100 Participants Needed

Mindfulness Training for Postpartum Depression

(MORPHE Trial)

Recruiting at 1 trial location
NK
ES
Overseen ByEmily S Miller, MD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Nina Ayala
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

What data supports the effectiveness of the treatment Digital Mindfulness Training, Mindfulness-Based Intervention, Expectful for postpartum depression?

Research shows that mindfulness-based interventions (MBIs) during pregnancy can reduce the severity of postpartum depression symptoms in the first three months after childbirth. These interventions have been effective in women with a low risk of developing postpartum depression, suggesting potential benefits for broader use.12345

Is mindfulness training safe for postpartum depression?

The research does not provide specific safety data for mindfulness training in postpartum depression, but mindfulness-based interventions are generally considered safe for most people.23456

How is Digital Mindfulness Training different from other treatments for postpartum depression?

Digital Mindfulness Training is unique because it uses a smartphone-based approach to deliver mindfulness exercises, which can be more accessible and convenient for new mothers compared to traditional in-person therapy sessions. This treatment focuses on improving emotion regulation and cognitive control, which are key mechanisms in reducing postpartum depression symptoms.24789

What is the purpose of this trial?

Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.

Eligibility Criteria

This trial is for first-time pregnant mothers with low optimism early in pregnancy (less than 20 weeks), who speak English, can consent, and have a smartphone. They must not have had a prior delivery at or beyond 20 weeks gestation.

Inclusion Criteria

English speaking
Owns a smart phone
Pregnant with singleton fetus
See 4 more

Exclusion Criteria

I regularly practice mindfulness, meditation, or yoga at least once a week.
Plan to deliver at another institution
Pre-gestational hypertensive disorder
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the mindfulness training arm complete 8 weeks of daily mindfulness training exercises using Expectful

8 weeks
4 visits (virtual) for questionnaire completion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum assessments

6-12 weeks postpartum
1 visit (virtual) for postpartum assessment

Treatment Details

Interventions

  • Digital Mindfulness Training
Trial Overview The study tests the use of Expectful, a mindfulness app designed for pregnant women, against standard care to see if it improves optimism and reduces negative outcomes like cesarean deliveries and postpartum stress.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: App-based mindfulness trainingExperimental Treatment1 Intervention
App-based daily mindfulness training Standard prenatal and pregnancy care
Group II: Usual CareActive Control1 Intervention
Standard prenatal and pregnancy care

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nina Ayala

Lead Sponsor

Trials
1
Recruited
100+

The Miriam Hospital

Collaborator

Trials
252
Recruited
39,200+

Findings from Research

Mindfulness-Based Interventions (MBIs) delivered during pregnancy significantly reduce the severity of postpartum depression (PPD) symptoms in the first three months after childbirth, based on a systematic review of six randomized controlled trials involving pregnant women.
The effectiveness of MBIs was particularly notable in women who began the interventions with a low risk of developing PPD, suggesting that MBIs could be a beneficial preventive strategy for at-risk populations.
Mindfulness-Based Interventions During Pregnancy and Long-Term Effects on Postpartum Depression and Maternal Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Trapani, S., Caglioni, M., Villa, G., et al.[2023]
The study is a randomized control trial involving 74 women with a history of major depression, comparing the effectiveness of mindfulness-based cognitive therapy for perinatal depression (MBCT-PD) against standard prenatal care.
The trial aims to explore how MBCT-PD influences emotion regulation and cognitive control, using behavioral assessments and neuroimaging to identify mechanisms that could help prevent postpartum depression.
Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy.Mackiewicz Seghete, KL., Graham, AM., Lapidus, JA., et al.[2023]
A mobile-delivered mindfulness-based intervention (MBI) significantly reduced perinatal depression in 75 pregnant women, with effects lasting into the postpartum period, as evidenced by a substantial decrease in depression scores.
The MBI also correlated with improved obstetric outcomes, including a reduced risk of emergency cesarean sections and higher Apgar scores for newborns, suggesting that addressing maternal mental health can positively impact both mother and baby.
Antenatal mobile-delivered mindfulness-based intervention to reduce perinatal depression risk and improve obstetric and neonatal outcomes: A randomized controlled trial.Leng, LL., Yin, XC., Chan, CLW., et al.[2023]

References

Mindfulness-Based Interventions During Pregnancy and Long-Term Effects on Postpartum Depression and Maternal Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]
Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. [2023]
Antenatal mobile-delivered mindfulness-based intervention to reduce perinatal depression risk and improve obstetric and neonatal outcomes: A randomized controlled trial. [2023]
Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. [2021]
A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. [2020]
Applying Mindfulness Techniques to the Management of Depressive Tendencies in Women in Taiwan in the Perinatal Period: A Qualitative Study. [2022]
The effectiveness of mindfulness training on reducing the symptoms of postpartum depression. [2020]
The effect of mindfulness-based interventions during pregnancy on postpartum mental health: A meta-analysis. [2023]
Influence of adjuvant detached mindfulness and stress management training compared to pharmacologic treatment in primiparae with postpartum depression. [2018]
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