CARE Program for Postpartum Mental Health

(PMAD-CARE Trial)

No longer recruiting at 1 trial location

Overseen By Amanda Zayde, Psy.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Psychosis, Mania, Severe cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group therapy program called the Connecting and Reflecting Experience (CARE) to determine its effectiveness for parents with postpartum mood or anxiety disorders, such as postpartum depression. The researchers aim to assess whether the program is likable, feasible, and beneficial for mental health, reducing parenting stress, and enhancing the bond with their baby. Eligibility includes those who have given birth in the last 3 to 12 months, are receiving postpartum care at Montefiore Medical Center, and have experienced postpartum depression or anxiety. Participants will attend 12 group therapy sessions and complete surveys about their experiences. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for postpartum parents.

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 group therapy, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What prior data suggests that the CARE parenting program is safe for postpartum parents with PMADs?

Research shows that the Connecting and Reflecting Experience (CARE) parenting program is safe and well-received. Parents and caregivers of older children with mental health issues find it helpful and appealing. Although researchers have not specifically tested it for new parents with mood and anxiety disorders, the program's focus on improving parent-child relationships has succeeded in other groups. No reports link negative effects directly to the CARE program, making it a promising choice for those seeking to enhance mental health and parenting skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE Program for postpartum mental health because it offers a fresh approach through group therapy specifically designed for new parents. Unlike traditional treatments such as medication or one-on-one therapy sessions, the CARE Program facilitates a supportive community environment where participants can connect and reflect on their experiences as new parents. This communal setting aims to provide emotional support and shared understanding, which can be particularly beneficial for addressing the unique challenges of postpartum mental health. The program emphasizes the power of collective healing and shared experiences, which makes it a promising alternative or complement to existing treatment options.

What evidence suggests that the CARE Program is effective for postpartum mental health?

Research has shown that the Connecting and Reflecting Experience (CARE) program, which participants in this trial will receive, has been helpful for parents and caregivers of older children with mental health issues. Although it has not been specifically tested with new parents dealing with postpartum mood and anxiety disorders (PMADs), the program's focus on helping parents understand and manage their own and their children's emotions appears promising. This approach can strengthen parent-child relationships and reduce stress for parents. Early findings suggest that programs like CARE can be appealing and useful, making them worth considering for postpartum mental health challenges. ^{2 3 4 6 7}

Who Is on the Research Team?

Amanda Zayde, Psy.D.

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for postpartum parents who have given birth within the last 3-12 months, are English-speaking, and are currently receiving care at Montefiore Medical Center. It's aimed at those experiencing moderate to high levels of depression or anxiety after childbirth. Parents already in a CARE group or another parenting program, with severe mental health issues needing intense treatment, or current psychosis/mania can't participate.

Inclusion Criteria

English-speaking

I am a parent of a baby aged 3-12 months.

Receiving postpartum OB/GYN or mental health services at Montefiore Medical Center

Exclusion Criteria

You are currently experiencing severe mental health symptoms like hallucinations or extreme mood swings.

You have mental health, memory, or substance abuse problems that require more intense care than just visiting a doctor, such as being in the hospital.

Prior participation in a Connecting and Reflecting Experience (CARE) group at any time

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-session CARE parenting group therapy program

15 weeks

12 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in mental health, parenting stress, and parent-infant bonding after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Connecting and Reflecting Experience (CARE) Program

Trial Overview The study tests the Connecting and Reflecting Experience (CARE) Program—a group therapy designed to improve mental health, reduce parenting stress, and strengthen parent-infant relationships among postpartum parents with mood/anxiety disorders. Participants will attend 12 sessions and complete surveys to assess the program's impact on their well-being.

How Is the Trial Designed?

Group I: Connecting and Reflecting Experience (CARE) Program Experimental Treatment 1 Intervention

Participants will enroll in a 12-session CARE parenting group therapy.

Connecting and Reflecting Experience (CARE) Program is already approved in United States for the following indications:

Approved in United States as Connecting and Reflecting Experience (CARE) Program for:

• Postpartum mood and/or anxiety disorders (PMADs)
• Parenting stress
• Improving parent-infant relationships

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Published Research Related to This Trial

Thirteen states have implemented policies aimed at improving peripartum mental health, including mandates for depression screening and public awareness campaigns.

Despite these policies, evidence suggests they have a limited impact on clinical outcomes for postpartum depression, indicating a need for more effective interventions like home visits that include mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State mandates regarding postpartum depression. Rowan, PJ., Duckett, SA., Wang, JE.[2015]

A multidisciplinary health service intervention program significantly improved postpartum mental health in women, as indicated by a lower Edinburgh Postnatal Depression Scale (EPDS) score in the intervention group compared to the control group (2.74 vs. 4.58, p < 0.001).

The intervention group also had higher engagement in health services, with more women receiving counseling, attending maternal seminars, and receiving home visits from public health nurses, demonstrating the program's effectiveness in enhancing access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated mental health care in a multidisciplinary maternal and child health service in the community: the findings from the Suzaka trial. Tachibana, Y., Koizumi, N., Akanuma, C., et al.[2020]

A new outpatient psychotherapeutic treatment program has been developed specifically for mothers experiencing acute postpartum mental illness, addressing their unique needs during the perinatal period.

Empirical results suggest that this outpatient program is an effective alternative to hospitalization, allowing mothers to receive necessary treatment without being separated from their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient psychotherapy for mothers--a new treatment. Kersting, A., Fisch, S., Arolt, V.[2018]

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]

The newly adapted Lighthouse-Parenting Program aims to enhance the mentalizing abilities of parents with mental illnesses, which is crucial for improving their caregiving skills and the parent-child relationship.

Initial pilot testing suggests that the program is a promising and easily implementable approach within existing mental health care systems, with plans for a randomized controlled trial to further evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. Volkert, J., Georg, A., Hauschild, S., et al.[2019]

The 'Together in Mind' program, a 6-week psychoeducation intervention for mothers with moderate to severe mental illness and their infants, showed statistically significant improvements in maternal mental health and parenting confidence, with large to medium effect sizes across various measures.

The program's collaborative approach, involving perinatal mental health clinicians and child health nurses, effectively strengthened the maternal-infant relationship, highlighting the importance of early intervention in addressing complex mental health issues during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a collaborative group intervention for mothers with moderate to severe perinatal mental illness and their infants in Australia. Irvine, A., Rawlinson, C., Bor, W., et al.[2021]

The study aims to compare the effectiveness of two interventions for perinatal depression: the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the more comprehensive PRogram In Support of Moms (PRISM), which includes MCPAP plus additional support.

This research involves a cluster randomized controlled trial with ongoing recruitment of participants, who will be followed for up to 13 months postpartum, allowing for a thorough examination of depression symptom changes and treatment engagement across different stages of pregnancy and postpartum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. Moore Simas, TA., Brenckle, L., Sankaran, P., et al.[2023]

A brief psycho-educational program for first-time parents significantly reduced the incidence of postpartum mental disorders in women without a psychiatric history, with only 15% diagnosed in the intervention group compared to 29% in the control group.

The study involved 399 women and showed that the program effectively lowered the odds of developing depression or anxiety postpartum, with an adjusted odds ratio of 0.43, indicating a strong protective effect from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative psycho-educational program to prevent common postpartum mental disorders in primiparous women: a before and after controlled study. Fisher, JR., Wynter, KH., Rowe, HJ.[2023]

A novel mother-baby day hospital service was developed to address the mental health needs of pregnant and postpartum women, showing promise in improving the quality and acceptability of care for this population.

Preliminary data from five years of using this specialized service suggest it is an effective and fiscally viable approach to treating perinatal psychiatric disorders, although further research is needed to fully evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A psychiatric mother-baby day hospital for pregnant and postpartum women. Howard, M., Battle, CL., Pearlstein, T., et al.[2016]

Citations

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Consequences of maternal postpartum depression PPD is also defined symptomatically as exceeding a given threshold on a screening measure, such as the Edinburgh Postnatal Depression Scale (EPDS). In general, ...

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A Family-Based Collaborative Care Model for Treatment of ... The FBCCM includes the following two components: (1) a 10-session video-delivered family therapy treatment for perinatal depression and anxiety ...

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A Postpartum Adaptation Study of the Connecting and ... Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy ...

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Postpartum Depression and Maternal Care: Exploring the ... Postpartum depression (PPD) is a common and debilitating mental health condition affecting many mothers worldwide. This review article aims ...

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“Insight at a Cost”: Postpartum Depressed Mothers' ... The Circle of Security-Parenting (COSP™) program is an American psychoeducational intervention designed to improve parental sensitive ...

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Positive Parenting Can Reduce Risk for Postpartum ... A recent study investigated the effectiveness of two pediatric primary care interventions for reducing the risk for postpartum depressive symptoms.