StressNCT00468572
Using Affectionate Communication as a Response to Acute Stress
A study testing Affectionate Writing and Meaningless Writing in people with Stress, run by Arizona State University at 1 site in United States.
Trial summary
This study will examine the effects of tending to significant social relationships on managing and reducing stress. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Affectionate Writing and Meaningless Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2007
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Weigh at least 110 pounds
- Moderate to no anxiety about having blood drawn
Who cannot join
- Hypertension or diabetes
- Current or recent pregnancy
- Colorblindness
- History of cancer
- Current use of alpha blockers, beta blockers, or steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Sports Research Institute
Tempe, Arizona, 85287
About this study
Official title: Affectionate Communication as a Mechanism for Responding to Acute Stress
This study will examine the effects of tending to significant social relationships on managing and reducing stress.
Read the detailed 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.
- Conditions
- Stress
- Being tested
- Affectionate Writing, Meaningless Writing
- Keywords
- Emotion, Oxytocin, Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affectionate WritingBehavioural
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 WritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive treatment with affectionate writing Receives: Behavioral: Affectionate Writing |
| 2 | Active comparator | Participants will receive treatment with meaningless writing Receives: Behavioral: Meaningless Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin levels
Measured: Measured at Hour 2
Cortisol levels
Measured: Measured at Hour 2
Secondary outcomes (1)
Self-reported stress level
Measured: Measured at Hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2007
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 StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Kory Floyd, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468572
- Sponsor's protocol ID
- R03MH075757
- Other IDs
- R03MH075757, DATR A2-A1A
- Status last verified
- Jan 2012
- First submitted
- 1 May 2007
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1080/10410230701454015.
PubMed 17668992
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affectionate Communication as a Mechanism for Responding to Acute Stress
- ClinicalTrials.gov ID
- NCT00468572
- Acronym / sponsor ID
- R03MH075757
- Conditions
- Stress
- Keywords
- Emotion, Oxytocin, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 May 2007 (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 study will examine the effects of tending to significant social relationships on managing and reducing stress.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Affectionate WritingParticipants will receive treatment with affectionate writing |
| 2 | Active comparator | Behavioral: Meaningless WritingParticipants will receive treatment with meaningless writing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Weigh at least 110 pounds
- Moderate to no anxiety about having blood drawn
Key exclusion criteria (5 listed)
- Hypertension or diabetes
- Current or recent pregnancy
- Colorblindness
- History of cancer
- Current use of alpha blockers, beta blockers, or steroids
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 |
|---|---|---|
| Affectionate WritingParticipants 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. | Behavioural | 1 |
| Meaningless WritingParticipants 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. | Behavioural | 2 |
Primary outcome
Oxytocin levels
Time frame: Measured at Hour 2
Cortisol levels
Time frame: Measured at Hour 2
1 secondary outcome
Self-reported stress level
Time frame: Measured at Hour 2
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 10 Jan 2012.
- Background: PubMed 17668992Floyd 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. doi: 10.1080/10410230701454015.
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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.
Kory Floyd, PhD principal investigator
Arizona State 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 Affectionate Writing and Meaningless Writing in people with Stress, run by Arizona State 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 3 inclusion and 5 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 10 Jan 2012. 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?
Oxytocin levels (time frame: Measured at Hour 2). The study lists 2 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 NCT00468572, 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 10 Jan 2012.