Posttraumatic Stress DisorderNCT03383536
Neuroeconomics of Social Behavior Following Trauma Exposure
An observational study of Posttraumatic Stress Disorder, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Age 18-45
- Self-reported healthy volunteer status
- 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)
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- Right handedness
- Age 18-45
- English as a first language
Who cannot join
- 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:
- History of neurological illness (including head injury with loss of consciousness > 5 minutes)
- Medical conditions that may influence neuroimaging (e.g. HIV)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Elizabeth Olson, PhD, 617-855-2268, adlab@partners.org
About this study
Official title: Social Withdrawal Following Trauma Exposure: a Neuroeconomic Approach
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- fMRI, stress, peptide, social, neuroimaging
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured on the day of the MRI scan
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: Measured on the day of the MRI scan
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: Measured on the day of the MRI scan
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: Measured on the day of the MRI scan
Secondary outcomes (2)
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: Measured on the day of the MRI scan
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: Measured on the day of the MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start14 Nov 2017
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Elizabeth Olson, Mclean Hospital
- Investigators
- Elizabeth Olson, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383536
- Sponsor's protocol ID
- 2017P001423
- Other IDs
- K23MH112873-01A1
- Status last verified
- Aug 2022
- First submitted
- 19 Dec 2017
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will evaluate requests for deidentified data on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Withdrawal Following Trauma Exposure: a Neuroeconomic Approach
- ClinicalTrials.gov ID
- NCT03383536
- Acronym / sponsor ID
- 2017P001423
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- fMRI, stress, peptide, social, neuroimaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (9 listed)
- Age 18-45
- Self-reported healthy volunteer status
- Female
- Trauma exposure appropriate to group
- For trauma-exposed groups the index trauma is actual or threatened physical assault or sexual violence
Key exclusion criteria (14 listed)
- 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.
- History of neurological illness (including head injury with loss of consciousness > 5 minutes)
- Medical conditions that may influence neuroimaging (e.g. HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
2 secondary outcomes
Mediation analysis
Time frame: Measured on the day of the MRI scan
Functional connectivity (psychophysiological interaction)
Time frame: Measured on the day of the MRI scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided. We will evaluate requests for deidentified data on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Olson, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Olson, PhD (617-855-2268, adlab@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in neuroeconomic game performance (time frame: Measured on the day of the MRI scan). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.