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

Not Applicable

Recruiting

• Conditions: Depression, Postpartum; Postpartum Care

• Registration Number: NCT06877104
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study Start: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-02-28
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS) Screening Score	At 6 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Postpartum visit attendance	Up to 3 months postpartum	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.
Count of unscheduled emergency room/postpartum triage visits	Up to 6 weeks postpartum	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
Mode of feeding	At baseline and 6 weeks postpartum	Patient asked mode of feeding at two time points. Options are exclusively breastfeeding, formula feeding only, or both breast and formula feeding.
Scores of self-efficacy in infant care	At baseline and at 6 weeks postpartum	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.
Knowledge of postpartum warning signs	At baseline and at 6 weeks postpartum	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
Score of Postpartum sleep: quality	At baseline and at 6 weeks postpartum	One question Likert scale ranking quality of sleep from terrible to excellent.
Postpartum sleep: hours	At baseline and at 6 weeks postpartum	Average number of hours slept in the past 7 days.
Postpartum pain score	24 hours prior to discharge from hospital	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.
Social support and maternal functioning score	At 6 weeks postpartum	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.
Implementation outcome: Acceptability of Intervention Measure	At 6 weeks postpartum	4-item Likert scale where scores can range from 4 to 20. High scores indicate higher acceptability. Given to the intervention group only.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States