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Completed

NCT Number: NCT03646539

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

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.

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Key information

Conditions

Cognitive Therapy Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mental Health Mood Disorders Personal Satisfaction Pregnancy Complications Psychological Well-Being Puerperal Disorders Telemedicine Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Department of Obstetrics and Gynecology

Stanford, California, 94305, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of smartphone application (app)

Behavioral

Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.

Treatment as Usual

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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