Recruiting

Observational Study

Sponsor:

Mclean Hospital

Code:

NCT03383536

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT03383536

Start date

Nov 14, 2017

Status verified date

Aug, 2022

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

168 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Group differences in neuroeconomic game performance [ Time Frame: Measured on the day of the MRI scan ]
  • Group differences in fMRI BOLD signal [ Time Frame: Measured on the day of the MRI scan ]
  • Correlations between behavior and fMRI BOLD signal [ Time Frame: Measured on the day of the MRI scan ]
  • PACAP correlations [ Time Frame: Measured on the day of the MRI scan ]

Central Contacts and Locations

Central contacts

Elizabeth Olson, PhD

617-855-2268adlab@partners.org

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Elizabeth Olson, PhD

617-855-2268adlab@partners.org

More Information

Sponsor

Mclean Hospital

Last update posted

Aug 31, 2022

Last verified

Aug, 2022

Keywords

  • fMRI
  • stress
  • peptide
  • social
  • neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2022-08-31.