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

NCT ID: NCT03627247

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-01
• Study Completion Date: 2014-08-30

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.

Detailed 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.

Conditions

Pregnancy Related; Stress, Physiological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Stress Management

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Stress Management

Intervention Type: 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).

Attention Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

California State University, Long Beach

OTHER

Sponsor Role: lead

Responsible Party

Guido Urizar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guido Urizar, PhD

Role: PRINCIPAL_INVESTIGATOR

California State University, Long Beach

References

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.

Reference Type: RESULT

PMID: 26275372 (View on PubMed)

Other Identifiers

07373610

Identifier Type: -

Identifier Source: org_study_id