SuicidePLFNCT02525575
Suicide Safety Planning Group Treatment: "Project Life Force"
A study testing Project Life Force Group Treatment in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
Trial summary
For suicidal individuals, minimizing future risk and fostering recovery are critical public health concerns, especially among Veterans, as very few effective interventions exist. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicide
- What is being tested?
- Project Life Force Group Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 1 Mar 2018
- 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
- Veterans > 18
- Able to give consent
- Recent Completion of a VA suicide safety plan
Who cannot join
- IQ<80
- Does not speak English
- Inability to tolerate group therapy format
- There is no exclusion based on medical or psychiatric treatment status.
- There are no special restrictions with regard to gender, ethnic status or race
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Suicide Safety Planning Group Treatment - "Project Life Force"
For suicidal individuals, minimizing future risk and fostering recovery are critical public health concerns, especially among Veterans, as very few effective interventions exist. This proposal tests a novel group psychotherapy treatment that combines emotion regulation skill based, and psychoeducational approaches, with suicide safety planning development and implementation.
"Project Life Force" (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family.
Read the detailed description
Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a "best practice", is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The investigators' pilot data on patterns of SSP use in suicidal Veterans over a 30 day time frame demonstrates that only 65% of Veterans used their safety plans, coping strategies listed on the plan were often mismatched or inadequate to the individual's needs, and limited access to the SSP during times of stress negatively impacted its utility. To the investigators' knowledge, there are currently no recommended guidelines or mechanisms for refinement of the SSP in adult populations beyond its initial development. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide. Additionally, PLF's weekly format facilitates VA-mandated monitoring for any Veteran placed on the suicide "high risk" list.
Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy and provide pilot data for a larger randomized clinical trial. The project is comprised of two phases. In Phase 1, the investigators will finalize the PLF intervention and accompanying manual and handouts. In Phase 2, the investigators will conduct an open label trial of PLF in 50 suicidal Veterans to evaluate the feasibility and acceptability of the intervention. The investigators will also test whether PLF affects outcomes of suicide ideation, depression, hopelessness, and outpatient compliance by examining clinically meaningful differences in these measures before and after PLF.
- Conditions
- Suicide
- Being tested
- Project Life Force Group Treatment
- 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 Force Group TreatmentBehavioural
PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide.
| Study group | Role | What they receive |
|---|---|---|
| Project Life Force Group Treatment | Experimental | Project Life Force Clinical Intervention: is a manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". The use of Dialectical Behavior Therapy skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation (ER), distress tolerance and interpersonal effectiveness in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on strengthening friendships and education pertaining to suicide risk, suicide means restriction and suicide prevention mobile Apps. Receives: Behavioral: Project Life Force Group Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Scale for Suicide Ideation (BSS)
Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation.
Measured: Baseline, 3 Month, 6 Month
Columbia Suicide Rating Scale (C-SSRS)
The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS 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 C-SSRS.
Measured: Baseline, 3 Month, 6 Month
Beck Depression Inventory-II
Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). 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 then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.
Measured: Baseline, 3 Month, 6 Month
Beck Hopelessness Scale
Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients.
Measured: Baseline, 3 Month, 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marianne S Goodman, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525575
- Sponsor's protocol ID
- D1911-P
- Other IDs
- GOO-15-037
- Acronym
- PLF
- Status last verified
- Oct 2019
- First submitted
- 14 Aug 2015
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Safety Planning Group Treatment - "Project Life Force"
- ClinicalTrials.gov ID
- NCT02525575
- Acronym / sponsor ID
- PLF / D1911-P
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For suicidal individuals, minimizing future risk and fostering recovery are critical public health concerns, especially among Veterans, as very few effective interventions exist. This proposal tests a novel group psychotherapy treatment that combines emotion regulation skill based, and psychoeducational approaches, with suicide safety planning development and implementation.
"Project Life Force" (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family.
Detailed description
Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a "best practice", is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The investigators' pilot data on patterns of SSP use in suicidal Veterans over a 30 day time frame demonstrates that only 65% of Veterans used their safety plans, coping strategies listed on the plan were often mismatched or inadequate to the individual's needs, and limited access to the SSP during times of stress negatively impacted its utility. To the investigators' knowledge, there are currently no recommended guidelines or mechanisms for refinement of the SSP in adult populations beyond its initial development. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide. Additionally, PLF's weekly format facilitates VA-mandated monitoring for any Veteran placed on the suicide "high risk" list.
Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy and provide pilot data for a larger randomized clinical trial. The project is comprised of two phases. In Phase 1, the investigators will finalize the PLF intervention and accompanying manual and handouts. In Phase 2, the investigators will conduct an open label trial of PLF in 50 suicidal Veterans to evaluate the feasibility and acceptability of the intervention. The investigators will also test whether PLF affects outcomes of suicide ideation, depression, hopelessness, and outpatient compliance by examining clinically meaningful differences in these measures before and after PLF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project Life Force Group Treatment | Experimental | Behavioral: Project Life Force Group TreatmentProject Life Force Clinical Intervention: is a manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". The use of Dialectical Behavior Therapy skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation (ER), distress tolerance and interpersonal effectiveness in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on strengthening friendships and education pertaining to suicide risk, suicide means restriction and suicide prevention mobile Apps. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans > 18
- Able to give consent
- Recent Completion of a VA suicide safety plan
Key exclusion criteria (5 listed)
- IQ<80
- Does not speak English
- Inability to tolerate group therapy format
- There is no exclusion based on medical or psychiatric treatment status.
- There are no special restrictions with regard to gender, ethnic status or race
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 Force Group TreatmentPLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide. | Behavioural | Project Life Force Group Treatment |
Primary outcome
Beck Scale for Suicide Ideation (BSS)
Time frame: Baseline, 3 Month, 6 Month
Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation.
Columbia Suicide Rating Scale (C-SSRS)
Time frame: Baseline, 3 Month, 6 Month
The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS 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 C-SSRS.
Beck Depression Inventory-II
Time frame: Baseline, 3 Month, 6 Month
Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). 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 then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.
Beck Hopelessness Scale
Time frame: Baseline, 3 Month, 6 Month
Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site 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 Group Treatment in people with Suicide, run by VA Office of Research and Development at 1 site 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 5 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Oct 2019). 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?
Beck Scale for Suicide Ideation (BSS) (time frame: Baseline, 3 Month, 6 Month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2019.