Stress DisorderNCT01328665
Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors
A study testing Expressive Writing in people with Stress Disorder, run by Santa Clara University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorder
- What is being tested?
- Expressive Writing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hepatitis
- Endocrine Disease
- Kidney or Liver Disease
- Cancer (in any form)
- Cushing's disorder
- Rheumatological disorders
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Clara University, Health Center
Santa Clara, California, 95053
About this study
Official title: 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.
- Conditions
- Stress Disorder
- Being tested
- Expressive Writing
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingOther
Writing intervention for cognitive appraisal of stressor.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Writing | Experimental | Affectionate Writing Intervention for 20 minutes per day, 2 times per week, 6 weeks. Receives: Other: Expressive Writing |
| No writing | No intervention | Control Group -- No writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lipids from baseline
Lipid panel includes total cholesterol, High-density lipoproteins, low-density lipoprotein, and triglycerides.
Measured: Week 1 and Week 6
Change in high-sensitivity c-Reactive Protein from baseline
Measured: 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.
Measured: Week 1 and Week 6
Secondary outcomes (3)
Change in Perceived Global Stress over time
Psychological measure of stress
Measured: Week 1, Week 3, Week 6
Change in Organizational Stress over time
Psychological measure of stress as a function of organizational involvement.
Measured: Week 1, Week 3, Week 6
Change in Perception of Communication Restriction of Stressor over time
Restrictedness of a communicative stressor
Measured: Week 1, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Clara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin P. Boren, Santa Clara University
- Investigators
- Justin P Boren, Ph.D., Principal investigator, Santa Clara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328665
- Sponsor's protocol ID
- SCUIRB03282011-1
- Status last verified
- May 2013
- First submitted
- 30 Mar 2011
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Expressive Writing Intervention About Communicatively-Restricted Organizational Stressors: A Six-Week Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01328665
- Acronym / sponsor ID
- SCUIRB03282011-1
- Conditions
- Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Santa Clara UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing | Experimental | Other: Expressive WritingAffectionate Writing Intervention for 20 minutes per day, 2 times per week, 6 weeks. |
| No writing | No intervention | –Control Group -- No writing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Hepatitis
- Endocrine Disease
- Kidney or Liver Disease
- Cancer (in any form)
- Cushing's disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive WritingWriting intervention for cognitive appraisal of stressor. | Other | Expressive Writing |
Primary outcome
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.
Change in high-sensitivity c-Reactive Protein from baseline
Time frame: 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.
3 secondary outcomes
Change in Perceived Global Stress over time
Time frame: Week 1, Week 3, Week 6
Change in Organizational Stress over time
Time frame: Week 1, Week 3, Week 6
Change in Perception of Communication Restriction of Stressor over time
Time frame: Week 1, Week 3, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- BackgroundFloyd, 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin P Boren, Ph.D. principal investigator
Santa Clara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing in people with Stress Disorder, run by Santa Clara University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lipids from baseline (time frame: Week 1 and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01328665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.