Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

May 17, 2013 updated by: Justin P. Boren, Santa Clara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Santa Clara, California, United States, 95053
        • Santa Clara University, Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 and Week 6
Change in high-sensitivity c-Reactive Protein from baseline
Time Frame: Week 1 and Week 6
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.
Week 1 and Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • SCUIRB03282011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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