NCT00468572

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

May 1, 2007

Last Update Submit

January 6, 2012

Conditions

Keywords

EmotionOxytocinCortisol

Outcome Measures

Primary Outcomes (2)

  • Oxytocin levels

    Measured at Hour 2

  • Cortisol levels

    Measured at Hour 2

Secondary Outcomes (1)

  • Self-reported stress level

    Measured at Hour 2

Study Arms (2)

1

EXPERIMENTAL

Participants will receive treatment with affectionate writing

Behavioral: Affectionate Writing

2

ACTIVE COMPARATOR

Participants will receive treatment with meaningless writing

Behavioral: Meaningless Writing

Interventions

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.

1

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.

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Weigh at least 110 pounds
  • Moderate to no anxiety about having blood drawn

You may not qualify if:

  • Hypertension or diabetes
  • Current or recent pregnancy
  • Colorblindness
  • History of cancer
  • Current use of alpha blockers, beta blockers, or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Sports Research Institute

Tempe, Arizona, 85287, United States

Location

Related 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. doi: 10.1080/10410230701454015.

    PMID: 17668992BACKGROUND

Study Officials

  • Kory Floyd, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 2, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations