Clinical trial NCT05840900: Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
Official title: Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Psychiatric Disorders
Keywords: dispositional optimism
mindfulness
adverse perinatal outcomes
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
First posted: 2023-05-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants completing the assigned mindfulness exercises
timeFrame: 8-week intervention period
measure: Intervention acceptability
timeFrame: After 8 week intervention period, approximately 16-28 weeks gestation.
Secondary outcomes:
measure: Dispositional optimism
timeFrame: Study enrollment and 6-12 weeks postpartum
measure: Cesarean delivery
timeFrame: Delivery
measure: Hypertensive disorder of pregnancy
timeFrame: 6-12 weeks postpartum
measure: Gestational diabetes mellitus
timeFrame: Delivery
measure: Preterm birth
timeFrame: Delivery
measure: Traumatic birth
timeFrame: Delivery
measure: Postpartum post-traumatic stress symptoms
timeFrame: 6-12 weeks postpartum
Other outcomes:
Locations:
city: Providence
country: United States
facility: Obstetrics and Gynecology Care Center
state: Rhode Island
city: Providence
country: United States
facility: Prenatal Diagnosis Center
state: Rhode Island
Study officials:
References: