Suicide Safety Planning Group Treatment - "Project Life Force"
Phase: NA
Conditions: Suicide
Sponsor: VA Office of Research and Development

Date: August 15, 2014 
 
ID: D1911-P 
NCT ID: NCT02525575 
PI: Marianne S Goodman, MD 
 
Title: Suicide Safety Planning Group Treatment - "Project Life Force" 

2) Background and Significance.
2A. Suicide in the VA.  The prevention of suicide and treatment of those at greatest risk remains a 
national priority for both civilians and Veterans, as evidenced by the 2012 calls to action for suicide 
prevention from the United States Public Health Service and the Surgeon General, and President 
Obama's August 31, 2013 executive order pleading for stronger suicide prevention and treatment 
efforts in the VA.  However, even with the VA's implementation of extensive services nationwide to 
high-risk Veterans, there were over 8,000 completions, averaging 22 deaths daily1 and over 15,000 
Veteran suicide attempts in 201212. These statistics highlight the urgent need for the development of 
additional suicide prevention, rehabilitation and recovery-based interventions for suicidal Veterans. 
2B. Specific VA treatment efforts targeting suicidal Veterans.  Recommendations from the 2011 
RAND study on suicide prevention and treatment for active duty soldiers3 emphasize the need to 
provide "high quality mental health care." The VA has thus implemented a large-scale effort for suicidal 
Veterans targeting ready access to high quality care, public education and specialized services to those 
at highest risk. Each VA hospital now employs a Suicide Prevention Coordinator (SPC), who closely 
monitors all patients who are at high risk (HR) of suicide. The SPC also makes sure that each of these 
patients completes a VA-mandated Safety Plan developed by Drs. Stanley and Brown4,5.  This plan 
mirrors recommendations from the Suicide Prevention Resource Center and Suicide Prevention Action 
Network (Department of Veteran Affairs. SPRC Best Practices Registry: Section III, 2011).  
2C. Interventions to prevent suicide- VA Suicide Safety Plan. 
2C.1. Safety Plan description.  The Suicide Prevention Resource Center (http://www.sprc.org) 
has designated the Safety Plan as a ‘best practice,’ which means that the intervention meets 
programmatic guidelines and standards of accuracy and safety. The SSP is strongly recommended by 
an array of governmental and not-for-profit agencies both in the US and in Canada. 
The VA SSP is a prioritized, sequential written list of coping strategies and sources of support 
developed collaboratively by patient and clinician to mitigate suicide risk after hospitalization for suicide 
attempt or self-harm4,5. In 2008, the US Department of Veterans Affairs (VA) mandated that clinicians 
oversee the construction of a SSP for every patient meeting these criteria. The patient takes the SSP 
home for his/her use during (or at the onset of) suicidal crises. 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 thought; contact family members or friends who may help 
resolve a crisis; provide contact information for VA professionals to help; and, how to make the 
immediate environment safer (see Appendix 1). 
2C.2.  Efficacy Data Pertaining to the VA Suicide Safety Plan.  Since safety planning was 
instituted nationwide, minimal data have been collected to show: 1) how SSPs are constructed, 2) 
actual use patterns by Veterans, and 3) the extent to which Veterans perceive them to be helpful.  Data 
from the Inspector General (OIG) report titled "Combined Assessment Program Summary Report: Re-
Evaluation of Suicide Prevention Safety Plan Practices in Veteran’s Health Administration, 2011,
pertains to implementation rates only13. Unpublished usability and perceived helpfulness data from Dr. 
Stanley and her colleagues, of 100 non-hospitalized, moderate risk Veterans who received a Safety 
Planning Intervention found that only 61% used the plan, and of these individuals, 10% used it daily, 
66% used it when they had difficulty. 99% found aspects of the SSP helpful and an overall satisfaction 
rating was (1-5 scale; 1=high; 5=low) was very high (1.3±.5) (Dr. Stanley, personal communication). 
These data demonstrate the perceived helpfulness of safety planning, but also highlight a significant 
percentage that did not use the intervention. Additional studies are needed in higher risk cohorts, with 
extended longitudinal follow-up and in identifying strategies to maximize SSP use. The Project Life 
Force Intervention addresses these gaps.  
2D. Theoretical Model. Figure 1, describes Hawton and collegues14 stress-diathesis conceptual model 
of suicide detailing interactions between genetic/biological and personality factors, environmental 
stressors, and psychiatric disturbance that precipitate psychological distress, hopelessness and suicidal 
ideation. Exposure to suicide and availability of means, move suicidal ideation toward action. The skills 
training and psychoeducation of the PLF intervention directly targets items in Figure 1 shaded in blue. 
3) Significance and Innovation.
Suicide treatment research has been hampered by a paucity of  empirical studies. Research on suicidal

populations is difficult due to the 
inherent risk of studying these 
patients and lack of evidence-
based treatment interventions 
targeting both suicide prevention 
and recovery for those who do 
not 
die 
from 
their 
suicidal 
symptomatology.  
This application  proposes a 
novel clinical group intervention 
integrating DBT skills with the 
mandated VA suicide safety 
planning 
to 
reach 
high-risk 
suicidal 
Veterans, 
including 
those 
who 
have 
just 
been 
discharged from a psychiatric 
inpatient unit. This short term, 
12-session 
group 
therapy 
intervention 
is 
designed 
to 
complement VA mandated monitoring requirements, and primary purpose is to enhance the safety plan 
with the necessary instruction in emotional regulation, interpersonal/friendship and distress tolerance 
skills to enable even acutely suicidal Veterans to be able to implement steps of the safety plan. The 
group format allows Veterans to learn from each other, offers social support, and mitigates the sense of 
isolation and loneliness that has been associated with suicide11. The group is designed to be a helpful 
adjunctive treatment, with close communication and feedback to the Veteran’s primary psychiatric 
outpatient team. The aim of this intervention is to foster recovery from suicidal symptomatology, 
integrate the suicidal veteran back into treatment, his family, and society. 
 
4)  Preliminary Work. 
 
4.1. Suicide Prevention- Qualitative Safety Planning Pilot Study. Twenty suicidal Veterans 
across two sites (James J. Peters VA (JJPVA) and Manhattan VA) participated in two semi-structured 
interviews, the first upon completing the SSP and the second a month later. The majority of Veterans 
found SSP construction to be a helpful experience, however, 30% were unable to identify contacts to 
call. At follow-up, only 65% Veterans reported having reviewed their plans at least once in the month. 
Even participants who reported benefits offered criticisms. A common complaint was that in crisis, the 
strategies listed on the SSP were inadequate and coping skills were difficult to access. Some reported 
difficulty in keeping track of the sheet of paper on which the plan was written. Most said they would 
prefer to have the plan in a more compact form, or in a mobile electronic format. For some, the most 
important use of the plan was sharing it with others, including family and close friends. These pilot data 
demonstrate several avenues to maximize the utility of SSP including: 1) the need to incorporate the 
teaching of distress tolerance and emotion regulation skills9, 2) potential use of mobile SSP 
Application10, 3) helping identify individuals one can call for help and, 4) develop more detailed ways 
how to share the plans with others. These strategies are directly incorporated into our PFL intervention. 
 
4.2. Suicide Prevention- randomized clinical trial (RCT). The PI (Dr. Goodman) has extensive 
clinical and research experience with high risk suicidal Veterans, including the development of a DBT 
Clinical Program since 2002, and two current Department of Defense (DoD)-funded studies including a 
four-year RCT (with 18-month follow-up) of DBT for suicidal Veterans. This project also includes an 
extensive baseline assessment (5-6 hours) identifying suicide risk factors. Baseline recruitment to date 
exceeded project goals; 368 consented participants and 324 completed assessments. RCT recruitment 
of suicidal inpatients has been brisk with 93 randomized to our trial. 59% of subjects completed the 6-
month trial, and 51% were retained at the 12-month follow-up. Additionally, recruitment for our DoD 
supplement examining affective startle in suicidal Veterans is ahead of schedule (n=165).  These 
numbers highlight our ability to recruit and retain large numbers of suicidal Veterans and successfully 
conduct treatment trials in this population. The current proposal will benefit from our current suicidal 

inpatient recruitment infrastructure as well as expansion into populations of suicidal outpatients.  
5)  Research Design and Methods. 
5A. Overview.  The current study proposes to finalize development of  “Project Life Force” (PLF) 
manual and to conduct a small-randomized trial (n=40) in suicidal Veterans to examine the feasibility, 
acceptability and preliminary efficacy of the intervention.  
5B. 
Phase 
1: 
Development of PLF 
 
5B.1. 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”. 
Session content is 
described in Table 
1. The use of DBT 
skills9 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. 
 
 This is an open-group format, with new members joining throughout the 12-week cycle to allow 
immediate access to the skills and accommodate the need for expeditious safety planning for higher 
risk Veterans. While traditional DBT skills groups enter patients at designated points (e.g. the beginning 
of new skills modules), there is a growing evidence base of the effectiveness of DBT skills groups 
offered in more flexible frameworks, including drop-in formats15. Our open-group framework facilitates 
ease of entry. Since the program runs continuously, Veterans who join after session #1, can pick up 
any missed material in the next cycle. This project will randomize subjects over a one-year time frame 
to 12 weeks of either TAU or PLF. The study will include 4 cycles of the PLF intervention. See 
Appendix 2 for PLF handouts and more detail on individual session lesson plans. PLF session format 
will be modeled after DBT skills groups and include: 1) brief check in and any follow up pertaining to 
use of the safety plan, 2) homework review, 3) teaching of new material and skill, 4) in-class practice of 
the skill, and 5) assignment of homework/ outside practice/development of safety plan.  
 
5B.2. Finalize PLF manual: With input and feedback from co-investigators Drs. Barbara Stanley 
(SSP original developer), Deborah Perlick (clinical trial development, family interventions), David 
Banthin (DBT, psychotherapy engagement), Lisa Dixon (health services, implementation) and Rachel 
Yehuda (PCC Director), the PI will finalize the PLF manual and associated handouts. We will also 
create a tool for assessing fidelity to PLF (see 5C.3.1). 
5C. Phase 2, Randomized Clinical Trial:  40 suicidal Veterans will be randomized to PLF and TAU to 
examine the feasibility, acceptability and preliminary efficacy of PLF. 
        5C.1. Study Site. The study will recruit 40 suicidal Veterans over 1 year from the James J. Peters 
VAMC (JJPVA) (Bronx, NY). The JJPVA has functioned as the main site of recruitment for Dr. 
Goodman’s DoD study on suicidal behavior that recruited and successfully assessed 324 suicidal 
Veterans over the course of the study. The current proposal will benefit from the infrastructure already 
in place for recruitment of HR suicidal Veterans. JJPVA has a 30-bed psychiatric inpatient unit, an 

average length of stay of 12 days and over 518 psychiatric admissions last year. Approximately 18% 
(n=82) of these admissions involved suicidal symptomatology, requiring the construction. Safety Plans 
prior to discharge. In addition, we will also recruit from outpatient clinicians and suicide prevention 
coordinators who have identified Veterans requiring a SSP; a strategy we used for our qualitative pilot 
study on safety planning (see preliminary work, section 4.1). We do not anticipate any difficulty 
recruiting 40 subjects across inpatient and outpatient services. 
 
5C.2. Veteran Participants. 40 Subjects identified for use of a safety plan (e.g. discharged from 
inpatient hospitalization for suicidality, placed on the high-risk list, or outpatients who evidence increase 
in suicidality but not severe enough to warrant hospitalization) will be recruited for the study.  Inclusion 
Criteria include: 1. Veterans > 18; 2. Able to give consent; 3. Recent Suicidality and recommendation 
for a SSP initial construction or revision. Exclusion Criteria include:  1. Does not speak English.  2. 
Schizophrenia diagnosis. 3. Inability to tolerate group therapy format.   
 
 5C.3. Experimental Condition- PLF.  The pilot will use the PLF intervention finalized during 
Phase 1a of the proposed project. PLF is a 90-minute, 12 sessions, held weekly run by two clinicians 
using the final version manual and handouts from Phase 1a (see research plan, 5B.1, and appendix 2 
for current version) with the stated purpose of developing, refining and implementing the SSP. The 
treatment is adjunctive and SSPs developed in the PLF Intervention will be shared with the Veteran’s 
treatment team for feedback/approval. Veterans randomized to PLF will continue with their psychiatrist, 
case manager and services by the suicide prevention coordinator as indicated. 
 
 
5C.3.1. PLF Training and Fidelity.  Our research team (Drs. Goodman, Perlick, Dixon) has 
experience developing psychosocial interventions and establishing their fidelity. Similar to our DBT 
RCT for suicidal Veterans (see preliminary work, section 4.2), PFL training will include weekly 
supervision with therapists and videotaping and review of sessions for fidelity using an objective scale.  
This adherence scale will be finalized with assistance by Dr. Perlick during phase 1a of the project, and 
include ratings along a 5 point Likert scale (0- unacceptable, 5- excellent) assessing core features of 
the framework, content and principles of the treatment for each session along with competence 
variables including ability to manage the group, build rapport, manage crises. For the PLF RCT (phase 
2), ratings will be performed by an independent rater on randomly selected group sessions. Overall 
ratings require an average score of 4 or above for adequate adherence to the intervention. 
 
5C.4 Comparison Condition- TAU. The comparison condition, treatment as usual (TAU) will 
consist of the standard treatment delivered to suicidal Veterans in the VA including visits with the 
outpatient psychiatrist and case manager, with content of sessions and treatment appointment intervals 
determined by the subject’s treatment team and suicide prevention coordinator’s suggestions. 
  
5C.5. Randomization Procedure. After the baseline assessment, participants will be informed 
of their assigned condition. Subjects will be assigned to study group using a blocked randomization 
plan with blocks of random sizes.  Block sizes will be of either 2, or 4.  The blocking will aid in keeping 
investigators blinded to study group assignment.  A total of 20 Veterans are randomized to each group. 
5C.6. Participant Assessment.  
 
 
5C.6.1.  Subject Characterization (see Table 2).  
 
1. Clinical Characteristics- Lifetime suicide attempts: Columbia Suicide History Form (CSHF) 
records lifetime suicide attempts & methods, including lethality, precipitant, and surrounding 
circumstances (5-10 minutes). The scale has inter-rater reliability of 0.97, and been used extensively in 
prospective suicide studies16.  
 
2. Demographics: The study team will collect data via EHR- age; ethnicity, psychiatric treatment 
history, including medications; medical history; years of education; marital, housing and employment. 
 
 
 3.  Diagnosis: It is well 
known 
that 
certain 
mental 
illnesses place individuals at high 
risk for suicide. These include 
MDD, bipolar disorder, borderline 
and 
antisocial 
personality 
disorders, substance abuse and 
schizophrenia. Diagnosis will be 
determined by chart review.  

 
 
 
 
5C.6.2.  Measurement of Feasibility and Acceptability of PLF. To examine feasibility we 
will track participation, retention and dropout in PLF by measuring the number of session and specific 
sessions each Veteran attends, and clinician preparation and supervision time allocated to the 
intervention.  For acceptability of PLF, participants will complete a brief survey (see Appendix 3) 
soliciting feedback upon completion of the PLF intervention at the 3-month assessment point. 
 
 
5C.6.3. Efficacy Outcomes and Measures Overview. Veteran participants will be 
assessed in-person at baseline and at months 1, 3 and 6 (e.g. 3 months post intervention). These time 
points were specifically selected to allow us in order to collect information on the creation of the plan 
(baseline) and its use during the highest-risk period (first 4 weeks) and after acute symptom 
stabilization (12 weeks) (see table 3). 
 
 
 
5C.6.3a.  Primary Outcome Measure. Suicidal ideation will be measured using The 
Beck Scale for Suicide Ideation (BSI)17: 21-item self-report designed to assess severity of suicidal 
attitudes and plans 
for suicide (5 to 10 
minutes). 
It 
is 
based 
on 
the 
semi-structured 
interview, 
the 
Scale for Suicidal 
Ideation. 
BSI 
is 
internally 
consistent, 
high 
internal 
reliability 
(Cronbach 
α 
coefficients 
.87-
.97)18,19 
and 
moderate 
test-
retest reliability (r=.54)20. A principal factor analysis identified 3 factors for the BSI: desire for death, 
preparation for suicide and actual suicide desire15.  
5C.6.3b. Secondary Outcome Measures: proximal psychosocial outcomes include depression, 
hopelessness, reasons for living, and outpatient mental health treatment utilization.  
 
Beck Depression Inventory-II (BDI-II) 21 consists of 21 items related to symptoms of depression 
and is scored based on a Likert scale. Widely used in adults and adolescents, it has high internal 
consistency (Cronbach coefficient α = .92). 
 
The Beck Hopelessness Scale (BHS)22 is a 20-item self-report measure with true-false items that 
assess hopelessness and the extent of positive and negative beliefs about the future.  Adequate 
reliability and concurrent validity data exist for this measure23.  
 
The Reasons for Living Inventory (LRFL)24 is a 48-item self-report measure with 6 subscales: 
Survival and Coping Beliefs (24 items), Responsibility to Family (7 items), Child-Related Concerns (3 
items), Fear of Suicide (7 items), Fear of Social Disapproval (3 items), and Moral Objections (4 items). 
These beliefs and expectations about not dying by suicide are rated on a 6-point Likert scale. The LRFL 
has high internal reliability and good test-retest reliability25. 
 
Outpatient Mental Health Treatment Utilization: Using CPRS we will count the number of 
outpatient mental health visits attended by participants prior to the intervention and compare to the 
number of outpatient visits attended 3 months post intervention. 
 
 
        5C.6.3c.  Exploratory Measure: The Computer Adaptive Test version of the 
Community Reintegration of Injured Service Members measure (CRIS-CAT)26 consists of three scales 
measuring extent of, perceived limitations in, and satisfaction with community integration, has minimal 
patient burden and sound measurement properties including reliability, and predictive validity. 
5D. Data Analytic Plan. 
5D.1. Preliminary analyses. We will perform descriptive analyses to detect potential errors, 
check for missing data, identify outliers and ascertain whether there is sufficient dispersion for 
analyses, and that variable distributions accord with our statistical models. If the distribution of our 

outcome measures does not accord with the assumptions of our statistical models, the appropriate 
power or logarithmic transformations will be used or we will create categorical variables as necessary. 
While patients were randomly assigned to our two study groups, we will also check for differences in 
demographics variables and baseline measures using chi-square tests, or t-tests, as appropriate. 
 
5D.2. Missing Data. In handling missing data, all analyses will be intent to treat. For primary 
and secondary outcome measures, every effort will be made to assess all study participants at  1, 3 
and 6-month time points. A direct likelihood approach in the analysis of mixed models27 will be used. 
This method has the advantage of using all available data, and does not require any imputation. 
 
5D.3. Analytic Strategy: Feasibility and Acceptability.  Rates of recruitment, engagement, 
and attendance will be compared to published reports of similar type interventions. Acceptability will be 
analyzed with qualitative methods described in section 5C.6.2. 
 
5D.4. Quantitative Analytic Strategy:  Efficacy. We will first explore if any demographic 
features (e.g. gender, chart diagnosis) influence number of sessions attended and will include these 
demographic variables as covariates in our analyses where appropriate. The primary endpoint is self-
reported suicidal ideation and secondary endpoints include self-reported measures of depression, 
hopelessness, reasons for living, and a treatment utilization measure of number of outpatient mental 
health visits attended.  All of these metrics, except for treatment utilization, are continuous scales that 
will be measured at baseline and again at months 1, 3, and 6.  For these outcomes, linear mixed 
models for longitudinal data28 will be used for analysis. In these models, the fixed effects will be time, 
treatment group, and the interaction between time and treatment. The random effects will be the 
subjects.  The interaction term in each model will test whether the trend in response over time differs 
between the treatment groups. The last secondary outcome, number of outpatient mental health visits 
attended, measures counts. A Poisson regression model will be fit to these data using Generalized 
Estimating Equations (GEE)28 and the model will allow for testing whether the rate of outpatient visits 
for mental health differs between the two treatments. All statistical tests will be two-tailed with an alpha 
=.05. 
 For the Exploratory Aim, an Analysis of Covariance model with an interaction term will be 
used.  In this model the outcome variable will be the CRIS-CAT score, the binary treatment variable will 
be whether the subject received PLF or TAU, the covariate will be the BSI, and the interaction will be 
that between the treatment variable and the Beck scale covariate.  If there is no interaction, then the 
focus will be on the treatment effect.  In this situation the regression lines relating CRIS-CAT to BSI will 
be parallel, and the treatment effect will measure the distance between the parallel lines providing a 
measure of the improvement in community integration over the entire range of the BSI in subjects 
receiving PLF compared to patients receiving TAU.  On the other hand, if there is a significant 
interaction, this will correspond to a situation of intersecting regression lines for the two treatment 
groups.  In such a circumstance, the improved community integration of one treatment group will be 
limited to a sub-range of the Beck scale. 
 
 5D.5. Power and Sample Size Justification.  
Although this is a pilot study with the purpose of investigating feasibility and collecting preliminary data 
to aid in planning a larger study, power calculations were carried out for the proposed sample size of 40 
enrollees.  With 20 subjects randomized to each of the two treatment groups, there will be 80% power 
to detect an effect size of 0.91.  We recognize that this effect size is probably larger than the true effect 
size for these treatments, but one of the outcomes of this pilot trial will be the data allowing us to 
improve the required sample size estimates for a future study.                                                           
 
6) Time Line.  (See Figure 2)  
RCT Recruitment is ongoing and 
Veterans can enter at any point 
during the RCT. During this time 
frame, we expect to recruit 4-5 
Veterans/month 
from 
both 
inpatient and outpatient services. 
 
 
Figure 2--Study Time Line