Impact of Stress Management on Cortisol Patterns in Low-Income Pregnant Women

Pregnancy Related Clinical Trial

Official title:

Impact of a Cognitive Behavioral Stress Management Intervention on Cortisol Regulation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627247
• Other study ID #: 07373610
• Status: Completed
• Phase: N/A
• Start date: December 1, 2010
• Est. completion date: August 30, 2014

Study information

• Verified date: August 2018
• Source: California State University, Long Beach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PROJECT SUMMARY: As demonstrated by a growing number of studies, stress experienced during pregnancy can lead to significant long-term health problems for mothers and their infants. One biological mechanism that has been identified in heightening a woman's risk for developing stress-related health complications during pregnancy and the postpartum period is the stress hormone cortisol. However, the best methods for regulating cortisol, in order to optimize maternal and infant health outcomes, have received little attention. The objective of the proposed research is to conduct a two-arm, pilot randomized controlled study to test the efficacy of a prenatal cognitive behavioral stress management (CBSM) intervention in regulating cortisol and stress levels among low-income pregnant women. A total of 100 women will be randomized to either a group-based, 8-week prenatal CBSM arm (i.e., cognitive coping and relaxation skills training) or a standard-of-care comparison arm (i.e., usual pre- and postnatal care) to examine whether women receiving the CBSM intervention will have significantly lower cortisol output and stress levels, relative to women randomized to the standard-of-care comparison arm. This study will also examine whether these decreases in cortisol and stress levels are mediated through behavior change processes (e.g., increased self-efficacy and use of cognitive coping and relaxation skills). This hypothesis has been formulated on the basis of preliminary data collected by the principal investigator and study collaborators. Through formative research, this pilot work will develop and empirically test a prenatal CBSM stress management intervention among low-income pregnant women for use in local prenatal centers. The results of the proposed work have substantial public health implications and are expected to advance the investigator's understanding of how pregnant women effectively use these cognitive coping and relaxation skills to adopt healthy behaviors and produce change that can positively impact their health, as well as that of their infant. Further, the proposed research will yield a CBSM intervention that can be readily delivered in community settings, is scalable, and is relatively low cost. Finally, these results will help identify those subgroups of pregnant women that may do particularly well (or poorly) with these innovative approaches to stress management. This has important implications for the tailoring of CBSM programs to individual needs and preferences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2014
• Est. primary completion date: August 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• less than 17 weeks pregnant

• fluent in either Spanish or English

Exclusion Criteria:

• Major medical problems (e.g., gestational diabetes, major depression)

• Taking medications that may interfere with cortisol levels (e.g., asthma inhaler, antidepressants).

Related Conditions & MeSH terms

• Pregnancy Related
• Stress, Physiological

Intervention

Behavioral:
• Cognitive Behavioral Stress Management
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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
California State University, Long Beach	University of California, Irvine, University of California, Los Angeles

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Secondary	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 was assessed using the 14-item version of the Perceived Stress Scale (PSS-14; Cohen & Williamson, 1988). The PSS-14 measures the degree to which situations in one's life over the past month were appraised as stressful, with higher scores (range = 0-56) reflecting higher stress levels. The PSS-14 has shown good test-retest reliability and internal consistency in both general and pregnancy populations (Huizink et al., 2002) and has demonstrated sensitivity to changes in the perceived stress levels of pregnant women receiving a relaxation intervention (Bastani et al., 2005). The PSS-14 demonstrated good internal consistency across the four time points in the current study (a range = 0.74-0.75). Change in total perceived stress will be examined used mixed methods models throughout 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.