Parenting Intervention for Postpartum Depression

(MInD Trial)

Overseen By Jamie Adachi, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Washington

Must not be taking: Psychotropic medications

Disqualifiers: Severe substance use, Suicidal ideation, Bipolar, Psychotic disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: Up to 9 months

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Perinatal Collaborative Care for postpartum depression?

Research shows that the Perinatal Collaborative Care model improves depression screening and treatment recommendations, and it helps reduce the impact of negative birth events on postpartum depression, especially among women with lower income. Additionally, it has been effective in reducing racial disparities in depression care and increasing access to treatment for women in rural areas. ^{1 2 3 4 5}

Is the Parenting Intervention for Postpartum Depression safe for humans?

The available research on the collaborative care model for perinatal depression, which includes various forms of parenting interventions, does not report any specific safety concerns for humans. These studies focus on improving access to care and treatment recommendations, suggesting that the interventions are generally considered safe. ^{1 2 3 4 5}

How is the Parenting Intervention for Postpartum Depression treatment different from other treatments?

The Parenting Intervention for Postpartum Depression uses a Perinatal Collaborative Care model, which is a team-based approach integrating behavioral health into perinatal care, and includes Promoting First Relationships-Brief (PFR-Brief) to enhance mother-infant interactions. This approach is unique because it addresses both mental health and parenting skills, and is designed to be accessible even in rural areas through video-delivered sessions. ^{1 2 3 5 6}

What is the purpose of this trial?

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.

Research Team

Amritha S Bhat, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Maternal Infant Dyadic Care Experimental Treatment 2 Interventions

Perinatal collaborative care and Promoting First Relationships-Brief

Group II: Control Active Control 1 Intervention

Perinatal collaborative care only

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Depression Screening and Treatment Recommendations After Implementation of a Perinatal Collaborative Care Program. Miller, ES., Grobman, WA., Ciolino, JD., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The collaborative care model (CoCM) is effective for treating perinatal depression, but its implementation has faced challenges, which this study aimed to address.

The use of longitudinal remote coaching (LRC) as an implementation strategy in a multistate trial showed promise in supporting the CoCM, indicating that LRC could enhance the integration of behavioral health services in perinatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Remote Coaching for Implementation of Perinatal Collaborative Care: A Mixed-Methods Analysis. Bhat, A., Bennett, IM., Bauer, AM., et al.[2021]

The implementation of a perinatal collaborative care model significantly reduced racial disparities in antenatal depression care, as evidenced by improved screening and treatment recommendations for Black individuals compared to before the model was implemented.

In a study of 4,710 pregnant and postpartum individuals, after the model's implementation, there were no significant differences in depression screening or treatment recommendations between Black and White individuals, indicating a more equitable approach to maternal mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Implementation of the Collaborative Care Model and Disparities in Perinatal Depression Care. Snowber, K., Ciolino, JD., Clark, CT., et al.[2023]

The Family-Based Collaborative Care Model (FBCCM) was implemented with 24 mothers and their families, showing significant reductions in maternal depressive and anxiety symptoms, as well as family conflict, over a 6-month period.

The model's feasibility was supported by high attendance rates in therapy sessions (average of 9.79 sessions for mothers and 9.42 for family members), indicating that video-delivered therapy can effectively increase access to care for perinatal women in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Family-Based Collaborative Care Model for Treatment of Depressive and Anxiety Symptoms in Perinatal Women: Results From a Pilot Study. Cluxton-Keller, F., Olson, A.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mother-infant interactions in postpartum depression: an early intervention program. Milgrom, J.[2015]

References

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

Increased Depression Screening and Treatment Recommendations After Implementation of a Perinatal Collaborative Care Program. [2021]

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

Collaborative Care for Perinatal Depression Among Socioeconomically Disadvantaged Women: Adverse Neonatal Birth Events and Treatment Response. [2019]

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

Longitudinal Remote Coaching for Implementation of Perinatal Collaborative Care: A Mixed-Methods Analysis. [2021]

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

Associations Between Implementation of the Collaborative Care Model and Disparities in Perinatal Depression Care. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

A Family-Based Collaborative Care Model for Treatment of Depressive and Anxiety Symptoms in Perinatal Women: Results From a Pilot Study. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Mother-infant interactions in postpartum depression: an early intervention program. [2015]