Mindfulness Training for Postpartum Depression

(MORPHE Trial)

Recruiting at 1 trial location

Overseen By Emily S Miller, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nina Ayala

Disqualifiers: Mind-body practice, Hypertension, Diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

100 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.

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. ^{1 2 3 4 5}

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. ^{2 3 4 5 6}

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. ^{2 4 7 8 9}

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

Exclusion Criteria

I regularly practice mindfulness, meditation, or yoga at least once a week.

Plan to deliver at another institution

Pre-gestational hypertensive disorder

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

Group I: App-based mindfulness training Experimental Treatment 1 Intervention

App-based daily mindfulness training Standard prenatal and pregnancy care

Group II: Usual Care Active Control 1 Intervention

Standard prenatal and pregnancy care

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study involving 168 pregnant women showed that an 8-week smartphone-based mindfulness training significantly improved symptoms of perinatal depression and anxiety compared to a control group, with medium effect sizes observed.

The mindfulness training was particularly beneficial for nulliparous women (first-time mothers), who experienced greater reductions in depression symptoms, indicating that this group may be especially responsive to mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. Sun, Y., Li, Y., Wang, J., et al.[2021]

This study will evaluate the effectiveness of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program, including compassion training, for reducing perinatal depression in 122 pregnant women and their partners in primary care settings.

The trial aims to provide evidence for a low-cost, non-pharmacological intervention that could serve as a preventive measure against mood disorders during pregnancy and postpartum, with outcomes assessed at multiple time points using standardized measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sacristan-Martin, O., Santed, MA., Garcia-Campayo, J., et al.[2020]

The study involved 16 women with probable perinatal depression who participated in an 8-week mindfulness-based program, revealing that mindfulness training helped them become more aware of their physical and emotional changes during and after pregnancy.

Participants reported improved family relationships and greater confidence in managing childbirth challenges, suggesting that mindfulness interventions can be effective in addressing depressive symptoms in perinatal women and should be included in prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Mindfulness Techniques to the Management of Depressive Tendencies in Women in Taiwan in the Perinatal Period: A Qualitative Study. Pan, WL., Gau, ML., Hsu, TC., et al.[2022]

Mindfulness training significantly reduced symptoms of postpartum depression in new mothers, as evidenced by a decrease in Beck Depression Inventory scores from a mean of 24.75 to 18.5 after 8 sessions of training.

In a study involving 67 mothers, the experimental group that received mindfulness training showed a statistically significant improvement (p<0.001) compared to the control group, which did not receive any training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness training on reducing the symptoms of postpartum depression. Sheydaei, H., Ghasemzadeh, A., Lashkari, A., et al.[2020]

Mindfulness-based interventions (MBIs) significantly reduce depressive symptoms in pregnant women, with a strong effect size in both case-control and self-control studies, indicating their potential effectiveness in preventing postpartum depression.

However, MBIs are not effective for high-risk pregnant women with severe depressive symptoms prior to delivery and do not show significant advantages over other intervention methods, suggesting that they may not be suitable for all pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based interventions during pregnancy on postpartum mental health: A meta-analysis. Min, W., Jiang, C., Li, Z., et al.[2023]

In a study of 45 new mothers with postpartum depression (PPD) treated with an SSRI, those who received additional detached mindfulness (DM) or stress management training (SMT) showed significantly greater reductions in depression symptoms compared to those receiving only medication.

The improvements in depression symptoms were not only significant during the 8-week treatment period but also remained stable at the follow-up, indicating that combining psychotherapy with pharmacological treatment can lead to longer-lasting benefits for mothers with PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of adjuvant detached mindfulness and stress management training compared to pharmacologic treatment in primiparae with postpartum depression. Ahmadpanah, M., Nazaribadie, M., Aghaei, E., et al.[2018]

References

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

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]

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

Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Antenatal mobile-delivered mindfulness-based intervention to reduce perinatal depression risk and improve obstetric and neonatal outcomes: A randomized controlled trial. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. [2021]

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

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]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Applying Mindfulness Techniques to the Management of Depressive Tendencies in Women in Taiwan in the Perinatal Period: A Qualitative Study. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness training on reducing the symptoms of postpartum depression. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based interventions during pregnancy on postpartum mental health: A meta-analysis. [2023]

9. Austria pubmed.ncbi.nlm.nih.gov

Influence of adjuvant detached mindfulness and stress management training compared to pharmacologic treatment in primiparae with postpartum depression. [2018]