Clinical trial NCT03646539: RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood
Official title: Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Therapy
Depression, Postpartum
Mental Health
Depression
Depressive Disorder
Anxiety
Telemedicine
Keywords: Automated conversational agent
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.

Detailed description: The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).

Eligibility criteria: Inclusion Criteria:

* Postpartum day 0-7 after delivery
* Medically stable and cleared for discharge
* Owns smartphone
* English-speaking (because all intervention materials are in English)

Exclusion Criteria:

* Neonatal demise this admission
* Intrauterine fetal demise this admission

Primary outcomes:
measure: Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
timeFrame: Baseline; 6 weeks post-delivery
measure: Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks
timeFrame: Baseline; 6 weeks post-delivery
Secondary outcomes:
measure: Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery
timeFrame: Baseline; 2 weeks post-delivery
measure: Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery
timeFrame: Baseline; 4 weeks post-delivery
measure: Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks
timeFrame: Baseline; 2 weeks post-delivery
measure: Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks
timeFrame: Baseline; 4 weeks post-delivery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Department of Obstetrics and Gynecology
state: California
Study officials:
affiliation: Stanford University
name: Amy Judy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.