SuicidePLFNCT03653637

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

A study testing Project Life Force and Treatment as Usual in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Suicide
What is being tested?: Project Life Force and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 294 participants
Where: 2 sitesUnited States
Study dates: 15 Oct 2018to 30 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Suicide
Being tested: Project Life Force, Treatment as Usual
Keywords: Suicide, Safety Plan, Group Treatment, Veterans
Medical subject headings: Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Project Life ForceBehavioural
Also called PLF
A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Treatment as UsualBehavioural
Also called TAU
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.

Study groups in NCT03653637
Study group	Role	What they receive
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. Receives: Behavioral: Project Life Force
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. Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 12 Month

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201830 Mar 2024

First posted31 Aug 2018
Study start15 Oct 2018
Primary completion31 Dec 2023
Study completion30 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SuicideStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03653637
Sponsor's protocol ID: MHBB-025-17F
Other IDs: 1I01CX001705-01A1
Acronym: PLF
Status last verified: Oct 2025
First submitted: 29 Aug 2018
Last updated: 10 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 42213437
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.
PubMed 41801754

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
ClinicalTrials.gov ID: NCT03653637
Acronym / sponsor ID: PLF / MHBB-025-17F
Conditions: Suicide
Keywords: Suicide, Safety Plan, Group Treatment, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Corporal Michael J. Crescenz VA Medical Center
Study start: 15 Oct 2018 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 30 Mar 2024 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants are assigned to one of two groups in parallel for the duration of the study.

Arm	Type	Receives
Project Life Force	Experimental	Behavioral: Project Life ForceA 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	Behavioral: Treatment as UsualThe 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.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Project Life ForceAlso: PLFA 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.	Behavioural	Project Life Force
Treatment as UsualAlso: TAUThe 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.	Behavioural	Treatment-As-Usual

Primary outcome

Columbia Suicide Rating Scale (C-SSRS)
Time frame: Baseline, 3 Month, 6 Month, 12 Month
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.
Suicidal Behavior by Chart Abstraction
Time frame: 12 Month
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.
Death by Suicide by National Death Index Survey Findings
Time frame: 12 Month
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.

6 secondary outcomes

Beck Depression Inventory-II Change
Time frame: Baseline, 3 Month, 6 Month, 12 Month
Beck Hopelessness Scale Change
Time frame: Baseline, 3 Month, 6 Month, 12 Month
Suicide-related Coping Scale Change
Time frame: Baseline, 3 Month, 6 Month, 12 Month
Outpatient Mental Health Treatment Utilization
Time frame: 12 Month
Drug Abuse Screening Test 10 (DAST-10)
Time frame: 12 Month
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Time frame: 12 Month

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Project Life Force	101	63
Treatment-As-Usual	106	68

Primary outcome: Columbia Suicide Rating Scale (C-SSRS)

Time frame: Baseline, 3 Month, 6 Month, 12 Month. Number. Unit: participants with an event

Measure	Project Life Force n = 101	Treatment-As-Usual n = 105
Value	22	30

Project Life Force vs Treatment-As-Usual: Hazard Ratio (HR): 0.75 (95% CI 0.43 to 1.30), p = 0.263, Regression, Cox

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

Primary outcome: Suicidal Behavior by Chart Abstraction

Time frame: 12 Month

Population analysed: 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 outcome: Death by Suicide by National Death Index Survey Findings

Time frame: 12 Month

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from participant consent date through study completion, average of one year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Project Life Force	31 of 101 (30.7%)	8 of 101 (7.9%)	1 of 101
Treatment-As-Usual	29 of 106 (27.4%)	4 of 106 (3.8%)	3 of 106

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42213437Goodman 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.
Derived from this study: PubMed 41801754Glatt 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marianne S. Goodman, MD principal investigator

James J. Peters Veterans Affairs Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Project Life Force and Treatment as Usual in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Columbia Suicide Rating Scale (C-SSRS) (time frame: Baseline, 3 Month, 6 Month, 12 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03653637, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.