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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression, Postpartum; Postpartum Care
• Intervention / Treatment: Other: Healing @ Home Program (H@H 2.0)

Detailed Description

Healing at Home (H@H) 2.0 is a comprehensive technology-based postpartum support program which provides 24/7 support to individuals through use of an SMS chatbot for six weeks postpartum. This will be a randomized controlled trial (RCT) with an intervention arm consisting of patients who are planning to be discharged at routine timing (as determined by their clinical team) with access to H@H 2.0 postpartum SMS chatbot platform and a control arm which consists of usual postpartum care.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meaghan G McCabe, MPH; Phone Number: 973-747-2824; Email: meaghan.mccabe@pennmedicine.upenn.edu
• Study Contact Backup: Name: Angelina Malenda; Phone Number: 551-482-3655; Email: angelina.malenda@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Angelina Malenda; Phone Number: (551) 482-3655; Email: angelina.malenda@pennmedicine.upenn.edu
      • Principal Investigator: Kirstin Leitner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Routine postpartum care.
Experimental: Healing @ Home Program (H@H 2.0); 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); 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.; Other Names: Penny the Chatbot; H@H 2.0; W2H

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum visit attendance	Whether or not the patient attended their routine postpartum visit which should occur around the 6-week postpartum mark. We will accept routine postpartum visits up to 12-weeks postpartum.	Up to 3 months postpartum
Count of unscheduled emergency room/postpartum triage visits	The number of unscheduled visits, reason for visit, whether or not patient was admitted to hospital in the first 6 weeks postpartum will be counted	Up to 6 weeks postpartum
Mode of feeding	Patient asked mode of feeding at two time points. Options are exclusively breastfeeding, formula feeding only, or both breast and formula feeding.	At baseline and 6 weeks postpartum
Scores of self-efficacy in infant care	Scores from the validated Self-efficacy in the Nurturing Role (SENR) tool will be calculated using Likert scale scoring criteria for each of the 16 items. Negative items are reverse-scored such that higher scores on the items always reflect greater self-efficacy.	At baseline and at 6 weeks postpartum
Knowledge of postpartum warning signs	Using a question from the Pregnancy Risk Assessment measure survey (PRAMS) to ask patients to identify warning signs of complications that can occur after birth	At baseline and at 6 weeks postpartum
Score of Postpartum sleep: quality	One question Likert scale ranking quality of sleep from terrible to excellent.	At baseline and at 6 weeks postpartum
Postpartum sleep: hours	Average number of hours slept in the past 7 days.	At baseline and at 6 weeks postpartum
Postpartum pain score	Scores from a 10-item question from the validated Brief Pain Inventory short form will be calculated using Likert scale scoring criteria with scores ranging from 0-100. Higher scores mean higher pain.	24 hours prior to discharge from hospital
Social support and maternal functioning score	Scores from the validated Barkin Index of Maternal Functioning tool will be calculated using Likert scale scoring criteria for each of the 20 questions. The total score ranges from 0 to 120, with a score of 120 representing perfect functioning.	At 6 weeks postpartum
Implementation outcome: Acceptability of Intervention Measure	4-item Likert scale where scores can range from 4 to 20. High scores indicate higher acceptability. Given to the intervention group only.	At 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: March of Dimes
• Investigators: Principal Investigator: Kirstin Leitner, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Postpartum Care; Chat tool; Text message based program
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depressive Disorder; Behavior; Depression; Depression, Postpartum
• Other Study ID Numbers: 857508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No