild-moderate depression as measured by the HAMD-6 score >7 and <13 at screening Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit Exclusion Criteria: Gestation less than 28 weeks HAMD-6 score ≤7 or ≥13 (severe depression) at screening Currently pregnant or plans to become pregnant within the next 8 weeks History of drug and/or alcohol use disorder within the past 12 months Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD Current or lifetime psychosis Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device History of treatment-resistant depression (TRD) Fetal demise within the past 18 months

Ages Eligible for Study
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Minimum Age: 22 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
Interventional Model Description: 1:1 randomization
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WB001 with adjunctive Treatment as Usual<br>Participants randomized to the WB001 + TAU group will be asked to download and use the study application. | Device: WB001<br>* WB001 is a digital therapeutic for postpartum depression.<br>|
| Other: Educational Control (ED001) with adjunctive Treatment as Usual<br>Participants randomized to the ED001 + TAU group will be asked to download and use the study application. | Device: ED001<br>* ED001 is a digital therapeutic for postpartum depression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) | Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression. | Change from Baseline to Post-treatment at Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postpartum Depression Scale (EPDS) | Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression. | Change Baseline to Post-treatment at Week 8 | 
| Patient Health Questionnaire (PHQ-9) | Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression | Change Baseline to Post-treatment at Week 8 | 
| Generalized Anxiety Disorder Questionnaire (GAD-7) | Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety. | Change from Baseline to Post-treatment at Week 8 | 
| Mother-to-Infant Bonding Scale (MIBS) | Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding. | Change from Baseline to Post-treatment at Week 8 | 
| Clinical Global Impressions Scale - Severity of Illness (CGI-S) | Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill). | Change Baseline to Post-treatment at Week 8 | 
| Clinical Global Impressions Scale - Global Improvement (CGI-I) | Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse). | Change from Mid-treatment at Week 4 to Post-treatment at Week 8 | 
| Patient Global Impression Scale (PGI) | Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). | PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8 | 
| Client Satisfaction Questionnaire (CSQ-8) | An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment. | Post-treatment at Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression, PPD, Postpartum Depression Treatment, PPD Treatment, Smartphone application, Digital therapeutic