Clinical trial NCT01328665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorder
Lead sponsor: Santa Clara University
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Lipids from baseline
timeFrame: Week 1 and Week 6
measure: Change in high-sensitivity c-Reactive Protein from baseline
timeFrame: Week 1 and Week 6
measure: Change in Cortisol Awakening Response from Baseline
timeFrame: Week 1 and Week 6
Secondary outcomes:
measure: Change in Perceived Global Stress over time
timeFrame: Week 1, Week 3, Week 6
measure: Change in Organizational Stress over time
timeFrame: Week 1, Week 3, Week 6
measure: Change in Perception of Communication Restriction of Stressor over time
timeFrame: Week 1, Week 3, Week 6
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Santa Clara University, Health Center
state: California
Study officials:
affiliation: Santa Clara University
name: Justin P Boren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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