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Group (Project Life Force) vs. Individual Suicide Safety Planning RCT

Group (Project Life Force) vs. Individual Suicide Safety Planning RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653637
Acronym
PLF
Enrollment
294
Registered
2018-08-31
Start date
2018-10-15
Completion date
2024-03-30
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicide, Safety Plan, Group Treatment, Veterans

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALProject 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.

BEHAVIORALTreatment 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.

Sponsors

Corporal Michael J. Crescenz VA Medical Center
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.

Intervention model description

Participants are assigned to one of two groups in parallel for the duration of the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Discharge from inpatient unit for suicidal ideation or attempts, or placement on the high-risk suicide list maintained by suicide prevention coordinators * Completion of a safety plan during the past 6 months prior to entry * Concurrence from the patient's mental health provider for the Veteran to participate in the study and the provider is willing to work with the research team.

Exclusion criteria

* Unable to provide informed consent or complete study requirements * Unable to speak English * Cognitive difficulties that impair consent capacity * Unable or unwilling to provide at least one verifiable contact for emergency or tracking purposes * Unable to attend outpatient group treatment program or tolerate group therapy format * Active alcohol or opiate dependence requiring medically supervised withdrawal * Schizophrenia diagnosis * Participation in another intervention RCT

Design outcomes

Primary

MeasureTime frameDescription
Columbia Suicide Rating Scale (C-SSRS)Baseline, 3 Month, 6 Month, 12 MonthColumbia 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.
Death by Suicide by National Death Index Survey Findings12 MonthAt 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.
Suicidal Behavior by Chart Abstraction12 MonthAn 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.

Secondary

MeasureTime frameDescription
Beck Depression Inventory-II ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Beck Hopelessness Scale ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Suicide-related Coping Scale ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Outpatient Mental Health Treatment Utilization12 MonthOutpatient Mental Health Treatment Utilization was quantified using CPRS. The number of outpatient non-PLF mental health visits from the past three months was counted.
Drug Abuse Screening Test 10 (DAST-10)12 MonthThe 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.
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)12 MonthThe 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.

Other

MeasureTime frameDescription
The Group Cohesion Scale-Revised ChangeWeeks 1, 5, 10Group 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.
Buss-Perry Aggression Questionnaire ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Interpersonal Needs Questionnaire ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Insomnia Severity Index ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Beck Lethality Scale Change12 MonthThe 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.
Beck Suicide Intent Scale ChangeBaseline, 3 Month, 6 Month, 12 MonthThe 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.
Ohio State University Traumatic Brain Injury Identification MethodBaselineThe 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.
Mini International Neuropsychiatric InterviewBaselineThe 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).
Mini Mental State ExamBaselineThe 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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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.
101
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.
106
Total207

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath13
Overall StudyLost to Follow-up2930
Overall StudyPhysician Decision11
Overall StudyWithdrawal by Subject74

Baseline characteristics

CharacteristicTotalProject Life ForceTreatment-As-Usual
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
16 Participants9 Participants7 Participants
Age, Categorical
Between 18 and 65 years
187 Participants90 Participants97 Participants
Age, Continuous46.1 years
STANDARD_DEVIATION 13.9
45.9 years
STANDARD_DEVIATION 13.8
46.4 years
STANDARD_DEVIATION 14
Beck Depression Inventory-II31.46 scores on a scale
STANDARD_DEVIATION 13.83
32.03 scores on a scale
STANDARD_DEVIATION 12.45
30.90 scores on a scale
STANDARD_DEVIATION 15.08
Beck Hopelessness Scale9.75 scores on a scale
STANDARD_DEVIATION 6.48
10.11 scores on a scale
STANDARD_DEVIATION 6.35
9.40 scores on a scale
STANDARD_DEVIATION 6.61
Buss-Perry Aggression Questionnaire
Anger
20.23 scores on a scale
STANDARD_DEVIATION 7.04
20.18 scores on a scale
STANDARD_DEVIATION 7.23
20.27 scores on a scale
STANDARD_DEVIATION 6.88
Buss-Perry Aggression Questionnaire
Hostility
25.53 scores on a scale
STANDARD_DEVIATION 8.01
25.38 scores on a scale
STANDARD_DEVIATION 7.83
25.66 scores on a scale
STANDARD_DEVIATION 8.22
Buss-Perry Aggression Questionnaire
Physical aggression
26.50 scores on a scale
STANDARD_DEVIATION 8.96
25.96 scores on a scale
STANDARD_DEVIATION 8.91
27.0 scores on a scale
STANDARD_DEVIATION 9.02
Buss-Perry Aggression Questionnaire
Verbal aggression
15.06 scores on a scale
STANDARD_DEVIATION 4.85
14.64 scores on a scale
STANDARD_DEVIATION 4.87
15.45 scores on a scale
STANDARD_DEVIATION 4.83
Ethnicity (NIH/OMB)
Hispanic or Latino
69 Participants36 Participants33 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
124 Participants59 Participants65 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
14 Participants6 Participants8 Participants
Insomnia Severity Index17.55 scores on a scale
STANDARD_DEVIATION 7.56
18.17 scores on a scale
STANDARD_DEVIATION 7.26
16.98 scores on a scale
STANDARD_DEVIATION 7.81
Interpersonal Needs Questionnaire-15
Perceived burdensomeness
19.60 scores on a scale
STANDARD_DEVIATION 11.11
19.63 scores on a scale
STANDARD_DEVIATION 10.73
19.57 scores on a scale
STANDARD_DEVIATION 11.5
Interpersonal Needs Questionnaire-15
Thwarted belongingness
38.88 scores on a scale
STANDARD_DEVIATION 11.89
38.64 scores on a scale
STANDARD_DEVIATION 11.43
39.11 scores on a scale
STANDARD_DEVIATION 12.36
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
4 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
72 Participants27 Participants45 Participants
Race (NIH/OMB)
More than one race
26 Participants14 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants12 Participants7 Participants
Race (NIH/OMB)
White
80 Participants45 Participants35 Participants
Region of Enrollment
United States
207 participants101 participants106 participants
Sex: Female, Male
Female
28 Participants16 Participants12 Participants
Sex: Female, Male
Male
170 Participants81 Participants89 Participants
Suicide Intent Scale16.41 scores on a scale
STANDARD_DEVIATION 4.27
16.74 scores on a scale
STANDARD_DEVIATION 4.55
16.06 scores on a scale
STANDARD_DEVIATION 3.94
Suicide-Related Coping Scale48.74 scores on a scale
STANDARD_DEVIATION 10.98
48.30 scores on a scale
STANDARD_DEVIATION 10.79
49.17 scores on a scale
STANDARD_DEVIATION 11.19

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1013 / 106
other
Total, other adverse events
8 / 1014 / 106
serious
Total, serious adverse events
31 / 10129 / 106

Outcome results

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.

Time frame: 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).

ArmMeasureValue (NUMBER)
Project Life ForceColumbia Suicide Rating Scale (C-SSRS)22 participants with an event
Treatment-As-UsualColumbia Suicide Rating Scale (C-SSRS)30 participants with an event
p-value: 0.26395% CI: [0.43, 1.3]Regression, Cox
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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Project Life ForceAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)1.95 Score on a scaleStandard Deviation 2.99
Treatment-As-UsualAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)1.62 Score on a scaleStandard Deviation 2.56
p-value: 0.83Wilcoxon (Mann-Whitney)
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceBeck Depression Inventory-II ChangeBaseline32.03 score on a scaleStandard Deviation 12.45
Project Life ForceBeck Depression Inventory-II Change3 month23.54 score on a scaleStandard Deviation 14.4
Project Life ForceBeck Depression Inventory-II Change12 month23.87 score on a scaleStandard Deviation 12.02
Project Life ForceBeck Depression Inventory-II Change6 month23.82 score on a scaleStandard Deviation 12.52
Treatment-As-UsualBeck Depression Inventory-II Change12 month21.69 score on a scaleStandard Deviation 17.28
Treatment-As-UsualBeck Depression Inventory-II ChangeBaseline30.90 score on a scaleStandard Deviation 15.08
Treatment-As-UsualBeck Depression Inventory-II Change3 month24.32 score on a scaleStandard Deviation 16.04
Treatment-As-UsualBeck Depression Inventory-II Change6 month25.19 score on a scaleStandard Deviation 17.41
p-value: 0.7295% CI: [-0.43, 0.3]Mixed Models Analysis
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceBeck Hopelessness Scale ChangeBaseline10.11 Score on a scaleStandard Deviation 6.35
Project Life ForceBeck Hopelessness Scale Change3-month7.74 Score on a scaleStandard Deviation 6.67
Project Life ForceBeck Hopelessness Scale Change6-month8.18 Score on a scaleStandard Deviation 6.38
Project Life ForceBeck Hopelessness Scale Change12-month7.48 Score on a scaleStandard Deviation 6.26
Treatment-As-UsualBeck Hopelessness Scale Change12-month7.57 Score on a scaleStandard Deviation 7.23
Treatment-As-UsualBeck Hopelessness Scale ChangeBaseline9.40 Score on a scaleStandard Deviation 6.61
Treatment-As-UsualBeck Hopelessness Scale Change6-month7.67 Score on a scaleStandard Deviation 7.16
Treatment-As-UsualBeck Hopelessness Scale Change3-month8.21 Score on a scaleStandard Deviation 6.59
p-value: 0.2395% CI: [-0.43, 0.3]Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Project Life ForceDrug Abuse Screening Test 10 (DAST-10)4.0 Score on a scaleStandard Deviation 2.83
Treatment-As-UsualDrug Abuse Screening Test 10 (DAST-10)3.57 Score on a scaleStandard Deviation 3.15
p-value: 0.5295% CI: [-1.78, 0.91]t-test, 2 sided
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.

Time frame: 12 Month

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceOutpatient Mental Health Treatment Utilization6-months post consent45.28 visit countStandard Deviation 44.4
Project Life ForceOutpatient Mental Health Treatment UtilizationBaseline (3-months pre-treatment)17.96 visit countStandard Deviation 21.5
Treatment-As-UsualOutpatient Mental Health Treatment UtilizationBaseline (3-months pre-treatment)17.53 visit countStandard Deviation 15.89
Treatment-As-UsualOutpatient Mental Health Treatment Utilization6-months post consent37.82 visit countStandard Deviation 30.98
p-value: 0.1595% CI: [-0.42, 2.76]Mixed Models Analysis
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceSuicide-related Coping Scale ChangeBaseline48.30 Score on a scaleStandard Deviation 10.79
Project Life ForceSuicide-related Coping Scale Change3-month53.68 Score on a scaleStandard Deviation 10.67
Project Life ForceSuicide-related Coping Scale Change6-month53.15 Score on a scaleStandard Deviation 10.84
Project Life ForceSuicide-related Coping Scale Change12-month53.95 Score on a scaleStandard Deviation 10.19
Treatment-As-UsualSuicide-related Coping Scale Change12-month52.88 Score on a scaleStandard Deviation 12.15
Treatment-As-UsualSuicide-related Coping Scale ChangeBaseline49.17 Score on a scaleStandard Deviation 11.19
Treatment-As-UsualSuicide-related Coping Scale Change6-month49.22 Score on a scaleStandard Deviation 13.68
Treatment-As-UsualSuicide-related Coping Scale Change3-month50.09 Score on a scaleStandard Deviation 14.12
p-value: 0.0996% CI: [-0.04, 0.58]Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Project Life ForceBeck Lethality Scale Change4.41 score on a scaleStandard Deviation 4.1
Treatment-As-UsualBeck Lethality Scale Change3.36 score on a scaleStandard Deviation 4.45
p-value: 0.6795% CI: [-0.68, 0.48]Mixed Models Analysis
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceBeck Suicide Intent Scale ChangeBaseline16.74 score on a scaleStandard Deviation 4.55
Project Life ForceBeck Suicide Intent Scale Change12-month3.23 score on a scaleStandard Deviation 2.41
Project Life ForceBeck Suicide Intent Scale Change3-month16.71 score on a scaleStandard Deviation 4.42
Project Life ForceBeck Suicide Intent Scale Change6-month15.25 score on a scaleStandard Deviation 7.27
Treatment-As-UsualBeck Suicide Intent Scale Change6-month15.14 score on a scaleStandard Deviation 4.67
Treatment-As-UsualBeck Suicide Intent Scale ChangeBaseline16.06 score on a scaleStandard Deviation 3.94
Treatment-As-UsualBeck Suicide Intent Scale Change3-month16.00 score on a scaleStandard Deviation 3.57
Treatment-As-UsualBeck Suicide Intent Scale Change12-month17.30 score on a scaleStandard Deviation 16.14
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceBuss-Perry Aggression Questionnaire Change12-month (verbal aggression subscale)14.56 Score on a scaleStandard Deviation 4.74
Project Life ForceBuss-Perry Aggression Questionnaire ChangeBaseline (anger subscale)20.18 Score on a scaleStandard Deviation 7.23
Project Life ForceBuss-Perry Aggression Questionnaire Change3-month (verbal aggression subscale)13.56 Score on a scaleStandard Deviation 4.89
Project Life ForceBuss-Perry Aggression Questionnaire ChangeBaseline (physical aggression subscale)25.96 Score on a scaleStandard Deviation 8.91
Project Life ForceBuss-Perry Aggression Questionnaire Change6-month (anger subscale)19.51 Score on a scaleStandard Deviation 6.57
Project Life ForceBuss-Perry Aggression Questionnaire Change6-month(physical aggression subscale)24.15 Score on a scaleStandard Deviation 7.73
Project Life ForceBuss-Perry Aggression Questionnaire Change12-month (anger subscale)18.54 Score on a scaleStandard Deviation 6.68
Project Life ForceBuss-Perry Aggression Questionnaire Change3-month(physical aggression subscale)24.61 Score on a scaleStandard Deviation 8.93
Project Life ForceBuss-Perry Aggression Questionnaire ChangeBaseline (hostility subscale)25.38 Score on a scaleStandard Deviation 7.83
Project Life ForceBuss-Perry Aggression Questionnaire Change6-month (verbal aggression subscale)13.92 Score on a scaleStandard Deviation 4.56
Project Life ForceBuss-Perry Aggression Questionnaire Change3-month (hostility subscale)23.67 Score on a scaleStandard Deviation 7.69
Project Life ForceBuss-Perry Aggression Questionnaire Change3-month (anger subscale)19.33 Score on a scaleStandard Deviation 6.98
Project Life ForceBuss-Perry Aggression Questionnaire Change6-month (hostility subscale)23.86 Score on a scaleStandard Deviation 6.9
Project Life ForceBuss-Perry Aggression Questionnaire Change12-month(physical aggression subscale)24.35 Score on a scaleStandard Deviation 9.19
Project Life ForceBuss-Perry Aggression Questionnaire Change12-month (hostility subscale)23.73 Score on a scaleStandard Deviation 6.85
Project Life ForceBuss-Perry Aggression Questionnaire ChangeBaseline (verbal aggression subscale)14.64 Score on a scaleStandard Deviation 4.87
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change12-month (hostility subscale)23.54 Score on a scaleStandard Deviation 8.71
Treatment-As-UsualBuss-Perry Aggression Questionnaire ChangeBaseline (verbal aggression subscale)15.45 Score on a scaleStandard Deviation 4.83
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change3-month (verbal aggression subscale)15.7 Score on a scaleStandard Deviation 4.83
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change6-month (verbal aggression subscale)15.41 Score on a scaleStandard Deviation 5.17
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change12-month (verbal aggression subscale)14.36 Score on a scaleStandard Deviation 4.77
Treatment-As-UsualBuss-Perry Aggression Questionnaire ChangeBaseline (physical aggression subscale)27.0 Score on a scaleStandard Deviation 9.02
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change3-month(physical aggression subscale)27.51 Score on a scaleStandard Deviation 9.31
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change6-month(physical aggression subscale)26.93 Score on a scaleStandard Deviation 9.77
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change12-month(physical aggression subscale)25.72 Score on a scaleStandard Deviation 8.51
Treatment-As-UsualBuss-Perry Aggression Questionnaire ChangeBaseline (anger subscale)20.27 Score on a scaleStandard Deviation 6.88
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change3-month (anger subscale)20.69 Score on a scaleStandard Deviation 7.32
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change6-month (anger subscale)19.56 Score on a scaleStandard Deviation 7.49
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change12-month (anger subscale)19.30 Score on a scaleStandard Deviation 6.59
Treatment-As-UsualBuss-Perry Aggression Questionnaire ChangeBaseline (hostility subscale)25.66 Score on a scaleStandard Deviation 8.22
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change3-month (hostility subscale)24.33 Score on a scaleStandard Deviation 8.13
Treatment-As-UsualBuss-Perry Aggression Questionnaire Change6-month (hostility subscale)23.93 Score on a scaleStandard Deviation 8.53
Comparison: This analysis concerns the verbal aggression subscale.p-value: 0.2895% CI: [-0.06, 0.19]Mixed Models Analysis
Comparison: This analysis concerns the physical aggression subscale.p-value: 0.4895% CI: [-0.25, 0.12]Mixed Models Analysis
Comparison: This analysis concerns the anger subscale.p-value: 0.395% CI: [-0.24, 0.07]Mixed Models Analysis
Comparison: This analysis concerns the hostility subscale.p-value: 0.8295% CI: [-0.17, 0.22]Mixed Models Analysis
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceInsomnia Severity Index ChangeBaseline18.17 Score on a scaleStandard Deviation 7.26
Project Life ForceInsomnia Severity Index Change3-month14.59 Score on a scaleStandard Deviation 8.46
Project Life ForceInsomnia Severity Index Change6-month13.63 Score on a scaleStandard Deviation 8.08
Project Life ForceInsomnia Severity Index Change12-month13.94 Score on a scaleStandard Deviation 6.6
Treatment-As-UsualInsomnia Severity Index Change12-month13.63 Score on a scaleStandard Deviation 8.81
Treatment-As-UsualInsomnia Severity Index ChangeBaseline16.98 Score on a scaleStandard Deviation 7.81
Treatment-As-UsualInsomnia Severity Index Change6-month15.15 Score on a scaleStandard Deviation 8.36
Treatment-As-UsualInsomnia Severity Index Change3-month14.88 Score on a scaleStandard Deviation 8.15
p-value: 0.4195% CI: [-0.27, 0.11]Mixed Models Analysis
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.

Time frame: Baseline, 3 Month, 6 Month, 12 Month

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

ArmMeasureGroupValue (MEAN)Dispersion
Project Life ForceInterpersonal Needs Questionnaire ChangeBaseline38.64 Score on a scaleStandard Deviation 11.43
Project Life ForceInterpersonal Needs Questionnaire Change6-month33.7 Score on a scaleStandard Deviation 12.79
Project Life ForceInterpersonal Needs Questionnaire Change12-month32.29 Score on a scaleStandard Deviation 12.04
Project Life ForceInterpersonal Needs Questionnaire Change3-month33.98 Score on a scaleStandard Deviation 12.99
Treatment-As-UsualInterpersonal Needs Questionnaire Change12-month34.73 Score on a scaleStandard Deviation 14.57
Treatment-As-UsualInterpersonal Needs Questionnaire ChangeBaseline39.11 Score on a scaleStandard Deviation 12.36
Treatment-As-UsualInterpersonal Needs Questionnaire Change3-month36.18 Score on a scaleStandard Deviation 13.85
Treatment-As-UsualInterpersonal Needs Questionnaire Change6-month36.20 Score on a scaleStandard Deviation 13.67
p-value: 0.2495% CI: [-0.58, 0.15]Mixed Models Analysis
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).

Time frame: Baseline

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

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.

Time frame: Baseline

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

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.

Time frame: Baseline

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

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.

Time frame: Weeks 1, 5, 10

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

Source: ClinicalTrials.gov · Data processed: May 31, 2026