Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355284
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Brief Title:
Overcontrol and Suicide in PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Pathways to Hope Pilot fMRI Study of OCPD and Suicide Risk in Trauma-Exposed Veterans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSP
Brief Summary:
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
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
Detailed Description:
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
1 Assess the feasibility of our recruitment strategy and evaluate interpersonal functioning in a cohort of trauma-exposed Veterans exhibiting overcontrolled traits
2 Test the feasibility and acceptability of a three-session weekly fMRI protocol focused on the circuitry of overcontrol while evaluating within-subject reliability of observed neural correlates
3 Examine the feasibility and acceptability of a three-week protocol for remote monitoring of weekly variance in socio-occupational functioning and emotional regulation
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 PVAMCs Trauma Recovery Clinic TRC or Womens 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 inclusionexclusion criteria and will be invited to complete additional psychosocial assessments A subset of participants up to n18 will be invited to complete three MRI sessions and six brief at-home assessments asking questions about stress emotional regulation and socio-occupational functioning
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
1 Assess the feasibility of our recruitment strategy and evaluate interpersonal functioning in a cohort of trauma-exposed Veterans exhibiting overcontrolled traits
2 Test the feasibility and acceptability of a three-session weekly fMRI protocol focused on the circuitry of overcontrol while evaluating within-subject reliability of observed neural correlates
3 Examine the feasibility and acceptability of a three-week protocol for remote monitoring of weekly variance in socio-occupational functioning and emotional regulation
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 PVAMCs Trauma Recovery Clinic TRC or Womens 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 inclusionexclusion criteria and will be invited to complete additional psychosocial assessments A subset of participants up to n18 will be invited to complete three MRI sessions and six brief at-home assessments asking questions about stress emotional regulation and socio-occupational functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None