An interventional study of Digital Mindfulness Training in Postpartum Psychiatric Disorders, sponsored by Nina Ayala. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Nina Ayala · Not applicable, Interventional, and Treatment
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.
This randomized clinical trial of nulliparous women with low dispositional optimism in early pregnancy seeks to determine whether use of a pregnancy-oriented digital mindfulness application will be feasible and acceptable and show preliminary evidence of efficacy in improving dispositional optimism, reducing adverse perinatal outcomes and improving postpartum post-traumatic stress symptoms.
This pilot will include 100 women recruited from the obstetrical service at Women and Infants Hospital of Rhode Island. Women will be included if they are nulliparous, have a singleton pregnancy at \<20 weeks gestational age, speak English and have low dispositional optimism (a score of ≤14 on the validated, Revised Life Orientation Test). Eligible participants will be randomized to either using the digital app Expectful or standard pregnancy care.
Women will be randomized with equal probability to the intervention group using block randomization stratified by race/ethnicity (Hispanic, non-Hispanic White/Other or non-Hispanic Black).
Women in the mindfulness training arm will complete 8 weeks of daily mindfulness training exercises using Expectful. Women in the standard care group will receive standard pregnancy and postpartum care. Pregnancy and labor management will be at the discretion of each participant's obstetric provider.
Participants in both groups will be asked to complete 4 questionnaires: one at enrollment, a post-intervention one at 8 weeks, at the time of delivery and at 6-8 weeks postpartum. Half of the participants in each arm (total n=50), will be asked to complete a qualitative, semi-structured interview on the role of optimism and other resilience factors in pregnancy.
This is the only study on the registry with Nina Ayala as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
App-based daily mindfulness training Standard prenatal and pregnancy care
Behavioral: Digital Mindfulness Training
Standard prenatal and pregnancy care
Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
Percentage of participants completing the assigned mindfulness exercises
The intervention will be considered feasible if ≥75% participants complete \>50% of the assigned daily mindfulness exercises over the 8-week intervention period
Time frame: 8-week intervention period
Intervention acceptability
The intervention will be considered acceptable if ≥75% report "satisfied" or "very satisfied" on a post-intervention consumer satisfaction survey with a 5-point Likert scale from very unsatisfied to very satisfied.
Time frame: After 8 week intervention period, approximately 16-28 weeks gestation.
Dispositional optimism
Change in dispositional optimism score (on validated Revised Life Orientation Test, scale range 0-24, higher scores indicate higher optimism) between enrollment and postpartum assessments
Time frame: Study enrollment and 6-12 weeks postpartum
Cesarean delivery
Binary yes/no
Time frame: Delivery
Hypertensive disorder of pregnancy
Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia
Time frame: 6-12 weeks postpartum
Gestational diabetes mellitus
Binary yes/no
Time frame: Delivery
Preterm birth
Binary yes/no; Delivery between 20w0d and 36w6d gestation
Time frame: Delivery
Traumatic birth
Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant
Time frame: Delivery
Postpartum post-traumatic stress symptoms
Continuous scale score using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5, scale range 0-80, higher scores indicate worse post-traumatic stress symptoms)
Time frame: 6-12 weeks postpartum
Plan to share: No
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