- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383536
Neuroeconomics of Social Behavior Following Trauma Exposure
Social Withdrawal Following Trauma Exposure: a Neuroeconomic Approach
Study Overview
Status
Conditions
Detailed Description
Impaired social functioning is a frequent and disabling sequela of trauma-related disorders. PTSD is associated with a high rate of severe impairment in quality of life relative to other anxiety disorders, including panic disorder, social phobia, and OCD, with particularly marked impairment in social quality of life. Mounting evidence indicates that impairment in quality of life in PTSD is strongly related to its effect on social functioning. Such difficulties are widespread and affect multiple social networks, including marital relationships, and friendships and family relationships. Social withdrawal, defined here in terms of reduced social network size, is of particular interest because of its strong relationship with health outcomes, including increased risk of disability, reduced immune response, and increased mortality risk; most critically, poor social integration is associated with a threefold increase in suicide risk. Because women are at a 2.3-to-3-fold increased risk compared to men of developing PTSD following trauma, understanding the differential neurobiological pathways that may contribute to the development of stress-related disorders in women is particularly critical. Women are more likely than men to endorse social detachment following trauma, especially when the trauma involves exposure to violence.
In this project, we propose abnormal reward processing (anhedonia) as a specific mechanism underlying social withdrawal in trauma-exposed women, and we present a paradigm that capitalizes on advances in neuroeconomics to elucidate the neural underpinnings of social withdrawal. Additionally, we propose to identify the possible influences of a stress peptide (pituitary adenylate cyclase-activating polypeptide: PACAP) implicated in sex-specific changes in social behavior following stress exposure.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Elizabeth Olson, PhD
- Phone Number: 617-855-2268
- Email: adlab@partners.org
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- Recruiting
- McLean Hospital
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Contact:
- Elizabeth Olson, PhD
- Phone Number: 617-855-2268
- Email: adlab@partners.org
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Phase 1 will include healthy volunteers (age 18-45, n = 60).
Phase 2 will include posttraumatic spectrum-socially anhedonic women (PTS-SA, n = 36), posttraumatic spectrum-non-socially anhedonic women (PTS-nonSA), and healthy controls (HC, n = 36).
Description
Phase 1:
Inclusion Criteria:
- Age 18-45
- Self-reported healthy volunteer status
Exclusion Criteria:
- Inability to provide written informed consent in English
- Inability to see task due to visual impairment
- Participants who produce T-scores of 65 or higher on any Brief Symptom Inventory (BSI) subscales will not be eligible to remain in the Trust Task participant pool.
Phase 2:
Inclusion Criteria:
- Female
- Trauma exposure appropriate to group
- For trauma-exposed groups the index trauma is actual or threatened physical assault or sexual violence
- PCL-5 score 33 and above (for PS-SA and PS-nonSA groups)
- Right handedness
- Age 18-45
- English as a first language
Exclusion Criteria:
- History of neurological illness (including head injury with loss of consciousness > 5 minutes)
- Medical conditions that may influence neuroimaging (e.g. HIV)
- Current or past DSM-5 Axis I disorder (for HC group)
- History of bipolar disorder or schizophrenia spectrum disorder
- Contraindications for MRI
- Alcohol dependence in the past 5 years
- Substance dependence in the past 3 years
- Daily substance use in the past year
- Prescribed psychotropic medication use in the past month
- Wechsler Abbreviated Scale of Intelligence- Second Edition (WASI-II) FSIQ < 70.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Phase 1
Healthy control participants will provide neuroeconomic game responses to form a pool of potential responses for participants to interact with during Phase 2.
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Phase 2: PTS-SA
posttraumatic spectrum-socially anhedonic
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Phase 2: PTS-nonSA
posttraumatic spectrum-non-socially anhedonic
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Phase 2: HC
healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group differences in neuroeconomic game performance
Time Frame: Measured on the day of the MRI scan
|
Compared to the PTS-nonSA and HC groups, the PTS-SA group will demonstrate lower investments and slower learning rates on the Trust Task than on the non-social risk task compared with PTS-nonSA and HC subjects
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Measured on the day of the MRI scan
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Group differences in fMRI BOLD signal
Time Frame: Measured on the day of the MRI scan
|
The HC and PTS-nonSA groups will show greater ventral striatum (VS), dorsal striatum (DS), and medial prefrontal cortex (mPFC) responses during the outcome phase of the trust game for 'share' versus baseline, compared to the PTS-SA group, for the real partner condition (Trust Task), but not for the risk task.
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Measured on the day of the MRI scan
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Correlations between behavior and fMRI BOLD signal
Time Frame: Measured on the day of the MRI scan
|
Because social withdrawal will occur in response to reduced social reward value, we hypothesize that across the PTS groups, reduced VS, DS, and mPFC activity during the outcome phase of the trust game for 'share' outcomes will be associated with lower Trust Task investments, greater self-reported social anhedonia, and smaller social network size.
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Measured on the day of the MRI scan
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PACAP correlations
Time Frame: Measured on the day of the MRI scan
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Elevated PACAP levels will be associated with lower investments on the Trust Task; decreased social reward signals during the outcome phase for 'share' outcomes in the VS, DS, and mPFC; and smaller social network size.
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Measured on the day of the MRI scan
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mediation analysis
Time Frame: Measured on the day of the MRI scan
|
Within the PTS groups, decreased VS, DS, and mPFC response to 'share' outcomes will mediate the relationship between social anhedonia and reduced social network size.
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Measured on the day of the MRI scan
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Functional connectivity (psychophysiological interaction)
Time Frame: Measured on the day of the MRI scan
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PTS individuals with higher self-reported social anhedonia and social withdrawal will show reduced VS-mPFC connectivity for social rewards on the Trust Task.
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Measured on the day of the MRI scan
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Olson, PhD, McLean Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P001423
- K23MH112873-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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