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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Change from Baseline BSS at 1-, 3-, and 6-months

Results posted on

2024-06-26

Participant Flow

Participant milestones

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

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

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-months

Population: 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

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-months

Population: 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

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-months

Population: 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

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-month

Population: 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

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-months

Population: 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

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-months

Population: 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

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-months

Population: 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

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-months

Population: 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

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-months

Population: 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

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Usual Care

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 802-295-9363

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place