Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
Not provided
Not provided
Not provided
Not provided
In the United States (U.S.), suicide is a major public health concern. U.S. Veterans who live in rural areas may be at even higher risk for suicide than their urban counterparts. Available evidence indicates that suicide risk in rural U.S. Veterans is most concentrated during high-risk care transition scenarios such as discharge from an emergency room. There is limited knowledge about effective interventions to address suicide risk. There is a critical need to develop targeted interventions that address suicide risk during high-risk care transition periods. To be effective, these interventions should address key contributors to suicide risk such as reduced engagement in treatment. This clinical trial evaluates the effect of a suicide prevention intervention to support treatment engagement during high risk transition periods such as discharge from an emergency room.
In the United States (U.S.), death by suicide is a notable public health concern and a particular problem in the U.S. Veteran population. Furthermore, U.S. Veterans who live in rural areas may be at even greater risk for suicide than their urban counterparts. These risks may be concentrated during times of transition in their treatment such as after emergency room discharge. Multiple interventions have been developed to target suicide risk during periods of transition but there is limited evidence regarding their efficacy in preventing suicide. Furthermore, a key contributor to suicide risk may include limited or no engagement in care. Therefore, developing interventions to support engagement in treatment may be effective ways to help mitigate suicide risk and promote participation in care. This clinical trial studies an intervention that is designed to help support treatment engagement during periods of high risk in Veterans who live in rural areas. The trial will recruit Veterans from various treatment settings such as the emergency room, residential drug treatment programs, primary care mental health clinics, and/or inpatient psychiatric units and follow them for a period of six months. The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suicide Prevention Program | Experimental | Behavioral: Suicide Prevention Program Structured care management to improve adherence to discharge planning. |
|
| Usual Care | No Intervention | Standard care that occurs as part of mental health treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suicide Prevention Program | Behavioral | Structured care management to improve adherence to discharge planning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Beck Scale for Suicidal Ideation (BSS) | The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated. | Change from Baseline BSS at 1-, 3-, and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| The Beck Scale for Hopelessness (BHS) | The BHS ranges from 0-20 with higher scores associated with increased hopelessness. | Change from Baseline BHS at 1-, 3-, and 6-months |
| The Partners in Health Scale (PIH) (Self Management) |
Not provided
Inclusion Criteria:
Inpatient psychiatric unit:
Inpatient medical-surgical unit:
Residential Rehabilitation Center (RRC) program:
Primary Mental Health Clinic (PMHC):
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian R Shiner, MD, MPH | White River Junction Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White River Junction VA Medical Center | White River Junction | Vermont | 05009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35202942 | Derived | Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Suicide Prevention Program | Suicide Prevention Program: Structured care management to improve adherence to discharge planning. |
| FG001 | Usual Care | Standard care that occurs as part of mental health treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Standard care that occurs as part of mental health treatment. |
| BG001 | Suicide Prevention Program | Suicide Prevention Program: Structured care management to improve adherence to discharge planning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Beck Scale for Suicidal Ideation (BSS) | The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline BSS at 1-, 3-, and 6-months |
|
Adverse event data were collected throughout the entirety of participant activities (approximately three to six months).
Because our study enrolled a high-risk population, it was expected that patients would potentially report worsening mental health symptoms and/or problems specific to substance use. In some of these cases, these patients would then be expected to be hospitalized or seen in the emergency room to treat these symptoms. Based on local approval from our Institutional Review Board, these events were treated as adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suicide Prevention Program | Suicide Prevention Program: Structured care management to improve adherence to discharge planning. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Mental Health | Psychiatric disorders | Systematic Assessment | Events included worsening mental health symptoms. We determined that these adverse events were expected in this high-risk population and unrelated to study procedures. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Shiner | White River Junction VA Medical Center | 802-295-9363 | 6070 | brian.shiner@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2019 | Apr 5, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2019 | Feb 21, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated.
| Change from Baseline PIH at 1-, 3-, and 6-months |
| The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB) | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for thwarted belongingness being 7-49. Mean scores at baseline were calculated. | Baseline, 1-month, 3-month, 6-month |
| Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB) | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49. The perceived burdensomeness Mean scores at baseline were calculated. | Change from Baseline INQ-15 PB at 1-, 3-, and 6-months |
| Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. | Number of events according to the CSSR-S at 1-, 3-, and 6-months |
| Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant others. The scale has been shown to have good internal and test-retest reliability as well as good validity. The score range is 1-7 with higher values indicating increased perception of social support. | Change from Baseline MSPSS at 1-, 3-, and 6-months |
| Suicide-Related Coping Scale (SRCS) | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping. Mean scores at baseline were calculated. | Change from Baseline SRCS at 1-, 3-, and 6-months |
| App Engagement Scale (AES) - for Mobile Applications | The App Engagement Scale (AES) is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent" with scores ranging from 0 - 40. Higher scores are associated with increased perceived quality of the mobile application. | Change in AES scores at 1- and 6-months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The Beck Scale for Suicidal Ideation (BSS) - Mean Score at Baseline | The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Beck Scale for Hopelessness (BHS) - Mean Score at Baseline | The BHS ranges from 0-20 with higher scores associated with increased hopelessness. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Partners in Health Scale (PIH) (self management) - Mean Score at Baseline | The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB) -Mean Score at Baseline | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for thwarted belongingness being 7-49. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Interpersonal Needs Questionnaire-15: Perceived Burdensomeness(INQ-15 PB)-Mean Score at Baseline | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49. The perceived burdensomeness Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Scale of Perceived Social Support (MSPSS) - Mean Score at Baseline | The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant others. The scale has been shown to have good internal and test-retest reliability as well as good validity. The score range is 1-7 with higher values indicating increased perception of social support. Mean scores at baseline were calculated. | The MSPSS was added later in the study, after some participants had completed all assessments. | Mean | Standard Deviation | units on a scale |
|
| Suicide-Related Coping Scale (SRCS) - Mean Score at Baseline | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping. Mean scores at baseline were calculated. | The SRCS was added later in the study, after some participants had completed all assessments. | Mean | Standard Deviation | units on a scale |
|
Suicide Prevention Program: Structured care management to improve adherence to discharge planning. |
|
|
| Secondary | The Beck Scale for Hopelessness (BHS) | The BHS ranges from 0-20 with higher scores associated with increased hopelessness. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline BHS at 1-, 3-, and 6-months |
|
|
|
| Secondary | The Partners in Health Scale (PIH) (Self Management) | The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline PIH at 1-, 3-, and 6-months |
|
|
|
| Secondary | The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB) | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for thwarted belongingness being 7-49. Mean scores at baseline were calculated. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1-month, 3-month, 6-month |
|
|
|
| Secondary | Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB) | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49. The perceived burdensomeness Mean scores at baseline were calculated. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline INQ-15 PB at 1-, 3-, and 6-months |
|
|
|
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. | Posted | Number | number of events | Number of events according to the CSSR-S at 1-, 3-, and 6-months |
|
|
|
| Secondary | Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant others. The scale has been shown to have good internal and test-retest reliability as well as good validity. The score range is 1-7 with higher values indicating increased perception of social support. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. The MSPSS was added later in the study, after some participants had completed all assessments. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline MSPSS at 1-, 3-, and 6-months |
|
|
|
| Secondary | Suicide-Related Coping Scale (SRCS) | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping. Mean scores at baseline were calculated. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups. The SRCS was added later in the study, after some participants had completed all assessments. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline SRCS at 1-, 3-, and 6-months |
|
|
|
| Secondary | App Engagement Scale (AES) - for Mobile Applications | The App Engagement Scale (AES) is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent" with scores ranging from 0 - 40. Higher scores are associated with increased perceived quality of the mobile application. | Participants scores were analyzed if they completed the assessment at either baseline, 1-, and 6-month follow-ups. No participants reported using the optional app associated with this study. | Posted | Change in AES scores at 1- and 6-months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 9 |
| 31 |
| EG001 | Usual Care | Standard care that occurs as part of mental health treatment | 0 | 28 | 0 | 28 | 8 | 28 |
|
| Alcohol/Substance Use Relapse | Psychiatric disorders | Systematic Assessment | Events included relapse from alcohol and/or other substances. We determined that these adverse events were expected in this high-risk population and unrelated to study procedures. |
|
| Cardiac-Related Issues | Cardiac disorders | Systematic Assessment | Events included cardiac-related issues. We determined these adverse events to be unrelated to our study. |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 1-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|
| 3-month Follow-up |
|
|
| 6-month Follow-up |
|
|