Parenting Intervention for Postpartum Depression

(MInD Trial)

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AB
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Overseen ByJamie Adachi, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing postpartum depression by combining a parenting program with usual care. Researchers compare this combination to usual care alone to determine which is more effective for improving mental health and parenting outcomes. The trial is open to pregnant women who speak English, are between 13-24 weeks into their pregnancy, experience symptoms of depression, and can send and receive text messages. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important mental health research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are receiving ongoing active treatment with psychotropic medications from a mental health specialist, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both treatments in this trial, Perinatal Collaborative Care and Promoting First Relationships-Brief, have been safe in previous studies.

Perinatal Collaborative Care is generally well-tolerated. This program improves mental health care for new mothers and has been used across the United States to support women with perinatal depression. No significant negative effects have been reported from this care model.

Promoting First Relationships-Brief has also proven safe. This program helps build strong early bonds between parents and their babies. One study found that mothers who participated had better interactions with their children. No harmful side effects have been reported in these studies.

Overall, past research indicates both treatments are safe, with no major side effects noted.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for postpartum depression because they focus on strengthening the bond between mother and infant, which is a unique approach compared to traditional treatments like antidepressants and therapy. The Perinatal Collaborative Care combined with Promoting First Relationships-Brief aims to enhance the mother-infant relationship, potentially improving mental health outcomes by fostering emotional connections early on. This approach is different because it integrates caregiving techniques directly into mental health care, offering a holistic strategy that may address both emotional and relational aspects of postpartum depression.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Research has shown that the Promoting First Relationships-Brief program, part of the Maternal Infant Dyadic Care arm in this trial, can help with postpartum depression. One study found that mothers at risk for postnatal depression felt better and developed stronger connections with their babies after participating in this program. These mothers were also less likely to experience worsening depression. By improving the bond between mothers and their infants, the program benefits both mental health and parenting. This suggests the program could be a good option for those dealing with postpartum depression.26789

Who Is on the Research Team?

AS

Amritha S Bhat, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant women aged 18 or older, who are between 13-24 weeks into their pregnancy and have a depression score (EPDS) of 10 or higher. They must be able to send and receive text messages.

Inclusion Criteria

You can use text messages.
Your EPDS score is 10 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MInD intervention or usual collaborative care starting in the second trimester of pregnancy

Up to 9 months
≥6 care manager sessions (≥3 prenatal and ≥3 postpartum)

Follow-up

Participants are monitored for mental health and parenting outcomes postpartum

6 months postpartum
Assessments at 6 weeks, 3 months, and 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Perinatal Collaborative Care
  • Promoting First Relationships-Brief
Trial Overview The study is testing if adding a parenting program called 'Promoting First Relationships-Brief' to the usual care helps improve mental health and parenting outcomes in women with postpartum depression compared to just the usual care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Maternal Infant Dyadic CareExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

The implementation of the COMPASS perinatal collaborative care program significantly increased the rate of antenatal depression screening among women, rising from 33% to 81% after the program was introduced, based on a study of 7,028 women.
Following the program's implementation, women who screened positive for depression were more likely to receive treatment recommendations, with an increase from 44% to 61%, indicating improved care for perinatal depression.
Increased Depression Screening and Treatment Recommendations After Implementation of a Perinatal Collaborative Care Program.Miller, ES., Grobman, WA., Ciolino, JD., et al.[2021]
Postnatal interventions are crucial for preventing the negative effects of postpartum depression on mother-infant relationships, highlighting the need for timely identification and modification of interaction difficulties.
The Baby Happiness, Understanding, Giving and Sharing (HUGS) Programme is a proposed intervention that integrates direct support for mother-infant interactions while considering broader factors like cognitive style and social support, aiming to improve overall relationship quality.
Mother-infant interactions in postpartum depression: an early intervention program.Milgrom, J.[2015]
The MOMCare intervention effectively reduced the risk of postpartum depressive symptoms in women with antenatal depression, regardless of whether they experienced adverse birth events, as shown by similar depression scores between those with and without such events.
In contrast, women receiving the MSS-Plus intervention who experienced adverse birth events showed higher postpartum depression scores, indicating that MOMCare provides better support for this vulnerable group.
Collaborative Care for Perinatal Depression Among Socioeconomically Disadvantaged Women: Adverse Neonatal Birth Events and Treatment Response.Bhat, A., Grote, NK., Russo, J., et al.[2019]

Citations

1.samhsa.govsamhsa.gov/
Home | SAMHSA - Substance Abuse and Mental Health ...SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.
Randomized Trial of Promoting First Relationships® for ...Mothers were eligible if they initiated treatment after mental health screening (depression, anxiety, post-traumatic stress disorder/PTSD) at a community or ...
Oxford CV April 2021associated with both worsening postpartum depression and negative child outcomes. This study will improve usability of a parenting ...
Randomized trial of promoting first relationships for new ...Developmental Psychology, Vol 57(8), Aug 2021, 1228-1241. NLM Title Abbreviation. Dev Psychol. ISSN. 1939-0599(Electronic); 0012-1649(Print) ...
Mothers who were considered at risk of postnatal ...Women who experience mood disorders after the birth of their child need caregiving support to assure the developing relationship with their baby ...
a health services approach to perinatal depression care - PMCOur objective was to integrate lessons learned from perinatal collaborative care programs across the United States, recognizing the diversity of practice ...
A Collaborative Care Model for Perinatal Depression ...Ultimately, less than one out of every ten women with perinatal depression will receive adequate mental health treatment. COMPASS is a perinatal collaborative ...
Associations Between Implementation of the Collaborative ...Implementation of the perinatal collaborative care model is associated with a mitigation of racial disparities in antenatal depression care.
A qualitative examination of the implementation ...We conducted qualitative interviews with 20 patients and 10 stakeholders from Collaborative Care Model for Perinatal Depression Support Services (COMPASS).
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