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

NCT03646539 | Completed

• 1 other identifier: IRB-46467
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Automated conversational agent

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery

  Baseline; 2 weeks post-delivery

• Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery

  Baseline; 4 weeks post-delivery

• Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks

  Baseline; 2 weeks post-delivery

• Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks

  Baseline; 4 weeks post-delivery

Study Arms (2)

Smartphone use + treatment as usual

EXPERIMENTAL

Participants will receive treatment as usual and use the smartphone app for the management of mood.

Behavioral: Use of smartphone application (app); Other: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Participants will receive treatment as usual.

Other: Treatment as usual

Interventions

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.

Smartphone use + treatment as usual

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.

Smartphone use + treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Neonatal demise this admission
• Intrauterine fetal demise this admission

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Department of Obstetrics and Gynecology

Stanford, California, 94305, United States

Location

Related 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. doi: 10.2196/mental.7785.

  PMID: 28588005 RESULT

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being; Depression; Depressive Disorder; Anxiety Disorders

Interventions

Amyloid; Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Amy Judy, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: October 1, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)