Postpartum Psychiatric Disorders
Conditions
Keywords
dispositional optimism, mindfulness, adverse perinatal outcomes
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.
Interventions
BEHAVIORALDigital Mindfulness Training
Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
Sponsors
The Miriam Hospital
Nina Ayala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and clinicians will not be blinded, but the outcomes assessor and analytic teams will be blinded to participant allocation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants completing the assigned mindfulness exercises | 8-week intervention period | The intervention will be considered feasible if ≥75% participants complete \>50% of the assigned daily mindfulness exercises over the 8-week intervention period |
| Intervention acceptability | After 8 week intervention period, approximately 16-28 weeks gestation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertensive disorder of pregnancy | 6-12 weeks postpartum | Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia |
| Gestational diabetes mellitus | Delivery | Binary yes/no |
| Dispositional optimism | Study enrollment and 6-12 weeks postpartum | 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 |
| Traumatic birth | Delivery | Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant |
| Postpartum post-traumatic stress symptoms | 6-12 weeks postpartum | 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) |
| Preterm birth | Delivery | Binary yes/no; Delivery between 20w0d and 36w6d gestation |
| Cesarean delivery | Delivery | Binary yes/no |
Countries
United States
Contacts
Primary ContactNina K Ayala, MD, MSCR
Backup ContactEmily S Miller, MD, MPH
Outcome results
None listed