Depression, PostpartumHEALEDNCT06877104
Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression
A study testing Healing @ Home Program (H@H 2.0) in people with Depression, Postpartum and Postpartum Care, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Postpartum Care
- What is being tested?
- Healing @ Home Program (H@H 2.0)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Baby not discharged with mother at postpartum discharge
- Does not have access to a mobile phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Depression, Postpartum, Postpartum Care
- Being tested
- Healing @ Home Program (H@H 2.0)
- Keywords
- Chat tool, Depression, Text message based program, Postpartum Care
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing @ Home Program (H@H 2.0)Other
Also called Penny the Chatbot, H@H 2.0, W2H
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Healing @ Home Program (H@H 2.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 weeks postpartum
Secondary outcomes (10)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: At baseline and at 6 weeks postpartum
Score of Postpartum sleep: quality
One question Likert scale ranking quality of sleep from terrible to excellent.
Measured: At baseline and at 6 weeks postpartum
Postpartum sleep: hours
Average number of hours slept in the past 7 days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start13 Mar 2025
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- March of Dimes
- Responsible party
- Principal investigator, Kirstin Leitner, University of Pennsylvania
- Investigators
- Kirstin Leitner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877104
- Sponsor's protocol ID
- 857508
- Acronym
- HEALED
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression
- ClinicalTrials.gov ID
- NCT06877104
- Acronym / sponsor ID
- HEALED / 857508
- Conditions
- Depression, Postpartum, Postpartum Care
- Keywords
- Chat tool, Depression, Text message based program, Postpartum Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- March of Dimes
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Routine postpartum care. |
| Healing @ Home Program (H@H 2.0) | Experimental | Other: Healing @ Home Program (H@H 2.0)Routine postpartum care and the use of an algorithm-based text message support program for six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Baby not discharged with mother at postpartum discharge
- Does not have access to a mobile phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing @ Home Program (H@H 2.0)Also: Penny the Chatbot, H@H 2.0, W2HHealing @ 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 | Healing @ Home Program (H@H 2.0) |
Primary outcome
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.
10 secondary outcomes
Postpartum visit attendance
Time frame: Up to 3 months postpartum
Count of unscheduled emergency room/postpartum triage visits
Time frame: Up to 6 weeks postpartum
Mode of feeding
Time frame: At baseline and 6 weeks postpartum
Scores of self-efficacy in infant care
Time frame: At baseline and at 6 weeks postpartum
Knowledge of postpartum warning signs
Time frame: At baseline and at 6 weeks postpartum
Score of Postpartum sleep: quality
Time frame: At baseline and at 6 weeks postpartum
Postpartum sleep: hours
Time frame: At baseline and at 6 weeks postpartum
Postpartum pain score
Time frame: 24 hours prior to discharge from hospital
Social support and maternal functioning score
Time frame: At 6 weeks postpartum
Implementation outcome: Acceptability of Intervention Measure
Time frame: At 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstin Leitner, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing @ Home Program (H@H 2.0) in people with Depression, Postpartum and Postpartum Care, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) Screening Score (time frame: At 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.