Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Nina Ayala
Study ID
NCT05840900
Status
Recruiting
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Conditions

  • Postpartum Psychiatric Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Mindfulness Training — BEHAVIORAL
    Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful

Study Details

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.

Key Dates

Start date
Feb 20, 2024
Status verified
Aug 2025
Primary completion
Apr 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: App-based mindfulness training
    App-based daily mindfulness training Standard prenatal and pregnancy care
  • No Intervention: Usual Care
    Standard prenatal and pregnancy care

Primary Outcome Measure

Percentage of participants completing the assigned mindfulness exercises [ Time Frame: 8-week intervention period ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Obstetrics and Gynecology Care CenterProvidenceRhode Island02905
Nina K. Ayala, MD
Prenatal Diagnosis CenterProvidenceRhode Island02905
Nina K. Ayala, MD

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Obstetrics and Gynecology Care Center· Providence, RIPrenatal Diagnosis Center· Providence, RI