Mental Health Programs for Pregnancy-Related Depression and Anxiety
(IMPACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two approaches to improve mental health support for depression and anxiety during and after pregnancy. It evaluates the effectiveness of these programs when adapted for diverse communities in Iowa and Indiana. Participants will receive either standard support (Standard Implementation) or enhanced support through home visits (Adapted Facilitation). The trial seeks staff or volunteers working with home visiting programs in these states. As an unphased trial, it offers a unique opportunity to contribute to innovative mental health solutions tailored for diverse communities.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that special support programs for mental health during pregnancy can be safe and effective. Research indicates that these programs, which provide structured help to expectant mothers, can improve mental health. For example, one study found that focusing on mental health during pregnancy helped reduce anxiety and depression. Participants generally handled the programs well, with few reports of negative side effects.
While the specific program under discussion hasn't been detailed in available studies, similar programs have generally been well-received. They often include techniques like relaxation exercises, which studies have shown to lower stress and improve overall mental health in pregnant women. Overall, evidence suggests that these support programs are a safe option for addressing mental health concerns during pregnancy.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to support mental health in pregnant individuals facing depression and anxiety. Unlike the standard of care, which often involves medication or traditional therapy sessions, the "Adapted Facilitation" approach offers a tailored method by training home visiting supervisors to provide specialized support. This method aims to enhance the effectiveness of the existing "Mothers and Babies" program, potentially leading to improved outcomes for mothers. The trial could reveal more about how personalized facilitation in a home setting impacts mental health during pregnancy compared to standard practices.
What evidence suggests that this trial's treatments could be effective for pregnancy-related depression and anxiety?
This trial will compare two approaches to implementing mental health support for pregnancy-related depression and anxiety: Adapted Facilitation and Standard Implementation. Research has shown that integrating mental health support into prenatal care can significantly reduce anxiety and depression. Studies have found that psychological help is more effective than no intervention in lowering anxiety around the time of birth. One study showed that pregnant women using a guided online tool experienced significant improvements in depression and anxiety. Additionally, a mindfulness program for pregnant women successfully reduced anxiety and depression. These findings suggest that mental health programs during pregnancy can enhance emotional well-being.56789
Who Is on the Research Team?
Elissa Z Faro, PhD
Principal Investigator
Hackensack Meridian Health
Are You a Good Fit for This Trial?
This trial is for staff or volunteers currently working with home visiting programs in Iowa or Indiana. Participants must be involved with these programs at the time they join the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implementation Facilitation
Home visitors receive training and support to implement the Mothers and Babies intervention using adapted facilitation strategies.
Standard Implementation
Control arm home visitors receive standard implementation support for the Mothers and Babies intervention.
Follow-up
Participants are monitored for depressive symptoms and intervention fidelity after the implementation phase.
What Are the Treatments Tested in This Trial?
Interventions
- Adapted Facilitation
- Standard Implementation
Trial Overview
The study compares two ways of putting mental health support into practice: an adapted facilitation approach versus standard implementation, to see which works better for improving mental health care in home visiting settings.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Home visitors in the adapted facilitation group will receive standard Mothers and Babies support plus adapted facilitation delivered by home visiting supervisors trained in adapted implementation facilitation.
Control arm home visitors will receive standard Mothers and Babies implementation support from their supervisors.
Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elissa Faro
Lead Sponsor
University of Iowa
Lead Sponsor
Hackensack Meridian Health
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
The efficacy of collaborative psychological interventions in ...
Various studies have shown that the integration of psychological services into antenatal care can achieve great success in overcoming anxiety [ ...
Couples-based interventions for perinatal depression and ...
Six of 12 studies measuring anxiety reported significant reductions, with mixed evidence regarding the role of partner attendance. Studies reported inconsistent ...
Effects of relaxation interventions during pregnancy on ... - PMC
This systematic review and meta-analysis aimed to evaluate their effectiveness in terms of maternal mental health, pregnancy and birth outcomes.
Clinical Outcomes of a Tech-enabled Perinatal Collaborative ...
Despite these limitations, this study demonstrates significant improvements in depression and anxiety symptoms among patients enrolled in a ...
The Effectiveness of a Guided Internet-Based Tool for ...
This study aimed to examine the effectiveness of a guided internet intervention (MamaKits online) for pregnant women with moderate to severe symptoms of ...
Effect of multidisciplinary closed-loop care on pregnancy ...
CONCLUSION. This integrated multidisciplinary closed-loop intervention model effectively improves maternal and infant outcomes and enhanced postpartum recovery ...
The risk and protective factors of heightened prenatal ...
A recent meta-analysis found heightened mental health problems with 43% of pregnant women experiencing anxiety and 32% depression during the ...
An analysis of key factors related to adaptation during ... - PMC
Our study identifies key protective factors against perinatal depression in the third trimester, including imagining a positive future with the ...
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researchgate.net
researchgate.net/publication/377954106_Effect_of_Childbirth_Education_Program_on_Maternal_Anxiety_A_Randomized_Controlled_Trial_Using_Roy's_Adaptation_ModelEffect of Childbirth Education Program on Maternal Anxiety
PDF | Background: Globally, 5.1 - 37.5 % of mothers suffer from anxiety during pregnancy due to adaptation problems.
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