Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroeconomics of Social Behavior Following Trauma Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03383536
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Elizabeth Olson, Mclean Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed women. By also gathering self-report measures of social anhedonia, performance on non-social and social reward valuation tasks, and measures of real-world social functioning including social network size, we aim to specify how alterations in social reward processing result in social withdrawal and functional impairment.

Condition or disease
Posttraumatic Stress Disorder

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Social Withdrawal Following Trauma Exposure: a Neuroeconomic Approach
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.
Phase 2: PTS-SA
posttraumatic spectrum-socially anhedonic
Phase 2: PTS-nonSA
posttraumatic spectrum-non-socially anhedonic
Phase 2: HC
healthy controls


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. PACAP correlations [ Time Frame: Measured on the day of the MRI scan ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. Functional connectivity (psychophysiological interaction) [ Time Frame: Measured on the day of the MRI scan ]
    PTS individuals with higher self-reported social anhedonia and social withdrawal will show reduced VS-mPFC connectivity for social rewards on the Trust Task.


Biospecimen Retention:   Samples Without DNA
Blood samples for PACAP (stress peptide) analysis

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).

Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383536


Contacts
Layout table for location contacts
Contact: Elizabeth Olson, PhD 617-855-2268 adlab@partners.org

Locations
Layout table for location information
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Elizabeth Olson, PhD    617-855-2268    adlab@partners.org   
Sponsors and Collaborators
Mclean Hospital
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Olson, PhD Mclean Hospital
  Study Documents (Full-Text)

Documents provided by Elizabeth Olson, Mclean Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] November 15, 2017

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Elizabeth Olson, Instructor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03383536     History of Changes
Other Study ID Numbers: 2017P001423
K23MH112873-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will evaluate requests for deidentified data on a case-by-case basis.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Olson, Mclean Hospital:
fMRI
stress
peptide
social
neuroimaging

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders