RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood

Depression Clinical Trial

Official title:

Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646539
• Other study ID #: IRB-46467
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 4, 2019

Study information

• Verified date: September 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 4, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cognitive Therapy
• Depression
• Depression, Postpartum
• Depressive Disorder
• Mental Health
• Telemedicine

Intervention

Behavioral:
• Use of smartphone application (app)
Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.

Other:
• Treatment as usual
Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.

Locations

Country	Name	City	State
United States	Stanford University Department of Obstetrics and Gynecology	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	Baseline; 6 weeks post-delivery
Primary	Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.	Baseline; 6 weeks post-delivery
Secondary	Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	Baseline; 2 weeks post-delivery
Secondary	Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	Baseline; 4 weeks post-delivery
Secondary	Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.	Baseline; 2 weeks post-delivery
Secondary	Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.	Baseline; 4 weeks post-delivery