Overcontrol and Suicide in PTSD (NCT06355284) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Overcontrol and Suicide in PTSD
United States59 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General Inclusion:
* 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.
* 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.
* 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).
Exclusion Criteria:
General Exclusion:
* 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 impla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of potential participants screened per month meeting the overcontrol criterion.
Timeframe: 18 months
2
Percentage of sessions completed by participants receiving MRI.