Suicide Prevention
Conditions
Keywords
Mental health education, Clinical trial, Suicidal ideation, Suicide, attempted
Brief summary
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: * Does BESST combined with standard care improve suicide-related outcomes among this population compared to standard care alone? 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: * 1 one-hour brief educational session; * Seven follow-up check-ins (\ 30 minutes each) 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.
Interventions
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.
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.
Sponsors
Study design
Masking description
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
Intervention model description
Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.
Eligibility
Inclusion criteria
* The patient was recently discharged from a VA community care mental health treatment setting * The patient is at risk for self-harm * Be a patient connected to the White River Junction VA Medical Center (VAMC), the Togus VA Medical Center (VAMC), or the Manchester VA Medical Center (VAMC); * Be a Veteran; * Be 18 years or older; * Be able to speak English;
Exclusion criteria
* Unable to provide informed consent; * The investigators do not plan to enroll any potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients; * Study physician deems the patient not clinically appropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) | 3 months post-baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness | 3 months post-baseline | 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. |
| Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness | 3 months post-baseline | 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. |
| Patient Engagement: General Self-Efficacy Scale (GSES) | 3 months post-baseline | 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. |
| Hopelessness: Beck Hopelessness Scale (BHS) | 3 months post-baseline | 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. |
| Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale | 3 months post-baseline | 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. |
| Number of Participants With Suicide Attempts | 3 months post-baseline | 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. |
| Number of Participants With Substance Use at 3 Months Post-baseline | 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. |
| Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale | 3 months post-baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Control | BESST |
|---|---|---|---|
| Age, Continuous | 42.35 years STANDARD_DEVIATION 10.16 | 42.0 years STANDARD_DEVIATION 11.63 | 42.7 years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 10 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Generalized Self-Efficacy Scale (GES) | 26.45 units on a scale STANDARD_DEVIATION 5.17 | 25.9 units on a scale STANDARD_DEVIATION 4.41 | 27.0 units on a scale STANDARD_DEVIATION 6.02 |
| Interpersonal Needs Questionnaire-15, Perceived Burdensomeness (INQ-15 PB) | 15.75 units on a scale STANDARD_DEVIATION 7.59 | 15.3 units on a scale STANDARD_DEVIATION 6.82 | 16.2 units on a scale STANDARD_DEVIATION 8.65 |
| Interpersonal Needs Questionnaire-15, Thwarted Belongingness (INQ-15 TB) | 32.75 units on a scale STANDARD_DEVIATION 9.09 | 31.3 units on a scale STANDARD_DEVIATION 7.54 | 34.2 units on a scale STANDARD_DEVIATION 10.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 10 Participants | 10 Participants |
| Region of Enrollment United States | 20 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 9 Participants |
| Suicide Related Coping Scale (SRCS) External Coping Subscale | 22.7 units on a scale STANDARD_DEVIATION 4.01 | 23.4 units on a scale STANDARD_DEVIATION 3.66 | 22.0 units on a scale STANDARD_DEVIATION 4.42 |
| Suicide Related Coping Scale (SRCS) Internal Coping Subscale | 19.2 units on a scale STANDARD_DEVIATION 6.09 | 20.0 units on a scale STANDARD_DEVIATION 5.56 | 18.4 units on a scale STANDARD_DEVIATION 6.79 |
| The Beck Scale for Hopelessness (BHS) | 9.25 units on a scale STANDARD_DEVIATION 3.93 | 8.7 units on a scale STANDARD_DEVIATION 3.43 | 9.8 units on a scale STANDARD_DEVIATION 4.49 |
| The Beck Scale for Suicidal Ideation (BSS) | 7.0 units on a scale STANDARD_DEVIATION 8.39 | 9.4 units on a scale STANDARD_DEVIATION 9.8 | 4.6 units on a scale STANDARD_DEVIATION 6.293 |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | 4.67 units on a scale STANDARD_DEVIATION 1.2 | 4.99 units on a scale STANDARD_DEVIATION 0.84 | 4.34 units on a scale STANDARD_DEVIATION 1.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) | 2.0 units on a scale | Standard Deviation 4.22 |
| Control | Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) | 10.7 units on a scale | Standard Deviation 9.48 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness | 10.2 units on a scale | Standard Deviation 5.98 |
| Control | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness | 17.4 units on a scale | Standard Deviation 12.24 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness | 29.1 units on a scale | Standard Deviation 11.3 |
| Control | Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness | 32.3 units on a scale | Standard Deviation 15.72 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Hopelessness: Beck Hopelessness Scale (BHS) | 5.6 units on a scale | Standard Deviation 4.74 |
| Control | Hopelessness: Beck Hopelessness Scale (BHS) | 10.4 units on a scale | Standard Deviation 6.5 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BESST | Number of Participants With Substance Use at 3 Months Post-baseline | 3 Participants |
| Control | Number of Participants With Substance Use at 3 Months Post-baseline | 5 Participants |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BESST | Number of Participants With Suicide Attempts | 0 Participants |
| Control | Number of Participants With Suicide Attempts | 0 Participants |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Patient Engagement: General Self-Efficacy Scale (GSES) | 30.4 units on a scale | Standard Deviation 7.85 |
| Control | Patient Engagement: General Self-Efficacy Scale (GSES) | 28.1 units on a scale | Standard Deviation 6.59 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale | 24.6 units on a scale | Standard Deviation 3.63 |
| Control | Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale | 22.1 units on a scale | Standard Deviation 7.26 |
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.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BESST | Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale | 25.2 units on a scale | Standard Deviation 4.39 |
| Control | Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale | 20.2 units on a scale | Standard Deviation 7.79 |