Trial Outcomes & Findings for Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT (NCT NCT03653637)

NCT ID: NCT03653637

Last Updated: 2025-11-10

Results Overview

Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The CSSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy. C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

294 participants

Primary outcome timeframe

Baseline, 3 Month, 6 Month, 12 Month

Results posted on

2025-11-10

Participant Flow

294 participants were consented and screened. 87 participants were ineligible and therefore were not randomized, leaving a total of 207 participants randomized to treatment.

Participant milestones

Participant milestones
Measure
Project Life Force
A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Treatment-As-Usual
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Overall Study
STARTED
101
106
Overall Study
COMPLETED
63
68
Overall Study
NOT COMPLETED
38
38

Reasons for withdrawal

Reasons for withdrawal
Measure
Project Life Force
A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Treatment-As-Usual
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Overall Study
Death
1
3
Overall Study
Lost to Follow-up
29
30
Overall Study
Physician Decision
1
1
Overall Study
Withdrawal by Subject
7
4

Baseline Characteristics

The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Project Life Force
n=101 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=106 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Total
n=207 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
0 Participants
n=104 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
0 Participants
n=203 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
Age, Categorical
Between 18 and 65 years
90 Participants
n=99 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
97 Participants
n=104 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
187 Participants
n=203 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
Age, Categorical
>=65 years
9 Participants
n=99 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
7 Participants
n=104 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
16 Participants
n=203 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from the analysis.
Age, Continuous
45.9 years
STANDARD_DEVIATION 13.8 • n=99 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from this analysis.
46.4 years
STANDARD_DEVIATION 14.0 • n=104 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from this analysis.
46.1 years
STANDARD_DEVIATION 13.9 • n=203 Participants • The number analyzed differs from the total enrollment of the study because 4 participants did not provide their age and were therefore excluded from this analysis.
Sex: Female, Male
Female
16 Participants
n=97 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
12 Participants
n=101 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
28 Participants
n=198 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
Sex: Female, Male
Male
81 Participants
n=97 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
89 Participants
n=101 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
170 Participants
n=198 Participants • The number analyzed differs from the total enrollment of the study because 9 participants did not provide their sex and were therefore excluded from the analysis
Ethnicity (NIH/OMB)
Hispanic or Latino
36 Participants
n=101 Participants
33 Participants
n=106 Participants
69 Participants
n=207 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
59 Participants
n=101 Participants
65 Participants
n=106 Participants
124 Participants
n=207 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants
n=101 Participants
8 Participants
n=106 Participants
14 Participants
n=207 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
1 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
1 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
Asian
2 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
2 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
4 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
0 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
0 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
Black or African American
27 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
45 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
72 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
White
45 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
35 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
80 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
More than one race
14 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
12 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
26 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
n=100 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
7 Participants
n=102 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
19 Participants
n=202 Participants • The number analyzed differs from the total enrollment of the study because 6 participants did not provide their sex and were therefore excluded from the analysis.
Region of Enrollment
United States
101 participants
n=101 Participants
106 participants
n=106 Participants
207 participants
n=207 Participants
Beck Depression Inventory-II
32.03 scores on a scale
STANDARD_DEVIATION 12.45 • n=98 Participants • Some participants were missing this assessment.
30.90 scores on a scale
STANDARD_DEVIATION 15.08 • n=102 Participants • Some participants were missing this assessment.
31.46 scores on a scale
STANDARD_DEVIATION 13.83 • n=200 Participants • Some participants were missing this assessment.
Beck Hopelessness Scale
10.11 scores on a scale
STANDARD_DEVIATION 6.35 • n=99 Participants • Some participants were missing this assessment.
9.40 scores on a scale
STANDARD_DEVIATION 6.61 • n=102 Participants • Some participants were missing this assessment.
9.75 scores on a scale
STANDARD_DEVIATION 6.48 • n=201 Participants • Some participants were missing this assessment.
Suicide-Related Coping Scale
48.30 scores on a scale
STANDARD_DEVIATION 10.79 • n=99 Participants • Some participants were missing this assessment.
49.17 scores on a scale
STANDARD_DEVIATION 11.19 • n=103 Participants • Some participants were missing this assessment.
48.74 scores on a scale
STANDARD_DEVIATION 10.98 • n=202 Participants • Some participants were missing this assessment.
Insomnia Severity Index
18.17 scores on a scale
STANDARD_DEVIATION 7.26 • n=93 Participants • Some participants were missing this assessment.
16.98 scores on a scale
STANDARD_DEVIATION 7.81 • n=103 Participants • Some participants were missing this assessment.
17.55 scores on a scale
STANDARD_DEVIATION 7.56 • n=196 Participants • Some participants were missing this assessment.
Suicide Intent Scale
16.74 scores on a scale
STANDARD_DEVIATION 4.55 • n=84 Participants • The suicide intent scale was only given to participants with specific suicide histories.
16.06 scores on a scale
STANDARD_DEVIATION 3.94 • n=79 Participants • The suicide intent scale was only given to participants with specific suicide histories.
16.41 scores on a scale
STANDARD_DEVIATION 4.27 • n=163 Participants • The suicide intent scale was only given to participants with specific suicide histories.
Buss-Perry Aggression Questionnaire
Physical aggression
25.96 scores on a scale
STANDARD_DEVIATION 8.91 • n=97 Participants • Some participants were missing this assessment.
27.0 scores on a scale
STANDARD_DEVIATION 9.02 • n=103 Participants • Some participants were missing this assessment.
26.50 scores on a scale
STANDARD_DEVIATION 8.96 • n=200 Participants • Some participants were missing this assessment.
Interpersonal Needs Questionnaire-15
Thwarted belongingness
38.64 scores on a scale
STANDARD_DEVIATION 11.43 • n=96 Participants • Some participants were missing this assessment.
39.11 scores on a scale
STANDARD_DEVIATION 12.36 • n=103 Participants • Some participants were missing this assessment.
38.88 scores on a scale
STANDARD_DEVIATION 11.89 • n=199 Participants • Some participants were missing this assessment.
Interpersonal Needs Questionnaire-15
Perceived burdensomeness
19.63 scores on a scale
STANDARD_DEVIATION 10.73 • n=96 Participants • Some participants were missing this assessment.
19.57 scores on a scale
STANDARD_DEVIATION 11.50 • n=103 Participants • Some participants were missing this assessment.
19.60 scores on a scale
STANDARD_DEVIATION 11.11 • n=199 Participants • Some participants were missing this assessment.
Buss-Perry Aggression Questionnaire
Verbal aggression
14.64 scores on a scale
STANDARD_DEVIATION 4.87 • n=97 Participants • Some participants were missing this assessment.
15.45 scores on a scale
STANDARD_DEVIATION 4.83 • n=103 Participants • Some participants were missing this assessment.
15.06 scores on a scale
STANDARD_DEVIATION 4.85 • n=200 Participants • Some participants were missing this assessment.
Buss-Perry Aggression Questionnaire
Anger
20.18 scores on a scale
STANDARD_DEVIATION 7.23 • n=97 Participants • Some participants were missing this assessment.
20.27 scores on a scale
STANDARD_DEVIATION 6.88 • n=103 Participants • Some participants were missing this assessment.
20.23 scores on a scale
STANDARD_DEVIATION 7.04 • n=200 Participants • Some participants were missing this assessment.
Buss-Perry Aggression Questionnaire
Hostility
25.38 scores on a scale
STANDARD_DEVIATION 7.83 • n=97 Participants • Some participants were missing this assessment.
25.66 scores on a scale
STANDARD_DEVIATION 8.22 • n=103 Participants • Some participants were missing this assessment.
25.53 scores on a scale
STANDARD_DEVIATION 8.01 • n=200 Participants • Some participants were missing this assessment.

PRIMARY outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: TAU has 106 participants, but one participant was excluded because we were missing their suicide attempt history information (which the analytic model adjusted for).

Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The CSSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy. C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.

Outcome measures

Outcome measures
Measure
Project Life Force
n=101 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=105 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Columbia Suicide Rating Scale (C-SSRS)
22 participants with an event
30 participants with an event

PRIMARY outcome

Timeframe: 12 Month

Population: Data for suicidal behavior measured by the (1) Columbia-Suicide Severity Rating Scale (C-SSRS); Suicidal behavior by Chart Abstraction; and the Death by Suicide by National Death Index Survey Findings were combined into one metric. We mistakenly registered the three outcomes separately, but we intended to use these three data sources to make one suicide attempt variable. As such, we reported all suicidal behavior descriptives and models under the C-SSRS outcome.

An independent research assessor who is blinded to study condition will complete all outcome assessments. Data for all types of suicidal behavior including suicides, suicide attempts, interrupted attempts, aborted attempts, and preparatory behavior for suicide, will be obtained. The nomenclature and definitions for suicide-related behaviors will follow the Center for Disease Control and Prevention's (CDC) definitions. Suicidal behavior over the 12-month time frame is a cumulative outcome such that detection of suicidal behavior at any of the outcome points, or by any method, leads to a "positive" indication for the suicidal behavior composite.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 Month

Population: Data for suicidal behavior measured by the (1) Columbia-Suicide Severity Rating Scale (C-SSRS); Suicidal behavior by Chart Abstraction; and the Death by Suicide by National Death Index Survey Findings were combined into one metric. We mistakenly registered the three outcomes separately, but we intended to use these three data sources to make one suicide attempt variable. As such, we reported all suicidal behavior descriptives and models under the C-SSRS outcome.

At month 42, each site's research assistant will query the site's state vital statistics registry for all individuals on this list. For all those who are found to be deceased, data will be abstracted pertaining to his/her death and the probability of suicide from the Death Certificate. The 12-month delay in review is necessary because of the well-known lag in recording deaths in state vital statistics registries.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Beck Depression Inventory-II (BDI-II) measures depressive severity with 21 items on a Likert scale. It has high internal consistency, construct validity, and test-retest reliability. Each question has a set of at least four possible answer choices ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer, and items are summed for a total score (ranging from 0-63). Higher scores indicate worse depressive severity.

Outcome measures

Outcome measures
Measure
Project Life Force
n=98 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=102 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Beck Depression Inventory-II Change
Baseline
32.03 score on a scale
Standard Deviation 12.45
30.90 score on a scale
Standard Deviation 15.08
Beck Depression Inventory-II Change
3 month
23.54 score on a scale
Standard Deviation 14.40
24.32 score on a scale
Standard Deviation 16.04
Beck Depression Inventory-II Change
6 month
23.82 score on a scale
Standard Deviation 12.52
25.19 score on a scale
Standard Deviation 17.41
Beck Depression Inventory-II Change
12 month
23.87 score on a scale
Standard Deviation 12.02
21.69 score on a scale
Standard Deviation 17.28

SECONDARY outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Beck Hopelessness Scale (BHS) measures hopelessness with 20 binary (true/false) items. Items are recoded so that optimistic beliefs equal 0 and pessimistic beliefs equal 1. Recoded items are summed for a total score (ranging from 0-20), and higher scores indicate more severe hopelessness. The BHS demonstrates excellent internal reliability and external validity.

Outcome measures

Outcome measures
Measure
Project Life Force
n=99 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=102 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Beck Hopelessness Scale Change
3-month
7.74 Score on a scale
Standard Deviation 6.67
8.21 Score on a scale
Standard Deviation 6.59
Beck Hopelessness Scale Change
6-month
8.18 Score on a scale
Standard Deviation 6.38
7.67 Score on a scale
Standard Deviation 7.16
Beck Hopelessness Scale Change
12-month
7.48 Score on a scale
Standard Deviation 6.26
7.57 Score on a scale
Standard Deviation 7.23
Beck Hopelessness Scale Change
Baseline
10.11 Score on a scale
Standard Deviation 6.35
9.40 Score on a scale
Standard Deviation 6.61

SECONDARY outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Suicide-Related Coping Scale (SRCS) has 17 items assessing suicide-related coping (knowledge of, and perceived confidence in, using internal coping strategies and external supports to regulate suicidal thoughts and urges). Items are rated on a 5-point scale (Strongly disagree (0) - Strongly agree (4)). All items are summed for a total score (range 0-68), and the first 14 items can also be used for "external coping" and "internal coping" subscales (7 items each; total range 0-28). Higher scores show improved suicide-related coping. The SRCS has acceptable internal and external validity.

Outcome measures

Outcome measures
Measure
Project Life Force
n=99 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=103 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Suicide-related Coping Scale Change
Baseline
48.30 Score on a scale
Standard Deviation 10.79
49.17 Score on a scale
Standard Deviation 11.19
Suicide-related Coping Scale Change
3-month
53.68 Score on a scale
Standard Deviation 10.67
50.09 Score on a scale
Standard Deviation 14.12
Suicide-related Coping Scale Change
6-month
53.15 Score on a scale
Standard Deviation 10.84
49.22 Score on a scale
Standard Deviation 13.68
Suicide-related Coping Scale Change
12-month
53.95 Score on a scale
Standard Deviation 10.19
52.88 Score on a scale
Standard Deviation 12.15

SECONDARY outcome

Timeframe: 12 Month

Outpatient Mental Health Treatment Utilization was quantified using CPRS. The number of outpatient non-PLF mental health visits from the past three months was counted.

Outcome measures

Outcome measures
Measure
Project Life Force
n=94 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=100 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Outpatient Mental Health Treatment Utilization
Baseline (3-months pre-treatment)
17.96 visit count
Standard Deviation 21.50
17.53 visit count
Standard Deviation 15.89
Outpatient Mental Health Treatment Utilization
6-months post consent
45.28 visit count
Standard Deviation 44.40
37.82 visit count
Standard Deviation 30.98

SECONDARY outcome

Timeframe: 12 Month

Population: This measure was only administered at the 12-month follow-up. 81 participants filled out the DAST-10 at this assessment point.

The DAST-10 measures drug use over the past twelve months to identify potential drug use disorder with 10 binary items (0/1). Total scores range from 0 to 10. Scores of 0 indicate no problems, 1-2 low-level, 3-5 moderate level, 6-8 substantial level, and 9-10 severe level.

Outcome measures

Outcome measures
Measure
Project Life Force
n=35 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=46 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Drug Abuse Screening Test 10 (DAST-10)
4.0 Score on a scale
Standard Deviation 2.83
3.57 Score on a scale
Standard Deviation 3.15

SECONDARY outcome

Timeframe: 12 Month

Population: This measure was only administered at the 12-month follow-up. 124 participants filled out the DAST-10 at this assessment point.

The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief 3-item alcohol screening tool used to identify individuals who may be at risk for hazardous drinking or have an alcohol use disorder. Each item is rated from 0 to 4, and total scores range from 0 - 12. Higher scores indicated an increased likelihood that an individual's drinking is endangering his or her safety.

Outcome measures

Outcome measures
Measure
Project Life Force
n=61 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=63 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
1.95 Score on a scale
Standard Deviation 2.99
1.62 Score on a scale
Standard Deviation 2.56

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 1, 5, 10

Population: Data were not collected on this scale when the protocol shifted to virtual treatment due to COVID-19.

Group cohesion will be measured by the The Group Cohesion Scale-Revised, a 25-item self-report measure that assesses aspects of group cohesion including communication, interaction, member retention, decision making, vulnerability among group members and consistency between group and individual goals with a four-point scale. This scale will be used for participants randomized to the PLF treatment at 3 times points before a group session. The scale demonstrated high validity and reliability in research settings and was found to be sensitive to change in a psychodrama group treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Interpersonal Needs Questionnaire-15 (INQ-15) consists of 15 items assessing thwarted interpersonal needs along two domains: Thwarted Belongingness (TB, nine items) and Perceived Burdensomeness (PB, six items). All items are rated from one (not at all true for me) to seven (very true for me). Six items from the TB subscale are reverse-keyed and reverse-scored. Items are summed for total scores (TB total score range: 9-63 and PB score range: 6-42). Higher scores indicate increased severity of TB and PB.

Outcome measures

Outcome measures
Measure
Project Life Force
n=96 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=103 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Interpersonal Needs Questionnaire Change
Baseline
38.64 Score on a scale
Standard Deviation 11.43
39.11 Score on a scale
Standard Deviation 12.36
Interpersonal Needs Questionnaire Change
3-month
33.98 Score on a scale
Standard Deviation 12.99
36.18 Score on a scale
Standard Deviation 13.85
Interpersonal Needs Questionnaire Change
6-month
33.7 Score on a scale
Standard Deviation 12.79
36.20 Score on a scale
Standard Deviation 13.67
Interpersonal Needs Questionnaire Change
12-month
32.29 Score on a scale
Standard Deviation 12.04
34.73 Score on a scale
Standard Deviation 14.57

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Buss-Perry Aggression Questionnaire (BPAQ) assesses aggression in four domains (anger, hostility, physical aggression, and verbal aggression) with 29 items on a 4-point scale (Extremely uncharacteristic (0) - Extremely characteristic (3)). Items in each domain are summed for domain scores, and higher scores indicate more aggression severity in the respective domain. Total score ranges are: anger: 7-35, hostility: 8-40, physical aggression: 9-45, verbal aggression: 5-25.

Outcome measures

Outcome measures
Measure
Project Life Force
n=97 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=103 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Buss-Perry Aggression Questionnaire Change
Baseline (verbal aggression subscale)
14.64 Score on a scale
Standard Deviation 4.87
15.45 Score on a scale
Standard Deviation 4.83
Buss-Perry Aggression Questionnaire Change
3-month (verbal aggression subscale)
13.56 Score on a scale
Standard Deviation 4.89
15.7 Score on a scale
Standard Deviation 4.83
Buss-Perry Aggression Questionnaire Change
6-month (verbal aggression subscale)
13.92 Score on a scale
Standard Deviation 4.56
15.41 Score on a scale
Standard Deviation 5.17
Buss-Perry Aggression Questionnaire Change
12-month (verbal aggression subscale)
14.56 Score on a scale
Standard Deviation 4.74
14.36 Score on a scale
Standard Deviation 4.77
Buss-Perry Aggression Questionnaire Change
Baseline (physical aggression subscale)
25.96 Score on a scale
Standard Deviation 8.91
27.0 Score on a scale
Standard Deviation 9.02
Buss-Perry Aggression Questionnaire Change
3-month(physical aggression subscale)
24.61 Score on a scale
Standard Deviation 8.93
27.51 Score on a scale
Standard Deviation 9.31
Buss-Perry Aggression Questionnaire Change
6-month(physical aggression subscale)
24.15 Score on a scale
Standard Deviation 7.73
26.93 Score on a scale
Standard Deviation 9.77
Buss-Perry Aggression Questionnaire Change
12-month(physical aggression subscale)
24.35 Score on a scale
Standard Deviation 9.19
25.72 Score on a scale
Standard Deviation 8.51
Buss-Perry Aggression Questionnaire Change
Baseline (anger subscale)
20.18 Score on a scale
Standard Deviation 7.23
20.27 Score on a scale
Standard Deviation 6.88
Buss-Perry Aggression Questionnaire Change
3-month (anger subscale)
19.33 Score on a scale
Standard Deviation 6.98
20.69 Score on a scale
Standard Deviation 7.32
Buss-Perry Aggression Questionnaire Change
6-month (anger subscale)
19.51 Score on a scale
Standard Deviation 6.57
19.56 Score on a scale
Standard Deviation 7.49
Buss-Perry Aggression Questionnaire Change
12-month (anger subscale)
18.54 Score on a scale
Standard Deviation 6.68
19.30 Score on a scale
Standard Deviation 6.59
Buss-Perry Aggression Questionnaire Change
Baseline (hostility subscale)
25.38 Score on a scale
Standard Deviation 7.83
25.66 Score on a scale
Standard Deviation 8.22
Buss-Perry Aggression Questionnaire Change
3-month (hostility subscale)
23.67 Score on a scale
Standard Deviation 7.69
24.33 Score on a scale
Standard Deviation 8.13
Buss-Perry Aggression Questionnaire Change
6-month (hostility subscale)
23.86 Score on a scale
Standard Deviation 6.9
23.93 Score on a scale
Standard Deviation 8.53
Buss-Perry Aggression Questionnaire Change
12-month (hostility subscale)
23.73 Score on a scale
Standard Deviation 6.85
23.54 Score on a scale
Standard Deviation 8.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Insomnia Severity Index (ISI) is a 7-item brief screening measure of insomnia. Items include insomnia severity (falling asleep, staying asleep, and waking too early), satisfaction with sleep, the extent to which sleep difficulties impair daily functioning, how noticeable low quality of life due to sleep difficulties is to others, and distress about sleep difficulties. Item responses range from 0 - 4 and are summed for total scores (range 0-28). Higher scores indicate more severe insomnia. The ISI has good internal consistency and validity for treatment research.

Outcome measures

Outcome measures
Measure
Project Life Force
n=93 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=103 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Insomnia Severity Index Change
Baseline
18.17 Score on a scale
Standard Deviation 7.26
16.98 Score on a scale
Standard Deviation 7.81
Insomnia Severity Index Change
3-month
14.59 Score on a scale
Standard Deviation 8.46
14.88 Score on a scale
Standard Deviation 8.15
Insomnia Severity Index Change
6-month
13.63 Score on a scale
Standard Deviation 8.08
15.15 Score on a scale
Standard Deviation 8.36
Insomnia Severity Index Change
12-month
13.94 Score on a scale
Standard Deviation 6.60
13.63 Score on a scale
Standard Deviation 8.81

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Month

Population: Number of people who had a suicide attempt (actual attempt) over the study course, excluding baseline attempts, and filled out the Beck Lethality Scale about these attempts.

The Beck Lethality Scale (BLS) is an interview-administered measure of medical lethality of a suicide attempt for eight possible methods (i.e., coma-producing drugs, non-coma-producing drugs, shooting, burning, drowning, cutting, jumping, and hanging). The BLS was used following suicidal behavior over the full study duration. Each item (i.e., each method) is rated from "0" (none or minimal damage) to "10" (death) based on an examination of the patient's physical condition on admission, review of the medical charts, and consultation with the attending physician. Higher scores on each method indicate higher lethality for that method. The highest lethality rating across all of the eight methods (none or minimal damage to death) was used as a total score.

Outcome measures

Outcome measures
Measure
Project Life Force
n=8 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=18 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Beck Lethality Scale Change
4.41 score on a scale
Standard Deviation 4.10
3.36 score on a scale
Standard Deviation 4.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 Month, 6 Month, 12 Month

Population: Participant drop-out and missing assessment points occurred throughout the duration of the study.

The Suicide Intent Scale (SIS) measures the retrospective intensity of the wish to die at the time of a suicide attempt with 20 items. Each item is graded in intensity from 0 to 2, and the first 15 items are summed for a total score (ranging from 0 to 30). Higher scores indicate higher suicide intent. The SIS has high inter-rater reliability and internal consistency.

Outcome measures

Outcome measures
Measure
Project Life Force
n=101 Participants
Project Life Force: A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=106 Participants
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Beck Suicide Intent Scale Change
3-month
16.71 score on a scale
Standard Deviation 4.42
16.00 score on a scale
Standard Deviation 3.57
Beck Suicide Intent Scale Change
12-month
3.23 score on a scale
Standard Deviation 2.41
17.30 score on a scale
Standard Deviation 16.14
Beck Suicide Intent Scale Change
Baseline
16.74 score on a scale
Standard Deviation 4.55
16.06 score on a scale
Standard Deviation 3.94
Beck Suicide Intent Scale Change
6-month
15.25 score on a scale
Standard Deviation 7.27
15.14 score on a scale
Standard Deviation 4.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: This measure was used for the study's eligibility criteria and was not intended to be an outcome measure.

The Ohio State University Traumatic Brain Injury Identification Method is a standardized, 3-5-minute structured interview designed elicit a person's lifetime history of TBI.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: This measure was used for the study's eligibility criteria and was not intended to be an outcome measure.

The Mini International Neuropsychiatric Interview (MINI) is a structured diagnostic interview that assesses the presence of psychiatric disorders according to DSM-IV or ICD-10 criteria, with good interrater and test-retest reliability. The MINI was used to determine psychiatric diagnoses (lifetime and current).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: This measure was used for the study's eligibility criteria and was not intended to be an outcome measure.

The Mini Mental State Exam is a questionnaire used to measure cognitive impairment. This scale has good validity and construct validity and will be used to examine if participants are cognitively able to participate in the study.

Outcome measures

Outcome data not reported

Adverse Events

Project Life Force

Serious events: 31 serious events
Other events: 8 other events
Deaths: 1 deaths

Treatment-As-Usual

Serious events: 29 serious events
Other events: 4 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Project Life Force
n=101 participants at risk
A novel, 10-session intervention to enhance VA suicide safety planning in a group setting. PLF is a manualized, weekly 90-minute treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Session content is described in Table 1 (see appendix A). Six PLF sessions correspond to steps of the safety plan and teach skills maximizing use of each step of the plan. Emotion regulation skills in PLF differ from other DBT interventions in focusing primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care. A novel,10-session group intervention enhancing currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicide. PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=106 participants at risk
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Musculoskeletal and connective tissue disorders
Hospitalized for knee replacement
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Hospitalized inpatient psych unit
22.8%
23/101 • Number of events 23 • Adverse event data were collected from participant consent date through study completion, average of one year.
18.9%
20/106 • Number of events 20 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Inpatient Psychiatric Hospitalization
20.8%
21/101 • Number of events 27 • Adverse event data were collected from participant consent date through study completion, average of one year.
17.9%
19/106 • Number of events 21 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Suicide attempt without medical intervention
3.0%
3/101 • Number of events 4 • Adverse event data were collected from participant consent date through study completion, average of one year.
2.8%
3/106 • Number of events 4 • Adverse event data were collected from participant consent date through study completion, average of one year.
Cardiac disorders
Heart Failure
0.99%
1/101 • Number of events 4 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Emergency Department visit for rib pain
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Emergency Department visit for orthopedic concerns
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
General disorders
Medical hospitalization (unspecified)
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
General disorders
Hospitalized following motor vehicle accident
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Hospitalized for shoulder surgery
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Hospitalized for attempted overdose
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Respiratory, thoracic and mediastinal disorders
Hospitalized for pulmonary embolism
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Cardiac disorders
Emergency Department visit for chest pain
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Respiratory, thoracic and mediastinal disorders
Hospitalized for COVID-19
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Emergency Department visit for tremors and headache
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Cardiac disorders
Emergency Department visit for high blood pressure
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Hospitalized for broken hip
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.

Other adverse events

Other adverse events
Measure
Project Life Force
n=101 participants at risk
A novel, 10-session intervention to enhance VA suicide safety planning in a group setting. PLF is a manualized, weekly 90-minute treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Session content is described in Table 1 (see appendix A). Six PLF sessions correspond to steps of the safety plan and teach skills maximizing use of each step of the plan. Emotion regulation skills in PLF differ from other DBT interventions in focusing primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care. A novel,10-session group intervention enhancing currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicide. PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment-As-Usual
n=106 participants at risk
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals. Treatment as Usual: The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Social circumstances
Loss of employment
2.0%
2/101 • Number of events 2 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Cardiac disorders
Emergency Department visit for blood clot post surgical operation
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for COPD
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Emergency Department visit for substance withdrawl
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Emergency Department visit for leg pain
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for trouble breathing due to air quality
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Social circumstances
Financial hardship and housing insecurity
0.00%
0/101 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Emergency Department visit for back pain
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Musculoskeletal and connective tissue disorders
Emergency Department visit for jaw pain
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for cough, headache, chills, fever
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Skin and subcutaneous tissue disorders
Emergency Department visit for rash
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.
Psychiatric disorders
Increase in suicidal ideation/depression
0.99%
1/101 • Number of events 3 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.94%
1/106 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
Social circumstances
Challenges transferring inpatient programs
0.99%
1/101 • Number of events 1 • Adverse event data were collected from participant consent date through study completion, average of one year.
0.00%
0/106 • Adverse event data were collected from participant consent date through study completion, average of one year.

Additional Information

Dr. Marianne Goodman

James J. Peters VA Medical Center

Phone: 6462457071

Results disclosure agreements

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