Mental Health Wellness 1, Preterm Birth
Conditions
Keywords
Latina, Pregnancy, Mental Health, Corticotropin Releasing Hormone, Progesterone, Estriol, Gestational age, African American women
Brief summary
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.
Detailed description
To address the gaps related to interventions for Hispanic Mexican American and African American pregnant women, the investigators have developed and successfully pilot tested the Mastery Lifestyle Intervention (MLI): a culturally-relevant, manualized psychosocial group intervention that integrates two evidence-based behavioral therapies - Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). The MLI is a 6-week program designed to be integrated into regular prenatal care to facilitate more comprehensive care delivered by a nurse practitioner (NP) or certified nurse midwife (CNM). We propose the following hypotheses for a randomized controlled trial: Hypothesis 1a: Participants in the 6-week MLI will have decreased depressive symptoms, anxiety, stress, disengaged coping, and increased active coping compared to UC at end-of-treatment and after 6 weeks. Hypothesis 1b: The effects of MLI versus UC on depression, anxiety, stress, acculturative stress, and coping will be mediated via psychological flexibility and moderated by acculturation. Hypothesis 2a: Compared to UC, MLI participants will have significantly lower mean levels of CRH over time from baseline to end-of-treatment. Hypothesis 2b: Compared to UC, MLI participants will have significantly higher progesterone levels and lower estriol levels (higher progesterone/estriol ratios) over time from baseline to end-of-treatment. Hypothesis 3: As compared to UC, infants from mothers in the MLI group will have longer gestational age, greater birth weight, and fewer NICU admissions.
Interventions
BEHAVIORALThe Mastery Lifestyle Intervention
Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
Sponsors
University of Houston
Microgen LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The PI will not be allowed to review any data that is not deidentified. The statistician will also not know which participant is in which group by participant names, only by deidentified data. The clinical outcomes assessor will not know the group the participant has been in or their study number, but will know the participant names to be able to put the clinical outcomes in the database.
Intervention model description
Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Providing informed consent; * Ability to read and speak English * Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care * Self-identification as African American or Hispanics * Age 18 to 45 years * Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen. * Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as administered by clinical staff of the participating provider * Willingness to adhere to the MLI regimen or usual care regimen
Exclusion criteria
After initial review of the electronic health record (EHR): * Major systemic infections such as HIV, hepatitis * \<18 years of age or \>45 years of age * Enrollment in a prenatal program such as the Nurse Family Partnership * Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol * Inability to read English Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant | Self Report questionnaire-PSS |
| Depression | Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant | Self Report questionnaire CES-D |
| Anxiety | Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant | Self Report questionnaire GAD-7 |
| Coping levels | Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant | Self Report questionnaire The Brief Cope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol. | Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation | Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms. |
| To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment. | Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation | Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms. |
| To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment. | Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation | Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To explore the effect of the MLI on infant gestational age at birth | After delivery | Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy. |
| To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit | After Delivery | Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy. |
| To explore the effect of the MLI on infant birthweight | After Delivery | Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy. |
Countries
United States
Contacts
Primary ContactRoberta J. Ruiz, PhD
Backup ContactKathryn Tart, EdD, MSN, RN
Outcome results
None listed