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

NCT03627247 | Completed

• 1 other identifier: 07373610
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnancy Related; Stress, Physiological

Keywords

cognitive behavioral; stress management; pregnancy; cortisol

Outcome Measures

Primary Outcomes (3)

• 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 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 Outcomes (1)

• 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.

Study Arms (2)

Cognitive Behavioral Stress Management

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Stress Management

Attention Control Group

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Stress Management BEHAVIORAL

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).

Cognitive Behavioral Stress Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• less than 17 weeks pregnant
• fluent in either Spanish or English

You may not qualify if:

• Major medical problems (e.g., gestational diabetes, major depression)
• Taking medications that may interfere with cortisol levels (e.g., asthma inhaler, antidepressants).

Sponsors & Collaborators

• California State University, Long Beach: lead
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator

Related 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.

  PMID: 26275372 RESULT

Study Officials

• Guido Urizar, PhD

  California State University, Long Beach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff completing assessments were blind to participants' study condition
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, pre-test post-test, experimental control group design

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 13, 2018
• Study Start: December 1, 2010
• Primary Completion: August 30, 2014
• Study Completion: August 30, 2014
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share