NCT01328665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 20, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

March 30, 2011

Last Update Submit

May 17, 2013

Conditions

Stress Disorder

Outcome Measures

Primary Outcomes (3)

  • Change in Lipids from baseline

    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

    Week 1 and Week 6

  • 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.

    Week 1 and Week 6

Secondary Outcomes (3)

  • Change in Perceived Global Stress over time

    Week 1, Week 3, Week 6

  • Change in Organizational Stress over time

    Week 1, Week 3, Week 6

  • Change in Perception of Communication Restriction of Stressor over time

    Week 1, Week 3, Week 6

Study Arms (2)

Expressive Writing

EXPERIMENTAL

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

Other: Expressive Writing

No writing

NO INTERVENTION

Control Group -- No writing

Interventions

Expressive WritingOTHER

Writing intervention for cognitive appraisal of stressor.

Expressive Writing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pounds in weight
  • Ability to fast for 8 hours prior to laboratory visit
  • Staff member at Santa Clara University

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Clara University, Health Center

Santa Clara, California, 95053, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Justin P Boren, Ph.D.

    Santa Clara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 5, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 20, 2013

Record last verified: 2013-05

Locations

US(1)