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| Name | Class |
|---|---|
| VHA Office of Rural Health | UNKNOWN |
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The goal of this pilot randomized controlled trial is to test an adapted suicide prevention program (the Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide or BESST) in rural Veterans discharged from community care mental health treatment settings. The main question it aims to answer is:
Participants will be assigned by change to a treatment group. Some will receive the BESST intervention combined with standard care, and some will receive standard care alone. All participants will be in this research study for up to three months.
Those receiving the BESST intervention will have:
All participants will have three assessment interviews where they will be asked about their mental health and treatment received outside of the VA.
The investigators will compare participants assigned to the BESST intervention combined with standard care vs participants assigned to standard care alone to see if the BESST intervention improves suicide-related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BESST | Experimental | Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care. |
|
| Control | Other | Patients randomized to the control arm will receive standard mental health care alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BESST | Behavioral | The BESST intervention is a suicide prevention program designed to meet the unique needs of Veterans receiving care from community mental health treatment settings. BESST can be delivered by a trained mental health staff member, such as a mental health nurse, social worker, psychologist, or psychiatrist. The intervention consists of two synergistic components that work to support the patient after a mental health-related discharge in community settings: 1) Brief educational session, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study interventionist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) | The Beck Scale for Suicidal Ideation (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. | 3 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hopelessness: Beck Hopelessness Scale (BHS) | The Beck Hopelessness Scale (BHS) is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients report on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. The BHS has good reliability and validity and is sensitive to change. There is some evidence that the BHS may be a measure of risk of suicide. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Riblet, MD, MPH | White River Junction VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White River Junction VA Medical Center | White River Junction | Vermont | 05009 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BESST | Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care. BESST: The BESST intervention is a suicide prevention program designed to meet the unique needs of Veterans receiving care from community mental health treatment settings. BESST can be delivered by a trained mental health staff member, such as a mental health nurse, social worker, psychologist, or psychiatrist. The intervention consists of two synergistic components that work to support the patient after a mental health-related discharge in community settings: 1) Brief educational session, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study interventionist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
| FG001 | Control | Patients randomized to the control arm will receive standard mental health care alone. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BESST | Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care. BESST: The BESST intervention is a suicide prevention program designed to meet the unique needs of Veterans receiving care from community mental health treatment settings. BESST can be delivered by a trained mental health staff member, such as a mental health nurse, social worker, psychologist, or psychiatrist. The intervention consists of two synergistic components that work to support the patient after a mental health-related discharge in community settings: 1) Brief educational session, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study interventionist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
| 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 | Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) | The Beck Scale for Suicidal Ideation (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. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
Adverse event data were collected throughout the entirety of the study participant activities (approximately 3 months).
Because our study enrolled a high-risk group of patients, it was expected that patients would potentially report worsening mental health symptoms and/or problems specific to substance use. In some of these cases, the patients would then be expected to be hospitalized or treated in the emergency room for these reasons. Based on local approval from our institutional review board, we treated these events as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BESST | Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care. BESST: The BESST intervention is a suicide prevention program designed to meet the unique needs of Veterans receiving care from community mental health treatment settings. BESST can be delivered by a trained mental health staff member, such as a mental health nurse, social worker, psychologist, or psychiatrist. The intervention consists of two synergistic components that work to support the patient after a mental health-related discharge in community settings: 1) Brief educational session, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study interventionist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal behavior | Psychiatric disorders | Systematic Assessment | Suicidal behavior including worsening suicidal ideation or preparatory behaviors. We determined that these symptoms or behaviors were expected in the population and unrelated to study procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie Riblet | White River Junction VA Medical Center | 1-802-295-9363 | 5893 | natalie.riblet@va.gov |
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| 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 27, 2023 | May 20, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 2, 2024 | Jun 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.
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The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
|
| Standard Mental Health Care | Other | Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
|
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| 3 months post-baseline |
| Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness | The Interpersonal Needs Questionnaire-15 (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 6-42. | 3 months post-baseline |
| Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness | The Interpersonal Needs Questionnaire-15 (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 7-63. | 3 months post-baseline |
| Patient Engagement: General Self-Efficacy Scale (GSES) | The General Self-Efficacy Scale (GSES) is a valid scale of self-efficacy that is designed for the general population (12 years or older) and it has been tested in various countries. It is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. Total scores range from 10 to 40, with higher scores suggesting increased self-efficacy. | 3 months post-baseline |
| Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale | The Suicide-Related Coping Scale (SRCS) 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. | 3 months post-baseline |
| Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale | The Suicide-Related Coping Scale (SRCS) 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. | 3 months post-baseline |
| Number of Participants With Suicide Attempts | Suicide attempts is measured using the seven-item subscale on the Columbia-Suicide Severity Rating Scale (C-SSRS), a valid and reliable scale that asks patients to self-report on suicide attempts. | 3 months post-baseline |
| Number of Participants With Substance Use at 3 Months Post-baseline | The investigators will assess substance use at follow-up assessments using a timeline follow-back approach. This method is commonly used in research studies to assess substance use patterns. Numerical scores do not apply to this assessment. | 3 months post-baseline |
| BG001 | Control | Patients randomized to the control arm will receive standard mental health care alone. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| The Beck Scale for Suicidal Ideation (BSS) | The BSS ranges from 0-38. While there is no established BSS cutoff score to classify risk of suicide, there is some 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 of clinical relevance. Mean BSS scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Beck Scale for Hopelessness (BHS) | The BHS ranges from 0-20 with higher scores associated with worse hopelessness. The mean BHS scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| Interpersonal Needs Questionnaire-15, Perceived Burdensomeness (INQ-15 PB) | The INQ-15 is a 15-item self-report scale that assesses thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item on the INQ-15 is measured on a 7-point Likert scale, with higher scores indicating lower perceived connectedness. The score range for the entire INQ-15 scale is 15-105, with the score range for perceived burdensomeness being 6-42. The perceived burdensomeness mean scores on the INQ-15 at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| 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 on the INQ-15 is measured on a 7-point Likert scale, with higher scores indicating lower perceived connectedness. The score range for the entire INQ-15 scale is 15-105, with the score range for thwarted belongingness being 7-63. Mean thwarted belonging scores on the INQ-15 at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| The Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS is a 12-item self-reported scale that is designed to inquire about support from several sources including family, friends, and significant others. The MSPSS 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. The mean MSPSS scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| Suicide Related Coping Scale (SRCS) External Coping Subscale | This scale includes 17 questions related to a patient's perception of their ability to cope with their 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. Higher scores indicate increased perception of suicide-related external coping. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| Suicide Related Coping Scale (SRCS) Internal Coping Subscale | This scale includes 17 questions related to a patient's perception of their ability to cope with their suicidal thoughts. Each item is assessed using a 5-point Likert scale. The SRCS 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 Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related internal coping. Mean scores at baseline were calculated. | Mean | Standard Deviation | units on a scale |
|
| Generalized Self-Efficacy Scale (GES) | The General Self-Efficacy Scale (GSES) is a valid scale of self-efficacy that is designed for the general population (12 years or older) and it has been tested in various countries. It is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. Total scores range from 10 to 40, with higher scores suggesting increased self-efficacy. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control | Patients randomized to the control arm will receive standard mental health care alone. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. |
|
|
| Secondary | Hopelessness: Beck Hopelessness Scale (BHS) | The Beck Hopelessness Scale (BHS) is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients report on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. The BHS has good reliability and validity and is sensitive to change. There is some evidence that the BHS may be a measure of risk of suicide. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness | The Interpersonal Needs Questionnaire-15 (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 6-42. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness | The Interpersonal Needs Questionnaire-15 (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 7-63. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Patient Engagement: General Self-Efficacy Scale (GSES) | The General Self-Efficacy Scale (GSES) is a valid scale of self-efficacy that is designed for the general population (12 years or older) and it has been tested in various countries. It is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. Total scores range from 10 to 40, with higher scores suggesting increased self-efficacy. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale | The Suicide-Related Coping Scale (SRCS) 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale | The Suicide-Related Coping Scale (SRCS) 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | Number of Participants With Suicide Attempts | Suicide attempts is measured using the seven-item subscale on the Columbia-Suicide Severity Rating Scale (C-SSRS), a valid and reliable scale that asks patients to self-report on suicide attempts. | Posted | Count of Participants | Participants | 3 months post-baseline |
|
|
|
| Secondary | Number of Participants With Substance Use at 3 Months Post-baseline | The investigators will assess substance use at follow-up assessments using a timeline follow-back approach. This method is commonly used in research studies to assess substance use patterns. Numerical scores do not apply to this assessment. | Posted | Count of Participants | Participants | 3 months post-baseline |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Control | Patients randomized to the control arm will receive standard mental health care alone. Standard Mental Health Care: Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings. | 0 | 10 | 0 | 10 | 4 | 10 |
|
| Psychological distress | Psychiatric disorders | Systematic Assessment | Self report of increased psychological distress. We determined that these symptoms were expected in the population and unrelated to study procedures. |
|
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