Clinical trial NCT06877104: Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression
Official title: Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Postpartum
Postpartum Care
Keywords: Chat tool
Depression
Text message based program
Postpartum Care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: March of Dimes
First posted: 2025-03-14
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS) Screening Score
timeFrame: At 6 weeks postpartum
Secondary outcomes:
measure: Postpartum visit attendance
timeFrame: Up to 3 months postpartum
measure: Count of unscheduled emergency room/postpartum triage visits
timeFrame: Up to 6 weeks postpartum
measure: Mode of feeding
timeFrame: At baseline and 6 weeks postpartum
measure: Scores of self-efficacy in infant care
timeFrame: At baseline and at 6 weeks postpartum
measure: Knowledge of postpartum warning signs
timeFrame: At baseline and at 6 weeks postpartum
measure: Score of Postpartum sleep: quality
timeFrame: At baseline and at 6 weeks postpartum
measure: Postpartum sleep: hours
timeFrame: At baseline and at 6 weeks postpartum
measure: Postpartum pain score
timeFrame: 24 hours prior to discharge from hospital
measure: Social support and maternal functioning score
timeFrame: At 6 weeks postpartum
measure: Implementation outcome: Acceptability of Intervention Measure
timeFrame: At 6 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kirstin Leitner, MD
role: PRINCIPAL_INVESTIGATOR
References: