NCT03627247|Completed
Impact of Stress Management on Cortisol Patterns in Low-Income Pregnant Women
Impact of a Cognitive Behavioral Stress Management Intervention on Cortisol Regulation During Pregnancy
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Impact of a Cognitive Behavioral Stress Management Intervention on Cortisol Regulation During Pregnancy
Sponsor study identifier
interventional
100
0 countries
N/A
Study Start
December 1, 2010
Actual (reported)Primary Completion
August 30, 2014
Actual (reported)Study Completion
August 30, 2014
Actual (reported)PROJECT NARRATIVE: As demonstrated by a growing number of studies, experiencing high levels of stress during pregnancy, including elevated levels of the stress hormone cortisol, can lead to significant long-term health problems for mothers and their infants. The objective of the proposed research is to test whether an innovative stress management intervention, offered during pregnancy, is effective in reducing stress and cortisol levels among low-income pregnant women. The results of the proposed work have substantial public health implications in helping to prevent the onset of stress-related health complications among mothers and their infants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2014
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2010
Actual (reported)August 30, 2014
Actual (reported)August 30, 2014
Actual (reported)July 27, 2018
Actual (reported)August 13, 2018
Actual (reported)Change in Overall Salivary Cortisol Output during Pregnancy and Early Postpartum calculated from seven saliva samples collected on one collection day at each study time point.
The overall amount of cortisol secreted throughout the day was computed using area under the curve (AUC) in nmol/L. Larger numbers of AUC represent a greater amount of cortisol produced throughout the day. Elevated overall cortisol secretion throughout the day (AUC) has been associated with a number of adverse health outcomes. Change in AUC will be examined using mixed methods models throughout each study time point.
Salivary cortisol assessments were conducted at baseline, during the second trimester (i.e., upon completing the eight-week program), third trimester (between 30-32 weeks of pregnancy), and at three months post partum.
Change in Cortisol Awakening Response during Pregnancy and Early Postpartum calculated from seven saliva samples collected on one collection day at each study time point.
The cortisol awakening response (CAR) was computed using the percent increase in morning cortisol in nmol/L. CAR measures the acute rise in cortisol typically seen after waking in the morning with larger numbers representing a greater percent increase in cortisol from waking to 30 minutes after waking. An altered CAR has been associated with a number of adverse health outcomes. Change in CAR will be examined used mixed methods models throughout each study time point.
Salivary cortisol assessments were conducted at baseline, during the second trimester (i.e., upon completing the eight-week program), third trimester (between 30-32 weeks of pregnancy), and at three months post partum.
Change in Perceived Stress during Pregnancy and Early Postpartum. One total perceived stress score will be calculated using Cohen's Perceived Stress Scale, which is a questionnaire completed by participants at each study time point.
Perceived stress assessments were conducted at baseline, during the second trimester (i.e., upon completing the eight-week program), third trimester (between 30-32 weeks of pregnancy), and at three months post partum.
Women randomized to CBSM participated in an eight-week prenatal course called SMART Moms (Stress Management and Relaxation Training for Moms) aimed at teaching coping and relaxation skills that address stressors and daily challenges experienced during pregnancy and motherhood.
Women randomized to the AC group participated in an eight-week program where they received printed materials (offered in Spanish and English) by mail once per week, on common prenatal health information topics (e.g., common discomforts of pregnancy, labor and delivery) chosen from the March of Dimes Foundation's "Becoming a Mom" handouts (March of Dimes, 2011). Women in this group were contacted once per week by phone by a research staff member to make sure that they received their mailed prenatal health information and to see if they had any questions.
Interactive activities (e.g., role-playing, use of physical props to introduce concepts related to coping and stress) were designed for each class to optimize participant engagement and understanding of the course material while tailoring class content to the stressors commonly reported by participants. Each week, participants were given coping and relaxation skills to practice at home (e.g., cognitive reappraisal, diaphragmatic breathing) and were asked to record their experiences on an activity log that was collected and discussed in class the following week. Course content was taught from a detailed training manual (Urizar \& Kofman, 2012).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Scheyer K, Urizar GG Jr. Altered stress patterns and increased risk for postpartum depression among low-income pregnant women. Arch Womens Ment Health. 2016 Apr;19(2):317-28. doi: 10.1007/s00737-015-0563-7. Epub 2015 Aug 15.
Guido Urizar, PhD
California State University, Long Beach
100 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2018
First Posted
August 13, 2018
Study Start
The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment
Smartphone Message to Improve the Drug Compliance in Pregnant Women.
Change in Diurnal Cortisol Slope during Pregnancy and Early Postpartum calculated from seven saliva samples collected on one collection day at each study time point.
Diurnal cortisol slope was estimated by calculating the change in cortisol from waking to 8PM in nmol/L, with larger numbers representing a flatter diurnal cortisol slope (i.e., smaller decrease in cortisol levels across the day). A flatter diurnal cortisol slope has been associated with a number of adverse health outcomes. Change in diurnal cortisol slope will be examined using mixed methods models throughout each study time point.
Salivary cortisol assessments were conducted at baseline, during the second trimester (i.e., upon completing the eight-week program), third trimester (between 30-32 weeks of pregnancy), and at three months post partum.
Contact the study team to confirm eligibility.
December 1, 2010
Primary Completion
August 30, 2014
Actual (reported)Study Completion
August 30, 2014
Actual (reported)Last Updated
August 13, 2018
Record last verified: 2018-08
Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared. Data not available / The data that has been used is confidential
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Source: ClinicalTrials.gov.
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