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Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Justin P. Boren, Santa Clara University
ClinicalTrials.gov Identifier:
NCT01328665
First received: March 30, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Stress Disorder
 Other: Expressive Writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial

Further study details as provided by Santa Clara University:

Primary Outcome Measures:
  • Change in Lipids from baseline [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
    Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.

  • Change in high-sensitivity c-Reactive Protein from baseline [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
  • Change in Cortisol Awakening Response from Baseline [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
    Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.


Secondary Outcome Measures:
  • Change in Perceived Global Stress over time [ Time Frame: Week 1, Week 3, Week 6 ] [ Designated as safety issue: No ]
    Psychological measure of stress

  • Change in Organizational Stress over time [ Time Frame: Week 1, Week 3, Week 6 ] [ Designated as safety issue: No ]
    Psychological measure of stress as a function of organizational involvement.

  • Change in Perception of Communication Restriction of Stressor over time [ Time Frame: Week 1, Week 3, Week 6 ] [ Designated as safety issue: No ]
    Restrictedness of a communicative stressor


Enrollment: 44
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328665

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: Justin P. Boren, Assistant Professor, Santa Clara University
ClinicalTrials.gov Identifier: NCT01328665     History of Changes
Other Study ID Numbers: SCUIRB03282011-1
Study First Received: March 30, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013