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CompletedNCT01328665Updated May 20, 2013

Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

An interventional study of Expressive Writing in Stress Disorder, sponsored by Santa Clara University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-20.

Sponsored by Santa Clara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Stress Disorder
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In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

This is the only study on the registry with Santa Clara University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Expressive Writing

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

    Other: Expressive Writing

  • No intervention
    No writing

    Control Group -- No writing

Interventions

  • OtherExpressive Writing

    Writing intervention for cognitive appraisal of stressor.

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What researchers measure

Primary outcomes

  1. Change in Lipids from baseline

    Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.

    Time frame: Week 1 and Week 6

  2. Change in high-sensitivity c-Reactive Protein from baseline

    Time frame: Week 1 and Week 6

  3. 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.

    Time frame: Week 1 and Week 6

Secondary outcomes

  1. Change in Perceived Global Stress over time

    Psychological measure of stress

    Time frame: Week 1, Week 3, Week 6

  2. Change in Organizational Stress over time

    Psychological measure of stress as a function of organizational involvement.

    Time frame: Week 1, Week 3, Week 6

  3. Change in Perception of Communication Restriction of Stressor over time

    Restrictedness of a communicative stressor

    Time frame: Week 1, Week 3, Week 6

07

Study locations

1 site
  • Santa Clara University, Health Center
    Santa Clara, California 95053, United States
08

References and documents

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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01328665
Lead sponsor
Santa Clara University
Responsible party
Justin P. Boren (Assistant Professor, Santa Clara University) — Principal investigator
First posted
Apr 5, 2011
Start date
Apr 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
May 20, 2013

Study contacts

Justin P Boren, Ph.D.
principal investigator · Santa Clara University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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