Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression

NCT06877104 | Recruiting

• 1 other identifier: 857508
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if access to a text-message based holistic chatbot support program "Healing at Home 2.0" decreases depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) compared to usual postpartum care for patients of color.

Conditions

Depression, Postpartum; Postpartum Care

Keywords

Chat tool; Depression; Text message based program; Postpartum Care

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale (EPDS) Screening Score

  Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen.

  At 6 weeks postpartum

Secondary Outcomes (10)

• Postpartum visit attendance

  Up to 3 months postpartum

• Count of unscheduled emergency room/postpartum triage visits

  Up to 6 weeks postpartum

• Mode of feeding

  At baseline and 6 weeks postpartum

• Scores of self-efficacy in infant care

  At baseline and at 6 weeks postpartum

• Knowledge of postpartum warning signs

  At baseline and at 6 weeks postpartum

Study Arms (2)

Standard of care

NO INTERVENTION

Routine postpartum care.

Healing @ Home Program (H@H 2.0)

EXPERIMENTAL

Routine postpartum care and the use of an algorithm-based text message support program for six weeks.

Other: Healing @ Home Program (H@H 2.0)

Interventions

Healing @ Home Program (H@H 2.0) OTHER

Healing @ Home 2.0 is a clinically used comprehensive technology-based postpartum support program, which provides 24/7 support to individuals through use of a text message based chatbot for six weeks postpartum. Content of H@H 2.0 includes anticipatory guidance regarding physical recovery, infant care and feeding, clinical algorithms to respond to urgent patient needs.

Also known as: Penny the Chatbot, H@H 2.0, W2H

Healing @ Home Program (H@H 2.0)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum patients who have delivered a singleton baby at or after 37w0d at the Hospital of the University of Pennsylvania
• Self-identify as a person of color (listed on chart as non-White race and confirmed with patient)
• Able to speak, read and write English
• Age ≥18
• Prenatal care at outpatient practice affiliated with the Hospital of the University of Pennsylvania
• Completion of clinically administered EPDS during inpatient stay
• Routine discharge timing, day 2 or more after vaginal delivery, day 3 or more after cesarean delivery

You may not qualify if:

• Unable to provide informed consent
• Baby not discharged with mother at postpartum discharge
• Does not have access to a mobile phone

Sponsors & Collaborators

• University of Pennsylvania: lead
• March of Dimes: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kirstin Leitner, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meaghan G McCabe, MPH

CONTACT

973-747-2824; meaghan.mccabe@pennmedicine.upenn.edu

Angelina Malenda

CONTACT

551-482-3655; angelina.malenda@pennmedicine.upenn.edu

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: Assistant Professor of Clinical Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 14, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)