Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

Not Applicable

Completed

• Conditions: Stress Disorder
• Interventions: Other: Expressive Writing

• Registration Number: NCT01328665
• Lead Sponsor: Santa Clara University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-30
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expressive Writing	Expressive Writing	Affectionate Writing Intervention for 20 minutes per day, 2 times per week, 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Lipids from baseline	Week 1 and Week 6	Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.
Change in high-sensitivity c-Reactive Protein from baseline	Week 1 and Week 6
Change in Cortisol Awakening Response from Baseline	Week 1 and Week 6	Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.

Secondary Outcome Measures

Name	Time	Method
Change in Perceived Global Stress over time	Week 1, Week 3, Week 6	Psychological measure of stress
Change in Organizational Stress over time	Week 1, Week 3, Week 6	Psychological measure of stress as a function of organizational involvement.
Change in Perception of Communication Restriction of Stressor over time	Week 1, Week 3, Week 6	Restrictedness of a communicative stressor

Trial Locations

Locations (1)

Santa Clara University, Health Center; 🇺🇸 Santa Clara, California, United States