This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
7
Woebot Investigational Site
Lafayette, California, United States
Woebot Investigational Site
Santa Ana, California, United States
Woebot Investigational Site
DeLand, Florida, United States
Woebot Investigational Site
Miami Lakes, Florida, United States
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.
Time frame: Change from Baseline to Post-treatment at Week 8
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Woebot Investigational Site
Seminole, Florida, United States
Woebot Investigational Site
Decatur, Georgia, United States
Woebot Investigational Site
Glen Oaks, New York, United States
Woebot Investigational Site
Cleveland, Ohio, United States
Time frame: 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).
Time frame: 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 responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes.
Time frame: 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.
Time frame: Post-treatment at Week 8