Woebot Health
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
Postpartum Depression
WB001
ED001
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 7 participants |
Masking : | Triple |
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 : | November 16, 2022 |
Estimated Primary Completion Date : | May 10, 2023 |
Estimated Study Completion Date : | May 10, 2023 |
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 |
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 |
Ages Eligible for Study: | 22 Years to 45 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Woebot Investigational Site
Lafayette, California, United States, 94549
Not yet recruiting
Woebot Investigational Site
Santa Anna, California, United States, 92704
Not yet recruiting
Woebot Investigational Site
DeLand, florida, United States, 32720
Not yet recruiting
Woebot Investigational Site
Miami Lakes, florida, United States, 33016
Not yet recruiting
Woebot Investigational Site
Seminole, florida, United States, 33777
Not yet recruiting
Woebot Investigational Site
Decatur, Georgia, United States, 30033
Not yet recruiting
Woebot Investigational Site
Glen Oaks, New York, United States, 11004
Not yet recruiting
Woebot Investigational Site
Cleveland, Ohio, United States, 44122