Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy (NCT05275101) | Clinical Trial Compass
CompletedNot Applicable
Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
United States191 participantsStarted 2021-07-28
Plain-language summary
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adults with current suicidal intent will be randomly assigned to receive either a 1-hour session of crisis response planning (CRP) or a 1-hour session of standard crisis risk management (Treatment as Usual). The effects of both conditions on changes in emotion regulation, behavioral inhibition, stress reactivity, and suicide risk will be evaluated post-intervention and at six-month follow-up. Additional assessments of changes in mood and suicidality will be collected daily during the first 10-days following intervention, and then monthly for a duration of six months. A cohort of healthy controls is included in the study but are not randomized to either treatment condition. The investigators hypothesize the following: 1) A single session of CRP will acutely change suicide risk and 2) Individuals who receive CRP will show sustained improvements in measures of suicidality when compared to individuals who received the Treatment as Usual intervention.
Who can participate
Age range
18 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:
* Generally medically and neurologically healthy
* Age 18 years or older at the time of consent
* Willing and able to give informed consent
* Individuals in the acutely suicidal group: endorse current suicide intent as indicated by a total score of 5 or greater on the Beck's Scale for Suicidal Ideation.
Exclusion Criteria:
* Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study
* Current or past manic/hypomanic episode, schizophrenia, or psychotic symptoms
* Deafness in either ear
* Currently pregnant or trying to become pregnant
* Electroconvulsive therapy (ECT) within the past 6 months
* Current moderate to severe substance use disorder
* Lack of fluency in English
* Positive alcohol breathalyzer test and/or acute drug intoxication the day of the fMRI scans
* Unwilling or unable to sign the informed consent document
* Under 18 years old at the time of enrollment
* Traumatic brain injury from a suicide attempt or another event
* Presence of ferrous-containing metals within the body
* Inability to tolerate small, enclosed spaces without significant anxiety
* Individuals enrolled as controls: no lifetime history of any DSM-5 disorder
* Individuals enrolled as controls: no lifetime history of suicide ideation or intent
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
Frontolimbic neural circuit activation and connectivity
Timeframe: Pre-treatment, Post-treatment, and 6-months follow-up.
2
Suicidality
Timeframe: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.