Trial Outcomes & Findings for Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios (NCT NCT04054947)
NCT ID: NCT04054947
Last Updated: 2024-06-26
Results Overview
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.
COMPLETED
NA
60 participants
Change from Baseline BSS at 1-, 3-, and 6-months
2024-06-26
Participant Flow
Participant milestones
| Measure |
Suicide Prevention Program
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
Usual Care
Standard care that occurs as part of mental health treatment
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
28
|
|
Overall Study
COMPLETED
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Suicide Prevention Program
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
Usual Care
Standard care that occurs as part of mental health treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
Baseline Characteristics
The MSPSS was added later in the study, after some participants had completed all assessments.
Baseline characteristics by cohort
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.61 years
STANDARD_DEVIATION 13.73 • n=28 Participants
|
52.97 years
STANDARD_DEVIATION 15.09 • n=31 Participants
|
51.0 years
STANDARD_DEVIATION 14.5 • n=59 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=28 Participants
|
4 Participants
n=31 Participants
|
11 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=28 Participants
|
27 Participants
n=31 Participants
|
48 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=28 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=28 Participants
|
30 Participants
n=31 Participants
|
57 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=59 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=28 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=59 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=28 Participants
|
30 Participants
n=31 Participants
|
52 Participants
n=59 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=59 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
31 participants
n=31 Participants
|
59 participants
n=59 Participants
|
|
The Beck Scale for Suicidal Ideation (BSS) - Mean Score at Baseline
|
9.3 units on a scale
STANDARD_DEVIATION 10.0 • n=28 Participants
|
11.0 units on a scale
STANDARD_DEVIATION 11.1 • n=31 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 10.6 • n=59 Participants
|
|
The Beck Scale for Hopelessness (BHS) - Mean Score at Baseline
|
9.7 units on a scale
STANDARD_DEVIATION 6.4 • n=28 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 6.2 • n=31 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 6.3 • n=59 Participants
|
|
The Partners in Health Scale (PIH) (self management) - Mean Score at Baseline
|
67.2 units on a scale
STANDARD_DEVIATION 12.9 • n=28 Participants
|
67.0 units on a scale
STANDARD_DEVIATION 15.4 • n=31 Participants
|
67.1 units on a scale
STANDARD_DEVIATION 14.2 • n=59 Participants
|
|
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB) -Mean Score at Baseline
|
37.2 units on a scale
STANDARD_DEVIATION 11.0 • n=28 Participants
|
35.4 units on a scale
STANDARD_DEVIATION 14.1 • n=31 Participants
|
36.2 units on a scale
STANDARD_DEVIATION 12.6 • n=59 Participants
|
|
The Interpersonal Needs Questionnaire-15: Perceived Burdensomeness(INQ-15 PB)-Mean Score at Baseline
|
17.9 units on a scale
STANDARD_DEVIATION 10.4 • n=28 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 11.2 • n=31 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 10.8 • n=59 Participants
|
|
Multidimensional Scale of Perceived Social Support (MSPSS) - Mean Score at Baseline
|
4.4 units on a scale
STANDARD_DEVIATION 1.7 • n=19 Participants • The MSPSS was added later in the study, after some participants had completed all assessments.
|
4.7 units on a scale
STANDARD_DEVIATION 1.6 • n=21 Participants • The MSPSS was added later in the study, after some participants had completed all assessments.
|
4.5 units on a scale
STANDARD_DEVIATION 1.6 • n=40 Participants • The MSPSS was added later in the study, after some participants had completed all assessments.
|
|
Suicide-Related Coping Scale (SRCS) - Mean Score at Baseline
|
51.8 units on a scale
STANDARD_DEVIATION 10.4 • n=19 Participants • The SRCS was added later in the study, after some participants had completed all assessments.
|
54.5 units on a scale
STANDARD_DEVIATION 10.4 • n=21 Participants • The SRCS was added later in the study, after some participants had completed all assessments.
|
53.2 units on a scale
STANDARD_DEVIATION 10.4 • n=40 Participants • The SRCS was added later in the study, after some participants had completed all assessments.
|
PRIMARY outcome
Timeframe: Change from Baseline BSS at 1-, 3-, and 6-monthsPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
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.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
The Beck Scale for Suicidal Ideation (BSS)
1-month Follow-up
|
-2.5 score on a scale
Standard Deviation 9.0
|
-6.0 score on a scale
Standard Deviation 9.9
|
|
The Beck Scale for Suicidal Ideation (BSS)
3-month Follow-up
|
-2.6 score on a scale
Standard Deviation 9.3
|
-5.7 score on a scale
Standard Deviation 10.1
|
|
The Beck Scale for Suicidal Ideation (BSS)
6-month Follow-up
|
1.4 score on a scale
Standard Deviation 6.5
|
-5.3 score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Change from Baseline BHS at 1-, 3-, and 6-monthsPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
The BHS ranges from 0-20 with higher scores associated with increased hopelessness.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
The Beck Scale for Hopelessness (BHS)
1-month Follow-up
|
-2.1 score on a scale
Standard Deviation 5.9
|
-3.2 score on a scale
Standard Deviation 5.9
|
|
The Beck Scale for Hopelessness (BHS)
3-month Follow-up
|
-3.0 score on a scale
Standard Deviation 6.0
|
-4.0 score on a scale
Standard Deviation 5.8
|
|
The Beck Scale for Hopelessness (BHS)
6-month Follow-up
|
-0.1 score on a scale
Standard Deviation 5.7
|
-2.7 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Change from Baseline PIH at 1-, 3-, and 6-monthsPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
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.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
The Partners in Health Scale (PIH) (Self Management)
1-month Follow-up
|
8.1 score on a scale
Standard Deviation 11.7
|
10.4 score on a scale
Standard Deviation 14.0
|
|
The Partners in Health Scale (PIH) (Self Management)
3-month Follow-up
|
6.8 score on a scale
Standard Deviation 13.0
|
8.1 score on a scale
Standard Deviation 14.8
|
|
The Partners in Health Scale (PIH) (Self Management)
6-month Follow-up
|
6.2 score on a scale
Standard Deviation 12.8
|
4.8 score on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Baseline, 1-month, 3-month, 6-monthPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
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.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
1-month Follow-up
|
-4.0 score on a scale
Standard Deviation 12.2
|
-8.2 score on a scale
Standard Deviation 13.0
|
|
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
3-month Follow-up
|
-6.4 score on a scale
Standard Deviation 14.0
|
-8.7 score on a scale
Standard Deviation 13.6
|
|
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
6-month Follow-up
|
3.4 score on a scale
Standard Deviation 15.6
|
-5.6 score on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Change from Baseline INQ-15 PB at 1-, 3-, and 6-monthsPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
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.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
1-month Follow-up
|
-1.8 score on a scale
Standard Deviation 9.4
|
-4.9 score on a scale
Standard Deviation 10.0
|
|
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
3-month Follow-up
|
-4.4 score on a scale
Standard Deviation 9.6
|
-5.6 score on a scale
Standard Deviation 10.4
|
|
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
6-month Follow-up
|
3.2 score on a scale
Standard Deviation 8.3
|
-5.9 score on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Number of events according to the CSSR-S at 1-, 3-, and 6-monthsPopulation: Participants scores were analyzed if they completed the assessment at either baseline, 1-, 3-, and 6-month follow-ups.
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.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=31 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
Baseline
|
0 number of events
|
0 number of events
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
1-month Follow-up
|
0 number of events
|
0 number of events
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
3-month Follow-up
|
0 number of events
|
0 number of events
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
6-month Follow-up
|
0 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: Change from Baseline MSPSS at 1-, 3-, and 6-monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=19 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=21 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
1-month Follow-up
|
0.6 score on a scale
Standard Deviation 1.7
|
0.5 score on a scale
Standard Deviation 1.6
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
3-month Follow-up
|
0.7 score on a scale
Standard Deviation 1.6
|
1.1 score on a scale
Standard Deviation 1.4
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
6-month Follow-up
|
0.4 score on a scale
Standard Deviation 1.7
|
-0.1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Change from Baseline SRCS at 1-, 3-, and 6-monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=19 Participants
Standard care that occurs as part of mental health treatment.
|
Suicide Prevention Program
n=21 Participants
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
|---|---|---|
|
Suicide-Related Coping Scale (SRCS)
1-month Follow-up
|
4.3 score on a scale
Standard Deviation 10.4
|
4.7 score on a scale
Standard Deviation 9.3
|
|
Suicide-Related Coping Scale (SRCS)
3-month Follow-up
|
5.0 score on a scale
Standard Deviation 11.0
|
7.9 score on a scale
Standard Deviation 9.3
|
|
Suicide-Related Coping Scale (SRCS)
6-month Follow-up
|
-2.9 score on a scale
Standard Deviation 10.5
|
4.4 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Change in AES scores at 1- and 6-monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Suicide Prevention Program
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suicide Prevention Program
n=31 participants at risk
Suicide Prevention Program: Structured care management to improve adherence to discharge planning.
|
Usual Care
n=28 participants at risk
Standard care that occurs as part of mental health treatment
|
|---|---|---|
|
Psychiatric disorders
Worsening Mental Health
|
22.6%
7/31 • Number of events 13 • 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.
|
10.7%
3/28 • Number of events 7 • 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.
|
|
Psychiatric disorders
Alcohol/Substance Use Relapse
|
9.7%
3/31 • Number of events 4 • 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.
|
10.7%
3/28 • Number of events 5 • 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.
|
|
Cardiac disorders
Cardiac-Related Issues
|
9.7%
3/31 • Number of events 4 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
Additional Information
Dr. Brian Shiner
White River Junction VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place