Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
Phase: NA
Conditions: Suicide
Sponsor: VA Office of Research and Development

 
Title: Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT 
NCT Number: NCT03653637 
Date Approved: 08/03/2024 
 

B. PROTOCOL SUMMARY 
 
1. Provide a brief (200-250 word) summary of background information for 
physician/scientists. List total # of subjects approved for enrollment by the IRB. 
List total number of subjects enrolled (Signed a consent form) over the life of this study. List total 
number of subjects enrolled(Signed a consent form)  in the current approval period. List total number 
of subjects terminated form study (Lost to follow-up, terminated by PI, withdrew consent, etc.). List 
total number of subjects that have completed all study tasks/procedures and follow-up visits. List total 
number of subjects currently receiving study treatment or participating in study activities.:  
 
 
At present, we are unaware of any empirically supported, manualized outpatient group 
treatments for suicidal individuals other than a published account of a 1-session inpatient 
safety planning group and description of an outpatient process oriented group of variable 
session length and duration. Dialectical Behavior Therapy (DBT) offers a group component 
in its comprehensive approach, but discussion of suicidal urges, thoughts and behaviors 
is discouraged in the group setting. The paucity of published literature on group 
approaches for suicidal individuals is surprising given the numerous advantages of group 
treatment that include: 1) diminishing social isolation and increasing social support, a 
protective factor against suicide; 2) it’s cost effectiveness and maximizing staff time; 3) 
the peer movement among those who have experienced suicidal crises is strong and 
growing; and 4) Veterans and military service members are used to working with a team 
approach to problems.  
 
PLF is one of the first outpatient manualized suicide prevention group intervention to date. 
The proposed study has direct VA and military relevance as psychotherapy groups are a 
standard treatment modality in both settings. 
 
2. State the purpose of the study: 
The study proposes to conduct a randomized clinical trial (RCT) of a group safety 
planning intervention, “PLF” versus individual safety planning in 180 suicidal Veterans. 
Compared with the comparison condition- individual safety planning, the current 
standard of care, designated as treatment as usual (TAU), the PLF group will show a 
decrease in suicidal ideation. 
 
3. Background of Study Population - Clinical Information: 
a. Describe the general population from which you plan to recruit subjects for this 
study (i.e., Demographics of potential subjects):  
Male and female Veterans from the JJP VA Medical Center will be recruited, ranging in 
ages from 18-89. Participants should represent the spectrum of ethnicities and races, as 
well as socioeconomic status of the Greater New York area. We will also be working with 
other IRBs at other VAs in the US to recruit but the participants will be enrolled at JJPVA 
 
 
b. Describe the medical condition in this population: 
Veterans will have a history of suicidal ideation and suicide attempts (actual, aborted, or 
interrupted). 
 
 
c. How does this condition affect this population (symptoms)? 

Models of suicidality stress the role of social factors in development and 
intensification of suicidal thoughts and behavior, including: feeling like a burden on 
family and friends feelings of isolation and not belonging (perceptions of diminished 
support from family/social network). 
 
 
d. Does this population have an understanding or knowledge of the medical 
condition being studied? 
Yes, this population will have at least a general understanding of the condition of 
suicidality. 
 
e. What is the traditional treatment provided for this condition? 
 Behavioral psychotherapy, couple’s therapy, and general safety planning with clinician. 
 
f. Explain how special needs that may arise with this population due to this medical 
condition are addressed (e.g. Additional care provided, supportive therapy, 
physiotherapy, behavioral therapy): Special needs that may arise will be 
addressed through contacting resident providers and support staff equipped to 
treat Veterans with suicidal symptoms. 
 
g. Describe how research subjects will be referred for appropriate care while they 
are enrolled in the study? 
Research staff will inform subjects of appropriate care based on the subject’s 
experience and on the research staff’s own clinical judgment of the subject’s 
wellbeing while enrolled. Examples include research staff informing subjects about 
enrolling in mental health services (i.e., psychiatrist, and psychosocial workers, 
Suicide Prevention Coordinators), providing information on the Rapid Access Clinic, 
and other resources such as substance abuse treatment and housing assistance that 
are available to all subjects. 
 
 
h. Describe whether providers (all clinical staff) have experience in providing care to 
subjects: 
The PI (Dr. Goodman) has extensive clinical and research experience with high risk 
suicidal Veterans, including the development of a DBT Clinical Program in VISN 3 since 
2002, that now includes 7 sites across New York and New Jersey and is PI on two 
Department of Defense (DoD)-funded studies. The DoD research involves implementing a 
four-year RCT (with 18-month follow-up) of DBT for suicidal Veterans. 
 
 
i. Does the James J. Peters VAMC have the appropriate medical or psychosocial 
resources required for any emergency needs for research subjects? 
 Yes. 
 
4. Selection of subjects: 
 
a. Indicate number of subjects to be enrolled at this site (Total # of subjects approved 
by IRB):  

180 
 
b. Indicate total number of subjects to be enrolled, if multisite study: 
 320 
 
c. Are veterans being enrolled at this site? 
 
YES   X 
NO 
 
 
d. Are non-veterans being enrolled at this site?  
 
YES    
NO 
X 
If no, proceed to question 4.f. 
Justify why non-veterans will be enrolled at this site: NA 
Of all subjects to be enrolled at this site, what percentage will be non-veterans? NA 
 
e. Describe the setting in which the research will be conducted (e.g., research office, 
clinic, lab, inpatient unit, outpatient unit):  
Recruitment will take place via referrals from suicide prevention coordinators and Dr. 
Leo Sher, the attending of the inpatient unit; We will also be working with other IRBs at 
other VAs in the US to recruit but the participants will be enrolled at JJPVA. assessments 
will be done in the privacy of a research office. The group sessions will be held in a clinic 
room on hospital wings 3B or 6A. However, during the time of COVID-19 when groups are 
no longer happening in person at the hospital, group sessions will be held through 
telehealth (e.g., VVC and VA WEBEX with VANTS line as a backup).  
 
f. What is the expected length of time a study subject will participate? (i.e., number 
of days, weeks, months, years)  
12-14 months 
 
5. Indicate the characteristics of study population (with the letter x in the appropriate 
column): 
a. Gender: 
 
 
YES 
NO 
Male 
x 
 
Female 
x 
 
 
b. Age range:  from        to        [max age is 89 years] 
 
c. Racial and Ethnic/Minority Groups: 
 
YES 
NO 
Caucasian 
X 
 
Alaskan Native 
X 
 
American Indian 
X 
 
Hispanic 
X 
 
Black 
X 
 
Asian/Pacific 
Islander 
X 
 

Other: (Specify)        
 
d. Justify any exclusion of specific gender, age, and racial or ethnic groups:  
NA 
 
 
6. State inclusion criteria for enrollment in study:  
Inclusion Criteria include: 1. Age 18 years or older, 2. Discharge from inpatient unit for 
suicidal ideation or attempts, or placement on the high-risk suicide list maintained by 
suicide prevention coordinators, or patient from outpatient service that meets criteria of 4 
or 5 on CSSRS or attempt within the past year 3. 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. 
 
7. State exclusion criteria for enrollment in study: 
Exclusion Criteria include: 1. Unable to provide informed consent or complete study 
requirements, 2. Unable to speak English, 3. Cognitive difficulties that impair consent 
Capacity, 4. Unable or unwilling to provide at least one verifiable contact for emergency 
or tracking purposes, 5. Unable to attend outpatient group treatment program or tolerate 
group therapy format, 6. Active alcohol or opiate dependence requiring medically 
supervised withdrawal, 7. Schizophrenia diagnosis, 8. Participation in another 
intervention RCT. 
 
8.  Will vulnerable subjects be enrolled in this study? 
 
YES   X 
NO 
 
 
 
YES 
NO 
Individuals with lack of 
decision-making mental 
capacity 
 
X 
Economically/socially 
disadvantaged persons         
X 
 
Educationally 
disadvantaged persons 
X 
 
Pregnant women, for 
minimal risk only 
 
 
Fetuses      Requires Medical Center Director authorization.  See IRB SOP.  
Children      Requires Medical Center Director authorization.  See IRB SOP. 
Prisoners    Requires CRADO authorization.  See IRB SOP. 
 
If Yes for any answer, provide a means by which vulnerability is determined: 
Vulnerability will be determined through gathering basic demographic data of each 
participant. James J. Peters VA Medical has a population of veterans who are 
economically, socially, and educationally disadvantaged; thus, the PI anticipates 
recruiting from vulnerable populations. 
 
9.  Are prospective subjects likely to feel vulnerable to coercion or undue influence to 
enter the study?  

YES    
NO 
X 
 
a. Are there any payments to subjects?   
YES   X 
NO 
 
 
b. If No, proceed to question 9.c. 
How much are the payments? $50-$75 
Provide a schedule (timing) of payments. Baseline, post intervention, 3 months 
post completion of intervention, 6 months post completion of intervention  
c. In your opinion, will such payments have any influence on a person’s decision to 
participate?  
YES    
NO 
X 
Why or why not? These payments should not have any influence on a person’s 
decision to participate because it is a relatively low amount meant to 
compensate the person for money spent on commuting, child care, taking off 
work, etc. 
  
d. What special safety precautions are utilized to minimize risk of coercion to 
protect the rights and welfare of these subjects [e.g., avoid financial incentives, 
consult with patient advocates or representatives]?  
 The PI will work closely with the providers and patient care representatives to 
ensure the rights and welfare of the subjects. 
 
10. As PI, do you have access to sufficient population that will allow recruitment of the 
necessary number of subjects?  
YES   X 
NO 
 
 
11. Indicate how potential subjects will be recruited: 
 One hundred and eighty suicidal Veterans will be identified by primary clinician referral 
from the JJP VA psychiatric inpatient unit, or by the suicide prevention coordinator. We 
will also be working with other IRBs at other VAs in the US to recruit but the participants 
will be enrolled at JJPVA.  All Veterans referred will be approached for consent or to 
participate in an information session about the study. This procedure will be followed in 
order of referral until the target number of cases have been consented and enrolled. 
Based on data from Dr. Goodman’s completed DoD intervention study for suicidal 
Veterans, the estimated ethnic/racial breakdown of the study sample is 45% Hispanic, 
48% White (non-Hispanic), 42% Black (non-Hispanic), 2% Asian/Pacific Islander, 2% 
American Indian and 6% multiple races. 
 
12. Description of the Consent Process: 
a. Describe the enrollment procedures for participation in the study:  
Subjects who express interest will then be explained the study by one of the PIs and consent 
obtained. Prior to participation in the protocols, patients meet with research personnel at 
which time the nature of our program, the procedures involved, and alternatives to the study 
are discussed.  The patient must understand and be able to articulate the risks and benefits 
of the research protocols and understand the alternatives. Patients who do not agree to 
participate in these protocols will continue to receive clinical care in our facilities.  Patients 
who agree to participate are reimbursed for their time and inconvenience at rates that do not 

represent inducement. After the protocol is described to the subject and the subject’s 
questions are answered, the subject will be asked to summarize the procedures that he/she 
will undergo and to describe 2 risks involved in the study. If there is any doubt about the 
subject’s capacity to give consent, an independent psychiatrist will assess the subject to 
determine whether they understand the study and can give informed consent. 
 
b. Indicate when and where consent will be obtained: 
 Consent will be obtained upon meeting with the Veteran if s/he agrees to participate in the 
study (over the phone at this time if it is unsafe to consent in person). This meeting will take 
place in the privacy of a research office or clinical office on 6B. 
 
c. Who will conduct the consent interview?  
Dr. Goodman, Ms. Sullivan, Ms. Mitchell or Ms. Harris. 
 
d. Will a legally authorized representative provide consent or permission for a subject, 
as appropriate?       
YES    
NO 
X 
 
e. What is the waiting period between informing the prospective subject about the 
study and obtaining consent?   
As long as the Veteran needs to make decision. 
Time devoted to consent discussion? 30-45 minutes 
Time allowed for a decision? Indefinite 
 
f. How will you insure that the language used by those obtaining consent will not 
include exculpatory language which would waive or appear to waive any of the 
subject’s legal rights? The information being communicated to the participant during 
the consent process will not include exculpatory language through which the 
participant is made to waive or appear to waive any of the participant’s legal rights.  
When the investigator verbally obtains consent, the participant will not be made to feel 
as if he or she has waived any of his or her rights as a human subject.  The main 
purposes of the consenting process are for the investigator to inform the participant in 
detail about what will actually take place during the study, to allow the participant to 
ask any questions that he or she may have, and to explain to the participant that he or 
she is a volunteer for the study and may choose to decide against taking part at any 
point in time. 
 
g. How will you insure that the information being communicated to the subject or the 
representative during the consent process will not include exculpatory language 
through which the subject or the legally authorized representative releases or appears 
to release the investigator, the sponsor, the institution, or its agents from liability for 
negligence?  
We ensure that the information being communicated to the participant during the 
consent process will not include exculpatory language through which the investigator, 
the sponsor, the institution or its agents are released from liability by providing 
patients with contact information for the PIs and co-investigators should they feel that 
they have suffered an injury.  Furthermore, patients are informed in the consent 
document that if they are eligible veterans, they are entitled to medical care and 

treatment if they experience any adverse effects resulting from the study.  Participants 
are also provided with the contact information for the JJP VA IRB should they have 
questions regarding the research or their rights. 
 
h. How will you know that the language is understandable to the prospective subject 
or the legally authorized representative?  
The individuals communicating information to the participant during the consent 
process will provide that information in language understandable to the participant. 
 
i. Indicate how you will determine whether the subjects (or their surrogates) 
understand the content of the information that is provided in the consent 
document: 
After the protocol is described to the subject and the subject’s questions are 
answered, the subject will be asked to summarize the procedures that s/he will 
undergo and to describe the risks involved in the study. A checklist will be used for 
this purpose by the person obtaining consent. If there is any doubt about the 
subject’s capacity to give consent, an independent psychiatrist will assess the 
subject to determine whether s/he understands the study and can give informed 
consent.  
j. How will you insure that the consent process will minimize the possibility of 
coercion or undue influence? 
As mentioned above, upon hearing the description of the study, the participant will be 
required to describe the procedures to the person obtaining consent, summarize what is 
expected of him or her and list two risks involved.  This will ensure that participants 
understand the implications of their decision to participate and are able to make a well-
informed decision and communicate this decision to the person obtaining consent. 
Consent will be obtained in a private setting by an investigator to minimize any power 
differential that the participant might feel.  Participants unable to communicate with the 
investigator for any reason will not be included in the study.  Only subjects having the 
capacity to give informed consent will be enrolled in the study.  The recruitment process 
will not be coercive or unduly influencing, as participants enter the research study 
voluntarily and understand that they have the right to withdraw at any time. Subjects will 
be told that non-participation in the study will not affect any current treatments they are 
receiving at VA or elsewhere. 
 
     
13. Summarize what actually will be done to the subjects during their participation in the 
study: 
The subject will fill out the informed consent. They will then fill out a series of clinician 
interviews and self-report measures asking questions related to thoughts and feelings 
about suicide, general mental and physical health, and relationship with other. After 
these are completed half the group will be randomized to the PLF intervention arm in 
which Veterans will participate in the 10 weekly groups.  
 
a. Provide a clear description of what is being done for research purposes and 
what is being done as part of “usual care”: 
For research purposes: Initial consult with research investigators and consenting, which 
will take approximately 30 – 45 minutes, completing assessments (1.5 hours) and 
answering interview-style questions pertaining to the research topic (30 minutes). 

Subject matter of the interview includes: communication quality with others, overall life 
satisfaction, frequency of suicidal ideation or urges, and reasons for attempting suicide. 
 
“Usual care”: Subjects will be able to continue all regular treatment outside of the study. 
 
b. Provide a detailed list of tests and procedures that will be performed for 
research purposes (e.g., blood tests, urine tests, cultures, interviews, 
questionnaires, surgical  procedures, cardiac catheterization, pulmonary function 
tests, X-rays, scans, etc) during the course of the study.  List must indicate tests 
and procedures only for subjects who sign a VA consent form, regardless of 
where tests and procedures take place: 
 
Test /Procedure: 
Where: 
Performed by 
Whom: 
(Insert Name or 
TBD if not yet 
known) 
When: 
# of times: 
Columbia Suicide 
Severity Rating 
Scale (CSSRS)–
current & since 
last visit version  
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12, 
weekly for 
PLF group 
participants 
4 
Access to Lethal 
Means 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Beck Depression 
Scale 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Beck 
Hopelessness 
Scale 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Self-report log 
based on the 
Modified Cornell 
Services Index 
(MCSI) 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Brief Survey of 
Safety Plan 
Utilization 
(BSSPU) 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Suicide-Related 
Coping Measure 
(SRCM)  
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Group 
Psychotherapy 
Process Measure* 
Research office 
 
Marianne 
Goodman 
1,5,10 
(weeks) 
3 

PLF treatment 
arm only 
K. Nidhi Kapil-Pair 
Buss-Perry 
Aggression 
Questionnaire  
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Reasons for 
Living  
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Attitudes Towards 
Seeking 
Professional 
Psychological 
Help 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Insomnia Severity 
Index 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Beck Lethality 
Scale 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
The Self‐Injurious 
Thoughts and 
Behaviors 
Interview 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Suicide Intent 
Scale 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Beck Scale for 
Suicidal Ideation 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Barratt 
Impulsiveness 
Scale 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Interpersonal 
Needs 
Questionnaire 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6,12 
4 
Mini-International 
Psychiatric 
interview (MINI) 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0 
1 
McLean 
Screening 
Research office 
Kyra Hamerling-
Potts, 
0 
1 

Instrument for 
BPD 
Lakshmi 
Chennapragada 
PLF Intervention 
Sessions 
Research office 
Marianne 
Goodman 
Weekly 
10 
Moral Injury 
Outcome Scale 
(MIOS) 
Research office 
Kyra Hamerling-
Potts, 
Lakshmi 
Chennapragada 
0, 3, 6, 12 
4 
 
c. If laboratory tests are part of this protocol, will some or all study-related tests be 
performed outside this medical center?    
YES   
 
NO 
 
N/A X 
 
d. Provide a statement that defines who will be financially responsible for the costs 
associated with participation in the study (e.g., examinations, procedures, drugs, 
devices, etc.) and a statement that defines what will be provided without cost to the 
subjects:  
The patient will not incur any costs from participating in this study. The PLF 
intervention will be provided free of charge. In the event of an injury resulting from the 
research study the facilities of the Bronx VA will be made available to patients. 
 
List all Authorized Prescribers of drugs (whether or not the drug is 
investigational) 
NA 
 
e. VHA Health Record (If yes to (i) below or if clinical resources are to be used, a  
VHA health record must be created in CPRS [VHA Handbook 1200.05 #29j). 
(i) Will the research intervention possibly lead to physical or psychological adverse 
events?    
YES   X 
NO 
 
 
(ii) Do you have a process in place to include a copy of the signed informed 
consent and HIPAA authorization in the medical record for the type research 
described above for each subject?   
 
YES   X 
NO 
 
 If yes, Please describe: A copy of each consent is scanned into subjects’ charts 
and a hard copy is retained in study records. 
 
(iii) Did the IRB determine that CPRS flagging is required?   
 
YES    
NO 
X 
 
14. Risks: 
 
a. Identify study risk:         
No Risk 
 
Minimal Risk 
 
Greater Than Minimal Risk 
X 

 
b. Describe the steps you could take to minimize risk to subjects, without changing 
the science of the study: 
No subject will be taken off of medication treatment for the purpose of entering the 
research.  We have selected our study tasks carefully to maximize the likelihood of 
obtaining an answer.  We have an adequate number of qualified staff members and the 
necessary facilities to conduct the research.  When appropriate, patients will be provided 
with medical or psychiatric referrals. 
 
c. Could you use the data obtained from “usual care” so that tests are not repeated 
for research purposes (to minimize risk to subjects)?  
 
YES    
NO 
X 
 
d. Describe the steps you could take to minimize risk to subjects by changing the 
science of the study or study design:  
We could offer this treatment in an inpatient setting where there is 24 hour supervision of 
the Veteran, however, this would limit availability of subjects and change the focus of the 
intervention. 
 
15. Clinical Trials: 
If this study is a clinical trial (Part I, question 7) answer a-e, as 
applicable:  
Has a description of this clinical trial been recorded on http://www.clinicaltrials.gov? 
YES    
NO 
 
NA 
X 
 
a. Provide a list of investigational drugs that will be administered: 
NA 
 
b. Is the investigational drug information record attached?  NA 
 
YES    
NO 
 
If yes, please attach VA Form 10-9012. (Investigational Drug Informational Record) if 
not a marketed drug. 
If a marketed drug, provide authorized prescribers:       
 
c. Is an investigational drug used in research for new or different purposes compared 
to that which the FDA approved? NA 
    
YES    
NO 
 
Is there an IND number for this drug?   NA 
 
YES    
NO 
 
IND number or other status (submit validation or correspondence):       
If there is no IND number, is there an FDA exemption? (If yes, please submit FDA 
correspondence.)?  
YES    
NO 
 
 
d. Will investigational devices be used:  

NA 
 
Is there an IDE issued by the FDA?  
 
YES    
NO 
 
IDE number or other status (submit validation or correspondence):       
Is there an abbreviated IDE?  
 
YES    
NO 
 
If there is no IDE number, is there an FDA exemption? (If yes, please submit 
correspondence with FDA.)? NA 
 
 
YES    
NO 
 
 NA 
How would you determine the risk-benefit analysis for investigational  
devices? NA 
 
 
e. Risks for Investigational Drugs/Device: 
For investigational drugs, what are the possible risks associated with the study drug 
relative to possible interactions with medications likely to be used by subjects? NA 
 
What will your approach be to such risks?  NA 
 
Will such subjects be excluded from the study? NA 
 
 
Have you reviewed scientific literature or relevant FDA and Sponsor Advisories 
alerts or warnings relevant to this medication/device?  NA 
 
YES    
NO 
 
If there was any new information, what were the possible risks to subjects based on 
this information? NA 
 
If there was any new information, how were potential benefits for subjects affected 
by this information? NA 
 
 
If new information is received from the FDA or Sponsor that may affect the conduct 
of this study, would you be willing to change the study design or study procedures?  
YES    
NO 
 
How will you inform subjects of any relevant information from the FDA or Sponsor 
Advisories? NA 
 
 
What advice will you provide to subjects if there are questions on continuing 
participation in the study? NA 

 
 
16. Research Safety: 
a. Describe your Data Safety Monitoring Plan for subjects (3-4 sentences):  
Data Monitoring Committee (through Hines VAMC in Chicago, IL) 
 
b. What information will you be collecting for AEs/SAEs and what is your plan for 
reporting these to the IRB? 
Subjects will be monitored by a study psychiatrist for symptomatic assessment, status 
of clinical condition and for suicidal ideation.  All clinical findings and concerns will be 
discussed with the PI and adverse events will be reported to the IRB according to 
institutional guidelines. 
This study is likely to have adverse events related to suicide attempts. Safety monitoring 
for adverse events (AEs) will be conducted in real time by the Principal Investigators and 
the research coordinators.  The PIs will supervise the research and respond directly to 
patient problems.  In the case of AEs, all of them will be indicated on the source 
documentation for the specific adverse event report form.  The PIs will determine the 
severity of the event, will assign attribution to the event, and will monitor the event until 
its resolution. 
 
How will you monitor adverse events? Adverse events will be monitored through 
regular contact with study participants, as well as contact with providers. 
Participants will be carefully monitored during the interview by the research staff 
who will be trained in noticing when the participant is uncomfortable or needs to 
take a break. In addition, research staff will follow-up via phone call with 
participants within a day of the interview to check in and assure the participant is 
not experiencing any delayed distress. Participants who demonstrated distress 
during the interview will be closely monitored through follow-up phone calls and 
the PI and RA will notify the primary provider of the participant’s experience 
during the interview. 
 
 
c. Provide a plan for periodic review of safety of research subjects and data: 
All risks and potential complications are discussed with the subjects during consent 
signing, and any new information regarding risks will be provided by phone immediately.  
Patients are monitored closely and should any unanticipated findings arise, the IRB will 
be notified. 
PI (MG) will be available to perform a suicide assessment at any point a rater or clinicians 
delivering PLF suspects that a subject is at risk for suicide as determined through 
clinical questioning or a research instrument assessing suicidal intent.  The senior 
clinicians will ask questions regarding suicidal ideation and suicide plan and arrange for 
transfer to the psychiatric emergency room and/or inpatient stabilization at the JJPVA 
should imminent suicidal behavior manifest itself. All suicide attempts and deaths will be 
reported to the JJPVA and the DSMB assembled for this study. 
 
d. Describe how you will determine whether the study should be continued in light 
of emerging information: 
The PI will work in conjunction with the IRB to evaluate any emerging 
information and determine if and how the study should be continued. 

 
e. Is there a Data Monitoring Committee (DMC) or a Data Safety Monitoring Board 
(DSMB)?   
DMC   
X 
DSMB 
 
NO 
 
If no, proceed to question 17. 
Describe your DMC or DSMB, including frequency of reporting:   
2018/2019 – Quarterly. 2020 onwards, biannually (January and July)    
Describe how the DMC or DSMB will communicate with the IRB: Reports 
submitted to IRB on this basis: 2018/2019 – Quarterly. 2020 onwards, 
biannually (January and July)    
 
17. Data Analysis and Sample Size: 
a. Describe the analysis that will be performed on the data: 
 All data will be de-identified before it is entered into a redcap database at the JJPVA, 
Philadelphia VA, Northport VA, and Central Texas VA over the intranet. All principal 
analyses will be conducted based on the intention-to-treat principle. Linear mixed 
models will be used to examine changes in primary and secondary outcomes for 
Veterans over time and to examine whether the effects of PLF and TAU on these 
outcomes vary with time adjusted for the time-dependent treatment, covariates of 
interest and imbalanced baseline prognostic factors, using data reduction methods as 
appropriate. For the PLF subjects, individual’s random effect will be nested within the group 
they are assigned to, while for TAU subjects, they will be nested within the clinician effect. 
All data will be entered into an SPSS database at the JJPVA constructed by the data 
manager. Tenets of our data system include double data entry, range checks and 
exclusion of identifiers that can be directly traced to individuals. Preliminary analyses 
will include computing descriptive statistics and inspecting features and patterns of data 
to determine whether data transformations are needed. Quantitative measures will be 
graphed and their distribution inspected for any outlier value, which will be winsorized. 
All principal analyses will be conducted based on the intent-to-treat principle, that is, all 
Veterans with data will be included, regardless of the actual treatment received. For 
subjects who drop out during the study, their data up to that point will be used, but not 
carried forward to subsequent time points. We will also conduct an economic cost 
analysis of the Project Life Force intervention to compare cost effectiveness of telehealth 
groups versus the in-person groups pre-COVID. We will use an implementation science 
framework, The Consolidated Framework for Implementation Research, to determine 
barriers and facilitators of the telehealth-delivered PLF safety planning intervention. 
Development of the script and qualitative analysis will be conducted by Sapana Patel, 
PhD; a qualitative and implementation expert.  
 
 
Analyses to Determine Generalizability of Results: We will compare the baseline 
characteristics (e.g., age, sex, education) of the study population to those that declined 
participation, and will evaluate reasons for refusal that will be tracked. A sensitivity 
analysis using the propensity score methodology would be applied if those who refuse 
participation were significantly different on important measures from the participants. 
Missing data and loss to follow-up are usually concerns in longitudinal studies 
presenting problems in interpretation. The validity of the resulting inferences depends 
critically on the underlying mechanism that generates the missing observation- MAR, 
MCAR or MNAR.44 Both survival analysis and mixed-effect models, the proposed 

statistical methodology, can handle data that is missing at random or missing completely 
at random; that is, if the mechanism for missing data does not depend on the value of the 
response variable, given the information in the predictor variables already in the model 
(treatment condition and baseline scores), then no further adjustment is necessary. 
However, when missing data are related to outcomes of interest even after conditioning 
on the known data (i.e. treatment condition), such as when in some patients side-effects 
of the active treatment affect the suicidal behavior risk and also cause drop-out, 
parameter estimates and resulting 
tests of hypotheses will be biased, and this can affect the generalizability as well as the 
reproducibility of the results. To address this problem, we will look for patterns of 
missingness. For example, data will be stratified according to their missing pattern (e.g., 
early and late termination, and incomplete follow-up); and, assuming a monotonic 
missingness pattern applies, we will use Diggle methodology, allowing us to examine the 
effects of missing-data patterns on outcome measures. We will explore other patterns 
using the techniques referenced above. 
 
 
b. Provide power analysis or describe how sample size was determined: 
For the survival analysis comparing the PLF and TAU treatment conditions, we 
assumed a 20% dropout in both groups based on previous safety planning data 
to date using SAFE-VET, exponential hazard functions, and considered four 
scenarios of suicide behavior reduction of PLF over TAU. We assumed a base 
rate of 49% for SB in the TAU group based on published data from ED-SAFE. The 
sample sizes needed for 80% power were calculated using the “Proc Power” 
procedure from SAS software © 2002- 2012. In the absence of pilot data, we used 
a published formula for the Variance Inflation Factor from the weighted log-rank 
test, to adjust the required sample size for within-group, and within-clinician, 
dependence. We assumed m=5 subjects per group or clinician, and an ICC for 
suicidal behavior within the group of r=0.01 based on literature. While power 
analyses were calculated for several reduction rates, we selected the 35% 
reduction rate as the most reasonable estimation for the reasons outlined below. 
The composite suicide behavior outcome has minimal data outside of ED-SAFE’s 
reduction of 18% in non-veterans recruited from an emergency room. Stanley and 
Brown’s SAFEVET data on Veterans presenting to an ED, reported a 45% 
reduction in suicide attempts (however the composite definition of suicidal 
behavior was not used). Moreover we anticipate PLF to have increased potency 
over SAFEVET due to the group setting and greater number of in-person 
sessions. Balancing the enhanced potency of the PLF intervention with the new 
composite definition of SB, the 35% reduction scenario is reasonable. Therefore, 
we expect the reduction to be above the minimum values indicated, and are 
confident that N=145 will provide ample power for this aim. Then, the research 
team included an additionally 35 to be consented who would likely not screen 
into the study or meet inclusion/exclusion criteria. 
 
18.  Community-based Participatory Research  
 
Is this research based on Community-based participation?     

YES    
NO 
X 
If Yes, answer questions (a-h). If No, proceed to Question 19.  
a. Describe the community that will be involved in this research: 
      
 
b. What is the role of the community in this research? 
      
 
c. Does this research include a community organization that is engaged in 
research?   
YES    
NO 
 
If Yes, does that organization have a Federal Wide Assurance (FWA)? 
YES    
NO 
 
 
d. Describe any part of this community-based research that an outside IRB will 
review:        
 
e. Describe the risks to the community as a result of this research: 
      
 
f. Do you have a plan for disclosure of individual results to research participants?  
YES    
NO 
X 
If Yes, please describe: 
      
 
g. Describe who will have access to study data if multiple groups are involved:  
      
 
h. Is there an agreement for this research (e.g. CRADA, subcontract) or a data 
ownership agreement?  
YES    
NO 
X 
If Yes, please provide details:       
 
19. Advertisements: 
 
a. Are you submitting advertisements for IRB review?   
YES    
NO 
X 
 
If yes, attach previously stamped ads. 
20. Privacy: 
 
a. Explain the plan to protect Privacy and the Privacy Interests of subjects: 
(1)Environment/Sharing of information (Time and place for study activities (e.g., 
potentially stigmatizing locations, such as a clearly identified pregnancy counseling 
center), nature of the information given, who receives and can use the information and 

whether information sought is of legitimate interest to the researcher): Participants will 
meet with study staff in neutral conference rooms or offices that are private. The 
information sought will relate only to relevant demographic information (age, 
gender, race, employment, etc.), and the assessment questions will have to do 
with the research topic. If at any point a participant feels stigmatized or in 
distress, the study staff will immediately stop the interview and have the PI 
consult with the participant. However, during the time of COVID-19 since 
participants will not be able to meet with study staff in person they will be given 
the option to consent via the phone with a staff member and a witness. 
Specifically, Veterans will be scheduled with a staff member (someone obtaining 
the consent the Veteran and witness) to further discuss involvement in the project 
and possibly consent (based on Veteran interest). Before consent is obtained over 
the phone the Veteran will be mailed or electronically sent a consent form to 
follow along and sign. Then a research staff member would go over the consent 
on the phone with the participant (as written in the phone script/consent form 
submitted with this amendment).  Please see check boxes Yes/No throughout. No 
procedures will take place until the verbal informed consent has been obtained 
with the two witnesses. Additionally, participants will be given the opportunity to 
do assessments over the phone (for which their data will be entered into a VA 
secure redcap directly) or via mail where only study PID will be on the paperwork. 
No names of identifiable information will be on mailed assessment packets.  
 
(2) Subject’s expectation of privacy, comfort in the research setting, comfort with research 
procedures: Once a Veteran consents to participate in the study, we shall first screen them 
to determine eligibility. We are only enrolling Veterans who regularly receive services from 
or work at the JJP VAMC, so the environmental experience will not differ from their usual 
routine. 
  
b. Data Use (Please also submit a completed Research Data Inventory Form): As Dr. 
Hanga Galfalvy is a VA WOC, information they receive is not being shared outside 
of the VA. As Dr. Rebecca Raciborski is a VA Employee, information they receive is 
not being shared outside of the VA. Dr. Sapana Patel will only receive some 
deidentified data and will not interact with participants or have access to PHI. 
Is data shared with external parties?   
YES   X 
NO 
 
If Yes, answer the following.  If No, proceed to question 20.c. 
Is there a Memo of Understanding with the external facility?  
PENDING   
 
EXECUTED 
 
NO 
X 
 
Is there a Data Use Agreement? 
PENDING   
 
EXECUTED 
 
NO 
X 
 
Indicate any other data agreements:       
PENDING   
 
EXECUTED 
 
N/A 
X 
 
c. Signature and Date: 
Are subjects incompetent or do they lack decision making capacity?  
YES   
 
NO 
X 
If Yes, is there a signature line on the HIPAA authorization for the person legally 
authorized in writing by the individual or the individual’s legal guardian?  

YES   
 
NO 
 
 
d. HIPAA Waiver:  
Is a HIPAA waiver being requested? Note: we have a HIPPA waiver for the consenting 
process but not for the entire study.  
YES   
 
NO 
X 
If No, proceed to 20e. 
(a) Is there a written plan to destroy identifiers at the earliest opportunity consistent with 
conduct of the research?  
YES   
 
NO 
 
 
e. Specimens: 
Are you collecting specimens (Blood, saliva, tissue, etc.) in this study?   
YES   
 
NO 
X 
Will you send specimens off site for analyses? (Material Transfer Agreement may be 
required, unless a CRADA is executed – see the AO for research, ext. 6017) 
YES   
 
NO 
X 
If yes, please indicate how transporting specimens (hand-delivered by courier, fedex,etc)  
who will transport and list name of institution, address and contact information for 
person(s) in charge of receiving, storing and processing of specimens at external site. 
Please also indicate how long specimens will be stored (for specimen storing), if all 
specimens will be used up or whether or not unused specimens will be destroyed, when 
they be destroyed, remaining specimens shipped back to PI at a later date, keep 
specimens stored indefinitely, whether or not specimens will be shared with other 
researchers (for specimen banking), for future analyses, etc.  NA 
 
If NOT sending specimens off site, please list procedure for storage here at JJPVAMC, 
handling, by whom, destroying, length of time storing and whether or not specimens will 
be used for future research. NA 
 
Does the study documentation state when specimens will be labeled with identifiable or 
de-identified information? NA 
YES   
 
NO 
 
 
f. De-Identification of Data: 
Does the protocol indicate whether or not data will be de-identified?  
YES   
X 
NO 
 
If so, please indicate all that apply.  If no, proceed to question 20.g. 
De-identified information is provided to PI (who has access to IIHI) by 
his/her research team per a HIPAA authorization or waiver of authorization. 
X 
De-identified information is provided by PI (who has access to IIHI)  
to his/her research team per a HIPAA authorization or waiver of 
authorization. 
X 
De-identified information is to be sent to non-VA research team  
member, such as a statistician. 
X 
De-identified information will be disclosed to a non-VA party.  If so, please 
identify:       
 
Check all that apply: 
 

             
   De-identified – Data does not contain any identifiers that could link the data 
to a specific participant.  (See VHA Handbook 1605.01, Appendix B, para 2b, for a list of 
identifiers 
that must be removed before data can be considered de-identified.  Data must be de- 
identified in accordance with HIPAA and Common Rule criteria.  Scrambling of names 
and social security numbers is not considered de-identified information. 
 
  
   Identified – Data contains direct identifiers sufficient to identify participants as 
indicated in VHA Handbook 1605.01, Appendix B, para 2b.   
 
             
   Coded – Data linked to a specific subject by a code rather than a direct 
identifier.  While the data may contain some protected health information only someone 
possessing the code can link the data to a particular participant.   
         
      If coded data is checked , specify how the link or code will be maintained, and 
list each  
         person/role who will have access  to the link or code:          
 
g. VA sensitive data: 
(a) Is VASI shared with parties external to JJP? 
YES    
NO 
X 
If Yes, is a Data Use Agreement (DUA) in place for this activity? (NOTE: See the Privacy 
Officer regarding DUA’s.) 
YES    
NO 
 
 
(b) Have all research staff who will transport, transmit, download, and/or store VA 
sensitive information (all formats and media, see VHA Handbook 1200.12, Definitions) 
outside of the VA protected environment obtained written approval from their immediate 
supervisor and JJP ISO (see the ISO for form “Authorization to Transport and Utilize VA 
Sensitive Information Outside Protected Environments”?  
YES    
NO 
 
If yes, please name individuals who have received authorization:       
 
(c) Collected or stored in hard copy outside of the James J Peters VAMC:  
YES    
NO 
X 
If Yes, how will it be protected?       
 
(d) Stored on non-VA computers or non-VA electronic media outside or inside the James J 
Peters VAMC: 
YES    
NO 
X 
If YES TO ANY OF THE FOUR PRECEDING QUESTIONS, answer i-ii below: 
i.Are VA sensitive data in hard copy shared with parties specified in the consent form?  
YES    
NO 
 
Are documents sent with a chain of custody (registered mail, FEDEX, UPS) or hand 
carried? 
YES    
NO 
 
If Yes, please specify:       
ii.Is VA sensitive data sharing/transmission with parties specified in the consent form FIPS 
140-2 compliant using encryption provided by VA (IRM)?  
Transferred using data storage media (e.g., CD, USB flash “thumb” drive): 

YES    
NO 
 
If Yes, please specify type of media:        
Transferred using electronic data transfer (e.g., email with PKI): 
YES    
NO 
 
If Yes, please specify type of electronic data transfer:        
h. Protection of Media Stored at Alternate Site:   
Will VA Sensitive Information be removed from the VA Protected Environment?  
YES    
NO 
 
Does the study team plan to store VA sensitive information outside the VA protected 
environment?  
YES    
NO 
X 
If Yes, by what method it will be protected?       
 
i. Data Repositories: 
Is any data collected for this study to be shared with any other research study? 
YES    
NO 
X 
Does this study use data that is collected under a separate research study? 
YES    
NO 
X 
If Yes, provide Protocol #:        MIRB #:       or non-VA entity.       
NOTE: If Yes for either question, please complete items a-d below for Data 
Research Repositories.  See R&D Committee Procedures Manual, IRB SOP, and VHA 
Handbook 1200.12 regarding compliance with VA Research Data Repository 
requirements. 
 
(a)If the repository received data, what were the sources of data being added to the research 
repository and the protocol(s) under which they were collected? 
 
(b)If the repository shared data, what were the type of data released to others for use, the 
protocol(s) under which they were used, and the planned disposition of the data once the 
protocol is terminated? 
 
(c) Were there any events involving risk to subjects or others, such as a breach of privacy or 
confidentiality?   
 
(d) Were there any findings linking a negative impact on the health status of individuals in the data 
repository with identified causal factors, including whether there may be a clinical intervention? 
 
 
21. Information Security: 
 
a. Software:   
Will specially obtained software be used?  
YES   X 
NO 
 
If Yes, please identify: SpeechExec Pro 
Source of the software JJPVA IT 
Will a license be required? No 
How will a license be funded? NA 
What data will be stored in temporary files on computer hard drives? Audio recordings of 
the PLF sessions. Then it will be moved into a study specific shared drive 

immediately upon download. Our team is currently working on this software request 
with Jake Pettway and IT services (Jacob.Pettway@va.gov). 
 
We purchased the Speech Exec Pro CD and dropped it off for him to install. It is 
approved by the VA (as Jake noted) so it’s just a matter of having it installed. Then 
the recorder can be hooked up to the computer directly and the recording saved to 
a study shared folder solely for study staff. VA Webex will now also be used to 
record the PLF groups and the Qualitative Interview. These recordings save directly 
to VA Webex behind the VA firewall. 
 
b. Web applications: (used for such purposes as recruiting subjects, completing 
questionnaires or processing data)  
YES   x 
NO 
 
If Yes, please identify: VA RedCap and VA Webex 
Web application’s security features: Security features of Redcap can be found 
following this link https://www.iths.org/wp-content/uploads/About-REDCap-
Vanderbilt.pdf. The VA-specific REDCap and VA Webex will only be used on VA 
computers and all the files will be de-identified. VA REDCap and VA Webex is only 
accessible within the VA firewall.  
 
c. Incident Reporting:   
Are procedures in place, in accordance with VA policy, for reporting incidents, i.e. theft or 
loss of data or storage media, unauthorized access of sensitive data or storage devices or 
non-compliance with security controls?  
YES   X 
NO 
 
If Yes, please describe the procedures, and briefly describe how they are conveyed to 
research staff. The research staff should report to the PI, who will then report 
to the proper authorities. 
 
DATA: 
a. Data Flow:  
Describe the data collection, data flow and/or data management process that will be used 
for the study: Hard copy data is secured by the research coordinator and filed in 
locked cabinets in a locked office.  Data that is entered electronically is stored on 
VA-secured server.  No one outside of the research staff has access to these files. A 
password protected spreadsheet will link research ID number with patient 
identification, stored on the VA-secured server. Only the PI and research assistants 
will have access to this linkage file. 
 
b. Data Security Plan:  
Will Electronic Data be stored?  
YES   x 
NO 
 
If Yes, please explain how it will be secured: All electronic data is stored on VA-
secured server. Any data entered on VA Recap will be De-Identified. 
Will Paper records be stored?  
YES   X 
NO 
 
If Yes, please explain how it will be secured: Hard copy data is secured in locked 
file cabinets in the research office. 
 
c. Data on a Hard Drive:  

Will VA research data be stored on a computer other than the VA network?    
YES    
NO 
X 
If Yes, will it be encrypted?  
YES    
NO 
 
If Yes, will data that is stored outside the VA network be backed up regularly and securely 
stored on the VA network?  
YES    
NO 
 
 
d. Storage Location:  
\\r04brxnas21.v03.med.va.gov\groups\MIRECC\Marianne Goodman\GOO-18-18 PLF 
RCT 
Identify location (facility, room number) where hard copy data will be stored: 9B-70 
 
e. Data Transmission:   
Will sensitive electronic information be transmitted? (Note:  VA sensitive data or 
information may only be transmitted using VA-approved solutions such as FIPS 140-2 
validated encryption)  
YES    
NO 
X 
If Yes, please provide the method of transmission:       
 
f. Data Backup:   
Will original electronic VA research data stored on a mobile device be backed up regularly 
and stored securely within VA’s protected environment?  
YES    
NO 
 
N/A 
X 
Will original electronic VA research data stored outside the VA protected environment be 
backed up regularly and stored securely within VA’s protected environment?  
YES    
NO 
 
N/A 
X 
 
g. Shipping Data:   
Will hard copy, electronic research data, or any encrypted media be sent via delivery 
service with a chain of custody?  
YES    
NO 
X 
N/A 
 
If Yes, please describe chain of custody:  
 
The answer is currently no, but at some point we may amend this as it is the backup 
option. Currently those reviewing the tapes are being WOC-ed and given remote 
access. This way they can be added to the study protocol through the IRB and 
given direct access (through remote access) to the study shared drive. If needed, 
we would update our protocol to include a chain of custody (registered mail, 
FEDEX, UPS) in which the DVD recordings would be broken after the WOCs listen to 
the sessions. However, we would put in an amendment and get approval before 
pursuing this option. Any data that will be shared will be De-Identified and shared 
via Fedex. The only data sent offsite will be De-Identified DVD recordings of 
sessions that will be broken once listened to for adherence. 
 
Is sensitive electronic research data that must be sent via common carrier (e.g., USPS, 
UPS, Fedex) encrypted with FIPS 140-2 validated encryption?  
YES    
NO 
X 
N/A 
 
 
h. Data Return (If no data is sent offsite, enter x here and proceed to i.):   

What VA information will be returned to the VA?        
How will the information be returned to the VA?       
 
i. Termination of Data Access:   
Will access to research study data be removed for study personnel when they are no 
longer part of the research team?  
YES   x 
NO 
 
 
j. Per CRADO memo “Creation of Research Data Inventory to resolve OIG report 11-
01823-294” of January 15, 2015, please submit a “Research Data Inventory Tool” to 
accompany this application.  This tool may be found on the Research intranet page under 
Other Forms. 
Is a form being submitted with this application? 
YES    
NO 
x 
 
EQUIPMENT: 
a. Will any portable, mobile or wireless devices be used for research purposes?   
YES   x 
NO 
 
If No, proceed to Question m. 
If Yes, are all these devices encrypted?  
YES   x 
NO 
 
How are these devices backed up?  N/A Working with IRM to get it installed in the 
software mentioned above. Recordings would immediately be deleted off of the 
recorder 
Is the encryption FIPS 140-2 validated (required)?  
YES   X 
NO 
 
Has the investigator’s immediate supervisor and the CIO authorized use of any such 
devices (contact the CIO for procedures)? 
YES   X 
NO 
 
 
b. Has all equipment owned by an affiliated institution, or purchased by such institution 
from grant funds, and used by the Investigator in this research project at JJP, been 
reported to the CIO (reporting to include: Type of equipment, Manufacturer, Model, Serial 
Number, PO Number, Vendor, Asset Value, Acquisition Date, Researcher’s Service, and 
Location (Room Number)?   
YES   X 
NO