Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

• Sponsor: Santa Clara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01328665
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorder	Other: Expressive Writing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expressive Writing Affectionate Writing Intervention for 20 minutes per day, 2 times per week, 6 weeks.	Other: Expressive Writing; Writing intervention for cognitive appraisal of stressor.
No Intervention: No writing Control Group -- No writing

Outcome Measures

Primary Outcome Measures

1. Change in Lipids from baseline [Week 1 and Week 6]

   Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.

2. Change in high-sensitivity c-Reactive Protein from baseline [Week 1 and Week 6]

3. 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

1. Change in Perceived Global Stress over time [Week 1, Week 3, Week 6]

   Psychological measure of stress

2. Change in Organizational Stress over time [Week 1, Week 3, Week 6]

   Psychological measure of stress as a function of organizational involvement.

3. Change in Perception of Communication Restriction of Stressor over time [Week 1, Week 3, Week 6]

   Restrictedness of a communicative stressor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Clara University, Health Center	Santa Clara	California	United States	95053

Sponsors and Collaborators

• Santa Clara University

Investigators

• Principal Investigator: Justin P Boren, Ph.D., Santa Clara University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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

• Responsible Party: Justin P. Boren, Assistant Professor, Santa Clara University
• ClinicalTrials.gov Identifier: NCT01328665
• Other Study ID Numbers: SCUIRB03282011-1
• First Posted: Apr 5, 2011
• Last Update Posted: May 20, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Stress Disorders, Traumatic

Study Results

No Results Posted as of May 20, 2013