Healing at Home for Postpartum Depression

(HEALED Trial)

Overseen By Angelina Malenda

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unable to consent, No phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a text-based support program, "Healing at Home 2.0" (H@H 2.0), can more effectively reduce postpartum depression symptoms in patients of color compared to regular postpartum care. Participants will receive either standard care or the chatbot support program alongside regular care. Eligible participants should have recently given birth to a single baby, identify as a person of color, and be able to use a mobile phone. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance postpartum care for people of color.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a text-message support program, so it's likely you can continue your usual medications, but you should confirm with the trial organizers.

What prior data suggests that the Healing @ Home Program (H@H 2.0) is safe?

Research shows that the Healing @ Home Program (H@H 2.0) is expected to be safe and easy to manage. The HEALED study is currently examining potential side effects, but no major issues have emerged so far.

Studies on similar home visit programs have shown good results. These programs have helped reduce symptoms of postpartum depression without causing significant problems. Telemedicine programs, like Healing @ Home, are known to reduce depression symptoms and are generally well-received by new mothers.

While researchers continue to study the Healing @ Home Program, evidence suggests it is a safe option for managing postpartum depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard postpartum depression treatments that often include medication and therapy, the Healing @ Home Program (H@H 2.0) offers a unique approach by integrating routine postpartum care with an algorithm-based text message support system. This program provides personalized support and encouragement to new mothers over six weeks, directly addressing their mental health needs in a familiar home environment. Researchers are excited about this approach because it has the potential to enhance accessibility and engagement, offering timely support without the need for in-person visits, which can be challenging for new moms.

What evidence suggests that the Healing @ Home Program (H@H 2.0) might be an effective treatment for postpartum depression?

Research shows that the Healing @ Home Program (H@H 2.0), tested in this trial, uses text messages for support and might help reduce depression. Participants will receive either the standard of care or the H@H 2.0 program. Similar programs, such as Mothers and Babies, have lowered stress and depression in new mothers. These programs send simple, supportive messages that can greatly improve mood and well-being. Although data on H@H 2.0 remains limited, early results suggest it could help with postpartum depression, especially for patients of color. ^{1 6 7 8 9}

Who Is on the Research Team?

Kirstin Leitner, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals of color who are pregnant or recently gave birth and may be experiencing postpartum depression. Participants should be willing to use a text-message based chatbot support program.

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

Exclusion Criteria

Baby not discharged with mother at postpartum discharge

Does not have access to a mobile phone

I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive access to the Healing at Home 2.0 SMS chatbot for postpartum support

6 weeks

Continuous access via SMS

Follow-up

Participants are monitored for depressive symptoms and other outcomes using various scales

Up to 3 months postpartum

Routine postpartum visit around 6 weeks, up to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healing @ Home Program (H@H 2.0)

Trial Overview The study tests if the 'Healing at Home 2.0' program, which offers holistic chatbot support via text messages, can reduce depressive symptoms in comparison to standard postpartum care.

How Is the Trial Designed?

Group I: Healing @ Home Program (H@H 2.0) Experimental Treatment 1 Intervention

Routine postpartum care and the use of an algorithm-based text message support program for six weeks.

Group II: Standard of care Active Control 1 Intervention

Routine postpartum care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

March of Dimes

Collaborator

Trials

24

Recruited

30,500+

Published Research Related to This Trial

Home-based psychological interventions, including cognitive behavioral, psychodynamic, and non-directive counseling approaches, have been shown to significantly reduce postpartum depression (PPD) in four out of six studies reviewed.

The review highlights the need for further research to identify factors that influence the effectiveness of these interventions and to develop targeted prevention strategies for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of home-based interventions to prevent and treat postpartum depression. Leis, JA., Mendelson, T., Tandon, SD., et al.[2018]

The Mothers and Babies Online Course (eMB) was designed to prevent postpartum depression (PPD) and was accessed by 208 users, including 37% perinatal women and 63% health providers, highlighting its potential to reach those with limited access to mental health resources.

User feedback indicated that while the lessons were rated positively for usefulness, engagement was low, with only 4.4% of participants completing all eight lessons, suggesting a need for improvements in content delivery to enhance user interaction and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention. Barrera, AZ., Morris, SY., Ruiz, A.[2022]

Therapist-assisted internet cognitive behavior therapy (TAICBT) is viewed positively by most women with postpartum depression (PPD), offering benefits like flexibility, accessibility, and enhanced self-awareness, based on feedback from 24 participants.

Despite the overall positive reception, some women faced challenges such as time management and the lack of face-to-face interaction, highlighting areas for improvement in future TAICBT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences of guided internet cognitive behavior therapy for postpartum depression: a qualitative study. Pugh, NE., Hadjistavropoulos, HD., Hampton, AJD., et al.[2022]

Listening Visits (LV) delivered by U.S. home visitors resulted in a significant reduction in depression symptoms and improved life satisfaction among 19 postpartum women with depressive symptoms.

The intervention was found to be acceptable to the participants, indicating its potential as an effective treatment for maternal depression, which affects about one in five women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening visits: an evaluation of the effectiveness and acceptability of a home-based depression treatment. Segre, LS., Stasik, SM., O'Hara, MW., et al.[2021]

In a 6-month project involving 273 mothers, a screening protocol for postpartum depression (PPD) was successfully implemented, achieving an 83.5% screening rate during well-child visits.

Of the mothers who screened positive for PPD, 73.1% were referred to mental health services, and 63.2% attended their referral, demonstrating effective follow-up and support for those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. Cohen, M., Stephens, CTD., Zaheer, A., et al.[2022]

A one-day online workshop utilizing cognitive behavioral therapy significantly improved symptoms of postpartum depression and anxiety, as well as enhancing social support and the mother-infant relationship.

This approach offers an efficient way to increase access to treatment for postpartum depression, suggesting it could be a valuable addition to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. Rosenberg, K.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35878827/

Results from an effectiveness-implementation evaluation of ... Conclusion: Mothers and Babies 1-on-1 delivered by lay home visitors leads to reductions in perceived stress and depressive symptoms, suggesting task shifting ...

2. withpower.com withpower.com/trial/phase-depression-postpartum-2-2025-7a389

Healing at Home for Postpartum Depression (HEALED Trial) 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722008011

Results from an effectiveness-implementation evaluation of ... Mothers and Babies 1-on-1 delivered by lay home visitors leads to reductions in perceived stress and depressive symptoms.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599364/

Testing the Effectiveness of Adding Group Therapy to Home ... A series of randomized controlled trials (RCTs) has demonstrated that MB reduces the incidence of new cases of major depression, reduces depressive symptoms, ...

5. mental.jmir.org mental.jmir.org/2023/1/e39253/

The Efficacy of Be a Mom, a Web-Based Intervention to ... Concerning adjustment outcomes (depressive and anxiety symptoms), the full constrained model presented globally a poor fit to data (depressive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11773636/

Home visiting for postpartum depression - PubMed Central - NIH Home visiting studies have reported reductions in maternal depressive symptoms even when the home visiting programs did not specifically target ...

7. cdc.gov cdc.gov/pcd/issues/2023/23_0107.htm

Timing of Postpartum Depressive Symptoms We found 7.2% of postpartum women had depressive symptoms at 9 to 10 months after giving birth, 57.4% of whom did not have postpartum depressive ...

8. omh.ny.gov omh.ny.gov/omhweb/statistics/postpartum-depression-screening-report.pdf

Postpartum Depression - New York State Office of Mental Health Patient Health Questionnaire PHQ-2, and PHQ-9; Edinburgh Postpartum Depression ... Maternal, Infant Early Childhood Home Visiting (MIECHV) program ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0266613820302783

The effectiveness of telemedicine interventions, delivered ... Telemedicine interventions significantly decrease postpartum depression symptoms. Women with no history of mental disorders are satisfied with postnatal ...