Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03646539
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Judy, Stanford University

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.

Condition or disease Intervention/treatment Phase
Cognitive Therapy Depression, Postpartum Mental Health Depression Depressive Disorder Anxiety Telemedicine Behavioral: Use of smartphone application (app) Other: Treatment as usual Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smartphone use + treatment as usual
Participants will receive treatment as usual and use the smartphone app for the management of mood.
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.

Active Comparator: Treatment as usual
Participants will receive treatment as usual.
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.




Primary Outcome Measures :
  1. Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery [ Time Frame: Baseline; 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.

  2. Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks [ Time Frame: Baseline; 6 weeks post-delivery ]
    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.


Secondary Outcome Measures :
  1. Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery [ Time Frame: Baseline; 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.

  2. Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery [ Time Frame: Baseline; 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.

  3. Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks [ Time Frame: Baseline; 2 weeks post-delivery ]
    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.

  4. Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks [ Time Frame: Baseline; 4 weeks post-delivery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646539


Locations
Layout table for location information
United States, California
Stanford University Department of Obstetrics and Gynecology Recruiting
Stanford, California, United States, 94305
Contact: Sanaa Suharwardy, MD    650-723-5505    sanaas@stanford.edu   
Contact: Maya Ramachandran, BS    5102904915    mayakram@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Amy Judy, MD Stanford University

Publications of Results:
Layout table for additonal information
Responsible Party: Amy Judy, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03646539     History of Changes
Other Study ID Numbers: IRB-46467
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy Judy, Stanford University:
Automated conversational agent

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications