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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01CX001705-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Corporal Michael J. Crescenz VA Medical Center | FED |
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The management of suicide risk is a pressing national public health issue especially among Veterans. This grant consists of two arms: the novel treatment and treatment-as-usual. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been developed to provide a mechanism to develop and enhance the Suicide Safety Plan (SSP) over time. PLF, a 10-session, group intervention, combines cognitive behavior therapy (CBT)/dialectical behavior therapy (DBT) skill based, and psychoeducational approaches, to maximize suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning coping, emotion regulation, and interpersonal skills to incorporate into their safety plans.
Worldwide someone dies by suicide every 40 seconds. In the United States, Veterans exhibit significantly higher suicide risk when compared to the general United States population. One in five suicide deaths is a Veteran and in spite of enhanced suicide prevention services in the Veterans Administration (VA), twenty Veterans commit suicide daily. These very concerning numbers demonstrate an urgent need to develop additional, empirically validated interventions for suicidal Veterans.
One component of the VA's coordinated effort to treat high-risk suicidal Veterans, and diminish suicide risk, is through the construction of a Suicide Safety Plan. Considered a best practice, the SSP instructs one to: recognize personal warning signs of suicide; use internal coping strategies; engage social contacts that can offer support and serve as distraction from suicidal thoughts; contact family members or friends who may help resolve a crisis; provide contact information for VA professionals to help and, specify steps for how to make the immediate environment safer. The patient takes the SSP home for his or her use during (or at the onset of) a suicidal crisis. Safety planning is based on the idea that suicide risk fluctuates over time, and aims to prevent suicidal crises from escalating, and stop individuals from acting on their suicidal thoughts and urges. Research suggests creation of the SSP is effective; one study found that Veterans who present to an emergency room show decreased suicide behavior after creating a SSP.
This study aims to fill this treatment gap by examining a novel intervention integrating skills training with safety planning for high risk suicidal Veterans, "Project Life Force" (PLF). The PLF intervention augments the SSP with skills training, and psychoeducation, to maximize use and effectiveness of the plan in a group setting. This intervention's skill instruction is delivered in a group format. Research suggests groups mitigate loneliness and increase a sense of belonging, which is in line with the extensive literature supporting the interpersonal psychological theory (i.e., that those who die by suicide have a low sense of belonging. More recently, reports on the relation of "military unit cohesion" and suicide risk, suggests that increasing unit cohesion may have a protective effect. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others.
The main objective of this RCT is to examine if Veterans who are at high risk for suicide will benefit from the novel group intervention, PLF, compared to Veterans who receive TAU.The specific aims and hypotheses of PLF are:
Aim 1: To conduct a multi-site randomized clinical trial (RCT) of a group safety planning intervention, "PLF" versus individual safety planning in 265 suicidal Veterans. PLF will be compared with the comparison condition- individual safety planning, the current standard of care, designated as TAU.
Exploratory Aim 2: To test whether increased suicide coping and improved belongingness partially mediates treatment response in PLF>TAU.
Exploratory Aim 3: To test whether group cohesion partially mediates treatment response in PLF.
Exploratory Aim 4: To test whether the change in Safety Plan Quality (post intervention - baseline) is greater PLF>TAU, as well as whether the change in safety plan quality partially mediates treatment response in the follow up period.
Hypothesis A1: Compared to TAU, Veterans who participate in PLF, will demonstrate a decrease in suicidal behavior.
Hypothesis A2: Compared to TAU, Veterans who participate in PLF will show a decrease in depression and hopelessness.
Hypothesis A3: Compared to TAU, Veterans who participate in PLF will have increased compliance and attitudes towards mental health treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project Life Force | Experimental | 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". Session content is described in Table 1 (see appendix A). 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Life Force | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Columbia Suicide Rating Scale (C-SSRS) | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Suicidal Behavior by Chart Abstraction | 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. | 12 Month |
| Death by Suicide by National Death Index Survey Findings | 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. | 12 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II Change | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Group Cohesion Scale-Revised Change | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne S. Goodman, MD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | United States | ||
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42213437 | Derived | Goodman M, Jager-Hyman S, Monahan M, Glatt S, Thase ME, O'Brien S, Krauss A, Galfalvy HC, Sullivan SR, Luther J, Brown GK. Group-Based Suicide Safety Planning and Skills Training for Veterans With High Suicide Risk: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2615029. doi: 10.1001/jamanetworkopen.2026.15029. | |
| 41801754 | Derived | Glatt S, Greene AL, Chan CC, Brown GK, Goodman M. Do the Beck Depression Inventory-II and Beck Hopelessness Scale reliably capture systematic change and within-person variation? Evidence from generalizability theory. Psychol Assess. 2026 Jun-Jul;38(6-7):466-473. doi: 10.1037/pas0001457. Epub 2026 Mar 9. |
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294 participants were consented and screened. 87 participants were ineligible and therefore were not randomized, leaving a total of 207 participants randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Project Life Force | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Columbia Suicide Rating Scale (C-SSRS) | 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. | TAU has 106 participants, but one participant was excluded because we were missing their suicide attempt history information (which the analytic model adjusted for). | Posted | Number | participants with an event | Baseline, 3 Month, 6 Month, 12 Month |
|
Adverse event data were collected from participant consent date through study completion, average of one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Project Life Force | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized inpatient psych unit | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department visit for back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Primarily, we experienced disruption in the planned procedures due to COVID-19 (e.g., necessitating a shift to remote treatment). This context limits the conclusions that can be drawn from this trial, as the in-person group setting was hypothesized to be an important mechanism of change and improvement in study outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marianne Goodman | James J. Peters VA Medical Center | 6462457071 | mggoodman2001@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 3, 2024 | May 12, 2025 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2025 | May 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants are assigned to one of two groups in parallel for the duration of the study.
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The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
|
|
| Treatment as Usual | Behavioral | 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. |
|
|
| Baseline, 3 Month, 6 Month, 12 Month |
| Beck Hopelessness Scale Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Suicide-related Coping Scale Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Outpatient Mental Health Treatment Utilization | 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. | 12 Month |
| Drug Abuse Screening Test 10 (DAST-10) | 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. | 12 Month |
| Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) | 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. | 12 Month |
| Weeks 1, 5, 10 |
| Interpersonal Needs Questionnaire Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Buss-Perry Aggression Questionnaire Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Insomnia Severity Index Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Beck Lethality Scale Change | 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. | 12 Month |
| Beck Suicide Intent Scale Change | 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. | Baseline, 3 Month, 6 Month, 12 Month |
| Ohio State University Traumatic Brain Injury Identification Method | 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. | Baseline |
| Mini International Neuropsychiatric Interview | 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). | Baseline |
| Mini Mental State Exam | 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. | Baseline |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 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. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 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 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beck Depression Inventory-II | The Beck Depression Inventory-II (BDI-II) measures depression symptom 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. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| Beck Hopelessness Scale | 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. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| Suicide-Related Coping Scale | 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; score range 0-28). Higher scores show improved suicide-related coping. The SRCS has acceptable internal and external validity. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| Insomnia Severity Index | 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. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| Suicide Intent Scale | 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. | The suicide intent scale was only given to participants with specific suicide histories. | Mean | Standard Deviation | scores on a scale |
|
| Interpersonal Needs Questionnaire-15 | 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. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| Buss-Perry Aggression Questionnaire | 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. | Some participants were missing this assessment. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | 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. |
|
|
|
| Primary | Suicidal Behavior by Chart Abstraction | 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. | 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. | Posted | 12 Month |
|
|
| Primary | Death by Suicide by National Death Index Survey Findings | 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. | 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. | Posted | 12 Month |
|
|
| Secondary | Beck Depression Inventory-II Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
|
|
|
|
| Secondary | Beck Hopelessness Scale Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Secondary | Suicide-related Coping Scale Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Secondary | Outpatient Mental Health Treatment Utilization | 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. | Posted | Mean | Standard Deviation | visit count | 12 Month |
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| Secondary | Drug Abuse Screening Test 10 (DAST-10) | 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. | This measure was only administered at the 12-month follow-up. 81 participants filled out the DAST-10 at this assessment point. | Posted | Mean | Standard Deviation | Score on a scale | 12 Month |
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| Secondary | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) | 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. | This measure was only administered at the 12-month follow-up. 124 participants filled out the DAST-10 at this assessment point. | Posted | Mean | Standard Deviation | Score on a scale | 12 Month |
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| Other Pre-specified | The Group Cohesion Scale-Revised Change | 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. | Data were not collected on this scale when the protocol shifted to virtual treatment due to COVID-19. | Posted | Weeks 1, 5, 10 |
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| Other Pre-specified | Interpersonal Needs Questionnaire Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Other Pre-specified | Buss-Perry Aggression Questionnaire Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Other Pre-specified | Insomnia Severity Index Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Other Pre-specified | Beck Lethality Scale Change | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 Month |
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| Other Pre-specified | Beck Suicide Intent Scale Change | 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. | Participant drop-out and missing assessment points occurred throughout the duration of the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Month, 6 Month, 12 Month |
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| Other Pre-specified | Ohio State University Traumatic Brain Injury Identification Method | 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. | This measure was used for the study's eligibility criteria and was not intended to be an outcome measure. | Posted | Baseline |
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| Other Pre-specified | Mini International Neuropsychiatric Interview | 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). | This measure was used for the study's eligibility criteria and was not intended to be an outcome measure. | Posted | Baseline |
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| Other Pre-specified | Mini Mental State Exam | 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. | This measure was used for the study's eligibility criteria and was not intended to be an outcome measure. | Posted | Baseline |
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| 1 |
| 101 |
| 31 |
| 101 |
| 8 |
| 101 |
| EG001 | 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. | 3 | 106 | 29 | 106 | 4 | 106 |
| Inpatient Psychiatric Hospitalization | Psychiatric disorders | Systematic Assessment |
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| Suicide attempt without medical intervention | Psychiatric disorders | Systematic Assessment |
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| Heart Failure | Cardiac disorders | Systematic Assessment |
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| Emergency Department visit for rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Emergency Department visit for orthopedic concerns | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Medical hospitalization (unspecified) | General disorders | Systematic Assessment |
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| Hospitalized following motor vehicle accident | General disorders | Non-systematic Assessment |
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| Hospitalized for shoulder surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalized for attempted overdose | Psychiatric disorders | Systematic Assessment |
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| Hospitalized for pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Emergency Department visit for chest pain | Cardiac disorders | Systematic Assessment |
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| Hospitalized for COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Emergency Department visit for tremors and headache | Psychiatric disorders | Systematic Assessment |
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| Emergency Department visit for high blood pressure | Cardiac disorders | Systematic Assessment |
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| Hospitalized for broken hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalized for knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Emergency Department visit for jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Emergency Department visit for cough, headache, chills, fever | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Emergency Department visit for rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Increase in suicidal ideation/depression | Psychiatric disorders | Systematic Assessment |
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| Challenges transferring inpatient programs | Social circumstances | Systematic Assessment |
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| Loss of employment | Social circumstances | Systematic Assessment |
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| Emergency Department visit for blood clot post surgical operation | Cardiac disorders | Systematic Assessment |
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| Emergency Department visit for COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Emergency Department visit for substance withdrawl | Psychiatric disorders | Systematic Assessment |
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| Emergency Department visit for leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Emergency Department visit for trouble breathing due to air quality | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Financial hardship and housing insecurity | Social circumstances | Systematic Assessment |
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Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| This analysis concerns the "physical aggression" subscale. | Mixed Models Analysis | The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect. | .48 | The p-value is for the treatment-by-time interaction. | Slope | -.07 | 2-Sided | 95 | -.25 | .12 | PLF is coded as 1 and TAU is coded as 0. | Superiority |
| This analysis concerns the "anger" subscale. | Mixed Models Analysis | The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect. | .30 | The p-value is for the treatment-by-time interaction. | Slope | -.08 | 2-Sided | 95 | -.24 | .07 | PLF is coded as 1 and TAU is coded as 0. | Superiority |
| This analysis concerns the "hostility" subscale. | Mixed Models Analysis | The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect. | .82 | The p-value is for the treatment-by-time interaction. | Slope | .02 | 2-Sided | 95 | -.17 | .22 | Superiority | PLF is coded as 1 and TAU is coded as 0. |
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