Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)
Phase: NA
Conditions: Mental Health
Sponsor: VA Office of Research and Development

 
 
Initial Testing of Whole Health STEPS (Structured Tiered 
Engagement with Peer Support) 
National Clinical Trial (NCT) Identified Number:  NCT04390451 
IRB/R&D #: 1622661 
Principal Investigator*: Emily M. Johnson 
Sponsors: VA Center for Integrated Healthcare and Syracuse VA Medical Center 
Grant Title: Initial Testing of Whole Health STEPS (Structured Tiered Engagement 
with Peer Support) 
Grant Number*: 1 IK2 RX003390-01A1 
Funded by: VA Office of Rehabilitation Research and Development 
Version Number:  v.9 
26 February 2025 
 

Initial Testing of Whole Health STEPS (Structured Tiered Engagement with Peer Support) 
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Table of Contents 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 2 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 3 
3 
STUDY DESIGN ............................................................................................................................................. 4 
3.1 
Overall Design ...................................................................................................................................... 4 
3.2 
Study Intervention Description: Whole Health STEPS ................................................................... 4 
3.3 
Control Description: Waitlist ............................................................................................................... 5 
3.4 
Fidelity & Peer Staff Qualifications .................................................................................................... 5 
3.5 
Study Intervention/Experimental Manipulation Adherence............................................................ 5 
4 
STUDY POPULATION .................................................................................................................................. 6 
4.1 
Inclusion Criteria .................................................................................................................................. 6 
4.2 
Exclusion Criteria ................................................................................................................................. 6 
5 
RECRUITMENT PLAN .................................................................................................................................. 7 
6 
ASSESSMENT PLAN .................................................................................................................................... 8 
6.1 
Plan for Orderly Termination of Participation................................................................................. 10 
6.2 
Participant Payment .......................................................................................................................... 10 
6.3 
Safety Monitoring Plan ...................................................................................................................... 11 
7 
RESEARCH STUDY DOCUMENTATION PLAN .................................................................................... 12 
8 
RISK AND BENEFITS ................................................................................................................................. 12 
8.1 
Risks .................................................................................................................................................... 12 
8.2 
Minimizing Risks ................................................................................................................................ 12 
8.3 
Benefits ............................................................................................................................................... 13 
9 
DATA SECURITY PLAN ............................................................................................................................. 13 
10 
DATA SHARING PLAN ............................................................................................................................... 14 
11 
DATA ANALYSIS PLAN .............................................................................................................................. 14 
12 
REFERENCES ............................................................................................................................................. 14 
 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Initial Testing of Whole Health STEPS (Structured Tiered Engagement with 
Peer Support) 
Grant Number: 
1 IK2 RX003390-01A1 
Study Description: 
This two-phase pilot trial (open trial followed by pilot RCT) is designed to 
evaluate the feasibility and acceptability of Whole Health STEPS.  
Study Population: 
The target population is primary care Veterans with mental health symptoms 
who are not engaged in mental health care. 
Description of 
Intervention: 
Whole Health STEPS (Structured Tiered Engagement with Peer Support) is a 
peer-delivered wellness service designed for delivery in VA primary care 
settings.  
 
 

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1.2 
SCHEMA  
 
Final Assessment
Treatment Phase 2
Mid Assessment
Treatment Phase 1
Randomization
Baseline Assessment
Recruitment & Pre-
screening
Recruitment DataPull
Identify Veterans for 
recruitment from EMR 
datapull
Estimated ~35,000 Veterans 
Recruit and screen for 
scheduling baseline 
Target screening n=738
Consent, determine eligibility, 
assess baseline functioning 
Target Enrolled n=90
Target Eligible n=54
First participants 
enroll in open 
trial 
Target n=10
Whole Health 
STEPS (~2-3 
months)
Post-treatment 
Assessment & 
Interview
Remaining partipants 
enroll in RCT
Target n=44
Whole Health 
STEPS (~2-3 
months)
Post-treatment 
Assessment & 
Interview
Maintenance (2 
months)
Follow-up 
Assessment
Waitlist (2 
months)
Pre-treatment 
Assessment
Whole Health 
STEPS (~2-3 
months)
Post-treatment 
Assessment & 
Interview

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
Functional impairment, limitation in social and occupational roles (Üstün & Kennedy, 2009), is a 
significant problem for Veterans. Across diagnostic categories, mental health symptoms are associated 
with functional impairment and difficulty with role-related task (Kazis et al., 1998; Löwe et al., 2008; 
Spitzer et al., 2006). Despite the availability of services, many Veterans with mental health symptoms do 
not engage in mental health treatment (Elbogen et al., 2013; Seal et al., 2010). Whole Health STEPS 
(Structured Tiered Engagement with Peer Support) is an innovative approach to engaging this 
population through combining two novel modalities to engage with Veterans, peer support and Whole 
Health, tailored for delivery in Primary Care Mental Health Integration (PCMHI) a platform designed 
to increase access to mental healthcare.  
 
This two phase pilot trial is designed to address two key objectives (1) evaluate the feasibility and 
acceptability of Whole Health STEPS and (2) evaluate the preliminary impact of Whole Health STEPS on 
patient outcomes.  
• 
Phase 1 addresses objective 1 and will be an open trial (Eligible n=10) to test the feasibility of 
peer delivery in primary care and acceptability to Veterans to inform further manual 
adjustments. Feasibility of research procedures will also be evaluated to inform adjustments to 
the research protocol. 
• 
Phase 2 addresses objective 2 and will be a pilot RCT with a waitlist control (Eligible n=44) to 
evaluate impact on functional impairment and feasibility for subsequent grant applications.  
2.2 
BACKGROUND  
Peers within VA are Veterans in recovery from mental illness with specialized training to support other 
Veterans with mental health concerns (Chinman et al., 2013). Within the context of their job duties, 
peers perform a number of functions including sharing their mental health recovery story, advocating 
for Veterans, acting as role models, providing crisis support, acting as liaisons with staff, providing 
outreach, supporting treatment, teaching coping skills, supporting patient engagement for patients with 
mental health concerns, and wellness coaching (Chinman et al., 2013; Swarbrick et al., 2016). Benefits 
from peer services include functional outcomes such as quality of life, socialization, recovery/hope, 
fatigue/sleep, daily functioning, and healthcare engagement (Chinman et al., 2014; Davidson et al., 
2006; Druss et al., 2010; Lorig et al., 2014). 
 
Whole Health is a patient-centered model of care within VA (Krejci et al., 2014) which incorporates a 
range of services with a range of intensities appropriate for peer-delivery. Early research within the VA 
on Whole health interventions suggests high acceptability and Veteran improvements on a broad range 
of outcomes including psychological well-being, mental health symptoms, physical health, ability to 
engage in valued activities, and wellness domains (Denneson et al., 2019; Hull et al., 2019; Mori et al., 
2019). 
 
PCMHI is a platform of care which significantly increases access and utilization of mental health services 
for primary care Veterans, but some Veterans still do not engage in care due to low mental health 
problem recognition and negative beliefs about psychotherapy (Johnson & Possemato, 2021; Kehle et 
al., 2011; Possemato et al., 2018; Wray et al., 2012). Peer support and Whole Health are well positioned 

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to address those barriers and be adapted for delivery in PCMHI using a stepped care model. Stepped 
care interventions are designed to offer the least intensive intervention that is likely to provide benefit 
and involve systematic monitoring of progress to increase the level of care as needed to “self-correct” 
(Bower & Gilbody, 2005). Preliminary evidence from a prior trial of Peer-Delivered Whole Health 
Coaching (Johnson et al., 2021) suggested positive results from a peer-delivered Whole Health approach 
and informed the stepped care design including the addition of lower intensity interventions as early 
steps and the frequency and duration of the intervention. 
3 
STUDY DESIGN 
3.1 
OVERALL DESIGN 
This study consists of a two phased clinical trial.  
 
Phase 1 is an open trial establishing preliminary feasibility and acceptability of Whole Health STEPS and 
informing adjustments to the clinical manual. Participants will be followed for the duration of their 
participation in Whole Health STEPS, a period of approximately 2-3 months. Following phase 1 
enrollment, the investigators will review the data, make adjustments to the Whole Health STEPS manual 
and research protocol as necessary, and proceed with enrollment in Phase 2.  
 
Phase 2 is a 2-arm single-site pilot randomized clinical trial with a waitlist control evaluating Whole 
Health STEPS impact on patient outcomes and feasibility. Random assignment will be made by research 
staff following eligibility determination using a stratified permuted block design based on baseline 
functional impairment (mild-moderate functional impairment IPF≤50 vs. severe-extreme functional 
impairment IPF≥51). Participants will be followed for a period of approximately 4-5 months, 2-3 months 
will be participation in Whole Health STEPS and 2 months will be either be waitlist or follow-up 
depending on randomization outcome.  
• 
Hypothesis 2a. Whole Health STEPS will demonstrate an effect size (d) > 0.3 on 
psychosocial functioning. 
• 
Hypothesis 2b. Whole Health STEPS will demonstrate clinical feasibility including 
positive results on process outcomes, retention, fidelity, and appropriateness on 
stepped-care decision points.  
3.2 
STUDY INTERVENTION DESCRIPTION: WHOLE HEALTH STEPS 
Whole Health STEPS is a stepped care package incorporating a range of Whole Health peer services into 
one structured protocol designed to be delivered by a peer in primary care. The whole package is 
designed to take place over approximately 2-3 months with regular contact with the peer to evaluate 
the need to increase/decrease the intensity of peer support. Levels of support include supported self-
management in which the Veteran completes a self-directed Whole Health tool (i.e., the Personal Health 
Inventory) and gets regular calls from a peer to check-in about progress, brief telephone support in 
which the peer asks additional questions to support Veterans’ progress (e.g., inquiry about personal 
meaning, focus, goals), and full length peer sessions (approximately 30-60 minutes) focused on Whole 
Health. All peer sessions at all levels will use a semi-structured interview tool to inquire about Veterans’ 
goals and goal progress and other mental health, physical health, and social needs. The peer will 
facilitate referrals and connections with community resources as appropriate for Veterans’ individual 
needs throughout Whole Health STEPS.   

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The proposed levels of support are all existing Whole Health services tailored for a peer scope of work. 
The innovative aspect of Whole Health STEPS is packaging these services together in a stepped care 
model. These are all variations of existing services and there are no known risks to peer services or 
Whole Health services.  
 
Peer contact including sessions and other contacts (e.g., reminders, brief check-ins, contact attempts) 
will be documented in the medical record. Peer sessions will occur either in person and/or remotely 
over the phone or via VA Video Connect depending on current safety guidelines for in person 
appointments and Veteran preference. Peer sessions will be audio-recorded using VA approved audio-
recording software to ensure the intervention is being delivered correctly and understand how Whole 
Health STEPS is being delivered. VA approved audio-recording software will also be used at a treatment 
feedback interview so that Veteran responses can be analyzed.  
3.3 
CONTROL DESCRIPTION: WAITLIST 
Veterans randomized to the waitlist control condition will receive Whole Health STEPS after a 2 month 
wait. During the waitlist period, Veterans will not be prohibited from pursuing any treatment or services 
they deem appropriate, and healthcare utilization will be tracked through EMR record reviews. Veterans 
will be provided with information about available emergency and urgent mental health services, 
resources for social needs (e.g., homelessness), and other important resources to ensure that they are 
aware of how to engage support as needed. 
 
Waitlist control was selected as the best option for the RCT to evaluate this service package because 
compared to designs with control groups where only one group receives Whole Health STEPS, it allows a 
more powerful test of Whole Health STEPS and it provides more feedback data to establish acceptability 
of the lower intensity interventions which are central to stepped care intervention design. 
3.4 
FIDELITY & PEER STAFF QUALIFICATIONS 
Peer staff may include Syracuse VA peer support specialists/apprentices, Syracuse VA or CIH staff 
employed in other roles who have appropriate peer qualifications, and/or peer support 
specialists/apprentices from other VA sites with whom we have active research or clinical partnerships 
(e.g., Palo Alto, Pittsburgh, Houston). Peers will have received training in peer support through a training 
program approved by the PI (e.g., the VA or New York State Peer Certification program) and will receive 
additional training in Whole Health STEPS procedures including training in Whole. Peer training in Whole 
Health STEPS will include training techniques such as reading materials (e.g., reviewing the manual) and 
structured practice (e.g., role plays). Peers will also receive ongoing supervision from the PI or another 
qualified peer supervisor to review ongoing cases and provide additional follow-up training as needed.  
Intervention fidelity will be evaluated through a fidelity checklist developed specifically for Whole Health 
STEPS.  
3.5 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Participant adherence to Whole Health STEPS will be tracked through peer documentation of 
appointment attendance and research staff documentation of retention (i.e., intervention and research 
withdrawal and/or lost to follow-up). Intervention retention will be evaluated through the percentage of 
Veterans who complete Whole Health STEPS. Completion is defined as either (1) continued engagement 

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with the peer specialist throughout the Whole Health STEPS phase as indicated by continuing to respond 
affirmatively to peer outreach efforts AND/OR (2) planned termination of Whole Health STEPS because 
the Veteran has made successful progress. 
4 
STUDY POPULATION 
4.1 
INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
Inclusion Criteria 
Operational Definition 
1. Veteran status 
Designated as a Veteran in the EMR 
2. Age 18 or older 
Age 18 or older in the EMR as of the date of 
enrollment 
3. Enrolled in primary care at the Syracuse VA 
Medical Center or affiliated Community-Based 
Outpatient Clinic 
Primary care clinic and/or Primary care 
provider in EMR are affiliated with Syracuse 
VAMC or CBOC 
4. Have at least mild functional impairment 
Inventory of Psychosocial Functioning (IPF ≥ 
11) 
5. Screen positive on at least one primary care 
mental health screener  
PHQ-9 ≥ 10, 
PCL-5 ≥ 31 AND a qualifying event on the 
LEC, 
GAD-7 ≥ 8, and/or  
AUDIT ≥ 8 for men/≥7 for women 
4.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
Exclusion Criteria 
Operational Definition 
1. Actively engaged with an equivalent 
or higher level of care with the 
exception of medication management 
for mental health concerns 
Pending or planned future appointments in: 
• 
Whole Health Coaching/Peer Support or 
other individual coaching/support for 
health, wellness, or lifestyle changes 
• 
PCMHI  
• 
Outpatient psychotherapy  
• 
Peer support  
2. Preference for direct referral to 
mental healthcare 
Veteran answers affirmatively to the question 
“Would you prefer a referral for mental health 
services rather than participate in this trial?”  
3. Recent changes to psychotropic 
medications 
Change in medication type or dose within the last 2 
months to a psychotropic medication or a 
medication prescribed for mental/behavioral health 
concerns 
4. Severe impairment preventing 
engagement with a peer, warranting 
direct referral to a licensed 
independent provider for monitoring 
• 
High risk based on the P4 screener, and/or 
• 
Significant cognitive impairment (BOMC > 
10), and/or 

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and follow-up, and/or affecting ability 
to complete research tasks. 
• 
Need for accommodations that would 
invalidate research measures, and/or 
• 
Inability to sustain attention/concentration 
to complete questionnaires, interviews, 
and/or peer sessions, and/or 
• 
Other significant concerns about 
impairment. 
5. Inability to independently 
communicate in verbal and written 
English 
Demonstrates inability to understand and respond 
to research interviews and self-report assessments 
during the baseline in English, without assistance 
from a translator or interpreter.  
 
5 
RECRUITMENT PLAN 
To recruit this sample, we intend to use direct marketing and/or referrals from the primary care team. 
Direct marketing could include a number of different strategies including posting paper flyers/brochures 
at VA and community locations (e.g., the Vet Center, ClearPath for Veterans, etc.), posting electronic 
flyers on electronic platforms (e.g., the VA television screens, VA facebook site), and tabling at the VA 
Medical Center and community events. Primary care team referrals will be facilitated by informational 
flyers and brochures, personal communication, and/or presentations at staff meetings. We will also 
conduct targeted chart reviews and electronic medical record datapulls to help providers identify 
potentially eligible Veterans and facilitate referrals. For recruitment purposes, the following criteria will 
be used to identify Veterans from medical records using a case finding procedure or the VA Informatics 
and Computing Infrastructure (VINCI):  
• 
Veteran status 
• 
Age 18 or older  
• 
Enrolled in primary care at the Syracuse VA or an affiliated clinic based on primary care services 
at one of the aforementioned locations 
• 
Positive behavioral health screen (i.e., PHQ-9, PHQ-2, PC-PTSD-5, PCL-5, GAD-7, AUDIT, or AUD-
C) or relevant mental health diagnosis (i.e., depression, anxiety, PTSD, hazardous alcohol use) on 
the same day as a recent primary care encounter 
• 
No recent (i.e., last month)1 or pending peer support, Whole Health Coaching, PCMHI, or 
psychotherapy appointments. 
• 
No recent (i.e., past two months) changes in dose or type of psychotropic medications 
• 
No high risk suicide flags in the last year or positive suicide screens (i.e., C-SSRS, PHQ-9 item #9) 
within the last month 
• 
Diagnosis of dementia within the last year 
Contact information and identifying information (i.e., name, address, phone number, SSN) will be 
accessed to allow research staff to verify EMR information and contact potential participants. 
 
 
1 Although recent appointments are not part of the exclusion criteria, Veterans with recent appointments 
are not included in the electronic medical records recruitment pool to reduce recruitment of Veterans who 
may be pending scheduling their next appointment with an established provider. If Veterans are referred 
from other sources who have recent appointments of these types, they will be eligible as long as they 
meet the inclusion/exclusion criteria including no pending appointments. 

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Demographic information (including race, ethnicity, gender/sex) will also be accessed to allow staff to 
recruit a diverse population and increase recruitment efforts to Veterans from under-represented 
groups as needed.  
For initial recruitment, Veterans identified through medical records will first be sent a recruitment 
packet (including a personalized invitation letter, study brochure, and informed consent information) 
then research staff will make multiple attempts to reach Veterans by the phone to conduct a phone 
screen. Veterans who are referred directly from a provider (e.g., warm handoff) or who contact the 
study through direct marketing (e.g., called the phone number on a flyer) will be given the option to 
complete the phone screen immediately and will be mailed information as soon as practical after initial 
contact. For all participants, an initial screening will be conducted to determine appropriateness of a 
baseline interview. Format of the screening (in person or telephone) will be determined based on 
Veteran preference and relevant safety-guidelines for in person meetings. 
 As appropriate, we will share names of Veterans we determine to be ineligible prior to contact with 
other studies approved to recruit using the same datapull procedures with overlapping eligibility criteria 
(e.g., if a participant schedules an appointment which would make them ineligible for our study after the 
datapull before recruitment, but that participant would otherwise be eligible for another study 
approved to access the name through the same means) we will share that information. 
See 1.2 Schema for the anticipated number of Veterans to be screened for the target enrollment. 
6 
ASSESSMENT PLAN  
Assessments will be conducted with Veterans in person, over the phone, or electronically using Qualtrics 
or REDCap (Research Electronic Data Capture) depending on format of the assessment, safety guidelines 
for in person meetings, and Veteran preference. Electronic data collection will be the primary data 
collection strategy but as a contingency plan if electronic administration is not feasible, staff will make 
every effort to collect the data in an alternate format (paper or oral format) to reduce data loss. If paper 
format is used, it will be returned in person or via pre-paid envelope. Research staff will call, text using a 
VA iPhone and/or send an SMS text via Qualtrics or REDCap, and/or send e-mails via a no-reply, 
Qualtrics or REDCap generated email address to remind participants to complete assessments as 
needed. See Data Security Plan for Qualtrics and REDCap security information. Email and text reminders 
will follow current VA guidance on information security procedures for these communication methods. 
If oral format is used, it will be through phone, VA approved video-conferencing format, or in person. As 
a safety precaution, when conducting assessments virtually, research staff will also confirm a phone 
number for call back, a physical address for where the Veteran is at that moment, an emergency contact 
person/phone number in case the Veteran has a medical or mental health emergency while on the 
phone, and two identifiers to confirm the Veteran’s identity.  
Electronic medical records data collection will be facilitated by research staff with recruitment activities 
occurring monthly and outcome data collection occurring at the end of the trial. Upon initial recruitment 
screening, baseline interviews will be scheduled to review consent and HIPAA information and to 
determine eligibility. If the Veteran chooses to participate in the study and appropriately answers 
comprehension questions, research staff will document verbal consent on the approved verbal informed 
consent script. This modification will reduce burden on participants by eliminating the requirement to 
travel for a baseline assessment to administer written consent and increase the feasibility of the 
research trial by broadening the population who will be able to participate.  
 

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After obtaining verbal consent, research staff will administer the following assessments at the specified 
timepoints:  
Construct/ Function 
Assessment 
Recruitment Admin Data 
Baseline Part 1 
Baseline Part 2 
Each Session  or Post-Session 
Mid Assessment 
Final Assessment 
Post-Treatment* 
Post-Study Admin Data 
Sample Description, 
Recruitment, & 
Screening  
EMR Patient Identifiers and 
Contact Information 
X 
 
 
 
 
 
 
 
Self-Report Contact 
Information 
 
X 
 
 
 
 
 
 
EMR Demographics 
X 
 
 
 
 
 
 
 
EMR Mental Health Screeners 
& Relevant Diagnoses 
X 
 
 
 
 
 
 
 
EMR Veteran Status 
X 
 
 
 
 
 
 
 
EMR Primary Care Team 
Information 
 
 
 
 
 
 
 
 
EMR Medications 
X 
 
 
 
 
 
 
 
EMR Problem List 
X 
 
 
 
 
 
 
 
BOMC (for cognition/ 
orientation) 
 
X 
 
 
 
 
 
 
P4 Screener (for suicidality) 
 
X 
 
 
 
 
 
 
Preference for direct referral 
to behavioral health 
 
X 
 
 
 
 
 
 
Demographics Questionnaire 
 
 
X 
 
 
 
 
 
Psychosocial 
Functioning (Primary 
Patient Outcome) 
IPF (psychosocial functioning) 
 
X 
 
 
X 
X 
 
 
Behavioral Health 
Symptoms 
PHQ-9 (depression) 
 
X 
 
 
X 
X 
 
 
GAD-7 (anxiety) 
 
X 
 
 
X 
X 
 
 
LEC (PTSD) 
 
X 
 
 
 
 
 
 
Criterion A Assessment 
(PTSD) 
 
X 
 
 
 
 
 
 
PCL-5 (PTSD) 
 
X 
 
 
X 
X 
 
 
AUDIT (alcohol use) 
 
X 
 
 
X 
X 
 
 
Other Peer Services 
Outcomes 
EMR VA Healthcare and 
Social Services Appointments 
X 
 
 
 
 
 
 
X 
Self-Report non-VA 
Healthcare and Social 
Services Utilization 
 
X 
 
 
X 
X 
 
 
RAS-SF (recovery) 
 
 
X 
 
X 
X 
 
 

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WAI (therapeutic relationship) 
 
 
 
 
 
 
X 
 
Other Whole Health 
Outcomes 
MILM (meaning in life) 
 
 
X 
 
X 
X 
 
 
QOLI (quality of life) 
 
 
X 
 
X 
X 
 
 
ACORN (resources) 
 
 
X 
 
X 
X 
 
 
WHGAT (Whole Health Goal 
Attainment) 
 
 
 
X 
 
 
 
 
Whole Health STEPS 
Feasibility 
Intervention retention 
 
 
 
 
 
 
 
X 
Fidelity Checklist 
 
 
 
X 
 
 
 
X 
Peer Post-session feedback 
forms (also falls under 
acceptability) 
 
 
 
X 
 
 
 
 
Supervisor Post-session 
feedback forms 
(design/manual usability) 
 
 
 
X 
 
 
 
 
UE-ATR (safety) 
 
 
 
 
 
 
 
 
Whole Health STEPS 
Acceptability 
Veteran post-session feedback 
forms 
 
 
 
X 
 
 
 
 
Veteran post-treatment 
feedback interview 
 
 
 
 
 
 
X 
 
CSQ (satisfaction) 
 
 
 
 
 
 
X 
 
Research Feasibility 
Recruitment and eligibility 
rates 
 
 
 
 
 
 
 
 
Data Collection & Procedural 
Problems 
 
 
 
 
 
 
 
 
Research retention 
 
 
 
 
 
 
 
X 
Notes. Assessments in bold are included in eligibility determination. Assessments in italics are for the open 
trial phase only. The post-treatment assessments are added to either the mid or final assessment as 
appropriate in the RCT phase. If a participant ends peer support services earlier than expected before the 
mid or final assessments are due (e.g., due to withdrawal from intervention but not research, because 
their goals were met with fewer sessions), the post-treatment will be administered at the participant’s 
earliest convenience separately from the mid or final assessments.  
6.1 
PLAN FOR ORDERLY TERMINATION OF PARTICIPATION 
When participants are discontinued from the project by investigator decision, research staff will 
communicate with the participants to inform participants of the discontinuation, the reason for 
discontinuation, and offer opportunities for participants to express concerns or ask questions.  
 
When participants are discontinued from the project for any reason (by participant choice or 
investigator decision), the peer and research staff will do their best to ensure that participants’ ongoing 
needs are met and facilitate referrals as appropriate.  
6.2 
PARTICIPANT PAYMENT 
Participants will be compensated at a rate of approximately $20 per hour for research activities (i.e., 
interviews and self-report assessments). This compensation rate is the rate used for similar behavioral 
health clinical trials at the Syracuse VA and does not appear to lead to undue influence or coercion. 

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Compensation will occur through established VA payment procedures approved for research activities 
(e.g., direct deposit or via a VA debit card). Research staff will collect the minimum required identifiable 
information to properly process their payments (e.g., if research staff need bank account information to 
complete a direct deposit form, they will collect the necessary information for the form). Veterans will 
not be compensated for intervention appointments (i.e., Whole Health STEPS appointments with peers). 
The compensation for each of the study activities is detailed below. 
Open Trial Study Activity 
Estimated Burden 
Compensation 
Baseline Part 1 Consent & Eligibility 
Determination 
~ 1 hour 
$20 
Baseline Part 2 Remaining Assessments 
~ 1 hour 
$20 
Post Session Rating Forms (approximately 6 
over the study)* 
~ ¼ hour each *6 total = 
~1.5 hours  
$5 each *6 total = 
$30 
Mid and Post Treatment Assessment 
~1½ hour  
$30 
Post Treatment Interview 
~ ½ hour  
$10 
* To reduce administrative burden with processing multiple payment vouchers for small amounts, the 
post-session rating forms will be paid in a lump sum at the end of the study along with the post-
treatment interview payment unless participants request a different payment schedule.  
RCT Study Activity 
Estimated 
Burden 
Compensation 
Baseline Part 1 Consent & Eligibility Determination 
~ 1 hour 
$20 
Baseline Part 2 Remaining Assessments 
~ 1 hour 
$20 
Mid Assessment 
~ 1 hour 
$20 
Final Assessment 
~ 1 hour 
$20 
Post Treatment Assessment (added to either Mid or Final 
Assessment depending on randomization, or administered ASAP 
after a participant ends peer support services) 
~ ½ hour  
$10 
Post Treatment Interview  
~ ½ hour  
$10 
 
6.3 
SAFETY MONITORING PLAN 
Following enrollment, participants will be monitored for safety by the peer, clinical staff and research 
staff. Research staff will review data for safety concerns on an ongoing basis throughout the study. 
Specifically, when research staff note AEs or SAEs in routine chart reviews or these are reported by 
participants, staff and/or the peer will document the finding and alert the PI and/or appropriate clinical 
back-up to ensure that participants have appropriate clinical services and appropriate reporting 
procedures are initiated.  
Suicidality will also be assessed at baseline, mid, and final assessments. Suicidality assessment will 
consist of the P4 and item 9 of the PHQ-9 at baseline. At follow-up assessments, item 9 of the PHQ-9 will 
be checked by research study staff immediately after receipt of questionnaires. Positive endorsements 
of PHQ-9 item 9 will be followed up directly with the Veteran to review original P4 risk assessment, 
inquire about changes, and re-administer the P4 risk assessment as needed. All Veterans scoring in the 

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higher risk category on the P4 will be referred to appropriate clinical services (e.g., on call study clinician 
and/or appropriate VA mental health resources, such as the Emergency Room, available VA mental 
health provider, Veterans Crisis Line, and/or the Syracuse VA Suicide Prevention Team) and the PI will be 
notified. 
In addition, Veterans will be monitored for safety concerns by the peer during intervention sessions. 
Peers are trained to recognize potential safety concerns and crises and ensure that the Veteran receives 
appropriate clinical support (e.g., on call study clinician and/or appropriate VA mental health resources, 
such as the Emergency Room, available VA mental health provider, Veterans Crisis Line, and/or the 
Syracuse VA Suicide Prevention Team). The PI will be conducting ongoing supervision of peer support 
providers and will check-in about potential safety concerns during supervision.  
All AEs and SAEs will be reported via established procedures.  
7 
RESEARCH STUDY DOCUMENTATION PLAN 
CPRS documentation will include documentation of research study initiation, research study completion, 
and relevant clinical tasks. Routine research study activities (e.g., completing self-report assessments) 
which are expected during the course of the study but do not inform the Veteran’s healthcare will be 
described in the research study initiation note but not documented separately. Peer services will be 
documented in clinically appropriate progress notes in a manner consistent with usual clinical practice 
and peers’ role as either clinical or research staff. Additional documentation will be entered into CPRS as 
needed and appropriate to ensure Veteran continuity of care (e.g., referrals for services, information 
regarding suicide risk, etc.).  
8 
RISK AND BENEFITS 
The potential benefits of the project outweigh the minimal risks.  
8.1 
RISKS 
There is minimal risk from participation in any of the research activities. The procedures are non-
invasive and will not cause physical harm to participants. There are no known risks associated with peer 
services or the Whole Health model; both are part of standard care offered through the VA. There is 
minimal psychological risk (i.e., embarrassment, discomfort) to participants when asked to share 
sensitive information about themselves (e.g., suicidal thoughts, mental health symptoms) with research 
staff or the peer. No deception is involved in this study. 
8.2 
MINIMIZING RISKS 
Participants will be assessed for suicide risk according to an established protocol and directly referred 
for additional services (e.g., Veterans’ Crisis Line, VA Emergency Room, VA mental health provider, 
Suicide Prevention Team) as appropriate if they are at high risk. Research assistants will be trained to 
provide grounding/relaxation activities as appropriate to participants who experience mild psychological 
discomfort (e.g., distress, frustration, anxiety) as a result of any study activities. Further, any Veteran can 
be connected with an on-call clinician or mental health provider at any point in the study at their 
request or if they report mental health symptoms which are concerning to the peer or research staff. 
Also, facilitating engagement with services, including mental health treatment as needed, is part of the 

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Whole Health STEPS approach. To minimize risk of breaching confidentiality, all electronic and paper 
self-report data collected will be identified by a random identification number rather than individually 
identifiable information. Identifiable information including voice recordings, informed consent, payment 
status, and enrollment information will be stored separately and in accordance with the data security 
and privacy procedures. Data security and privacy procedures are designed to minimize this risk. 
8.3 
BENEFITS 
The study has multiple potential direct and indirect benefits to participants. One potential direct benefit 
is that interviews, telephone screenings, and assessment sessions may provide the opportunity for 
participants to thoughtfully reflect on their current situation and which may increase insight and prompt 
change (e.g., behavior change or seeking additional treatment). Additionally, all Veterans will receive 
Whole Health STEPS which may be beneficial given past research on peer support and Whole Health 
services. Indirect benefits include the opportunity to learn about and participate in clinical research that 
aims to improve Veteran healthcare. The data and feedback collected in this project will serve to 
improve services offered for all Veterans. 
9 
DATA SECURITY PLAN 
The PI will oversee data and safety monitoring to ensure safety of participants and integrity of data 
collected. All research staff and the peer will have training appropriate to their roles in data 
management and security.  
The VA Informatics and Computing Infrastructure (VINCI) will be used to facilitate EMR data collection. 
VINCI is a Department of Veterans Affairs (VA) Health Services Research & Development (HSR&D) 
resource center that provides a secure, central analytic platform for performing research and supporting 
clinical operations activities. It is a partnership between the VA Office of Information Technology (OI&T) 
and the Veterans Health Administration Office of Research and Development (VHA ORD). VINCI includes 
a cluster of servers for securely hosting suites of databases integrated from select national VA data 
sources. VINCI servers for data, applications and virtual sessions are physically located at the VA Austin 
Information Technology Center (AITC), located in Austin, Texas. This secure enclave with 105 high-
performance servers and 1.5 petabytes of high-speed data storage has multiple layers of security and 
disaster recovery to prevent data loss. 
Coded self-report survey data will be collected using Qualtrics or REDCap, web-based data collection 
tool. Paper/Pen and oral administration (documented in Qualtrics, REDCap, or Paper/Pen) will be used 
as contingency plans. Participants will be invited to supply an email address during the baseline 
interview which will be used to generate a reminder email from Qualtrics or REDCap containing a link to 
complete follow-up assessments. This email will come from a no-reply, Qualtrics or REDCap generated 
email address. Participants can choose not to supply an email address. Participants who prefer to 
receive a text message link of Qualtrics or REDCap surveys will be texted via the phone number that is 
stored in the Access log. In instances where Qualtrics or REDCap are  used, participants will complete 
online surveys via Qualtrics or REDCap, but VA research staff will download and store all data in one 
database which will be built and will reside on a VA secured network drive. Qualtrics is hosted in a 
FedRAMP authorized environment and is compliant with VA security policy (See Qualtrics Security 
Statement, https://www.qualtrics.com/security-statement/). REDCap is hosted on the VA Enterprise 
Cloud (VAEC) and was developed specifically around HIPAA-Security guidelines. 

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All data from this study will be stored in locked filing cabinets and password-protected secure computer 
networks at the Syracuse VA. Only approved research staff and relevant oversight committees will have 
access to the data. All data will be kept strictly confidential and secure per VA policies, American 
Psychological Association (APA) ethical standards, and human subjects research policies. Identifiable 
data will be stored separate from de-identified data in locked filing cabinets and password protected 
computer files on a VA secured network drive.  
Study records will be retained in accordance with current VA policies (VHA Records Control Schedule). 
Identifiers will be maintained through the duration of the research study and then destroyed consistent 
with VA policy.  
10 DATA SHARING PLAN 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
• 
Publications from this research will be made available to the public through the National Library 
of Medicine PubMed Central website within one year after the date of publication.  
• 
This trial is registered at ClinicalTrials.gov and results from this trial will be submitted to 
ClinicalTrials.gov.  
• 
Final datasets underlying all publications resulting from the proposed research will be shared 
outside of VA under the following conditions. 
o A de-identified, anonymized dataset will be created and shared. It will be made available 
upon written request to allow for re-analysis and validation of results. All identifiable 
information and identifiers (e.g., ID numbers) will be removed from the dataset prior to 
sharing. Any data involving identifiable information(e.g., appointment dates) will be 
included as summary data (e.g., appointment counts) only. Sharing will take place under 
a written agreement prohibiting the recipient from identifying or re-identifying (or 
taking steps to identify or re-identify) any individual whose data are included in the 
dataset.  
11 DATA ANALYSIS PLAN 
Qualitative feedback (e.g., interview responses and open-ended items) will be analyzed using a rapid 
qualitative analysis approach (Hamilton, 2013). Quantitative analyses for descriptive aims (e.g., fidelity, 
feasibility) will be analyzed using descriptive statistics (e.g., central tendency and spread statistics such 
as counts, means, ranges, and standard deviations). Quantitative analyses for patient outcomes will be 
analyzed using statistical modeling to establish effect size which will be evaluated in comparison with 
the a priori effect size of d=.3.  
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