Clinical trial NCT02302430: Intranasal Oxytocin and Enhancement of Team Cohesion
Official title: Psychobiological Assessment and Enhancement of Team Cohesion and Psychological Resilience Using a Virtual Team Cohesion Test.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unit Cohesion
Keywords: Cohesion
Oxytocin
Trust
Virtual-reality
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: San Francisco Veterans Affairs Medical Center
First posted: 2014-11-27
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SOLO arm and ECHO arm -- Acquainted, Unacquainted
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in score on computer game task
timeFrame: Baseline, 2 hours after drug/placebo administration
Secondary outcomes:
measure: Change is psychophysiological output
timeFrame: Time based variability analyzed for 5 minute or 20 minute events
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California San Francisco, San Francisco Veterans Affairs Medical Center
name: Josh D Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: