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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00468572
Other study ID # R03MH075757
Secondary ID R03MH075757DATR
Status Completed
Phase N/A
First received May 1, 2007
Last updated January 6, 2012
Start date February 2007
Est. completion date December 2007

Study information

Verified date January 2012
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will examine the effects of tending to significant social relationships on managing and reducing stress.


Description:

Stress is a large part of daily modern life; however, it can cause a number of long-term problems for mental and physical health. Recent research has confirmed that there are definite mental and physical health benefits of maintaining significant positive social bonds. Many of these benefits appear to be associated with the ability to regulate stress that is caused by environmental challenges. Drawing on close relationships and expressing affection may help people to recover from stress more effectively. This study will evaluate the tend-and-befriend theory, which suggests that engaging in behaviors aimed at maintaining and strengthening significant social bonds can act as an adaptive response to acute stress.

All participants in this study will undergo a series of standard laboratory stressors designed to elevate cortisol levels. Cortisol, also known as the "stress hormone," is activated and secreted within the body in response to stress. Current research suggests that displaying signs of affection toward a loved one can lower cortisol levels, causing the body to relax and recover from a stressful situation more quickly. After lab tests have been completed, participants will be randomly assigned to an experimental or control group. Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well. Participants will also provide a self-report of their current stress level at the end of the study. Participation in this study will last approximately 2 hours. By examining associations between the communication of affection and responses to acute stress, this study may eventually lead to the development of new and better treatment options for people with constant acute stress.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- English-speaking

- Weigh at least 110 pounds

- Moderate to no anxiety about having blood drawn

Exclusion Criteria:

- Hypertension or diabetes

- Current or recent pregnancy

- Colorblindness

- History of cancer

- Current use of alpha blockers, beta blockers, or steroids

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Affectionate Writing
Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well.
Meaningless Writing
Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Participants will undergo the same testing during the writing session as the experimental group.

Locations

Country Name City State
United States Exercise and Sports Research Institute Tempe Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Floyd K, Mikkelson AC, Tafoya MA, Farinelli L, La Valley AG, Judd J, Haynes MT, Davis KL, Wilson J. Human affection exchange: XIII. Affectionate communication accelerates neuroendocrine stress recovery. Health Commun. 2007;22(2):123-32. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oxytocin levels Measured at Hour 2 No
Primary Cortisol levels Measured at Hour 2 No
Secondary Self-reported stress level Measured at Hour 2 No
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