Healing at Home for Postpartum Depression

(HEALED Trial)

Recruiting in Philadelphia (>99 mi)

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

Trial Summary

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 data supports the effectiveness of the Healing @ Home Program (H@H 2.0) treatment for postpartum depression?

The effectiveness of the Healing @ Home Program (H@H 2.0) for postpartum depression may be supported by similar treatments like Listening Visits, which have shown significant reductions in depression and improvements in life satisfaction for postpartum women. Additionally, internet-based cognitive behavior therapy and online workshops have been found to be promising interventions for postpartum depression, offering flexibility and accessibility. ^{1 2 3 4 5}

Is the Healing at Home program safe for humans?

The available research on similar home-based and digital interventions for postpartum depression, like the Mothers and Babies Online Course and Listening Visits, suggests they are generally safe and well-received by participants, with no significant safety concerns reported. ^{1 2 6 7 8}

How is the Healing @ Home Program (H@H 2.0) treatment different from other treatments for postpartum depression?

The Healing @ Home Program (H@H 2.0) is unique because it is a home-based intervention specifically designed for postpartum depression, potentially offering more accessible and personalized support compared to traditional in-person therapy sessions. This approach may incorporate elements from various psychological therapies, such as cognitive behavioral therapy, and is delivered in the comfort of the patient's home, which can be more convenient and less stigmatizing for new mothers. ^{1 4 9 10 11}

What is the purpose of this 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 symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) compared to usual postpartum care for patients of color.

Research Team

Kirstin Leitner, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Listening visits: an evaluation of the effectiveness and acceptability of a home-based depression treatment. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Client experiences of guided internet cognitive behavior therapy for postpartum depression: a qualitative study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Antepartum Services and Symptoms of Postpartum Depression in At-Risk Women. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Perinatal depression prevention through home visitation: a cluster randomized trial of mothers and babies 1-on-1. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Barriers to postpartum depression prevention and treatment: a policy analysis. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Mamma mia: a feasibility study of a web-based intervention to reduce the risk of postpartum depression and enhance subjective well-being. [2022]

10. Austria pubmed.ncbi.nlm.nih.gov

A systematic review of home-based interventions to prevent and treat postpartum depression. [2018]

11. Canada pubmed.ncbi.nlm.nih.gov

Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression via the Mothers and Babies Course: Protocol for a Cluster-Randomized Controlled Trial. [2020]