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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
238
Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
Women's Specialist of PLLC
Webster, Texas, United States
RECRUITINGAnxiety
Self Report questionnaire GAD-7
Time frame: Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Depression
Self Report questionnaire CES-D
Time frame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Stress
Self Report questionnaire-PSS
Time frame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Coping levels
Self Report questionnaire The Brief Cope
Time frame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
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.
Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time frame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
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.
Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time frame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.
Time frame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
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