RECRUITING

Overcontrol and Suicide in PTSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pathways to Hope: Pilot fMRI Study of OCPD and Suicide Risk in Trauma-Exposed Veterans

Quick Facts

Study Start:2024-07-01
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06355284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All prospective participants must be able to comprehend the study's procedures and associated risks and be capable of providing informed consent.
  2. * Mean scores on the rigidity, emotional overcontrol, and maladaptive perfectionism subscales of the Pathological Obsessive Compulsive Personality Scale (POPS) must be greater than an average score of four (4 = "slightly agree") across subscale items.
  3. * The POPS is a 49-item self-report assessment of maladaptive behaviors and thought patterns associated with OCPD.
  4. * While Veterans with primary psychotic disorders will be excluded, the presence of other disorders related to obsessive-compulsive tendencies or personality will not be grounds for exclusion.
  5. * Psychiatric medication usage will be assessed during enrollment, but this will not serve as an inclusion or exclusion criterion (with an additional stipulation outlined below for the MRI subsample).
  1. * 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.
  2. * 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).
  3. * Interested participants must meet the following additional criteria:
  4. * no medical contraindications for MRI (e.g., pacemakers, non-MRI safe implanted devices)
  5. * absence of neurological disorders
  6. * no moderate-to-severe traumatic brain injury (e.g., head trauma with loss of consciousness \>5 minutes)
  7. * no ongoing poorly controlled substance use disorder.
  8. * Lifetime history of seizures, primary or secondary CNS tumors, stroke, or cerebral aneurysm will also be exclusionary.
  9. * 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.
  10. * This medication criterion will not be applied to participants who do not complete MRI scans.
  11. * 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.

Contacts and Locations

Study Contact

Jennifer L Barredo
CONTACT
(401) 273-7100
Jennifer.Barredo@va.gov

Principal Investigator

Jennifer L Barredo
PRINCIPAL_INVESTIGATOR
Providence VA Medical Center, Providence, RI

Study Locations (Sites)

Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jennifer L Barredo, PRINCIPAL_INVESTIGATOR, Providence VA Medical Center, Providence, RI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Compulsive Personality Disorder
  • Stress Disorders, Post-Traumatic