The Biology of Resilience
1 other identifier
interventional
270
1 country
1
Brief Summary
Positive social relationships have consistently been associated with better health, although the neurobiological underpinnings of these observed effects remain largely unknown. The overall goal of the proposed work is to explore novel biological pathways that may explain how social relationships influence health. Recent theorizing suggests that the oxytocin system may underlie some of the observed beneficial effects. Four hypotheses will be examined:
- 1.Oxytocin ameliorates the deleterious neuroendocrine, cardiovascular, and subjective effects of stress.
- 2.Oxytocin and social support have similar and additive stress-buffering effects.
- 3.Effects of oxytocin are evident among younger and older adults.
- 4.Effects of oxytocin are stronger in women vs men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
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, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
November 26, 2012
CompletedNovember 26, 2012
October 1, 2012
3.2 years
November 10, 2009
September 13, 2012
October 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure
Systolic blood pressure (SBP)is connected with reaction to exposure to stress. Systolic blood pressure is collected at baseline and after nasal spray administration/directly before stress tasks; it represents anticipatory stress reaction. This measure represents the difference between baseline and pre-task systolic blood pressure values. A greater difference score represents an increase from baseline in systolic blood pressure during the pre-task, and so a larger difference score represents higher reactivity. A lower difference score, or negative difference score, indicates a lower increase, or even decrease, from baseline in systolic blood pressure during the pre-task and reflects less reactivity. Reactivity is associated with increased risk of developing hypertension. Range of baseline/pre-count differences in SBP: -11 to 37.7
within 2 hours of treatment
Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).
Based on 20-item Positive and Negative Affect Schedule (PANAS) which comprises two mood scales, positive affect and negative affect. Each item is rated on a 5-point scale ranging from (1 = very slightly or not at all) to (5 = extremely) to indicate how the respondent felt at the moment the question was asked. Here, we've used the negative affect sub-scale which consists of the sum of the 10 negative affect items, with a possible range of 10 (least negative affect) to 50 (most negative affect). This score was measured at baseline (study range: 10 to 29) and directly before stress exposure (study range: 10 to 37), and the reported value is the difference between these two scores (range of differences: -13 to 26). It estimates negative affect due to anticipatory stress. The value is the difference between the pre-stress measure and baseline measure, therefore a larger number for the difference means a bigger increase in negative affect due to anticipatory stress, and is a worse outcome.
2 hours
Speech Threat and Challenge
Measure of threat and challenge calculated from observation of non-verbal behavioral cues during stress exposure. Threat (negative reaction) results when an individual does not feel that he or she has sufficient resources to complete a task or manage a difficult situation. Its reverse, challenge (positive reaction), occurs when an individual perceives that he or she has sufficient resources. Independent observers used videotapes of behavior during the stress tasks and rated participants on 7 point scales for 11 challenge-related behaviors (comfortable, confident, enthusiastic, clear, alert, high level of eye contact, etc), and for 8 threat-related behaviors (agitation, rigid posture, speech disfluency, etc). Challenge scores were averaged, and threat scores averaged then reverse-scored. The mean of challenge and reversed threat scores comprise the score used here. Range: 1.1 to 6.1, with higher scores representing more challenge orientation and reflecting a better outcome.
2 hours
Study Arms (6)
Oxytocin
EXPERIMENTALOne primary experimental manipulation is the receipt of intranasal oxytocin vs placebo spray prior to participation in a psychosocial stress protocol
Placebo
PLACEBO COMPARATORThe comparison condition for receipt of oxytocin is receipt of a saline intranasal spray
Social Support
EXPERIMENTALParticipants bring a friend to the laboratory who sits with them while they engage in the stress protocol tasks
No Social Support
PLACEBO COMPARATORIndividuals in this condition do not have a friend present while they are engaging in the laboratory protocol.
Female Gender
OTHEREffects of oxytocin and social support are examined among women versus men
Male Gender
OTHERConsider effects of oxytocin and social support in men versus women
Interventions
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 will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after 24 IUs of oxytocin have been administered. Duration of administration is anticipated to be 2-5 minutes
Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after the full amount in the spray bottle has been used. Duration of administration is anticipated to be 2-5 minutes
Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. If instructed to bring a same-sex close friend (excluding spouses, participants are joined by their support partners join participants 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.
Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. They are then instructed to bring a same-sex close friend (excluding spouses) with them, or to come alone. If they come to the laboratory without a friend, they engage in all the laboratory procedures without a friend present.
Eligibility Criteria
You may qualify if:
- age 22-65, BMI \< 30, healthy, English-speaking, 9th grade reading level.
You may not qualify if:
- any known medical condition (including mental disorders) or on any type of medication
- high levels of social anxiety
- smokers
- high rates of alcohol or drug use
- pregnant or suspected pregnant
- breastfeeding
- blood pressures \> 140/90 mm Hg
- subject does not have a close friend available to participate in the study with him/her
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harvard School of Public Health
Boston, Massachusetts, 02115, United States
Related Publications (2)
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.
PMID: 20025778BACKGROUNDKubzansky 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.
PMID: 22387929RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data collected earlier in the study is missing blood pressure data due to technical problems.
Results Point of Contact
- Title
- Dr. Laura Kubzansky
- Organization
- Harvard School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Laura D Kubzansky, PhD
Harvard School of Public Health (HSPH)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 26, 2012
Results First Posted
November 26, 2012
Record last verified: 2012-10