Evaluating the Use of Peer Specialists to Support Suicide Prevention
Phase: NA
Conditions: Suicide
Sponsor: VA Office of Research and Development

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CIRB # 20-06: Evaluating the Use of Peer Specialists to Support Suicide Prevention 
Funding Agency: RR&D Small Projects in Rehabilitation Research 
Principal Investigator/Study Chair: Matthew Chinman, PhD 
Version 5.0, March 8, 2022 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
Abstract 
 
Preventing suicide is a top priority for the Veterans Health Administration (VHA). Suicide 
prevention efforts for high-risk patients focus on clinical (e.g., mental health) and service use (e.g., 
case management) factors. What has yet to be tested is an approach that targets factors in 
community living, as it is not only mental and physical illnesses that heighten suicide risk in VHA 
patients, but also their struggles with a sense of self-worth, meaning, and social connections in 
the community. To help VHA patients with high risk of suicide, this application proposes to adapt 
and test a promising approach called PREVAIL, which uses ‘Peer Specialists’ (i.e., Veterans with 
psychiatric disabilities who have been trained to help others with similar conditions) as an adjunct 
to standard VHA care. This project proposes to use Intervention Mapping, a multi-method, 
systematic approach using diverse stakeholders, to adapt and pilot PREVAIL. The VHA is the 
single, largest employer of Peer Specialists and research shows that they can enhance standard 
clinical care in mental health, physical health, and rehabilitative outcomes. However, Peer 
Specialists have only just begun to be deployed in suicide prevention efforts. The primary aims of 
this study are to: 1) Use Intervention Mapping to identify which components of PREVAIL require 
adaptation to reduce suicidal ideation in high risk VHA patients and to identify implementation 
strategies useful for the VHA system; and 2) Pilot test the feasibility and acceptability of the 
adapted PREVAIL, rehabilitative measures, and suicide- related outcomes for use in a rigorous 
prospective study. Needs assessment interviews with diverse VHA staff, Peer Specialists, and 
patients will be conducted to inform the adaptation. Based on results from the needs assessment 
and the literature on suicide prevention, psychiatric rehabilitation, and peer-based approaches, 
a steering committee will help adapt PREVAIL. Twelve high suicide risk Veterans with unipolar 
or bipolar depression will participate in a 3-month “pre-pilot” and provide feedback on how the 
adapted PREVAIL may be revised. After making any necessary modifications to the intervention, 
a second group of 12 high suicide risk Veterans with unipolar or bipolar depression will be 
recruited to participate in a formal pilot test to further evaluate the feasibility and acceptability of 
recruitment, retention, and assessment procedures. Patients and Peer Specialists will be from the 
VA Connecticut Healthcare System. All participants will receive standard VHA care from the 
Connecticut campuses while participating in this study. Participants will be assessed at baseline, 
post-intervention, and 3- month follow-up in their level of functional impairment and community 
integration; sense of hope, quality of life, meaning, and purpose; and self-views and social 
support. Chart reviews will also be completed at 3-month follow-up to assess for changes in health 
care visits involving suicidal behaviors. If acceptability (> 50% enrollment of eligible participants) 
and feasibility (> 70% of enrollees complete follow-up assessment) are demonstrated, this study 
will result in a novel rehabilitation-oriented suicide prevention intervention to test in a fully-
powered randomized controlled efficacy trial. 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 2 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
List of Abbreviations 
 
 
 
Term 
Abbreviation 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
INQ 
Interpersonal Needs Questionnaire 
IM 
Intervention Mapping 
PRFs 
Patient Record Flags 
PSs 
Peer Specialists 
QIDS 
Quick Inventory of Depressive Symptoms 
Q-LES-Q-SF 
The Quality of Life Enjoyment and Satisfaction Questionnaire 
QPR 
Questionnaire about the Process of Recovery 
SCS 
Suicide Cognitions Scale 
SDS 
SPC 
Sheehan Disability Scale 
Suicide Prevention Coordinator 
TUCP 
Temple University Community Participation 
VACT 
VA Connecticut Healthcare System 
VHA 
Veterans Health Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 3 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
 
 
 
 
Contents 
Protocol Title: Intervention Mapping to Develop a Peer-based Rehabilitation Intervention for 
High Suicide Risk Veterans ...................................................................................................................... 5 
1.0 
Study Personnel ............................................................................................................................. 5 
2.0 
Introduction ...................................................................................................................................... 5 
3.0 
Objectives ........................................................................................................................................ 8 
4.0 
Resources and Personnel ............................................................................................................. 9 
5.0 
Study Procedures ......................................................................................................................... 11 
5.1 Study Design .................................................................................................................................. 11 
5.2 Recruitment Methods .................................................................................................................... 18 
5.3 Informed Consent Procedures ..................................................................................................... 19 
5.4 Inclusion/Exclusion Criteria .......................................................................................................... 20 
5.5 Study Evaluations .......................................................................................................................... 22 
5.6 Data Analysis ................................................................................................................................. 23 
5.7 Withdrawal of Subjects ................................................................................................................. 24 
6.0 
Reporting ....................................................................................................................................... 25 
7.0 
Privacy and Confidentiality .......................................................................................................... 26 
8.0 
References .................................................................................................................................... 27 
 
 
 
 
 
 
 
 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 4 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
 
Protocol Title: Intervention Mapping to Develop a Peer-based 
Rehabilitation Intervention for High Suicide Risk Veterans 
 
 
1.0 
Study Personnel 
 
In addition to the Principal Investigator, the study team is comprised of several co- 
Investigators across the three project/performance site locations: VA Pittsburgh 
Healthcare System, VA Connecticut Healthcare System, and VA Ann Arbor Healthcare 
System. 
 
 
2.0 
Introduction 
 
Background and Rational 
 
Veteran suicide is a public health crisis: According to the most recent VA National 
Suicide Data Report: 2005-2016,29 the Veteran suicide rate increased by 26%, as 
compared to 21% for non-Veteran adults. Although suicide rates rose more sharply for 
non-VHA Veterans (26%) than for VHA patients (14%), the suicide rate among VHA 
patients is higher than Veterans who are not receiving VHA care. 
 
Suicidal ideation is a frequent precursor to non- fatal and fatal suicide attempts.30 Suicidal 
ideation is reported by 3%-52% of Veterans, depending on the time frame (e.g., past 
month vs. current) and population (e.g., general community, primary care, or urgent care 
psychiatric clinic).31-33 Similar rates for suicide attempts are reported by Veterans (2%-
48%). Despite increased relative risk of suicide among persons expressing suicide 
ideation, the absolute risk of suicide is low.34,35 
Care for high-risk Veterans features increased contact but lacks a focus on key life 
domains: VHA patients who attempt suicide, report serious suicidal ideation, or exhibit 
other warning signs of acute suicide risk have a Patient Record Flag (PRF) placed in 
their medical record for no less than 90-days. The VHA maintains a list of 
 
Version 4.0 
Suicide Prevention Protocol 
Page 5 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
Figure 1: Conceptual Model of Peer Specialist Rehabilitation Intervention 
active PRFs to alert all staff that increased follow-up and case management are 
required.36 Patients with PRFs must have at least 4 clinical contacts within the first 30 
days after the flag is placed or following discharge from the hospital. During these 30 
days, they must be also assessed four times. Clinical care focuses primarily on safety 
planning, use of the Veterans Crisis Line, stepped-up mental health care, and additional 
case management support from the Suicide Prevention Coordinator,37 rather than directly 
addressing needs in other life domains. Recent evaluations of the VHA suicide prevention 
initiatives observe deficits in tracking, safety planning, and care practices for high suicide 
risk Veterans.38 
 
Peer Specialists (PSs) are a promising, but untested, adjunct to suicide prevention: 
PS-based approaches involve being supported or mentored by a trained non-professional 
who is living with the same challenge. PS models do not devalue clinical care but expand 
the sphere of interest and intervention to include rehabilitative tasks of building a life of 
self-respect, meaning, purpose, and connectedness in one’s local community. These 
outcomes are achieved largely through offering empathy, hope, and practical advice 
based on one’s personal experience of mental health recovery.39 PSs and similar models 
can enhance standard clinical care in mental health, physical health multiple 
domains5,11,14,40 and rehabilitative outcomes,12,41 especially with increasing sense of 
empowerment and engagement. 
 
PSs appear well suited to reduce certain psychosocial factors associated with suicide risk 
in VHA patients with PRFs. Research with Veterans show that feeling hopeless, 
shameful, or burdensome, or being disconnected from others and meaningful activities 
are predictive of suicide ideation and lower help-seeking behavior for mental health 
reasons.42 Concerns about stigma, trust, and empathy are critical barriers to disclosing 
suicidal ideation to VHA 
providers.43 
Because 
PSs 
share 
patients’ 
mental 
health 
and 
military history, they may 
be particularly helpful in 
this respect as patients 
often 
feel 
more 
accepted, 
connected, 
and 
hopeful 
when 
working with PSs than 
traditional         providers 
Version 4.0 
Suicide Prevention Protocol 
Page 6 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
(Figure 1).3,4 The VA National Strategy calls for peer services and testing of promising 
approaches to assist with suicide prevention efforts. One promising approach is 
PREVAIL, a peer-based intervention developed for reducing suicidal ideation in adult 
civilians recently hospitalized for suicidal thoughts or behaviors.15 PREVAIL was 
developed for non-Veterans and needs to be adapted to “fit” the needs of VHA patients 
and health care setting. 
 
Adapting PREVAIL involves identifying which components need to be tailored to 
target the rehabilitation needs of VHA patients and implementation context in the 
VHA: Intervention Mapping (IM)16 is a systematic, multi-method approach to designing 
complex interventions and adapting them to new populations or settings. IM uses diverse 
stakeholder involvement and theory to understand barriers and facilitators to 
implementation at the patient-, provider-, and organizational- levels. IM draws on 
systems-based and participatory models to understand a health problem and its causes 
by including diverse stakeholders to plan an intervention that targets the most effective 
leverage points to improving health. Each step of IM involves multiple activities that are 
iterative and inform subsequent steps culminating in a novel approach to a problem. IM 
has been used successfully to develop and adapt a range of rehabilitative programs, 
including suicide prevention practices in primary care.44,45 In the VHA, similar multi-level 
approaches involving stakeholders have successfully yielded mental health and primary 
care programs19 as well as roll out of PSs in mental health.21 
 
Adapting interventions with IM involves identifying changes that need to be made to meet 
the needs of the new target population and to address differences between the original 
context and the new one in which it will be implemented. These steps include: 
(1) assessing organizational capacity (e.g., readiness to adopt a new program and role 
of new program in existing organizational relationships); (2) assessing behavioral 
determinants (e.g., psychosocial factors that differ from original sample to produce the 
desired change) and environmental determinants (e.g., key differences in the 
organizational characteristics from those of the original sample); and (3) identifying 
indicated changes to essential elements (e.g., tailoring the content of format to fit the new 
population). We propose to use Intervention Mapping to adapt PREVAIL to supplement 
the clinical care of VHA patients with PRFs for acute suicide risk using PSs to increase 
hope, sense of purpose, and community connections as a mechanism to reduce suicide 
ideation. 
 
Significance. The VA’s National Strategy for suicide prevention calls for the development 
of peer-to-peer services to help those at risk for suicide. Our proposal is innovative 
because it proposes using PSs in a new priority arena, suicide prevention. 
Version 4.0 
Suicide Prevention Protocol 
Page 7 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
This research has high impact because it seeks to reduce suicidal ideation among high 
suicide risk VHA patients. Our project is directly aligned with suicide prevention as a top 
priority for the VHA as well as RR&D major priority domains for implementing 
interventions and techniques designed to maximize psychological recovery. Data from 
this project will inform the development of an RR&D IIR proposal testing the rehabilitative 
PS-based suicide prevention intervention in a multi-site, randomized, controlled trial. 
 
 
3.0 
Objectives 
 
Study Aims 
The specific aims of the study are to: 
1) Use Intervention Mapping to identify which components of PREVAIL require 
adaptation to reduce suicidal ideation in high-risk VHA patients and to identify 
implementation strategies in the VHA system. 
2) Pilot test the feasibility and acceptability of the adapted PREVAIL, rehabilitative 
measures, and suicide-related outcomes for use in a rigorous prospective study. 
 
Hypothesis 
These data will inform the development of an RR&D IIR proposal testing the 
PREVAIL adaptation in a multi-center, randomized, controlled trial. The current 
intervention is innovative because it proposes using for the first time, VA Peer 
Specialists to improve rehabilitation of those who are suicidal. This research has 
high impact because it seeks to reduce suicidal ideation among VHA patients 
flagged for high suicide risk. 
 
 
 
 
4.0 
Resources and Personnel 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 8 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
PRIMARY SITE: VA PITTSBURGH HEALTHCARE SYSTEM (VAPHS), PITTSBURGH, 
PA 
The personnel at this site include the following: 
 
Principal Investigator: The PI will be responsible for overseeing all aspects of the study 
including development, management and integrity of the design, conduct, and reporting 
of the proposed research, achievement of the project aims, and development and 
maintenance of productive collaborative relationships with operational partners and co- 
investigators. They will lead the meetings of the monthly steering committee. They will 
also ensure budgetary compliance, and oversee data collection, data analysis, and the 
preparation of all reports, presentations, and publications. They will monitor the safety of 
all participating human subjects. Finally, the PI will lead several dissemination efforts that 
include regular reports to Dan O’Brien-Mazza, MS, the National Director of Peer Support 
in the VA; delivery of EES cyber- seminars to VA administrators and clinicians; and 
publication of interim and final study findings via CHERP and MIRECC dissemination 
vehicles and peer-reviewed publications. 
 
Co-Investigator: The Co-I will coordinate and manage the implementation and conduct of 
the study and serve as the qualitative methodologist. They will coordinate the efforts of 
the investigative team, develop the project manual of operations, develop the data 
tracking and management systems, assure the integrity of the data and protection of 
human subjects by directly working with the Central IRB, and help to manage the project 
budget. As described in the proposal, the Co-I will co-code 100% of the qualitative data 
(from the needs assessment and the interviews from the pre- and formal pilots) and lead 
the analysis of the qualitative data. They will oversee the development of documented 
coding audit trails and work with another Co-I to develop the qualitative codebooks. They 
will also contribute to the preparation of reports, presentations, and manuscripts related 
to the project. Finally, they will serve on the steering committee. 
 
Research Assistant: In Years 1 and 2, they will be responsible for assisting with preparing 
and submitting IRB documents for the Central IRB, at the Pittsburgh site, and helping with 
IRB documents at the other sites. They will also assist the Co-I and the transcriptionist 
with the qualitative coding and analysis. 
 
Transcriptionist: A trained transcriptionist from the CHERP Qualitative Core who will 
transcribe verbatim all the qualitative interviews. 
 
Transcriptionist - a Research Health Science Specialist in CHERP and a member of the 
Qualitative Core. They will verify all transcripts for accuracy. 
Version 4.0 
Suicide Prevention Protocol 
Page 9 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
SITE #2: West Haven, Connecticut: 
 
Site PI/Co-Investigator: The Site PI/Co-I will oversee the training of and provide weekly 
supervision to the peer specialists who will participate in the intervention arm of the 
proposed pilot study. They will also work closely with the Connecticut Suicide Prevention 
Coordinator who will provide names of potential patient participants to be approached for 
recruitment in the pilot study. They will facilitate collaborative relationships with 
operational partners in different VA care settings serving participating patients (e.g., acute 
care and outpatient settings) as well as with recruitment of participants for the needs 
assessment interviews in Year 1. The Site PI/Co-I will also assist with preparing reports, 
presentations, and publications. 
 
Co-Investigator: The Co-I will co-code 100% of the data from the interviews and co-lead 
the analysis of the qualitative data with another Co-I. They will assist with development 
of documented coding audit trails and work with another Co-I to develop the qualitative 
codebooks. 
 
Research Assistant (WOC): An experienced research assistant will be hired to work 
under the direction of the Site PI/Co-I and Co-I. They will start at 25% effort in the last 6 
months of year 1. They will meet with potential patient participants to discuss the study, 
including activities, potential risks, and benefits; complete the consent process, and 
administer questionnaires at baseline, postintervention, and follow-up for the pilot. They 
will also coordinate the completion of the qualitative interviews. They will also facilitate 
the steering committee meetings, sending out agendas, read-ahead documents, and 
taking and circulating minutes. Finally, they will coordinate project meetings of staff from 
the three sites. 
 
IPAs 
 
Interagency Personnel Agreement – Yale University. The Co-I will oversee the day-to- 
day execution of the project activities in Connecticut and serve as a liaison with the West 
Haven PI. This will involve collaborating with them in their direct work with the peer 
specialists and acting as the liaison between the Suicide Prevention Coordinator who will 
provide names of potential patient participants and Yale research assistant who will 
approach participants for the consent process. The Co-I will also assist the PI with the 
IRB process, data analysis, and preparation of reports, manuscripts, and publications. 
They will also conduct the qualitative interviews as part of the needs assessment in the 
Intervention Mapping process and will also conduct the qualitative interviews of those 
who participated in the pre and formal pilots in West Haven. 
Version 4.0 
Suicide Prevention Protocol 
Page 10 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
SITE #3: Ann Arbor, Michigan 
Personnel 
Site PI/Co-I: They will provide expertise to the development and implementation of the 
pilot intervention. In addition to meeting with Pittsburgh and West Haven staff as part of 
regular project meetings, the Co-I will also be a member of the steering committee. 
 
Consultants: VA leadership and staff in the areas of Suicide Prevention, Peer Specialist 
Implementation, Behavioral Health, and other relevant areas will be invited to serve as 
consultants on the Steering Committee. 
 
 
5.0 
Study Procedures 
 
5.1 Study Design 
 
This study will be conducted in three phases. The first phase will involve the use of 
Intervention Mapping to identify which components of PREVAIL require adaptation to 
reduce suicidal ideation in high-risk VHA patients to identify implementation strategies in 
the VHA system. Needs assessment is the first step in IM. 
Needs Assessment 
 
A Co-I will conduct a total of 12 interviews at the West Haven VHA site to learn more 
about: (1) attitudes toward PSs involvement in suicide prevention efforts, (2) current 
involvement of PSs in clinical care and safety planning, (3) PSs’ experiences working with 
persons with history of suicide ideation, (4) beliefs about how PSs can improve suicide 
prevention efforts, and (5) feedback on the focus, content, and process of the PREVAIL 
model. Interviews will be conducted with Veterans (n=3), PSs (n=3), and providers from 
primary care, behavioral health, rehabilitation, and emergency department settings (n=4). 
The Co-I will also interview clinical directors (n=2). Interviews will focus on current clinical 
practices involving peer specialists and suicide prevention services in terms of: (1) degree 
of perceived helpfulness; (2) perceived barriers; and (3) areas of value and possible 
improvement. Information from the interviews will be used to identify a range of potential 
barriers to the effective use of peer specialists in suicide 
Version 4.0 
Suicide Prevention Protocol 
Page 11 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
prevention efforts and possible changes to PREVAIL. 
 
Analyses of needs assessment data: Qualitative analyses of interviews from the needs 
assessment will be conducted with empirical phenomenological procedures used 
successfully by our team in previous studies.57 Verbatim transcripts of audio recordings 
from the interviews will be distributed to two of the Co-Investigators. Each researcher will 
independently review, analyze, and code the transcripts for themes that characterize 
participants’ experiences. After creating a narrative summary using the participants’ own 
language, the Co-Investigators will review each of their summaries to compare/contrast 
the identified themes before coming to consensus about important themes. A synthesized 
report will summarize the overarching themes. 
 
For Step #2 of the IM process, the steering committee will review the themes that were 
identified in the needs assessment interviews and data from the suicide prevention 
literature, provided by the Co-I who conducted the interviews. Preliminary qualitative 
and quantitative data on the PREVAIL model have already provided support for the logic 
model but identified minor modifications in the training and supervision provided to Peer 
Specialists. Based on information from the needs assessment interviews, the committee 
will help determine whether further refinements are appropriate or unnecessary. 
 
 
Pre-and Formal Pilot Testing 
 
Adaptation of PREVAIL: Steps #3 and #4 of the IM process will be completed during the 
monthly steering committee meetings. As recommended for adapting interventions,1,8,58 
proposed changes to PREVAIL will based on stakeholder input from the needs 
assessment results, literature reviews, and guidance from the original developer. Based 
on a recent meta-analysis of evidence-based psychotherapies adapted to new 
populations and settings, when changes are “discrete, well-defined, and based on sound 
theory and an understanding of the population for which the intervention is being 
adapted, they may result in better outcomes.” (p.409).59 To help inform potential changes 
to PREVAIL for the Veteran population, a Co-I will interview the PSs one two occasions. 
First, a focus group will be held on the last day of training in the PREVAIL to solicit 
feedback on possible changes to the curriculum. A second focus group will be conducted 
after PSs have delivered the intervention during the pre-pilot, with the possibility of 
individual interviews helping to elucidate specific topics brought up during the focus group. 
The conceptual model co-developed by Dr. Pfeiffer will be refined as needed by the needs 
assessment and steering committee, however, we do not anticipate any changes to this 
overarching structure based on preliminary feedback from the steering committee and 
needs assessment interviews. 
Version 4.0 
Suicide Prevention Protocol 
Page 12 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
The PREVAIL intervention consists of weekly interactions over the course of 3-months 
using a flexible approach to accommodate Veteran’s preferences and recovery needs 
over the course of the typical duration of a PRF. During weeks 1 and 2 of the intervention, 
Veterans meet twice weekly with a PS. During weeks 3 through 8, meetings are once 
weekly. During weeks 9 through 12, meetings typically occur once every other week. Over 
the course of the 3-month intervention, this approach bolsters the development of a strong 
therapeutic alliance in the beginning (weeks 1-2), followed by active teaching and 
reinforcing new skills (weeks 3-8), and then culminating with mastering new skills and 
preparing the Veteran for active self-management and sustained recovery. For a small 
number of PREVAIL participants, an additional 3 sessions were added over the span of 
the last 4 weeks to provide additional time to prepare for the end of the therapeutic 
relationship. A similar approach will be used for the current pilot. 
 
Meetings between PSs and Veterans will be approximately 45-60 minutes and occur 
primarily in the community, home, clinic, by telephone, or VA-approved video calling 
platform (e.g. VVC, WebEx). Session content will be rooted in PSs offering 
nonjudgmental empathic support, active listening, and constructive disclosure and role 
modeling. A primary focus will be helping patients with PRFs to identify and strengthen 
connections with informal supports and participation in activities in their community that 
will enable them to feel more worthwhile as individuals and hopeful about their future. 
 
The PREVAIL model uses a 4-step process as a guide to their interactions with patients 
each of the weekly meetings: (1) Invite discussion about hope- and belongingness- 
related topic; (2) Learn to find out more about what participants have already tried and 
what participants think might be helpful or relevant to their situation; (3) Share 
suggestions based on their personal experience or knowledge; and (4) Motivate “change 
talk,” including how taking action might be helpful, how they might practically go about 
implementing changes, and whether they have made a commitment to change. The 
PREVAIL model also includes having PSs “check in” midway through the 3-month 
intervention to gauge the patient’s preference for more- or less-structured conversations 
or sharing, and to remind participants they are half-way through the intervention so they 
anticipate and prepare for termination at the 3-month point. 
 
The second phase will involve pilot testing the feasibility and acceptability of the adapted 
PREVAIL, rehabilitative measures, and suicide-related outcomes for use in a rigorous 
prospective study. To mirror recommendations for adapting interventions and pilot studies 
to help prepare for larger trials,7,28 we will recruit 12 high suicide risk Veterans who will 
participate in a 3-month “pre-pilot” and provide feedback on how the 
Version 4.0 
Suicide Prevention Protocol 
Page 13 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
intervention may be improved. Pre-testing adapted materials and using retrospective 
feedback from participants are recommended steps to identifying any further changes 
prior to further implementation.7,8 After making any necessary modifications, for the third 
phase or 3-month “formal pilot”, we will recruit a second group of 12 Veterans who are 
at high suicide risk to further evaluate the feasibility and acceptability of recruitment, 
retention, and assessment procedures to be used in a future randomized trial. We will 
draw upon the support and existing resources at the VA Connecticut campuses, which 
house on the largest PSs programs. 
 
Veterans in both the pre-pilot and formal pilot will each meet with research staff for a 
Baseline Visit, Post-Intervention Visit, and a 3-Month Follow-Up Visit. All participants will 
also be invited to participate in an in-depth qualitative interview shortly after their 3- month 
follow-up assessments to assess their views of the intervention, including barriers, 
strengths, and recommended changes. All qualitative interviews will be recorded and 
transcribed. During the interviews, participants will be encouraged to avoid using names. 
If any name is recorded, it will be omitted from the written transcript (i.e., the transcript 
may read [name] in place of the actual name). Only the study team will have access to 
data collected by questionnaires, interviews, and medical record data. 
 
Risks and Risk Minimization 
Needs Assessment (Aim 1): There are no foreseeable physical or medical risks in this 
portion of the project. However, potential participants will be informed of the general 
nature of the study, what their involvement entails, the risks/benefits, and limitations to 
confidentiality prior to providing informed consent. The site PI for VA Connecticut and Co-
I will contact key staff and make arrangements for interviews.   Three Veterans will be 
identified pursuant to a HIPAA waiver, and a letter will be mailed to them inviting their 
participation. 
 
We will minimize risks to interview participants by thoroughly explaining to them that 
participation in the project is strictly voluntary and that the decision not to participate will 
have no bearing on their employment. Individual names of employment settings and 
associated responses will not be provided to any other agency. In reports, publications, 
or presentations using project research data, we will report the data in aggregate form 
and/or change names and disguise the identity of any individual we describe or quote 
for purposes of illustration or example. 
 
Pre-and Formal Pilot Testing (Aim 2): A potential risk to study participants is clinical 
deterioration of their mental health and/or an increase in suicidal thoughts or behaviors 
Version 4.0 
Suicide Prevention Protocol 
Page 14 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
related to receiving the pilot intervention. This risk is anticipated to be minimal based on 
the outcomes of a R34 pilot study and ongoing R01 conducted by Co-I (developer of the 
PREVAIL model informing this project), where suicidal ideation improved for the whole 
population from baseline to 3 months, and no adverse events were attributed to study 
participation. Additionally, a 2018 paper2 reports no iatrogenic effects from two intensive 
suicide research protocols involving Veterans. 
 
Another potential risk to study participants is loss of confidentiality related to self-report 
assessment data, medical record data, or audio recorded sessions or interviews. The risk 
of an inadvertent breach of confidentiality is minimal (see below regarding protections 
against risk). Because of the study involves reducing suicide risk, it is necessary to obtain 
detailed information about past and current suicidal thoughts, plans and behaviors. Loss 
of confidentiality may also occur in the event that the participant is assessed by a study 
clinician to be imminent risk for harm to self or others therefore requiring a breach of 
confidentiality to ensure safety of self or others (e.g., contacting a participant’s family 
member, law enforcement, or health care provider). Such a breach would only occur if 
there is no reasonably safe alternative. The informed consent process and documents 
will explain mandatory reporting requirements for information regarding intention to harm 
self or others prior to participating in the study. 
 
There is also a minimal risk of psychological discomfort to study participants from the 
questions asked in the assessments. Participants may become anxious or uncomfortable 
as a result of being asked personal questions. The study team members conducting 
assessments are trained to respond to this emotional distress and to refer the participant 
to their mental health provider or other appropriate resources as necessary. All 
participants are free to terminate the assessments at any time or refuse to respond to 
any questionnaire item. Additionally, there is a popular misperception that inquiring about 
suicidal thoughts, plans or prior behaviors could increase the likelihood that an individual 
will make a suicide attempt. Research has not found that suicide assessments increase 
the risk of suicidal behaviors and this misperception has had the unfortunate 
consequence of decreasing research on potentially suicidal individuals. However, the 
study of individuals at elevated risk for suicide does require a clear set of procedures to 
manage potential crisis situations. These are reviewed in detail in the Data Safety and 
Monitoring plan. 
 
 
Data Safety and Monitoring plan 
 
Several steps will be taken to minimize the risk of breaches of confidentiality. Unique 
identification numbers will be assigned to all participants who complete the initial 
Version 4.0 
Suicide Prevention Protocol 
Page 15 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
screening session. Chart reviews will be limited only to the data necessary for the 
research procedures (i.e., ICD codes for suicide ideation, self-harm). RAs completing the 
review will enter abstracted data directly into restricted-access databases kept behind 
the VA firewall. Data will be identified only by a unique study ID. Every effort is made to 
ensure that all study data are always confidential, in terms of staff training and data 
storage, so that data cannot be linked to a particular person. 
 
Unique identification numbers will be assigned to all participants who complete the initial 
screening sessions. Only individuals working on the actual data collection with the need 
to have access will be able to see the identifiers. Only the participant code will appear 
on the assessment forms and fidelity forms. All data forms and assessments will be coded 
with this number rather that with a name. All paper forms will be stored in locked file 
cabinets. All identified data will be behind the VA Firewall, and only current VA study staff 
will have access to this data on an as needed basis. Consent forms and participant list 
sheets will be stored separately from data, in locked cabinets because they contain 
identifying information and are linked to the participant ID. Only research team members 
will have access to the data.   The identifiers will be maintained as long as data collection 
activities are ongoing, and up to 5 years following the completion of the study. Audio-
recordings made on an approved, encrypted recorder will not include participant names 
and will be uploaded to a secure, password-protected server and deleted from the 
recording device after transcription. Transcriptions of audio-recordings used for qualitative 
analyses will be reviewed to ensure all identifiers are deleted. 
 
To minimize discomfort from study assessments or participation in the Peer Specialist 
sessions, we will train study staff in assessment and therapy techniques that are non- 
threatening, empathic, yet professional. In addition, Peer Specialists will receive training 
prior to the pre-pilot on topics such as therapeutic boundaries, self-care/compassion 
fatigue, and vicarious trauma. During weekly supervision, Peer Specialists will receive 
mutual support and ongoing assistance with a range of areas including case 
conceptualization, ensuring participant safety and self-care, and maintaining 
rapport/engagement to minimize potential therapeutic impasses. Peer Specialists will 
also be invited to share audio recorded segments from sessions to promote continued 
quality improvement. Study staff will also receive weekly supervision during the periods 
that baseline, post-intervention, and 3-month follow-up assessments are being 
completed. All study staff will be provided with specific suicide risk management protocols 
used in PREVAIL R34 in the case that a patient expresses severe distress or clinical 
deterioration (discussed below). 
 
The Site PI in cooperation with the Site PI/Co-I will be responsible for ensuring training 
and weekly supervision to all research staff working with participants with regard to 
Version 4.0 
Suicide Prevention Protocol 
Page 16 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
procedures for managing potential clinical deterioration, suicidal crisis situations, and/or 
adverse events. This training will include information regarding evaluating warning signs 
of acute suicidal ideation, planning, or intent that could occur during contact with 
participants, and means of addressing such issues. Peer specialists will inquire about 
suicidal ideation at every encounter (one visit per week) with participants, and participants 
complete self-report measures of suicidal ideation at baseline, postintervention, and 3-
month follow-up assessments conducted by RAs. In the case that a participant indicates 
any level of suicidal ideation or recent attempt during encounters with any study staff 
(including peer specialists), a suicide risk management protocol will be used. The protocol 
is based on the same approach used in the R34 and ongoing R01 evaluation of PREVAIL 
and utilizes an algorithm of scripted risk assessment questions and “action steps” 
dependent on the participant responses (See Appendices A and B for peer specialist and 
research assistant versions, respectively). Similar but separate protocols were developed 
because peer specialists will not ask as many detailed questions as research assistants. 
This approach ensures peer specialists stay out of a “risk assessment” role with the 
participants. For research assistants, they will be provided a more detailed risk 
assessment algorithm that involves an additional step for how to respond based on level 
of risk. 
 
Based on the level of risk determined by the algorithm, study staff may perform one or 
more of the following. In the presence of elevated acute suicide risk, several steps will be 
taken to ensure participant safety (See Appendices A and B). First and foremost, should 
the participant disclose suicidal plan and/or intent OR recent suicidal behavior (e.g., 
suicide attempt or preparatory behavior in the past month) then the peer specialist or 
research assistant will conduct a warm hand off to a licensed mental health provider to 
further assess and intervene as appropriate (e.g., Safety Planning, hospitalization). 
Similarly, should the participant report these factors during a research interview on a self-
report assessment (e.g., QIDS or C-SSRS), a warm hand off to a licensed mental health 
provider will be conducted. For lower, non-acute risk, steps taken by study staff include: 
a) recommend the participant call or be transferred to the Veteran Crisis Line or the VHA 
Psychiatric Emergency Services b) notify the participant’s primary Mental Health clinician 
and/or Suicide Prevention Coordinator regarding a non-imminent increase in suicide risk. 
When any suicidal ideation is reported, study staff will c) notify a designated on-call study 
team clinician when the suicide risk management algorithm has been activated, and 
when any questions arise regarding risk management. The on- call study clinician will be 
available via pager or cell phone at all times when there is potential contact between 
study staff (including peer specialists) and participants. Additionally, health and social 
service resources will be provided to the participant. This will include several resources, 
including suicide prevention resources which the participant can access. This will facilitate 
and enhance care on an ongoing basis among 
Version 4.0 
Suicide Prevention Protocol 
Page 17 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
this population. 
 
Participants will be instructed on how to contact the crisis hotlines, emergency services, 
or closest emergency department if they are experiencing a suicidal crisis. Peer specialists 
and study team members are not to further assess or manage suicide risk beyond the 
established protocol. Participants will be instructed to contact their clinicians or the Suicide 
Prevention Coordinator All outgoing voicemail messages on VA Connecticut phone lines 
are mandated to include instructions on how to contact crisis services. Due to policies 
associated with COVID-19, most meetings between peer specialists and participants will 
occur onsite at VA facilities in person or via VA Video Connect or WebEx during business 
hours. On the off chance of that meetings occur outside of regular business hours; clinician 
back up will be prearranged. Written safety procedures for conducting community-based 
meetings include use of public locations, during daylight hours, and mandatory call-in 
procedures. In our prior research, using such procedures with similar populations, no 
incidents where staff safety concerns became an issue occurred during follow-up 
assessments. All safety concerns will be reported immediately to the PI. 
 
Fidelity to the PREVAIL model will be evaluated by ‘blinded’ raters independent of the 
research team after participants complete their post-intervention assessment interview. A 
20% random sample of audio recorded sessions will be assessed in terms of adherence 
to PREVAIL principles (i.e., interactions that follow the format of Invite, Share, Learn, 
Motivate) and assessment of suicidal ideation as well as demonstration of general support 
skills. 
 
Benefits 
It is believed that research participants may be helped in a number of ways. Participants 
who take part in the peer specialist pilot may benefit from an improved sense of hope and 
belongingness as the intervention establishes a supportive relationship and helps restore 
community involvement. The peer specialists are trained and supervised to handle 
potential distress caused by participating in the intervention. The peer specialists will have 
immediate “on call” access to a supervising mental health clinician at all times they are 
meeting with a pilot participant. The pilot intervention is an adjunct to standard care VHA 
treatment, including assessments, admissions, and referrals if deemed appropriate by 
the clinical staff. The potential benefits for the research are expected to outweigh the risks 
to participants. 
 
Importance of Knowledge to be Gained 
Veterans account for approximately 8% of the U.S. adult population yet account for 
roughly 14% of deaths by suicide. In fact, the age-adjusted suicide rate in 2015 for VHA 
Version 4.0 
Suicide Prevention Protocol 
Page 18 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
Veterans was higher than both non-VHA using Veterans and non-Veterans. Preventing 
suicide is a top priority at the VA and new approaches to suicide prevention are critically 
needed as the VHA suicide rate has not reduced despite multiple VHA initiatives put 
into place over 10 years ago. Randomized controlled trials have shown that peer 
specialists are effective in improving symptoms of depression, reducing the likelihood of 
psychiatric hospital readmission, increasing hopefulness, and improving quality of life. 
However, the data are scant on the effectiveness of these approaches in suicide 
prevention. Developing an effective intervention for preventing suicidal behaviors would 
represent a major advancement given the few existing effective VHA interventions to 
date. This study will add to the knowledge base in this critical area. Given the potential 
for this study to improve the quality of life for patients with varying levels of access to 
evidence-based mental health services, the potential benefits outweigh the risks outlined 
above. 
 
5.2 Recruitment Methods 
 
Recruitment-Aim 1 
We will recruit a diverse group of 12 individuals for the Needs Assessment phase of the 
project to inform the adaptation of PREVAIL. This group will be comprised of Veterans 
(3), Peer Specialists (3), Providers from behavioral health, inpatient and outpatient 
psychiatry, and other relevant departments (4), and Clinical Directors (2). 
 
We will obtain a waiver of HIPAA authorization to identify Veterans to participate in the 
Needs Assessment. Once these Veterans are identified, they will be mailed a letter 
informing them about and requesting their participation in the Needs Assessment 
interviews. A member of the study team will follow-up with a telephone call approximately 
one week after the letter is the sent. The team members will attempt to reach the Veterans 
by phone 3 times and will leave no more than two messages. Providers, clinical directors, 
and Peer Specialists will either be sent an email or will be verbally invited in person to 
participate in the Needs Assessment. 
 
Recruitment for the Steering Committee 
The Steering Committee will be comprised of researchers and VHA leadership.   The site 
PI will identify appropriate VA staff and other providers and will contact them by phone or 
email. 
 
Recruitment-Aim 2 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 19 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
We will recruit 4-6 Peer Specialists who are currently working in VA Connecticut 
Healthcare System (VACT) to receive training in the PREVAIL model and to deliver the 
intervention for the pre- and formal pilot. All of the selected Peer Specialists have been 
trained and certified, with multiple years of clinical experience working with Veterans in 
recovery, including those who have been at some point ‘flagged’ for suicide risk. 
 
We will include a sample of up to 24 VHA patients identified as being high-risk for suicide 
at the VA Connecticut Healthcare System (VACT) to receive the pilot intervention as an 
adjunct to usual care. Patients will be considered high suicide risk if they have a Patient 
Record Flag (PRF) in their medical chart for a recent suicide attempt, serious suicidal 
ideation, or other warning signs of acute suicide risk. The VACT Suicide Prevention 
Coordinator maintains a list of patients with active PRFs. This population is targeted 
because they are at greatest risk for suicide and therefore most in need of intervention. 
 
In addition to reaching out to Veterans on the high-risk list, we also will engage Veterans 
via the New Haven VA psychiatric Emergency Room, inpatient units, and individual New 
Haven clinicians. Specifically, we will engage with staff to find out if any Veteran has 
received a score on the Columbia-Suicide Severity Rating Scale Screen of 3 or greater in 
the last three months. This measure is used commonly in the VA. Such a score is known 
to be an optimal cut off score for identifying individuals who would likely attempt suicide. 
In a recent study of nearly 19000 patients, those scoring over the cut-off of ⩾3 had almost 
four times the odds of dying by suicide within 1 week and 1 month, respectively, and 
doubled the odds of dying within a year90. We will also engage with individual clinicians to 
assess whether any of their patients have recently received a score of ⩾3 on the 
Columbia measures. In addition, we will ask these staff about any Veteran who made a 
suicide attempt in the last three months. Thus, the additional recruitment criteria we are 
adding will be: 
• Any Veteran from the New Haven VA psychiatric Emergency Room, the New Haven 
inpatient units, or from individual New Haven clinicians who received a score on the 
Columbia-Suicide Severity Rating Scale Screen of 3 or greater in the last three 
months 
• Any Veteran from the New Haven VA psychiatric Emergency Room, the New Haven 
inpatient units, or from individual New Haven clinicians who made a suicide attempt 
within the last three months 
 
Each month, there are approximately 105 VHA patients with PRFs for suicide risk at the 
CT VA campuses. In addition to those Veterans with a PRF, we also will be 
recruiting those Veterans with suicidal ideation or attempts.  This pool of 
Veterans should be sufficient  to recruit participants for the pre-pilot (n=12) and formal 
pilot (n=12). Assuming a 75% retention rate (as achieved in Dr. Pfeiffer’s PREVAIL pilot)15 
this will yield a final sample of 18 patients with outcome data at post-intervention and 3-
month follow-up. This sample size will yield reasonably precise estimates of feasibility in 
terms of actual rates of recruitment, retention, compliance/fidelity to intervention, and 
completion of outcome assessments. 
 
Once eligible Veterans are identified, they will be mailed a letter along with a study 
information sheet, inviting them to participate in Aim 2 of study. A member of the study 
team will follow-up with a telephone call approximately one week after the letter is the 
sent if they do not hear back from the Veterans. The team members will attempt to reach 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
the Veterans by phone 3 times and will leave no more than two messages. 
 
Additionally, the site PI will work with providers of eligible Veterans seeking their help in 
recruiting these Veterans into the study and will also provide them with a study 
information sheet. Once the provider identifies an eligible Veteran, they will discuss the 
study with the Veteran and if the Veteran is interested in hearing more about the study, 
the provider will call the study staff with the Veteran present or will share the number of 
the study staff with the Veteran so that they may call the study staff at their own 
convenience. In the event that the provider facilitates the phone call with study staff, the 
provider will step out of the room to give the Veteran a chance to learn more about the 
study. for this to occur. If a provider or research staff cannot reach the Veteran by phone, 
they will follow-up with a CIRB-approved letter as described above. 
Version 4.0 
Suicide Prevention Protocol 
Page 20 of 36 
Payments 
Veterans who participate in the Needs Assessment interview will receive $25 for their 
time and effort. Study participants will receive $25 upon completion of each assessment 
interview (baseline, post-intervention, 3-month follow-up), for a total of up to $75. 
Additionally, Veterans who participate in the one-time interview will receive $25 for their 
time and effort. 
 
5.3 Informed Consent Procedures 
 
Veterans 
 
Needs Assessment 
Pursuant to a Waiver of HIPAA Authorization, the site PI will identify three Veterans 
appropriate for the Needs Assessment in discussion with clinical providers. Selected 
Veterans will be mailed a letter describing the participation and requesting that the 
Veteran respond about their interest by calling the number provided or mailing back the 
return letter in the stamped envelope provided. If the Veteran is interested in participating 
in the Needs Assessment, a member of the research team will arrange a time to discuss 
the study with them and obtain their written consent. The member of research team will 
then conduct the Needs Assessment interview following written consent or will schedule 
a mutually agreed upon time to conduct the interview. 
 
 
Pre-Pilot and Formal Pilot 
 
A face-to-face meeting (interview and/or focus groups) will be held with Peer Specialists 
who have been selected to participate in the proposed study. Research staff will obtain 
verbal consent, including the permission to obtain audio-recordings of interviews and/or 
focus groups conducted after they have completed training in the PREVAIL approach as 
well as after the pre-pilot to inform potential modifications to the intervention. 
 
A face-to-face meeting will be held for Veterans who have been selected to participate 
in the pre-pilot and formal-pilot phases of the study. Research staff will administer written 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
informed consent (or Veteran assent along with consent of a conservator if applicable) 
and HIPAA authorization, including the permission to obtain audio- recordings, at the 
baseline visit. The ICF, HIPAA and other study materials will be submitted and approved 
by the CIRB prior to the start of any recruitment for the pre-pilot or pilot. 
 
VA Staff 
 
Needs Assessment Staff Interviews 
Pursuant to a waiver of documentation of ICF for staff who are going to be interviewed 
for the Needs Assessment, a member of the research staff will read through the ICF for 
staff over phone, obtain verbal consent from the staff member, and record the name of 
the staff member and date of consent for tracking purposes. 
 
Peer Specialist Interviews and/or Focus Groups 
Pursuant to a waiver of documentation of ICF for Peer Specialists who are going 
to be interviewed via a 1:1 interview and/or focus group following their participation 
in the PREVAIL training as well as after the pre-pilot, a member of the research 
staff will read through the ICF for staff over phone or via MS Teams, obtain verbal 
consent from the staff member, and record the name of the staff member and date 
of consent for tracking purposes. 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion Criteria for Aim 1 Veterans 
1. Experience related to suicide 
2. Voluntary informed consent (must be able to be given by the 
patient) 
3. Age 18 and older 
4. Fluent in English 
 
Exclusion Criteria for Aim 1 Veterans 
1. Active suicidal flag or currently hospitalized 
2. Pregnant and/or incarcerated 
3. Unable to provide voluntary, written informed consent for any 
reason (include incompetency) 
 
Inclusion Criteria for Aim 1 Staff 
1. Voluntary informed consent 
2. Age 18 and older 
Version 4.0 
Suicide Prevention Protocol 
Page 22 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
3. Peer Specialists with experience related to suicide (Peer 
Specialists only) 
4. Staff members with experience related to treating Veterans with 
experience related to suicide (Staff members only) 
5. Fluent in English 
 
Exclusion Criteria for Aim 1 Staff 
1. Unable to provide voluntary, written informed consent for any 
reason 
Inclusion Criteria for Aim 2 Veterans 
1. Voluntary informed consent (must be able to be given by the 
patient) or voluntary informed assent with consent of a conservator 
if applicable 
2. Age 18 and older 
3. High suicide risk evidenced by a Patient Record Flag in their 
medical chart. 
4. Fluent in English 
 
Exclusion Criteria for Aim 2 Veterans 
1. Substantially cognitively impaired as indicated by a score of 10 or 
higher on the Blessed Orientation, Memory, Concentration (BOMC) 
Test 
2. Unable to provide voluntary, written informed consent for any 
reason (include incompetency) 
3. Determined by patient’s attending psychiatrist that the peer-based 
intervention is not appropriate due to unstable psychosis, cognitive 
disorder, or severe personality disorder 
4. Residing outside of the VA Connecticut catchment area 
5. Pregnant and/or incarcerated 
 
Inclusion Criteria for Aim 2 Peer Specialists 
1. Voluntary informed consent 
2. Age 18 and older 
3. Employed by the VA as a Certified Peer Specialist 
 
Exclusion Criteria for Aim 2 Peer Specialists 
1. Unable to provide voluntary, verbal consent for any reason 
 
Version 4.0 
Suicide Prevention Protocol 
Page 23 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
2. Determined by Peer Specialists’ supervisor, attending 
psychiatrist, or other clinician that delivering the intervention 
is not appropriate due to prior trauma, clinical instability, or 
current concerns with suicide risk 
 
 
 
5.5 Study Evaluations 
 
Measures 
The measures used to collect data for Aims 1 and 2 include data from the CPRS record 
as well as several rehabilitation and depression & suicide variables described in further 
detail below. Additionally, a study-specific form will be used to collect information about 
age, sex, race, ethnicity, employment, education, income, and marital status. 
 
Rehabilitation Variables 
Sheehan Disability Scale (SDS)64. The SDS uses 3 items to measure how much work, 
social life, and family life are impaired by mental health symptoms. The SDS has been 
widely used in diverse samples,65-67 including Veterans,68,69 and found to be 
psychometrically sound and sensitive to treatment effects. 
 
Temple University Community Participation scale (TUCP)71. The TUCP is a 26-item 
measure of community inclusion in the past month. The TUCP has been used in 
previous studies with good reliability.71-74 
Questionnaire about the Process of Recovery (QPR)75. The QPR contains 15 items 
that measure connectedness, hope, identity, meaning, and empowerment. The QPR has 
demonstrated high internal and convergent validity as well as sensitivity to change.76,77 
 
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). The Q- 
LES-Q-SF consists of 16 items to assess life satisfaction in the past week. The Q-LES- 
Q-SF has been used extensively with Veterans as part of the National Health and 
Resilience in Veterans Study (NHRVS). 
 
Depression and Suicide Variables 
 
Version 4.0 
Suicide Prevention Protocol 
Page 24 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
Quick Inventory of Depressive Symptoms (QIDS)79. The QIDS consists of 16 
questions to assess depression severity. The QIDS has demonstrated high reliability, 
validity, and sensitivity to treatment change,80, including among Veterans.81 
Columbia-Suicide Severity Rating Scale (C-SSRS)82. The C-SSRS is used to assess 
suicidal ideation (past 30 days) and behaviors (past 3 months). Suicide ideation items 
include: (1) wish to be dead, (2) non-specific suicidal thoughts, (3) suicidal thoughts with 
methods, (4) suicidal intent, and (5) suicidal intent with plan. The suicide behavior 
subscales include: (1) attempts (actual, aborted, interrupted), (2) preparatory behavior, 
and (3) non-suicidal self-injurious behavior. We will also use two measures of 
psychosocial variables that potentially mediate suicide risk and are hypothesized to be 
impacted by PSs. 
 
Interpersonal Needs Questionnaire (INQ)83. The INQ uses 15 items to measure two 
underlying motives for suicidal desire (i.e., perceive burden and thwarted belonging). The 
INQ has established validity and reliability,84 including on Veterans.85 
Suicide Cognitions Scale (SCS)86.   The SCS contains 18 items that assess thoughts 
of unloveability, unsolvability, and unbearability. The SCS has strong psychometric 
qualities in diverse samples (including Veterans) with incremental validity to predicting 
suicidal behavior beyond depression, INQ scores, prior attempts, and suicidal 
ideation.87,88 
 
5.6 Data Analysis 
 
Per SPiRE protocol and discussions with an RR&D Scientific Program Manager, 
calculations for power and estimated effect size are not required because our proposal 
involves piloting a rehabilitation intervention with a small, high risk sample of VHA patients 
(as opposed to determining effectiveness in large samples via inferential statistical 
hypothesis testing). 
 
Aim 1 
Qualitative analyses of interviews from the needs assessment will be conducted with 
empirical phenomenological procedures used successfully by our team in previous 
studies.57 Verbatim transcripts of audio recordings from the interviews will be distributed 
to the Co-Investigators. Each researcher will independently review, analyze, and code 
the transcripts for themes that characterize participants’ experiences. After creating a 
narrative summary using the participants’ own language, they will review each of their 
summaries to compare/contrast the identified themes before coming to consensus about 
important themes. A synthesized report will summarize the overarching themes. 
 
Version 4.0 
Suicide Prevention Protocol 
Page 25 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
Aim 2 
WOC employees from the Program for Recovery and Community Health (PRCH) will 
conduct the data analysis for this aim. In line with SPiRE guidelines and 
recommendations for pilot studies,28,89 our focus will be on the feasibility of the 
intervention and assessment of outcomes. Therefore, quantitative analysis will be mostly 
descriptive in nature (e.g., frequencies, percentages, means, standard deviations) and 
will focus on the estimation of confidence intervals. This includes descriptive statistics on 
each of the measures at each assessment period, creation of confidence-intervals, and 
visual plotting of data to observe potential trends in the data associated with the 
intervention. Formal hypothesis testing will not be conducted as comparisons of outcomes 
would be unreliable estimates of any true effect given the small sample size. Instead, 
analyses will be used to evaluate the feasibility of measuring the primary outcomes and 
potential mediators as well as to inform decisions about power and sample sizes in a 
larger trial. Qualitative analyses of post-intervention interviews with Veterans will follow 
the same procedures as described for Aim #1. Qualitative analysis of interviews and/or 
focus groups with Peers Specialists conducted after completing the PREVAIL training 
and the pre-pilot of the intervention will also follow the same procedures as described in 
Aim #1. 
 
 
 
 
 
5.7 Withdrawal of Subjects 
 
As discussed in Section 5.1 of the protocol, the risk of clinical deterioration of mental 
health and/or an increase in suicidal thoughts or behaviors related to receiving the pilot 
intervention is anticipated to be minimal, therefore we believe that few participants will 
need to be terminated. Participants who are hospitalized during the project will not be 
withdrawn, but the intervention will continue, either during their stay if medically 
appropriate, or following their discharge. 
 
If study staff becomes aware of Veterans who are incarcerated and/or become pregnant 
during the study period, the Veteran will be withdrawn from the study. Other potential 
reasons for withdrawal include if a participant relocates out of state or misses the first four 
scheduled sessions. Any participant may withdraw from the study at any time, as stated 
in the ICF. If a participant calls the research staff to withdraw, the staff member 
Version 4.0 
Suicide Prevention Protocol 
Page 26 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
will thank the Veteran for their participation and ask whether the Veteran would like to 
schedule a behavioral health appointment related to their study participation or decision 
to withdraw. A note will be added to the Veteran’s medical record indicating their decision 
to withdraw, and the behavioral health provider of record will be informed. 
 
 
6.0 
Reporting 
 
Principal Investigators (PI), Co-investigators (Co-I), and all other study staff will monitor 
for adverse events (AE) and protocol deviations, and staff will notify the PI immediately 
of any AE or protocol deviation. CIRB guidelines will be strictly adhered to. The study staff 
member and PI will discuss the event in its entirety: (e.g. what happened, what caused it, 
if it was expected or unexpected, any ways to resolve or correct the issue, etc. The PI 
or project manager will file a report of all SAEs and protocol deviations with the Central 
Institutional Review Board (CIRB), and a copy of the report is kept on file in the project 
binder. When participants are consented into the study, they will be notified that they may 
leave the study at any time without repercussions to their regular care from the VA. In the 
event that a Veteran is incarcerated during the study they will be formally removed from 
the study and study staff will immediately notify the Central IRB (CIRB) of this event. 
 
The Principal Investigator or site PI will be responsible for contacting the CIRB within 5 
working days about any serious unanticipated adverse events or unanticipated problems 
involving risks to participants or others and completing any reports applicable. As 
necessary, either the PI or Site PI will submit Form 119 (CIRB Report of Unanticipated 
Serious Adverse Events and Unanticipated Problems) to the CIRB, and submit a copy to 
the other site, thus assuring that all parts of the study are well informed about any events 
or problems. 
 
They will also provide a summary report about adverse events and unanticipated 
problems that did not require immediate reporting to the CIRB at the continuing reviews 
and at study closure. The VA Central IRB table of reporting requirements time frames will 
be used in all cases. 
 
Due to the pilot nature of this study and small sample size, this study will not have a Data 
Monitoring Committee. 
 
Version 4.0 
Suicide Prevention Protocol 
Page 27 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
7.0 
Privacy and Confidentiality 
 
Study related questionnaires will be identified with unique ID numbers for each participant 
and will be collected in paper format. After the written informed consent process (Aims 1 
and 2) and the survey measures have been completed, the study documents will be kept 
in a locked file cabinet, within the locked office, within a locked building, of the study staff. 
Coded interview data will be manually entered by research staff into a database that will 
be stored on a VA server located behind the secure firewall. Windows integrated security 
will be used for all computer access. At the VA, all PCs, laptops, workstations, and remote 
devices are set to lock and are secured after being left unattended for 5 minutes or more, 
or by logging-off when the equipment will be unattended for an extended period. User 
and role permissions will be defined at the computer, file, directory server and database 
level to ensure data security. Source documents with private information (e.g., consent 
document, payment form, etc.) will be stored in a locked file cabinet, within the locked 
office, within a locked building, of the research staff. Research records may be released 
or disclosed if required by federal law. Study participants will not be specifically identified 
in any publication of research results. Records will be kept according to current VA 
regulations. 
 
All local policies will be adhered to for information security purposes. All identified data 
will be behind the VA Firewall, and only current VA study staff will have access to this 
data on an as needed basis. Research staff who leave the study will be removed from 
the study staff via the Study Staff Form and their access to the study drives and/or 
documents will also be terminated. If there is an improper use or disclosure of study data, 
we will notify the ISO and Privacy Officer immediately of said occurrence. 
 
All research records will be maintained in accordance with the Veterans Health 
Administration (VHA) Records Control Schedule. Paper records will be disposed of using 
methods deemed appropriate by the VAPHS Privacy Officer, and all electronic data will 
be sanitized using methods rendered appropriate by the VAPHS ISO.  
 
 
7.1 Communication Plan 
 
The Principal Investigator ultimately will be responsible for monitoring the data and safety 
with involvement from all of the study investigators. They will ensure that all relevant CIRB 
policies, procedures and stipulations are being followed. They also will be responsible for 
ensuring that other investigators and project staff adhere to the VA CIRB policies 
including: (1) all participants will understand, agree to and sign a written consent form 
before participating; (2) strict adherence to a participant’s right to withdraw or refuse to 
answer questions will be maintained; (3) the assessments will be 
Version 4.0 
Suicide Prevention Protocol 
Page 28 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
completely confidential and no names will be associated with the assessment data; (4) 
consent forms and identifying information will be kept separate from the actual participant 
data; (5) all identifying information (consents, tracking data) will be kept locked at all times 
and computer files will be saved with passwords; (6) participants will be informed in writing 
in the consent form how to contact the PI, the study coordinator, and VA CIRB office with 
any questions and/or concerns. 
 
The PI will directly supervise the data manager and the project coordinator and will be 
responsible for monitoring confidentiality procedures. Quality control and reliability of 
screening, baseline and follow-up assessments will be monitored by Dr. Chinman 
throughout the trial via regular meetings and observation of the project coordinator 
conducting standardized assessments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 29 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
8.0 
References 
 
1 
Ehde, D. M. et al. Developing, testing, and sustaining rehabilitation interventions 
via participatory action research. Arch. Phys. Med. Rehabil. 94, S30-S42 (2013). 
2 
Affairs., U. S. D. o. V. National Strategy for Preventing Veteran Suicide: 2018- 
2028., (Office of Mental Health and Suicide Prevention, 2018). 
3 
Walker, G. & Bryant, W. Peer support in adult mental health services: A 
metasynthesis of qualitative findings. Psychiatric Rehabilitation Journal 36, 28-34 
(2013). 
4 
Vandewalle, J. et al. Peer workers’ perceptions and experiences of barriers to 
implementation of peer worker roles in mental health services: A literature review. 
Int. J. Nurs. Stud. 60, 234-250 (2016). 
5 
Chinman, M. et al. Peer support services for individuals with serious mental 
illnesses: assessing the evidence. Psychiatr. Serv. 65, 429-441 (2014). 
6 
Fuhr, D. C. et al. Effectiveness of peer-delivered interventions for severe mental 
illness and depression on clinical and psychosocial outcomes: A systematic review 
and meta-analysis. Soc. Psychiatry Psychiatr. Epidemiol. 49, 1691-1702 (2014). 
7 
Levati, S. et al. Optimisation of complex health interventions prior to a randomised 
controlled trial: a scoping review of strategies used. Pilot and Feasibility Studies 2, 
17, doi:10.1186/s40814-016-0058-y (2016). 
8 
Highfield, L., Hartman, M., Mullen, P. & Leerlooijer, J. in Planning health promotion 
programs: an intervention mapping approach. San Franscisco: John Wiley & Sons 
Ch. 10, 596-649 (2016). 
9 
Chinman, M. et al. Early experiences of employing consumer-providers in the VA. 
Psychiatr. Serv. 59, 1315-1321 (2008). 
10 
Becker, D. R. Hiring Peers as Vocational Specialists. Psychiatr. Serv. 66, 337-337 
(2015). 
11 
Lloyd-Evans, B. et al. A systematic review and meta-analysis of randomised 
controlled trials of peer support for people with severe mental illness. BMC 
Psychiatry 14, 39 (2014). 
12 
Gassaway, J. et al. Effects of peer mentoring on self-efficacy and hospital 
readmission following inpatient rehabilitation of individuals with spinal cord injury: a 
randomized controlled trial. Arch. Phys. Med. Rehabil. (2017). 
13 
Jones, M. & Gassaway, J. Peer-supported self-management to facilitate community 
re-entry after discharge from spinal cord injury rehabilitation: Engaging peers as 
change agents and research partners. Ann. Phys. Rehabil. Med. 59, e128-e129 
(2016). 
14 
Pfeiffer, P. N., Heisler, M., Piette, J. D., Rogers, M. A. & Valenstein, M. Efficacy of 
peer support interventions for depression: a meta-analysis. Gen. Hosp. Psychiatry 
33, 29-36 (2011). 
Version 4.0 
Suicide Prevention Protocol 
Page 30 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
15 
Pfeiffer, P. N. et al. Development and pilot study of a suicide prevention 
intervention delivered by peer support specialists. Psychol. Serv., 
doi:10.1037/ser0000257 (2018. doi:10.1037/ser0000257). 
16 
Bartholomew, L. K., Parcel, G. S. & Kok, G. Intervention Mapping: A Process for 
Developing Theory and Evidence-Based Health Education Programs. Health Educ. 
Behav. 25, 545-563, doi:10.1177/109019819802500502 (1998). 
17 
Hesselink, G. et al. Improving patient discharge and reducing hospital readmissions 
by using Intervention Mapping. BMC Health Serv. Res. 14, 389 (2014). 
18 
Désiron, H. A., Crutzen, R., Godderis, L., Van Hoof, E. & de Rijk, A. Bridging health 
care and the workplace: formulation of a return-to-work intervention for breast 
cancer patients using an intervention mapping approach. Journal of occupational 
rehabilitation 26, 350-365 (2016). 
19 
Kirchner, J. et al. Using a multi-level approach to implement a primary care mental 
health (PCMH) program. Families, Systems, & Health 28, 161 (2010). 
20 
Hamilton, A. B. et al. Engaging multilevel stakeholders in an implementation trial of 
evidence-based quality improvement in VA women's health primary care. Transl. 
Behav. Med. 7, 478-485 (2017). 
21 
Hamilton, A. B., Chinman, M., Cohen, A. N., Oberman, R. S. & Young, A. S. 
Implementation of consumer providers into mental health intensive case 
management teams. The journal of behavioral health services & research 42, 100- 
108 (2015). 
22 
Chinman, M. et al. Early experiences of employing consumer-providers in the VA. 
Psychiatr. Serv. 59, 1315-1321 (2008). 
23 
Chinman, M., Young, A. S., Hassell, J. & Davidson, L. Toward the implementation 
of mental health consumer provider services. The Journal of Behavioral Health 
Services & Research 33, 176 (2006). 
24 
Davidson, L., Bellamy, C., Flanagan, E., Guy, K. & O'Connell, M. A participatory 
approach to person- centred research: maximising opportunities for recovery. 
Person-Centred Healthcare Research. West Sussex: WILEY Blackwell, 69-83 
(2017) 
25 
Pfeiffer, P. N. et al. Predictors of suicidal ideation among depressed veterans and 
the interpersonal theory of suicide. J. Affect. Disord. 152, 277-281 (2014). 
26 
Pfeiffer, P. N., Kim, H. M., Ganoczy, D., Zivin, K. & Valenstein, M. Treatment‐ 
Resistant Depression and Risk of Suicide. Suicide Life Threat. Behav. 43, 356-365 
(2013). 
27 
Schmutte, T., Olfson, M., Xie, M. & Marcus, S. C. Deliberate self-harm in older 
adults: A national analysis of U.S. emergency department visits and follow-up care. 
Int. J. Geriatr. Psychiatry (In press). 
28 
Moore, C. G., Carter, R. E., Nietert, P. J. & Stewart, P. W. Recommendations for 
planning pilot studies in clinical and translational research. Clin. Transl. Sci. 4, 332- 
337 (2011). 
29 
US Dept. of Veterans Affairs. (2018). VA National Suicide Data Report: 
2005–2015. Available at 
Version 4.0 
Suicide Prevention Protocol 
Page 31 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
https://www.mentalhealth.va.gov/suicide_prevention/Suicide-Prevention- 
Data.asp. 
30 
Dobscha, S. K. et al. Correlates of suicide among veterans treated in primary care: 
Case–control study of a nationally representative sample. J. Gen. Intern. Med. 29, 
853-860 (2014). 
31 
Blosnich, J. R., Gordon, A. J. & Bossarte, R. M. Suicidal ideation and mental 
distress among adults with military service history: results from 5 US states, 2010. 
Am. J. Public Health 104, S595-S602 (2014). 
32 
Ashrafioun, L., Pigeon, W. R., Conner, K. R., Leong, S. H. & Oslin, D. W. 
Prevalence and correlates of suicidal ideation and suicide attempts among 
veterans in primary care referred for a mental health evaluation. J. Affect. Disord. 
189, 344-350, doi:https://doi.org/10.1016/j.jad.2015.09.014 (2016). 
33 
McClure, J. R. et al. Prevalence of suicidal ideation and other suicide warning signs 
in veterans attending an urgent care psychiatric clinic. Compr. Psychiatry 60, 149- 
155, doi:https://doi.org/10.1016/j.comppsych.2014.09.010 (2015). 
34 
Hubers, A. et al. Suicidal ideation and subsequent completed suicide in both 
psychiatric and non- psychiatric populations: a meta-analysis. Epidemiology and 
psychiatric sciences 27, 186-198 (2018). 
35 
Franklin, J. C. et al. Risk factors for suicidal thoughts and behaviors: A meta- 
analysis of 50 years of research. Psychol. Bull. 143, 187-232 (2016). 
36 
Department of Veterans Affairs, Veterans Health Administration (2008). VHA 
DIRECTIVE 2008-036: Use of Patient Record Flags to Identify Patients at High 
Risk for Suicide. 
37 
Department of Veterans Affairs/Department of Defense. Clinical Practice Guideline 
for Assessment and Management of Patients At Risk for Suicide. June 2013. 
38 
Department of Veterans Affairs Office of the Inspector General (2017). Evaluation 
of Suicide Prevention Programs in Veterans Health Administration Facilities. Report 
No. 16-03808-215. Washington, DC. 
39 
Stratford, A. C. et al. The growth of peer support: an international charter. Journal 
of Mental Health, 1-6 (2017). 
40 
Cabassa, L. J., Camacho, D., Vélez-Grau, C. M. & Stefancic, A. Peer-based health 
interventions for people with serious mental illness: a systematic literature review. 
J. Psychiatr. Res. 84, 80-89 (2017). 
41 
Hanks, R. A., Rapport, L. J., Wertheimer, J. & Koviak, C. Randomized controlled 
trial of peer mentoring for individuals with traumatic brain injury and their significant 
others. Arch. Phys. Med. Rehabil. 93, 1297-1304 (2012). 
42 
Pietrzak, R. H., Pitts, B. L., Harpaz‐Rotem, I., Southwick, S. M. & Whealin, J. M. 
Factors protecting against the development of suicidal ideation in military veterans. 
World Psychiatry 16, 326-327 (2017). 
43 
Ganzini, L. et al. Trust is the basis for effective suicide risk screening and 
assessment in veterans. J. Gen. Intern. Med. 28, 1215-1221 (2013). 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 32 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
44 
Garba, R. M. & Gadanya, M. A. The role of intervention mapping in designing 
disease prevention interventions: A systematic review of the literature. PLoS One 
12, e0174438 (2017). 
45 
Wolk, C. B. et al. Developing implementation strategies for firearm safety promotion 
in paediatric primary care for suicide prevention in two large US health systems: a 
study protocol for a mixed- methods implementation study. BMJ open 7, e014407 
(2017). 
46 
Chinman, M. et al. Provision of peer specialist services in VA patient aligned care 
teams: protocol for testing a cluster randomized implementation trial. 
Implementation Science: IS 12, 57, doi:10.1186/s13012-017-0587-7 (2017). 
47 
Chinman, M. et al. A cluster randomized trial of adding peer specialists to intensive 
case management teams in the Veterans Health Administration. The journal of 
behavioral health services & research 42, 109-121 (2015). 
48 
Chinman, M., Shoai, R. & Cohen, A. Using organizational change strategies to 
guide peer support technician implementation in the Veterans Administration. 
Psychiatric rehabilitation journal 33, 269 (2010). 
49 
Chinman, M. et al. (Am Psychiatric Assoc, 2017). 
50 
Tanaka, K. & Davidson, L. The Challenge of Social Inclusion: A Basis for Enclave 
Community Approaches. Journal of Psychosocial Rehabilitation and Mental Health 
4, 189-204, doi:10.1007/s40737-017-0100-2 (2017). 
51 
Davidson, L. et al. Enabling or engaging? the role of recovery support services in 
addiction recovery. Alcoholism Treatment Quarterly 28, 391-416 (2010). 
52 
O'Connell, M. J. et al. Outcomes of a Peer Mentor Intervention for Persons With 
Recurrent Psychiatric Hospitalization. Psychiatr. Serv., appi. ps. 201600478 
(2018). 
53 
Rowe, M. et al. A peer-support, group intervention to reduce substance use and 
criminality among persons with severe mental illness. Psychiatr. Serv. 58, 955-961, 
doi:10.1176/ps.2007.58.7.955 (2007). 
54 
Sells, D., Black, R., Davidson, L. & Rowe, M. Beyond generic support: incidence 
and impact of invalidation in peer services for clients with severe mental illness. 
Psychiatr. Serv. (2015). 
55 
Chinman, M., McCarthy, S., Hannah, G., Byrne, T. H. & Smelson, D. A. Using 
Getting To Outcomes to facilitate the use of an evidence-based practice in VA 
homeless programs: a cluster-randomized trial of an implementation support 
strategy. Implementation Science 12, 34 (2017). 
56 
Smelson, D. A. et al. A cluster randomized Hybrid Type III trial testing an 
implementation support strategy to facilitate the use of an evidence-based practice 
in VA homeless programs. Implementation Science 10, 79 (2015). 
57 
Davidson, L., Wieland, M., Flanagan, E. & Sells, D. Using qualitative methods in 
clinical research. Handbook of research methods in abnormal and clinical 
psychology, 253-270 (2008). 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 33 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
58 
La Bash, H., Galovski, T. & Stirman, S. W. Adapting Evidence-Based 
Psychotherapies While Maintaining Fidelity. Current Treatment Options in 
Psychiatry, 1-12. 
59 
Wiltsey Stirman, S., Gamarra, J. M., Bartlett, B. A., Calloway, A. & Gutner, C. A. 
Empirical examinations of modifications and adaptations to evidence‐based 
psychotherapies: Methodologies, impact, and future directions. Clinical 
Psychology: Science and Practice 24, 396-420 (2017). 
60 
Katzman, R. et al. Validation of a short Orientation-Memory-Concentration Test of 
cognitive impairment. The American journal of psychiatry (1983). 
61 
Stiles, P. G., Poythress, N. G., Hall, A., Falkenbach, D. & Williams, R. Improving 
understanding of research consent disclosures among persons with mental illness. 
Psychiatr. Serv. 52, 780-785 (2001). 
62 
National Institute of Mental Health. (January, 2015). Notice Announcing Data 
Harmonization for NIMH Human Subjects Research via the PhenX Toolkit. 
Accessible at: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-15-009.html. 
63 
Glenn, C. R., Cha, C. B., Kleiman, E. M. & Nock, M. K. Understanding Suicide Risk 
Within the Research Domain Criteria (RDoC) Framework: Insights, Challenges, 
and Future Research Considerations. Clinical Psychological Science 5, 568-592 
(2017). 
64 
Sheehan, D., Harnett-Sheehan, K. & Raj, B. The measurement of disability. Int. 
Clin. Psychopharmacol., 89-95 (1996). 
65 
González-Blanch, C. et al. Domain-specific associations between disability and 
depression, anxiety, and somatization in primary care patients. Psychiatry Res. 
269, 596-601 (2018). 
66 
Mollayeva, T. et al. The relationship between insomnia and disability in workers 
with mild traumatic brain injury/concussion: Insomnia and disability in chronic mild 
traumatic brain injury. Sleep Med. 20, 157-166 (2016). 
67 
Sheehan, D. V., Harnett-Sheehan, K., Spann, M. E., Thompson, H. F. & Prakash, 
A. Assessing remission in major depressive disorder and generalized anxiety 
disorder clinical trials with the discan metric of the Sheehan disability scale. Int. 
Clin. Psychopharmacol. 26, 75-83 (2011). 
68 
Lang, A. J. et al. Randomized controlled trial of acceptance and commitment 
therapy for distress and impairment in OEF/OIF/OND veterans. Psychological 
Trauma: Theory, Research, Practice, and Policy 9, 74 (2017). 
69 
Peterson, A. L. et al. Intensive prolonged exposure therapy for combat-related 
posttraumatic stress disorder: Design and methodology of a randomized clinical 
trial. Contemp. Clin. Trials 72, 126-136 (2018). 
70 
Sheehan, K. H. & Sheehan, D. V. Assessing treatment effects in clinical trials with 
the discan metric of the Sheehan Disability Scale. Int. Clin. Psychopharmacol. 23, 
70-83 (2008). 
71 
Salzer, M. S., Brusilovskiy, E., Prvu-Bettger, J. & Kottsieper, P. Measuring 
community participation of adults with psychiatric disabilities: Reliability of two 
modes of data collection. Rehabil. Psychol. 59, 211 (2014). 
Version 4.0 
Suicide Prevention Protocol 
Page 34 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
72 
Burns-Lynch, B. & MUSA, E. B. An empirical study of the relationship between 
community participation, recovery, and quality of life of individuals with serious 
mental illnesses. The Israel journal of psychiatry and related sciences 53, 46 
(2016). 
73 
Salzer, M. S., Kottsieper, P. & Brusilovskiy, E. Intermethod reliability and factors 
affecting recall with the Temple University Community Participation measure. 
Journal of Mental Health 24, 189-195, doi:10.3109/09638237.2015.1036976 
(2015). 
74 
Terry, R., Townley, G., Brusilovskiy, E. & Salzer, M. S. The influence of sense of 
community on the relationship between community participation and mental health 
for individuals with serious mental illnesses. J. Community Psychol. 47, 163-175 
(2019). 
75 
Neil, S. T. et al. The questionnaire about the process of recovery (QPR): a 
measurement tool developed in collaboration with service users. Psychosis 1, 145- 
155 (2009). 
76 
Williams, J. et al. Psychometric evaluation of the Questionnaire about the Process 
of Recovery (QPR). The British Journal of Psychiatry 207, 551-555 (2015). 
77 
Law, H., Neil, S. T., Dunn, G. & Morrison, A. P. Psychometric properties of the 
questionnaire about the process of recovery (QPR). Schizophr. Res. 156, 184-189 
(2014). 
78 
Endicott, J., Nee, J., Harrison, W. & Blumenthal, R. Quality of Life Enjoyment and 
Satisfaction Questionnaire: a new measure. Psychopharmacol. Bull. (1993). 
79 
Rush, A. J. et al. The 16-Item Quick Inventory of Depressive Symptomatology 
(QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric 
evaluation in patients with chronic major depression. Biol. Psychiatry 54, 573-583 
(2003). 
80 
Weiss, R. B., Aderka, I. M., Lee, J., Beard, C. & Björgvinsson, T. A comparison of 
three brief depression measures in an acute psychiatric population: CES-D-10, 
QIDS-SR, and DASS-21-DEP. Journal of Psychopathology and Behavioral 
Assessment 37, 217-230 (2015). 
81 
Surís, A., Holder, N., Holliday, R. & Clem, M. Psychometric validation of the 16 item 
quick inventory of depressive symptomatology self-report version (QIDS-SR16) in 
military veterans with PTSD. J. Affect. Disord. 202, 16-22 (2016). 
82 
Posner, K. et al. Columbia-suicide severity rating scale (C-SSRS). New York, NY: 
Columbia University Medical Center (2008). 
83 
Van Orden, K. A., Witte, T. K., Gordon, K. H., Bender, T. W. & Joiner Jr, T. E. 
Suicidal desire and the capability for suicide: Tests of the interpersonal- 
psychological theory of suicidal behavior among adults. J. Consult. Clin. Psychol. 
76, 72-83 (2008). 
84 
Hill, R. M. et al. Evaluating the Interpersonal Needs Questionnaire: Comparison of 
the reliability, factor structure, and predictive validity across five versions. Suicide 
Life Threat. Behav. 45, 302-314 (2015). 
 
Version 4.0 
Suicide Prevention Protocol 
Page 35 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
85 
Silva, C. et al. Evidence for the propositions of the interpersonal theory of suicide 
among a military sample. J. Clin. Psychol. 73, 669-680 (2017). 
86 
Rudd, M. D., Schmitz, B., Mc Clenen, R., Joiner, T., Elkins, G., & Claassen, C. 
(2010). The Suicide Cognitions Scale: A Suicide-Specific Measure of Hoplessness. 
87 
Bryan, C. J. et al. Improving the detection and prediction of suicidal behavior 
among military personnel by measuring suicidal beliefs: An evaluation of the 
Suicide Cognitions Scale. J. Affect. Disord. 159, 15- 22 (2014). 
88 
Ellis, T. E. & Rufino, K. A. A psychometric study of the Suicide Cognitions Scale 
with psychiatric inpatients. Psychol. Assess. 27, 82 (2015). 
89 
Leon, A. C., Davis, L. L. & Kraemer, H. C. The role and interpretation of pilot 
studies in clinical research. J. Psychiatr. Res. 45, 626-629 (2011). 
90 
Bjurebery, J., Dahlin, M., Carlborg, A., Edberg, H., Haglund, A., Runeson, 
B. Columbia-Suicide Severity Rating Scale Screen Version: initial screening 
for suicide risk in a psychiatric emergency department. Psychol. Med. 1-9. 
(2021). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 4.0 
Suicide Prevention Protocol 
Page 36 of 36 
 
 
 
 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
Version 4.0 
Suicide Prevention Protocol 
Page 21 of 36 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022 
 
 
 
 
 

VA Central IRB Panel 2 
Effective Date: 
March 8, 2022