Recruiting

Mindfulness, Optimism, Resilience

Sponsor:

Nina Ayala

Code:

NCT05840900

Conditions

Postpartum Psychiatric Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Mindfulness Training

Study Details

Brief summary:

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.

Conditions

Postpartum Psychiatric Disorders

Study ID

NCT05840900

Start date

Feb 20, 2024

Status verified date

Aug, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to provide informed consent
  • English speaking
  • Nulliparous (no prior delivery at or greater than 20w0d gestation)
  • Pregnant with singleton fetus
  • <20w0d gestation
  • Low dispositional optimism (score </= 14 on the Revised Life Orientation Test)
  • Owns a smart phone

Exclusion Criteria:

  • Plan to deliver at another institution
  • Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga
  • Pre-gestational hypertensive disorder
  • Pre-gestational diabetes mellitus

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Digital Mindfulness Training

Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful

Primary outcome measure

  • Percentage of participants completing the assigned mindfulness exercises [ Time Frame: 8-week intervention period ]
  • Intervention acceptability [ Time Frame: After 8 week intervention period, approximately 16-28 weeks gestation. ]

Central Contacts and Locations

Central contacts

Nina K Ayala, MD, MSCR

401-274-1100nayala@carene.org

Emily S Miller, MD, MPH

401-274-1100emmiller@carene.org

Locations

Obstetrics and Gynecology Care Center

Recruiting

Providence, Rhode Island, United States, 02905

Prenatal Diagnosis Center

Recruiting

Providence, Rhode Island, United States, 02905

More Information

Sponsor

Nina Ayala

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • dispositional optimism
  • mindfulness
  • adverse perinatal outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nina Ayala on 2025-08-24.