The Biology of Resilience - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
Conditions:	Oxytocin Placebo
Interventions:	Drug: intranasal oxytocin Drug: Placebo Behavioral: Social support Behavioral: No Social Support

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in this study from 6/2008 to 4/2012. Initial screening was done by phone and email. Medical screening took place at a hospital clinic and the rest of the study took place at the Harvard School of Public Health.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After initial screening , participants were asked to sign consent form and screened in a medical clinic prior to group assignment. Participants were excluded for violating study criteria, including having BMI>30, high blood pressure, acute illness, smoking or drug use and chronic medical conditions. Refusal to sign consent also led to exclusion.

Reporting Groups

	Description
Female, OT, Alone	Effects of intranasal oxytocin and social support examined among women versus men. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, OT, Friend	Effects of intranasal oxytocin and social support examined among women versus men. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Female, Placebo, Alone	Effects of intranasal oxytocin and social support examined among women versus men. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, Placebo, Friend	Effects of intranasal oxytocin and social support examined among women versus men. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, OT, Alone	Effects of intranasal oxytocin and social support examined among men versus women. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, OT, Friend	Effects of intranasal oxytocin and social support examined among men versus women. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, Placebo, Alone	Effects of intranasal oxytocin and social support examined among men versus women. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, Placebo, Friend	Effects of intranasal oxytocin and social support examined among men versus women. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.

Participant Flow: Overall Study

	Female, OT, Alone	Female, OT, Friend	Female, Placebo, Alone	Female, Placebo, Friend	Male, OT, Alone	Male, OT, Friend	Male, Placebo, Alone	Male, Placebo, Friend
STARTED	36	20	36	18	47	29	52	32
COMPLETED	34	19	36	18	46	29	51	32
NOT COMPLETED	2	1	0	0	1	0	1	0
Withdrawal by Subject	2	1	0	0	1	0	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Female, OT, Alone	Effects of intranasal oxytocin and social support examined among women versus men. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, OT, Friend	Effects of intranasal oxytocin and social support examined among women versus men. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Female, Placebo, Alone	Effects of intranasal oxytocin and social support examined among women versus men. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, Placebo, Friend	Effects of intranasal oxytocin and social support examined among women versus men. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, OT, Alone	Effects of intranasal oxytocin and social support examined among men versus women. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, OT, Friend	Effects of intranasal oxytocin and social support examined among men versus women. Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, Placebo, Alone	Effects of intranasal oxytocin and social support examined among men versus women. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, Placebo, Friend	Effects of intranasal oxytocin and social support examined among men versus women. Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used. Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Total	Total of all reporting groups

Baseline Measures

	Female, OT, Alone	Female, OT, Friend	Female, Placebo, Alone	Female, Placebo, Friend	Male, OT, Alone	Male, OT, Friend	Male, Placebo, Alone	Male, Placebo, Friend	Total
Overall Participants Analyzed [Units: Participants]	36	20	36	18	47	29	52	32	270

Age [Units: Participants]
<=18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	36	20	36	18	47	29	52	32	270
>=65 years	0	0	0	0	0	0	0	0	0

Age [Units: Years] Mean (Standard Deviation)	32.9 (11.2)	28.7 (6.2)	34.3 (10.7)	33.7 (13.2)	34.8 (11.8)	28.4 (9.0)	36.0 (12.1)	32.4 (9.7)	33.2 (11.0)

Gender [Units: Participants]
Female	36	20	36	18	0	0	0	0	110
Male	0	0	0	0	47	29	52	32	160

Region of Enrollment [Units: Participants]
United States	36	20	36	18	47	29	52	32	270

Outcome Measures

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1. Primary:

Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure [ Time Frame: within 2 hours of treatment ]

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2. Primary:

Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure). [ Time Frame: 2 hours ]

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3. Primary:

Speech Threat and Challenge [ Time Frame: 2 hours ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data collected earlier in the study is missing blood pressure data due to technical problems.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Laura Kubzansky
Organization: Harvard School of Public Health
phone: 617-432-3589
e-mail: lkubzans@hsph.harvard.edu

Publications of Results:

Kubzansky LD, Mendes WB, Appleton AA, Block J, Adler GK. A heartfelt response: Oxytocin effects on response to social stress in men and women. Biol Psychol. 2012 Apr;90(1):1-9. doi: 10.1016/j.biopsycho.2012.02.010. Epub 2012 Feb 23. Erratum in: Biol Psychol. 2013 Feb;92(2):97.

Other Publications:

Kubzansky LD, Mendes WB, Appleton A, Block J, Adler GK. Protocol for an experimental investigation of the roles of oxytocin and social support in neuroendocrine, cardiovascular, and subjective responses to stress across age and gender. BMC Public Health. 2009 Dec 21;9:481. doi: 10.1186/1471-2458-9-481.

Responsible Party:	Laura Kubzansky, Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT01011465 History of Changes
Other Study ID Numbers:	1R21AG030632-01A2 ( U.S. NIH Grant/Contract )
Study First Received:	November 10, 2009
Results First Received:	September 13, 2012
Last Updated:	October 24, 2012