Overcontrol and Suicide in PTSD

NCT06355284 | Completed

• 1 other identifier: D5150-P
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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. 1.Our recruitment strategy and social functioning and mental health symptom assessments
2. 2.A three-session, weekly fMRI protocol.
3. 3.A three-week online protocol for remote monitoring of social and emotional functioning.

Conditions

Compulsive Personality Disorder; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (3)

• Number of potential participants screened per month meeting the overcontrol criterion.

  Indexes feasibility of recruitment and enrollment screening strategy.

  18 months

• Percentage of sessions completed by participants receiving MRI.

  Indexes feasibility of functional MRI protocol.

  22 months

• Percentage of remote questionnaires completed.

  Indexes feasibility of remote measurement of socio-occupational functioning and emotional regulation.

  22 months

Study Arms (1)

Overcontrol

Trauma-exposed veterans with PTSD symptoms and average rigidity, emotional overcontrol, and maladaptive perfectionism subscale scores on the Pathological Obsessive Compulsive Personality Scale greater than or equal to 4.

Other: Functional MRI

Interventions

Functional MRI OTHER

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).

Overcontrol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include Veterans 18-65 years old. They will be men or women from the greater Providence area receiving care at the VA who have been discharged from active duty, or who served in the National Guard or reserve units. Over 15 months, the investigators plan to screen 74 Veterans aged 18-65 receiving care in VAPHS's Trauma Recovery Clinic (TRC) and Women's Health Clinic (WHC), the latter included to boost female participation.

You may qualify if:

• All prospective participants must be able to comprehend the study's procedures and associated risks and be capable of providing informed consent.
• Mean scores on at least three subscales of the Pathological Obsessive Compulsive Personality Scale (POPS) must be greater than an average score of four (4 = "slightly agree") across subscale items.
• The POPS is a 49-item self-report assessment of maladaptive behaviors and thought patterns associated with OCPD.

You may not qualify if:

• The Mini International Neuropsychiatric Interview (M.I.N.I.) will be used to exclude participants with current psychosis or with past psychosis that was unrelated to depression.
• Additional MRI Criteria:
• Participants interested in taking part in the MRI portion of the study will undergo a thorough screening to ensure MRI compatibility (e.g., absence of metal in the body, absence of claustrophobia).
• Interested participants must meet the following additional criteria:
• no medical contraindications for MRI (e.g., pacemakers, non-MRI safe implanted devices)
• absence of neurological disorders
• no moderate-to-severe traumatic brain injury (e.g., head trauma with loss of consciousness \>5 minutes)
• no ongoing poorly controlled substance use disorder.
• For participants in the MRI segment of the study, continued medication use will not be a disqualifying factor if the medication regimen has remained stable for the past month, with no intentions of altering dosages during the study duration.
• This medication criterion will not be applied to participants who do not complete MRI scans.
• For this feasibility trial, individuals exhibiting active suicidal behavior or a score \>3 on the suicidal ideation module of the Columbia-Suicide Severity Rating Scale will be ineligible.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens retained.

MeSH Terms

Conditions

Compulsive Personality Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Jennifer L Barredo

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: July 1, 2024
• Primary Completion: February 27, 2026
• Study Completion: April 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)