Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05884476
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-05-22
Brief Title:
Randomized Clinical Trial of Re-Evaluating Suicidal Thoughts in Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effects of a Targeted Web-Based Suicide Prevention Intervention on Suicidal Ideation and Self-Directed Violence A Randomized Controlled Trial in Veterans
Status:
RECRUITING
Status Verified Date:
2024-01
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:
REST-V
Brief Summary:
Suicide prevention is a top priority for VA as all continue to seek new and inventive ways to reduce suicide rates among Veterans Many experts agree that suicide prevention efforts could be improved by making suicide-specific interventions easier to access The current project aims to move toward that goal by testing a web-based suicide prevention intervention using an experimental design The roughly 40-minute intervention aims to teach Veterans coping skills that are designed to ease the emotional distress that often comes with thoughts of suicide The project will evaluate whether Veterans who receive this intervention report more improvement in suicidal thoughts and behaviors than Veterans who receive a standard course of health care visits Suicidal thoughts and behaviors will be measured over the course of one month The investigators hypothesize that Veterans who receive the intervention will report lower suicidal thoughts and behaviors than those who receive the standard course of health care
Detailed Description:
Approximately 100000 United States Veterans have died by suicide since 2000 at age- and sex-adjusted rates which far outpace that of non-Veterans Suicide prevention remains VAs highest priority while the investigators seek innovative research driven approaches Psychotherapeutic interventions for suicide prevention are one area for further innovation Specifically strategies from evidence-based interventions that directly address suicidality could be distilled into briefer more scalable formats to expand access to suicide prevention interventions
Most psychotherapies target syndromes that contribute to suicidality eg depression which is arguably inefficient for reducing suicidality Instead effective suicide prevention interventions should directly target mechanisms that contribute to the progression from suicidal thoughts to plans preparations and attempts One mechanism associated with change in suicidality is psychological inflexibility In the context of suicide psychological inflexibility reflects a tendency to view suicidal thoughts as distressing and problematic resulting in struggles to eliminate them Suicide prevention interventions may therefore be more effective if they provision adaptive skills for coping with the psychological burden of suicidal ideation SI Of the few existing interventions that take this approach most are not accessible enough to adequately address the issue due to numerous barriers to mental health care Structured web-based interventions that provision adaptive coping responses for SI present one opportunity to overcome these barriers and reduce suicidality
Recognizing these limitations the PI developed a brief suicide-specific intervention Re-Evaluating Suicidal Thoughts REST which is designed to provision skills to improve psychological inflexibility in the context of SI Preliminary data from two samples both of which completed a single session of REST in the clinic are promising
The current proposal aims to build on that work by evaluating REST as an adjunctive suicide prevention intervention compared to treatment-as-usual TAU in a sample of Veterans In this two-arm RCT Veterans N 180 will be randomized 11 to complete REST TAU or to maintain TAU-only Psychological inflexibility will be indexed via self-report across five time-points Day 1 Pre-Intervention Day 1 Post-Intervention Day 3 Week 1 and Week 2 Psychological inflexibility will be indexed via the Acceptance and Action Questionnaire for Suicidal Ideation AAQ-SI Clinical outcomes of suicidal ideation severity self-report measurement and self-directed violence behaviors clinical interview will also be measured at five time-points Day 1 Pre-Intervention Day 3 Week 1 Week 2 and Month 1 Suicidal ideation severity will be indexed via the Beck Scale for Suicide Ideation BSS Suicidal self-directed violence behaviors will be indexed via the Columbia Suicide Severity Rating Scale C-SSRS interview
Aim 1 Evaluate the effect of REST on the putative therapeutic mechanism psychological inflexibility Hypothesis 1 Compared to TAU REST will be associated with significant differences between conditions in psychological inflexibility at Week 2 controlling for baseline psychological inflexibility
Aim 2 Evaluate the effect of REST on a suicidal ideation severity and b self-directed violence Hypothesis 2a and b Compared to TAU REST will be associated with significant differences between conditions in 2a suicidal ideation severity and 2b self-directed violence at Month 1 controlling for baseline suicidal ideation or behaviors
Aim 3 Evaluate the mechanism through which REST reduces suicidal ideation severity and behaviors Hypothesis 3a and b Differences in psychological inflexibility at Week 2 will mediate differences in 3a suicidal ideation severity and 3b suicidal behaviors at Month 1 controlling for baseline variables
Recruitment Veterans will be recruited from the Southeast Louisiana Veterans Health Care System SLVHCS
Personnel The study coordinator will conduct the initial contacts regarding study interest schedule participants administer study measures and conduct chart review The PI will conduct preliminary eligibility screenings based on chart review
Day 1Intervention Appointment Upon presentation to SLVHCS for the Day 1 appointment Veterans will complete informed consent Next they will complete a battery of baseline self-report measures followed by the C-SSRS interview and safety planning intervention with a clinician Eligible Veterans will then be randomized to condition Randomization will occur at the individual level Participants will be randomized at a 11 ratio to one of two conditions REST TAU or TAU-only control Veterans assigned to the REST TAU condition will complete the REST intervention alone on a computer or mobile device Following the intervention they will complete a post-intervention self-report measure of psychological inflexibility Veterans who are assigned to the TAU-only control condition will complete a post-assessment self-report measure of psychological inflexibility
Follow-up Appointments There will be four follow-up appointments that follow the Day 1Intervention appointment These will occur at Day 3 Week 1 Week 2 and Month 1 Appointment procedures will be nearly identical between conditions and across appointments with one exception for the Month 1 appointment during which time Veterans assigned to TAU-only will be offered the opportunity to complete the REST intervention Veterans will be given the choice of completing the follow-up appointments over virtual telehealth modalities or face-to-face
Most psychotherapies target syndromes that contribute to suicidality eg depression which is arguably inefficient for reducing suicidality Instead effective suicide prevention interventions should directly target mechanisms that contribute to the progression from suicidal thoughts to plans preparations and attempts One mechanism associated with change in suicidality is psychological inflexibility In the context of suicide psychological inflexibility reflects a tendency to view suicidal thoughts as distressing and problematic resulting in struggles to eliminate them Suicide prevention interventions may therefore be more effective if they provision adaptive skills for coping with the psychological burden of suicidal ideation SI Of the few existing interventions that take this approach most are not accessible enough to adequately address the issue due to numerous barriers to mental health care Structured web-based interventions that provision adaptive coping responses for SI present one opportunity to overcome these barriers and reduce suicidality
Recognizing these limitations the PI developed a brief suicide-specific intervention Re-Evaluating Suicidal Thoughts REST which is designed to provision skills to improve psychological inflexibility in the context of SI Preliminary data from two samples both of which completed a single session of REST in the clinic are promising
The current proposal aims to build on that work by evaluating REST as an adjunctive suicide prevention intervention compared to treatment-as-usual TAU in a sample of Veterans In this two-arm RCT Veterans N 180 will be randomized 11 to complete REST TAU or to maintain TAU-only Psychological inflexibility will be indexed via self-report across five time-points Day 1 Pre-Intervention Day 1 Post-Intervention Day 3 Week 1 and Week 2 Psychological inflexibility will be indexed via the Acceptance and Action Questionnaire for Suicidal Ideation AAQ-SI Clinical outcomes of suicidal ideation severity self-report measurement and self-directed violence behaviors clinical interview will also be measured at five time-points Day 1 Pre-Intervention Day 3 Week 1 Week 2 and Month 1 Suicidal ideation severity will be indexed via the Beck Scale for Suicide Ideation BSS Suicidal self-directed violence behaviors will be indexed via the Columbia Suicide Severity Rating Scale C-SSRS interview
Aim 1 Evaluate the effect of REST on the putative therapeutic mechanism psychological inflexibility Hypothesis 1 Compared to TAU REST will be associated with significant differences between conditions in psychological inflexibility at Week 2 controlling for baseline psychological inflexibility
Aim 2 Evaluate the effect of REST on a suicidal ideation severity and b self-directed violence Hypothesis 2a and b Compared to TAU REST will be associated with significant differences between conditions in 2a suicidal ideation severity and 2b self-directed violence at Month 1 controlling for baseline suicidal ideation or behaviors
Aim 3 Evaluate the mechanism through which REST reduces suicidal ideation severity and behaviors Hypothesis 3a and b Differences in psychological inflexibility at Week 2 will mediate differences in 3a suicidal ideation severity and 3b suicidal behaviors at Month 1 controlling for baseline variables
Recruitment Veterans will be recruited from the Southeast Louisiana Veterans Health Care System SLVHCS
Personnel The study coordinator will conduct the initial contacts regarding study interest schedule participants administer study measures and conduct chart review The PI will conduct preliminary eligibility screenings based on chart review
Day 1Intervention Appointment Upon presentation to SLVHCS for the Day 1 appointment Veterans will complete informed consent Next they will complete a battery of baseline self-report measures followed by the C-SSRS interview and safety planning intervention with a clinician Eligible Veterans will then be randomized to condition Randomization will occur at the individual level Participants will be randomized at a 11 ratio to one of two conditions REST TAU or TAU-only control Veterans assigned to the REST TAU condition will complete the REST intervention alone on a computer or mobile device Following the intervention they will complete a post-intervention self-report measure of psychological inflexibility Veterans who are assigned to the TAU-only control condition will complete a post-assessment self-report measure of psychological inflexibility
Follow-up Appointments There will be four follow-up appointments that follow the Day 1Intervention appointment These will occur at Day 3 Week 1 Week 2 and Month 1 Appointment procedures will be nearly identical between conditions and across appointments with one exception for the Month 1 appointment during which time Veterans assigned to TAU-only will be offered the opportunity to complete the REST intervention Veterans will be given the choice of completing the follow-up appointments over virtual telehealth modalities or face-to-face
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 |
|---|---|---|---|
| 1IK2CX002448-01A1 | NIH | None | httpsreporternihgovquickSearch1IK2CX002448-01A1 |