CARE Program for Postpartum Mental Health

(PMAD-CARE Trial)

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

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

What data supports the effectiveness of the CARE Parenting Program treatment for postpartum mental health?

The CARE Parenting Program may be effective because similar mentalization-based programs have been positively evaluated for improving parental skills and reducing stress in parents with mental illness, as seen in the Lighthouse Parenting Program study. ^{1 2 3 4 5}

How is the CARE Parenting Program treatment different from other treatments for postpartum mental health?

The CARE Parenting Program is unique because it involves both mothers and their infants in the treatment process, focusing on improving maternal-infant attachment and mental health through a collaborative group intervention, unlike most programs that only include the mother. ^{2 6 7 8 9}

What is the purpose of this trial?

This trial is testing a group therapy program called CARE for parents with postpartum depression or anxiety. The program helps parents understand their own and their baby's thoughts and feelings to improve mental health and reduce stress. The study targets parents with infants aged 3 to 12 months who are receiving care at Montefiore Medical Center.

Research Team

Amanda Zayde, Psy.D.

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Outpatient psychotherapy for mothers--a new treatment. [2018]

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

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

3. England 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Innovative psycho-educational program to prevent common postpartum mental disorders in primiparous women: a before and after controlled study. [2023]

6. United States 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. [2021]

7. England 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. [2020]

8. Austria pubmed.ncbi.nlm.nih.gov

A psychiatric mother-baby day hospital for pregnant and postpartum women. [2016]

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

State mandates regarding postpartum depression. [2015]