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.
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.
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.
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
Group
Value
95% CI
Project Life Force
48.30
± 10.79
Treatment-As-Usual
49.17
± 11.19
3-month
Group
Value
95% CI
Project Life Force
53.68
± 10.67
Treatment-As-Usual
50.09
± 14.12
6-month
Group
Value
95% CI
Project Life Force
53.15
± 10.84
Treatment-As-Usual
49.22
± 13.68
12-month
Group
Value
95% CI
Project Life Force
53.95
± 10.19
Treatment-As-Usual
52.88
± 12.15
Outpatient Mental Health Treatment UtilizationSecondary· 12 Month
Outpatient Mental Health Treatment Utilization was quantified using CPRS. The number of outpatient non-PLF mental health visits from the past three months was counted.
Baseline (3-months pre-treatment)
Group
Value
95% CI
Project Life Force
17.96
± 21.50
Treatment-As-Usual
17.53
± 15.89
6-months post consent
Group
Value
95% CI
Project Life Force
45.28
± 44.40
Treatment-As-Usual
37.82
± 30.98
Drug Abuse Screening Test 10 (DAST-10)Secondary· 12 Month
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.
Group
Value
95% CI
Project Life Force
4.0
± 2.83
Treatment-As-Usual
3.57
± 3.15
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)Secondary· 12 Month
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.
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.
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.
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
Group
Value
95% CI
Project Life Force
18.17
± 7.26
Treatment-As-Usual
16.98
± 7.81
3-month
Group
Value
95% CI
Project Life Force
14.59
± 8.46
Treatment-As-Usual
14.88
± 8.15
6-month
Group
Value
95% CI
Project Life Force
13.63
± 8.08
Treatment-As-Usual
15.15
± 8.36
12-month
Group
Value
95% CI
Project Life Force
13.94
± 6.60
Treatment-As-Usual
13.63
± 8.81
Beck Lethality Scale ChangeSecondary· 12 Month
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 ind
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
Group
Value
95% CI
Project Life Force
16.74
± 4.55
Treatment-As-Usual
16.06
± 3.94
3-month
Group
Value
95% CI
Project Life Force
16.71
± 4.42
Treatment-As-Usual
16.00
± 3.57
6-month
Group
Value
95% CI
Project Life Force
15.25
± 7.27
Treatment-As-Usual
15.14
± 4.67
12-month
Group
Value
95% CI
Project Life Force
3.23
± 2.41
Treatment-As-Usual
17.30
± 16.14
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from participant consent date through study completion, average of one year..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Project Life Force
Serious: 31/101 (31%)
Deaths: 1/101
Treatment-As-Usual
Serious: 29/106 (27%)
Deaths: 3/106
Serious adverse events (17 terms)
Reaction
System
Project Life Force
Treatment-As-Usual
Hospitalized inpatient psych unit
Psychiatric disorders
—
—
Inpatient Psychiatric Hospitalization
Psychiatric disorders
—
—
Suicide attempt without medical intervention
Psychiatric disorders
—
—
Heart Failure
Cardiac disorders
—
—
Emergency Department visit for rib pain
Musculoskeletal and connective tissue disorders
—
—
Emergency Department visit for orthopedic concerns
Musculoskeletal and connective tissue disorders
—
—
Medical hospitalization (unspecified)
General disorders
—
—
Hospitalized following motor vehicle accident
General disorders
—
—
Hospitalized for shoulder surgery
Musculoskeletal and connective tissue disorders
—
—
Hospitalized for attempted overdose
Psychiatric disorders
—
—
Hospitalized for pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Emergency Department visit for chest pain
Cardiac disorders
—
—
Hospitalized for COVID-19
Respiratory, thoracic and mediastinal disorders
—
—
Emergency Department visit for tremors and headache
Psychiatric disorders
—
—
Emergency Department visit for high blood pressure
Cardiac disorders
—
—
Hospitalized for broken hip
Musculoskeletal and connective tissue disorders
—
—
Hospitalized for knee replacement
Musculoskeletal and connective tissue disorders
—
—
Other adverse events (13 terms — click to expand)
Reaction
System
Project Life Force
Treatment-As-Usual
Loss of employment
Social circumstances
—
—
Emergency Department visit for back pain
Musculoskeletal and connective tissue disorders
—
—
Emergency Department visit for jaw pain
Musculoskeletal and connective tissue disorders
—
—
Emergency Department visit for cough, headache, chills, fever
Respiratory, thoracic and mediastinal disorders
—
—
Emergency Department visit for rash
Skin and subcutaneous tissue disorders
—
—
Increase in suicidal ideation/depression
Psychiatric disorders
—
—
Challenges transferring inpatient programs
Social circumstances
—
—
Emergency Department visit for blood clot post surgical operation
Cardiac disorders
—
—
Emergency Department visit for COPD
Respiratory, thoracic and mediastinal disorders
—
—
Emergency Department visit for substance withdrawl
Psychiatric disorders
—
—
Emergency Department visit for leg pain
Musculoskeletal and connective tissue disorders
—
—
Emergency Department visit for trouble breathing due to air quality
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07404787 — Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Ho
· NA
· recruiting
NCT07214233 — Youth Empowerment and Safety Intervention
· NA
· recruiting
NCT07343258 — Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline
· NA
· recruiting
NCT07523490 — Investigation on Suicide Risk Factors of Patients With Mood Disorders
· recruiting
NCT06571916 — Brief Skills for Safer Living (Brief-SfSL)
· NA
· recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 10 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03653637.