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Completed

NCT Number: NCT01328665

Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors

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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Key information

Conditions

Stress Disorder Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara University, Health Center

Santa Clara, California, 95053, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

expressive writing

Other

Writing intervention for cognitive appraisal of stressor.

Primary outcomes

  1. 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.

  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

    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

  1. Change in Perceived Global Stress over time

    Time frame: Week 1, Week 3, Week 6

    Psychological measure of stress

  2. Change in Organizational Stress over time

    Time frame: Week 1, Week 3, Week 6

    Psychological measure of stress as a function of organizational involvement.

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

    Time frame: Week 1, Week 3, Week 6

    Restrictedness of a communicative stressor

Sponsors and collaborators

Lead sponsor

Santa Clara University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 5, 2011
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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