Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734, United States
NCT Number: NCT06355284
High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time.
New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently.
In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of:
1. Our recruitment strategy and social functioning and mental health symptom assessments 2. A three-session, weekly fMRI protocol. 3. A three-week online protocol for remote monitoring of social and emotional functioning.
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Notify Me18 year–65 year
All sexes
Observational
Providence, Rhode Island, 02908-4734, United States
High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol, a transdiagnostic phenotype, is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is prevalent in obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others often causes interpersonal tension straining social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support and consequently, may have poorer outcomes.
Treatments enhancements are needed to improve interpersonal functioning, quality of life and mitigate suicide risk these vulnerable Veterans. Neuromodulation adjunctive to psychotherapy is a promising option. Key obstacles, however, impede the development of circuit-based treatments tailored to this phenotype: 1) limited validation of existing associations between interpersonal functioning and OCPD in a broader, overcontrolled sample, 2) the absence of a unified, transdiagnostic circuit model of overcontrol, and 3) robust methods for tracking gradual changes in individuals' functioning throughout the course of treatment.
This pilot project will develop methods to address these knowledge gaps. Specifically, the investigators aim to:
In service of these Aims, the investigators plan to enroll and screen up to 74 Veterans aged 18-65 who are currently receiving care at either PVAMC's Trauma Recovery Clinic (TRC) or Women's Health Clinic (WHC), the latter included to boost female participation. All those who consent to participate will complete the screening assessment. Of these 74 screened participants, the investigators anticipate that 36 Veterans will meet our inclusion/exclusion criteria and will be invited to complete additional psychosocial assessments. A subset of participants (up to n=18) will be invited to complete three MRI sessions and six brief at-home assessments asking questions about stress, emotional regulation, and socio-occupational functioning.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General Inclusion:
Exclusion criteria
General Exclusion:
Additional MRI Criteria:
While in the MRI scanner, participants will complete several classic experimental tasks designed to capture brain activity related to core cognitive features of overcontrol that impact social functioning. Tasks include the Stop Signal Task (error monitoring), Delay Discounting Task (valuation, impulsivity), and Reversal Learning (cognitive flexibility).
Time frame: 18 months
Indexes feasibility of recruitment and enrollment screening strategy.
Time frame: 22 months
Indexes feasibility of functional MRI protocol.
Time frame: 22 months
Indexes feasibility of remote measurement of socio-occupational functioning and emotional regulation.
VA Office of Research and Development
Fed
Pathways to Hope: Pilot fMRI Study of OCPD and Suicide Risk in Trauma-Exposed Veterans
Acronym: OSP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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