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NCT Number: NCT06877104

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Angelina Malenda

CONTACT

[email protected]

(551) 482-3655

Kirstin Leitner, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: Penny the Chatbot, H@H 2.0, W2H

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS) Screening Score

    Time frame: 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 outcomes

  1. Postpartum visit attendance

    Time frame: 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.

  2. Count of unscheduled emergency room/postpartum triage visits

    Time frame: 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

  3. Mode of feeding

    Time frame: 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.

  4. Scores of self-efficacy in infant care

    Time frame: 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.

  5. Knowledge of postpartum warning signs

    Time frame: 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

  6. Score of Postpartum sleep: quality

    Time frame: At baseline and at 6 weeks postpartum

    One question Likert scale ranking quality of sleep from terrible to excellent.

  7. Postpartum sleep: hours

    Time frame: At baseline and at 6 weeks postpartum

    Average number of hours slept in the past 7 days.

  8. Postpartum pain score

    Time frame: 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.

  9. Social support and maternal functioning score

    Time frame: 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.

  10. Implementation outcome: Acceptability of Intervention Measure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelina Malenda

CONTACT

[email protected]

551-482-3655

Meaghan G McCabe, MPH

CONTACT

[email protected]

973-747-2824

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • March of Dimes

Registry information

Acronym: HEALED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Jul 30, 2026

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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