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Clinical Trials/NCT01328665
NCT01328665
Completed
Not Applicable

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

Santa Clara University1 site in 1 country44 target enrollmentApril 2011
ConditionsStress Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorder
Sponsor
Santa Clara University
Enrollment
44
Locations
1
Primary Endpoint
Change in Lipids from baseline
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
June 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Santa Clara University
Responsible Party
Principal Investigator
Principal Investigator

Justin P. Boren

Assistant Professor

Santa Clara University

Eligibility 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
  • High blood pressure
  • Low blood pressure
  • Heart or cardiovascular problems

Outcomes

Primary Outcomes

Change in Lipids from baseline

Time Frame: 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

Time Frame: Week 1 and Week 6

Change in Cortisol Awakening Response from Baseline

Time Frame: Week 1 and Week 6

Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.

Secondary Outcomes

  • Change in Perceived Global Stress over time(Week 1, Week 3, Week 6)
  • Change in Organizational Stress over time(Week 1, Week 3, Week 6)
  • Change in Perception of Communication Restriction of Stressor over time(Week 1, Week 3, Week 6)

Study Sites (1)

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