- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328665
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
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.
|
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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
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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
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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