Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05931289
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-06-26
Brief Title:
Suicide Risk Interventions
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Suicide Risk Interventions A Comparison of Treatment Dose and Neural Markers of Treatment Outcome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The suicide rate among active duty service members and Veterans increased substantially following the onset of post-911 conflicts in Iraq and Afghanistan Accordingly Veteran suicide prevention has been identified as a national healthcare and research priority The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital The goals of this study are to examine if a a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking b a longer psychotherapy is more effective in reducing suicide risk and c if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy Additionally this study will use magnetic resonance imaging MRI neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later This study will explore a if brain markers can predict suicide attempts b if brain markers change over time as suicide risk changes and c if brain markers change differently for the two types of psychotherapy
Detailed Description:
The suicide rate among active duty service members and Veterans increased substantially following the onset of post-911 conflicts in Iraq and Afghanistan Accordingly Veteran suicide prevention has been identified as a national healthcare and research priority Psychosocial interventions for suicide risk vary substantially in dose and resource allocation Single-session interventions eg Enhanced Crisis Response Plans ECRP has been shown to reduce risk for future suicide attempts Other interventions consisting of 10-12 outpatient sessions following inpatient discharge eg Brief Cognitive Behavioral Therapy for suicide prevention BCBT have been shown to reduce suicide attempts by 50-60 relative to treatment as usual Although both forms of intervention have been shown to reduce risk interventions that vary in dose and resource allocation have yet to be directly compared leaving two critical gaps in the ability to intervene most effectively First the assumption that more time- and resource-intensive 10-12 session interventions translate to greater suicide risk reduction has yet to be demonstrated Second it may be that less resource intensive interventions are adequate for some individuals whereas others require more intensive care
Pharmacological and brain stimulation interventions for suicide risk are extremely limited This is due in part to an incomplete understanding of the neurobiological mechanisms of suicide risk Although numerous studies have examined cross-sectional neuroimaging correlates of current suicide ideation or compared individuals with and without history of a suicide attempt to date no studies have examined a neurobiological predictors of future suicide attempts in high-risk samples b how changes in neurobiological markers over time relate to changes in suicide risk or c theoretically and mechanistically relevant neuroimaging procedures in a prospective design Cross-sectional research examining neuroimaging markers of past or current self-injurious thoughts and behaviors SITBs has identified dysfunction in cognitive control networks CCN regions associated with emotion regulation inhibitory control and decision-making On the other hand dysfunction has also been observed in regions associated with negative affect and rumination such as limbic LN and default mode DMN networks Despite these findings identification of neuroimaging predictors of future suicide attempts and neural markers of successful suicide risk intervention outcomes represents a completely novel critical step to guiding optimal targeting of neurobiological interventions and translating these findings into practice Whether these potential neuroimaging predictors are identifiable during resting state or whether more suicide-relevant cognitive tasks are required remains an open yet critical question
The purpose of the investigators proposed study is to compare two evidence-based suicide risk interventions that vary in dose in order to a directly test if a more intensive intervention produces greater risk reduction b identify Veterans for whom a more intensive intervention is indicated and c identify resting-state and task-based neurobiological markers of future suicide attempts and examine how changes in these markers relate to changes in suicide risk over time The investigators will recruit and evenly randomize 136 male and female Veterans hospitalized for suicide risk to ECRP or BCBT The investigators will collect neuroimaging data immediately upon discharge post-treatment and 12-months post-discharge and assess SITBs out to 12-months post-discharge
Pharmacological and brain stimulation interventions for suicide risk are extremely limited This is due in part to an incomplete understanding of the neurobiological mechanisms of suicide risk Although numerous studies have examined cross-sectional neuroimaging correlates of current suicide ideation or compared individuals with and without history of a suicide attempt to date no studies have examined a neurobiological predictors of future suicide attempts in high-risk samples b how changes in neurobiological markers over time relate to changes in suicide risk or c theoretically and mechanistically relevant neuroimaging procedures in a prospective design Cross-sectional research examining neuroimaging markers of past or current self-injurious thoughts and behaviors SITBs has identified dysfunction in cognitive control networks CCN regions associated with emotion regulation inhibitory control and decision-making On the other hand dysfunction has also been observed in regions associated with negative affect and rumination such as limbic LN and default mode DMN networks Despite these findings identification of neuroimaging predictors of future suicide attempts and neural markers of successful suicide risk intervention outcomes represents a completely novel critical step to guiding optimal targeting of neurobiological interventions and translating these findings into practice Whether these potential neuroimaging predictors are identifiable during resting state or whether more suicide-relevant cognitive tasks are required remains an open yet critical question
The purpose of the investigators proposed study is to compare two evidence-based suicide risk interventions that vary in dose in order to a directly test if a more intensive intervention produces greater risk reduction b identify Veterans for whom a more intensive intervention is indicated and c identify resting-state and task-based neurobiological markers of future suicide attempts and examine how changes in these markers relate to changes in suicide risk over time The investigators will recruit and evenly randomize 136 male and female Veterans hospitalized for suicide risk to ECRP or BCBT The investigators will collect neuroimaging data immediately upon discharge post-treatment and 12-months post-discharge and assess SITBs out to 12-months post-discharge
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01CX002583 | NIH | None | httpsreporternihgovquickSearchI01CX002583 |