Unit CohesionPhase 1ECHONCT02302430
Intranasal Oxytocin and Enhancement of Team Cohesion
A Phase 1 study testing Oxytocin in people with Unit Cohesion, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Unit Cohesion
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 31 May 2019
- Phase
- Phase 1
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-28
- Speak English
- Ability to use a nasal spray
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: 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.
Read the 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.
- Conditions
- Unit Cohesion
- Being tested
- Oxytocin, Placebo comparator
- Keywords
- Cohesion, Oxytocin, Trust, Virtual-reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
20 International Units Intranasal Oxytocin
Placebo comparatorOther
Saline nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group will receive either 20IU or 40IU intranasal oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo group will receive a saline nasal spray Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 hours after drug/placebo administration
Secondary outcomes (1)
Change is psychophysiological output
Cardiac measures (HRV, Impedance) collected during computer based and group activities
Measured: Time based variability analyzed for 5 minute or 20 minute events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startOct 2015
- Primary completionMay 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unit CohesionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SOLO arm and ECHO arm -- Acquainted, Unacquainted
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, San Francisco Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Josh D Woolley, MD/PhD, Principal investigator, University of California San Francisco, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302430
- Sponsor's protocol ID
- 14-15259
- Acronym
- ECHO
- Status last verified
- Aug 2019
- First submitted
- 14 Nov 2014
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Assessment and Enhancement of Team Cohesion and Psychological Resilience Using a Virtual Team Cohesion Test.
- ClinicalTrials.gov ID
- NCT02302430
- Acronym / sponsor ID
- ECHO / 14-15259
- Conditions
- Unit Cohesion
- Keywords
- Cohesion, Oxytocin, Trust, Virtual-reality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense, San Francisco Veterans Affairs Medical Center
- Study start
- Oct 2015
- Primary completion
- May 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 27 Nov 2014 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SOLO arm and ECHO arm -- Acquainted, Unacquainted
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: OxytocinTreatment group will receive either 20IU or 40IU intranasal oxytocin |
| Placebo | Placebo comparator | Other: Placebo comparatorPlacebo group will receive a saline nasal spray |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-28
- Speak English
- Ability to use a nasal spray
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| OxytocinAlso: Syntocinon20 International Units Intranasal Oxytocin | Drug | Treatment |
| Placebo comparatorSaline nasal spray | Other | Placebo |
Primary outcome
Change in score on computer game task
Time frame: Baseline, 2 hours after drug/placebo administration
Subjects will work together in groups of 2-4 performing a computer-based task flying a virtual plane.
1 secondary outcome
Change is psychophysiological output
Time frame: Time based variability analyzed for 5 minute or 20 minute events
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 5 Aug 2019.
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.
Josh D Woolley, MD/PhD principal investigator
University of California San Francisco, San Francisco Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Unit Cohesion, run by University of California, San Francisco 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 9 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 5 Aug 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in score on computer game task (time frame: Baseline, 2 hours after drug/placebo administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2019.