The Biology of Resilience

Status

Completed

Phase

Not applicable

Enrollment

270 participants (actual)

Sponsor

Harvard School of Public Health (HSPH) · Other

Design

Randomized · Triple masking

Countries

1 country

United States

Start

Feb 2009

Primary completion

Apr 2012

Completion

Apr 2012

First posted

11 Nov 2009 (estimated)

Last update posted

26 Nov 2012 (estimated)

Conditions

Oxytocin · Placebo

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.

• Experimental

  Oxytocin

  One primary experimental manipulation is the receipt of intranasal oxytocin vs placebo spray prior to participation in a psychosocial stress protocol

• Placebo comparator

  Placebo

  The comparison condition for receipt of oxytocin is receipt of a saline intranasal spray

• Experimental

  Social Support

  Participants bring a friend to the laboratory who sits with them while they engage in the stress protocol tasks

• Placebo comparator

  No Social Support

  Individuals in this condition do not have a friend present while they are engaging in the laboratory protocol.

• Other

  Female Gender

  Effects of oxytocin and social support are examined among women versus men

• Other

  Male Gender

  Consider effects of oxytocin and social support in men versus women

1. Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure

   Time frame · within 2 hours of treatment

   Registry description

   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

2. 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

   Registry description

   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.

3. Speech Threat and Challenge

   Time frame · 2 hours

   Registry description

   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.