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Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

Primary Purpose

Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive Writing
Sponsored by
Santa Clara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Santa Clara University, Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Expressive Writing

No writing

Arm Description

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

Control Group -- No writing

Outcomes

Primary Outcome Measures

Change in Lipids from baseline
Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.
Change in high-sensitivity c-Reactive Protein from baseline
Change in Cortisol Awakening Response from Baseline
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
Psychological measure of stress
Change in Organizational Stress over time
Psychological measure of stress as a function of organizational involvement.
Change in Perception of Communication Restriction of Stressor over time
Restrictedness of a communicative stressor

Full Information

First Posted
March 30, 2011
Last Updated
May 17, 2013
Sponsor
Santa Clara University
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1. Study Identification

Unique Protocol Identification Number
NCT01328665
Brief Title
Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors
Official Title
Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Clara University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expressive Writing
Arm Type
Experimental
Arm Description
Affectionate Writing Intervention for 20 minutes per day, 2 times per week, 6 weeks.
Arm Title
No writing
Arm Type
No Intervention
Arm Description
Control Group -- No writing
Intervention Type
Other
Intervention Name(s)
Expressive Writing
Intervention Description
Writing intervention for cognitive appraisal of stressor.
Primary Outcome Measure Information:
Title
Change in Lipids from baseline
Description
Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.
Time Frame
Week 1 and Week 6
Title
Change in high-sensitivity c-Reactive Protein from baseline
Time Frame
Week 1 and Week 6
Title
Change in Cortisol Awakening Response from Baseline
Description
Measurement of Salivary Cortisol (hydrocortisone, compound-F) as a maximum difference between awakening and 30 minutes after awakening.
Time Frame
Week 1 and Week 6
Secondary Outcome Measure Information:
Title
Change in Perceived Global Stress over time
Description
Psychological measure of stress
Time Frame
Week 1, Week 3, Week 6
Title
Change in Organizational Stress over time
Description
Psychological measure of stress as a function of organizational involvement.
Time Frame
Week 1, Week 3, Week 6
Title
Change in Perception of Communication Restriction of Stressor over time
Description
Restrictedness of a communicative stressor
Time Frame
Week 1, Week 3, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin P Boren, Ph.D.
Organizational Affiliation
Santa Clara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara University, Health Center
City
Santa Clara
State/Province
California
ZIP/Postal Code
95053
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

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