Clinical trial NCT04576754: Pivotal Test: WB001
Official title: Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to :

1. 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
2. a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.


Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale for Depression (HAMD)
timeFrame: Post-treatment at 8 weeks
Secondary outcomes:
measure: Clinical Characteristic Questions
timeFrame: Baseline, Post-treatment at 8 weeks
measure: The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
measure: The Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
measure: Generalized Anxiety Disorder 2-item scale (GAD-2)
timeFrame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
measure: The Mother-to-Infant Bonding Scale (MIB)
timeFrame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks
measure: The Mental Health Self-Efficacy Scale (MHSES)
timeFrame: Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks
measure: The Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment at 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Labs Inc
state: California
Study officials:
References: