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

Sponsor

Woebot Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05551195

Collaborator

Iqvia Pty Ltd (Industry)

210

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression	Device: WB001 Device: ED001	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization1:1 randomization

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2022

Anticipated Primary Completion Date :

Nov 16, 2023

Anticipated Study Completion Date :

Jan 16, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Other: WB001 with adjunctive Treatment as Usual

Participants randomized to the WB001 + TAU group will be asked to download and use the study application.

Device: WB001

WB001 is a digital therapeutic for postpartum depression.

Other: Educational Control (ED001) with adjunctive Treatment as Usual

Participants randomized to the ED001 + TAU group will be asked to download and use the study application.

Device: ED001

ED001 is a digital therapeutic for postpartum depression.

Outcome Measures

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D) [Change from Baseline to Post-treatment at Week 8]
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.

Secondary Outcome Measures

Edinburgh Postpartum Depression Scale (EPDS) [Change Baseline to Post-treatment at Week 8]
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.
Patient Health Questionnaire (PHQ-9) [Change Baseline to Post-treatment at Week 8]
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
Generalized Anxiety Disorder Questionnaire (GAD-7) [Change from Baseline to Post-treatment at Week 8]
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.
Mother-to-Infant Bonding Scale (MIBS) [Change from Baseline to Post-treatment at Week 8]
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.
Clinical Global Impressions Scale - Severity of Illness (CGI-S) [Change Baseline to Post-treatment at Week 8]
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).
Clinical Global Impressions Scale - Global Improvement (CGI-I) [Change from Mid-treatment at Week 4 to Post-treatment at Week 8]
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).
Patient Global Impression Scale (PGI) [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]
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).
Client Satisfaction Questionnaire (CSQ-8) [Post-treatment at Week 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woebot Investigational Site	Lafayette	California	United States	94549
2	Woebot Investigational Site	Miami Lakes	Florida	United States	33016
3	Woebot Investigational Site	Glen Oaks	New York	United States	11004