Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

Stress Disorder Clinical Trial

Official title:

Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328665
• Other study ID #: SCUIRB03282011-1
• Status: Completed
• Phase: N/A
• First received: March 30, 2011
• Last updated: May 17, 2013
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Santa Clara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project evaluates the effectiveness of an intervention sought to reduce the physical effects of stress related to those issues that individuals cannot successfully communicate with anyone about. To do this, the investigators will be implementing a writing intervention over the course of the 6-week study. The investigators will be asking all participants to complete questionnaires over the course of the study period. The investigators are also asking participants to provide a small blood sample (from a fingerstick procedure) at two times during the study as well as saliva samples during that same time. The primary research question asks if this intervention procedure is effective. The investigators are evaluating total cholesterol, high sensitivity c-reactive protein, and cortisol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 110 pounds in weight

• Ability to fast for 8 hours prior to laboratory visit

• Staff member at Santa Clara University

• Certain level of inclusionary pretest stress measure

Exclusion Criteria:

• Hepatitis

• Endocrine Disease

• Kidney or Liver Disease

• Cancer (in any form)

• Cushing's disorder

• Rheumatological disorders

• Respiratory Disorders

• Diabetes

• High blood pressure

• Low blood pressure

• Heart or cardiovascular problems

• Chemotherapy

• Current use of alpha or beta blockers, steroids, or hormone replacements

• Pregnant and/or breastfeeding mothers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorder
• Stress Disorders, Traumatic

Intervention

Other:
• Expressive Writing
Writing intervention for cognitive appraisal of stressor.

Locations

Country	Name	City	State
United States	Santa Clara University, Health Center	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
Santa Clara University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Floyd, K., Boren, J. P., Hannawa, A. F., Hesse, C., McEwan, B., & Veksler, A. E. (2009). Kissing in marital and cohabiting relationships: Effects on blood lipids, stress, and relationship satisfaction. Western Journal of Communication, 73(2), 113 - 133. doi: 10.1080/10570310902856071

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lipids from baseline	Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.	Week 1 and Week 6	No
Primary	Change in high-sensitivity c-Reactive Protein from baseline		Week 1 and Week 6	No
Primary	Change in Cortisol Awakening Response from Baseline	Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.	Week 1 and Week 6	No
Secondary	Change in Perceived Global Stress over time	Psychological measure of stress	Week 1, Week 3, Week 6	No
Secondary	Change in Organizational Stress over time	Psychological measure of stress as a function of organizational involvement.	Week 1, Week 3, Week 6	No
Secondary	Change in Perception of Communication Restriction of Stressor over time	Restrictedness of a communicative stressor	Week 1, Week 3, Week 6	No