Neuroeconomics of Social Behavior Following Trauma Exposure

Posttraumatic Stress Disorder Clinical Trial

Official title:

Social Withdrawal Following Trauma Exposure: a Neuroeconomic Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383536
• Other study ID #: 2017P001423
• Secondary ID: K23MH112873-01A1
• Status: Recruiting
• Start date: November 14, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2022
• Source: Mclean Hospital
• Contact: Elizabeth Olson, PhD
• Phone: 617-855-2268
• Email: adlab[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group differences in neuroeconomic game performance	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	Measured on the day of the MRI scan
Primary	Group differences in fMRI BOLD signal	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.	Measured on the day of the MRI scan
Primary	Correlations between behavior and fMRI BOLD signal	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.	Measured on the day of the MRI scan
Primary	PACAP correlations	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.	Measured on the day of the MRI scan
Secondary	Mediation analysis	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.	Measured on the day of the MRI scan
Secondary	Functional connectivity (psychophysiological interaction)	PTS individuals with higher self-reported social anhedonia and social withdrawal will show reduced VS-mPFC connectivity for social rewards on the Trust Task.	Measured on the day of the MRI scan