Intranasal Oxytocin and Enhancement of Team Cohesion (ECHO)

Psychobiological Assessment and Enhancement of Team Cohesion and Psychological Resilience Using a Virtual Team Cohesion Test.

This study attempts to identify the psychological, behavioral, physiological, and hormonal predictors and mechanisms of an individual's ability to develop cohesion in a group working together as a team; and examine if administration of the prosocial neuropeptide oxytocin enhances the development of team cohesion. Through a deeper understanding of the underlying psychobiological predictors and mechanisms of team cohesion, the prospective identification of individuals whose unique characteristics promote or inhibit the development of group cohesion will become possible.

Study Overview

• Status: Completed
• Conditions: Unit Cohesion
• Intervention / Treatment: Drug: Oxytocin; Other: Placebo comparator

Detailed Description

The investigators will study up to one thousand subjects who will be randomized into same-gendered teams of three or volunteer as acquainted groups of three . Teams will be randomized to receive oxytocin or placebo. The investigators will first measure baseline personality traits including prosocial orientation. Cohesion will then be measured using a cooperative, virtual unmanned aerial vehicle (UAV) flying mission. All online behavior will be recorded within the task and all offline, real world, behavior will be video recorded throughout the study by digital cameras for later behavioral coding. To measure biobehavioral synchrony, autonomic physiology will be recorded and saliva samples will be taken throughout behavioral testing.

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-28
• Speak English
• Ability to use a nasal spray

Exclusion Criteria:

• Positive urine pregnancy test
• History of psychiatric or neurologic disorder
• Use of illicit drugs in the past month
• History of moderate-severe alcohol use disorder as defined by DSM-V criteria
• Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
• Nasal obstruction, discharge, or bleeding
• Habitually drinks large volumes of water
• Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
• Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment group will receive either 20IU or 40IU intranasal oxytocin	Drug: Oxytocin; 20 International Units Intranasal Oxytocin; Other Names: Syntocinon
Placebo Comparator: Placebo; Placebo group will receive a saline nasal spray	Other: Placebo comparator; Saline nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on computer game task	Subjects will work together in groups of 2-4 performing a computer-based task flying a virtual plane.	Baseline, 2 hours after drug/placebo administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is psychophysiological output	Cardiac measures (HRV, Impedance) collected during computer based and group activities	Time based variability analyzed for 5 minute or 20 minute events

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: United States Department of Defense; San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Josh D Woolley, MD/PhD, University of California San Francisco, San Francisco Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Oxytocin; Virtual-reality; Trust; Cohesion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 14-15259