RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-20
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05840900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * English speaking
  3. * Nulliparous (no prior delivery at or greater than 20w0d gestation)
  4. * Pregnant with singleton fetus
  5. * \<20w0d gestation
  6. * Low dispositional optimism (score \</= 14 on the Revised Life Orientation Test)
  7. * Owns a smart phone
  1. * Plan to deliver at another institution
  2. * Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga
  3. * Pre-gestational hypertensive disorder
  4. * Pre-gestational diabetes mellitus

Contacts and Locations

Study Contact

Nina K Ayala, MD, MSCR
CONTACT
401-274-1100
nayala@carene.org
Emily S Miller, MD, MPH
CONTACT
401-274-1100
emmiller@carene.org

Study Locations (Sites)

Obstetrics and Gynecology Care Center
Providence, Rhode Island, 02905
United States
Prenatal Diagnosis Center
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Nina Ayala

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • dispositional optimism
  • mindfulness
  • adverse perinatal outcomes

Additional Relevant MeSH Terms

  • Postpartum Psychiatric Disorders