Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans With PTSD
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

PEER-DELIVERED WHOLE HEALTH 
COACHING TO IMPROVE RECOVERY IN 
VETERANS WITH PTSD 
National Clinical Trial (NCT) Identified Number:  NCT03364192 
Principal Investigator: Emily M. Johnson, Ph.D. 
Funded by: VA Office of Rehabilitation Research and Development 
Project Number: 1IK1RX002476-01A2 
Abbreviated Final Protocol For Public Dissemination on ClinicalTrials.Gov 
Prepared and Uploaded 30 October 2020 
Abbreviated from Last IRB Approved Protocol Dated 28 January 2019 

  
Prepared from NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ....................................................................................................................... 1 
1 
PROTOCOL SUMMARY ......................................................................................................................... 1 
1.1 
Synopsis ......................................................................................................................................... 1 
1.2 
Schema .......................................................................................................................................... 1 
2 
INTRODUCTION ..................................................................................................................................... 1 
2.1 
Background & Rationale ............................................................................................................... 1 
2.2 
Risk/Benefit Assessment .............................................................................................................. 4 
3 
STUDY DESIGN ...................................................................................................................................... 5 
4 
STUDY POPULATION ............................................................................................................................ 6 
4.1 
Eligibility Criteria ............................................................................................................................ 6 
4.2 
Strategies for Recruitment and Retention ................................................................................... 7 
5 
STUDY INTERVENTION ........................................................................................................................ 8 
5.1 
Study Intervention(s) Administration ............................................................................................ 8 
5.1.1 
Study Intervention Description ................................................................................... 8 
6 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ................................................................................................................ 8 
6.1 
Investigator Discontinuation/Withdrawal from the study ............................................................. 8 
6.2 
Participant Discontinuation/Withdrawal from the Study .............................................................. 8 
7 
STUDY ASSESSMENTS AND PROCEDURES ................................................................................... 9 
7.1 
Assessments & Assessment Schedule ....................................................................................... 9 
7.2 
Payment ....................................................................................................................................... 10 
8 
STATISTICAL Analyses ........................................................................................................................ 10 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................. 10 
9.1 
Regulatory, Ethical, and Study Oversight Considerations........................................................ 10 
9.1.1 
Informed Consent Process....................................................................................... 10 
9.1.2 
Data and Safety Monitoring Plan ............................................................................. 11 
10 
REFERENCES ...................................................................................................................................... 11 
 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
1 
STATEMENT OF COMPLIANCE 
All investigators and clinical trial site staff responsible for the conduct, management, and 
oversight of this clinical trial completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
were submitted to the Institutional Review Board (IRB) for review and approval.  Approval of 
both the protocol and the consent form was obtained before any participant was enrolled.  All 
amendments to the protocol were reviewed and approved by the IRB before the changes were 
implemented to the study.  In addition, all changes to the consent form were IRB-approved. 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with 
PTSD 
Study Description: 
This project implemented peer-delivered Whole Health Coaching with 
Veterans experiencing clinically significant PTSD symptoms but who chose 
not to engage in specialty mental health. This project utilizes a 
concurrent/non-concurrent multiple baseline design across subjects to 
investigate patient outcomes (specifically, goal attainment) before, during, 
and after Whole Health Coaching.   
Objective: 
 
Identify changes in Veterans’ health and wellness behaviors after Whole 
Health Coaching.  
Primary Outcome: 
Goal Attainment Scaling 
Secondary Outcomes: 
PTSD Checklist for DSM-5 (PCL-5) 
Inventory of Psychosocial Functioning (IPF) 
Client Satisfaction Questionnaire-8 (CSQ-8) 
Study Population: 
Veterans enrolled in primary care at participating sites with probable PTSD 
defined as screening positive for a Criterion A event and PCL-5 score 33 or 
higher.  
Description of 
Sites/Facilities Enrolling 
Participants: 
Syracuse VA Medical Center and Affiliated Community Based Outpatient 
Clinics   
Description of Study 
Intervention: 
Whole Health Coaching is a Veterans Health Administration variation of 
integrative health coaching. For this study it will be administered by a peer 
support specialist. 
Study Duration: 
1 May 2018-31 October 2019 
Participant Duration: 
24 weeks 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
1 
1.2 
SCHEMA 
 
 
2 
 
INTRODUCTION 
2.1 
BACKGROUND & RATIONALE 
Veterans with PTSD have high rates of unhealthy behaviors and low rates of positive health and 
wellness behaviors. Veterans and service members with PTSD have high rates of smoking and substance 
use, worse health, more sick-call appointments, and low rates of preventative health behaviors (i.e., 
exercise and medical screening).1 Veterans with PTSD also have higher rates of inpatient 
hospitalizations.2,3 Also, despite dissemination of highly effective evidence based psychotherapies for 
PTSD across VHA,4 rates of engagement are low; for example, only 11.5% of Veterans entering treatment 
with a provider trained in Cognitive Processing Therapy or Prolonged Exposure initiated one of these two 
treatments, and only 7.9% completed the treatment protocol.5 Three classes of interventions 
demonstrate positive support for increasing “patients’ willingness and ability to take independent 
actions to manage their health and care”: (1) skill development, problem solving, and peer support; (2) 
social environment changes to facilitate healthy beliefs, social norms, and behaviors; and (3) tailored 
coaching, which facilitates goal setting at appropriate levels.6 
Whole Health Coaching seeks to increase health and wellness behaviors through a personalized plan 
for recovery and values-based goal setting. Whole Health Coaching is a health coaching service 
designed by the VHA OPCC&CT. Whole Health Coaching differs in approach, focus, and principle from 
Telephone Screening for Interest and Appropriateness
Assess for Eligibility at Baseline
Randomize and Complete Remaining Baseline Assessments
Baseline Phase (4 weeks, 8 weeks, or 12 weeks)
Pre-Whole Health Coaching Assessment
Peer-Delivered Whole Health Coaching (~8 weeks)
Post-Whole Health Coaching Assessment
Follow-up Phase (remainder of the 24 week trial period)
Follow-up Assessment

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
2 
traditional health coaching through defining success in terms of progress on personalized values-based 
goals rather than disease-specific outcomes. Sessions move through four phases to help Veterans 
progress on wellness goals. In phase 1, coaches work with Veterans to develop a personal health 
mission by exploring values and creating a vision for health. In phase 2, coaches conduct assessment to 
evaluate current and desired functioning in eight areas of self-care and develop a focus. In phase 3, 
coaches and Veterans develop a plan including setting goals, developing action steps, exploring 
barriers, and establishing accountability. In phase 4, coaches review progress and modify goals and 
action steps as needed. Coaches move through phases at the Veteran's pace and can return to a phase 
at any point as needed. 
Although there is no research directly evaluating the outcomes of Whole Health Coaching, it is based on 
a style of health coaching called integrative health coaching, which has good research support.7 
Integrative health coaching and Whole Health Coaching incorporate many skills similar to motivational 
interviewing7 (e.g., open-ended questions, reflections, scaling questions, exploring attitudes and beliefs 
around behaviors), behavioral activation (e.g., assessment of life goals and values, activity scheduling),8 
and goal setting. However, it is unique in its whole-person orientation to health rather than a focus on a 
specific behavioral concern (e.g., depression, weight loss).7 In principle, focusing on Veteran defined 
values and goals increases patient engagement and healthy behaviors (Figure 1). Recent reviews 
indicate that health coaching demonstrates efficacy for improving health behaviors, physical health, and 
social and mental health functioning.9,10 Further, evidence suggests that integrative health coaching can 
improve stress, healthy eating, exercise, and physical and emotional health in a high-risk population 
with multiple co-morbidities.11 
Figure 1. Proposed impact of WHC on outcomes 
Note that Whole Health Coaching is not a stand-alone treatment for any mental health or medical 
conditions, rather it is designed to increase patient engagement in treatment and healthy behaviors 
that are tailored for patient’s health needs. Typically, if a Veteran with PTSD is having problems at work 
and has co-morbid health problems like obesity and diabetes, this Veteran would get a series of 
problem-specific recommendations for each of these concerns from providers including a primary care 
provider, mental health providers, vocational rehabilitation specialist, endocrinologist, nutritionist, etc. 
While any of these providers might set specific goals and tailor treatment recommendations to the 
Veteran's presenting concerns, recommendations would likely be specific to the individual problem(s) 
being treated by that provider. In contrast, if this Veteran were to engage in Whole Health Coaching, 
the emphasis would be on a whole health evaluation; broad, non-problem specific domains of health 
(e.g., activity level, sleep, spirituality); and generating feasible goals and action steps based on the 
Veteran's values and ability. The coach can then help the Veteran make healthcare decisions and 
identify self-management strategies considering provider recommendations. The whole health 
emphasis is the primary difference, so Veterans are not working with a provider on a specific diagnosis, 
but rather overall health and wellness. There is a focus on domains and values that are uniquely 
important to the Veteran (Table 1). For Veterans with PTSD, this ideally includes engagement in 
evidence-based PTSD treatment as part of the personalized health plan. 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
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Once a focus is selected, Whole Health Coaches help 
Veterans specify goals, develop action steps to work 
towards those goals, and evaluate progress. Action steps 
toward goals might include treatment recommendations or 
self-care actions from healthcare providers. Coaches also 
provide support for goal attainment, help Veterans 
incorporate provider recommendations, and connect 
Veterans with appropriate services to follow through on 
action steps. For example, if a goal for a Veteran with PTSD 
is to reduce hypervigilance or irritability and the Veteran 
develops action steps towards self-management, then the 
coach would provide support for the self-management 
plan. However, if a Veteran with a goal to reduce 
hypervigilance or irritability develops action steps focused 
on engaging in formal treatment, then the coach would 
provide navigation to appropriate services (e.g., PTSD Clinic 
or anger management) and provide support for maximizing 
utilization of these services (e.g., developing action steps for attending sessions and completing 
homework.  
Since Primary Care-Mental Health Integration (PC-MHI) addresses population-level barriers to 
behavioral healthcare, it is an ideal setting for engaging Veterans with PTSD through Whole Health 
Coaching. PTSD is prevalent within VHA with 20% of outpatients screening positive for PTSD12 and 
11.5% of primary care patients meeting full diagnostic criteria.13 PTSD diagnoses are commonly (44% of 
the time) made in non-mental health settings such as primary care.14 PTSD in primary care patients is 
associated with worse mental health functioning, co-morbid mental health concerns, hazardous alcohol 
use, and elevated risk of suicidality.12,15-18 VHA’s PC-MHI initiative was designed to address population-
level barriers to mental healthcare including both access and stigma.19 Since PC-MHI providers are 
embedded within primary care clinics, they regularly interact with Veterans who typically do not follow 
through on mental health referrals. Thus, the PC-MHI setting provides an opportunity to engage with 
Veterans with PTSD who are not using specialty mental health care. 
Peer specialists can provide unique and valuable benefits to Veterans with PTSD. Peer specialists are 
Veterans with at least one year of personal recovery from a mental health concern whose role as VA 
employees is to provide support to Veterans.20 There are 1,100 peers working in VHA nationally, and 
large medical centers must employ at least 2 peer specialists.21 Within their role, they work with 
Veterans both individually and in groups to perform multiple functions including: sharing their recovery 
story, advocating for Veterans, acting as role models of recovery, providing crisis support, acting as 
liaisons with clinical staff, providing outreach education, supplementing treatment, providing case 
management and navigation, and teaching coping skills.20 Peers in the VHA are already receiving training 
in and delivering Whole Health Coaching, a movement that mirrors implementation of peer wellness 
coaching in other state healthcare systems.22 In fact, a recent review demonstrates support for three 
types of peer services, two of which are highly relevant to the role of the peer specialist delivering 
Whole Health Coaching in primary care.23 Evidence suggests that patients receiving care from peers 
delivering services as part of a team, such as multidisciplinary PACTs, show improvements in treatment 
engagement, social functioning, and quality of life.23 Further, research on peer-delivered structured 
curricula (e.g., coping, problem solving) demonstrated that peers were effective in this role.23 Evidence 
also suggests that mental health peers working with patients on mental health concerns and/or health 
Table 1. Sample of Whole Health 
Coaching Assessment and Goals. 
Assessment 
Domain 
Example 
Values  
Family and Work 
Area of 
Focus 
Power of the Mind: 
Relaxing and Healing 
SMART Goal 
In the next 3-6 months, I 
will learn relaxation and 
mindfulness skills to cope 
with irritability with my 
family and co-workers. 
Action Steps 
In the next week, I will 
read about VHA treatment 
options and try a yoga 
class at the YMCA. 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
4 
issues can improve patient outcomes including quality of life, socialization, hope, recovery, fatigue, 
sleep, symptoms, daily functioning, patient activation, and use of health services.23-26 
Veterans with PTSD report that peer services can significantly improve PTSD services through providing 
social support, normalizing symptoms, instilling hope for recovery, and linking Veterans with additional 
services.27 Some specific benefits that Veterans reported about working with a peer compared with a 
non-peer provider are: increased trust, increased likelihood of following through on recommended 
treatments, and increased hope for recovery along with decreased stigma.27 In addition, Veterans 
indicated that peer services to encourage implementation of provider recommendations and pursuit of 
life goals would be helpful.27 
2.2 
RISK/BENEFIT ASSESSMENT   
Potential Risks 
There is minimal risk to Veterans from their participation in any of the research activities. The 
procedures are non-invasive and will not cause physical harm to participants. There is minimal 
psychological risk (i.e., embarrassment, discomfort) to participants when asked to share sensitive 
information about themselves (e.g., regarding trauma and suicidality) with the research staff. 
Participants will be assessed for suicide risk according to an established protocol. No deception is 
involved in this study. 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 voice recordings will be stored separately and in accordance with the data 
security and privacy procedures below. Identifiable information for informed consent, payment, and 
enrollment status will be stored separately from study data and will also comply with the data security 
and privacy procedures. 
All research staff will be up to date on all required VA and IRB trainings in the responsible conduct of 
research including privacy, confidentiality, HIPAA regulations, recruitment procedures, informed 
consent, and data management. 
Additionally, the PI will provide study-specific training in those topics as well as appropriate conduct of 
the telephone screenings, interviewing skills, collection of self-report data, intervention delivery, and 
data entry/management, and analysis. The PI will supervise and provide regular internal trainings and 
audits of aspects of the responsible conduct of research. Only approved research staff will have access 
to the data. All data will be kept strictly confidential and secure per American Psychological Association 
(APA) ethical standards and IRB protocol. 
Veteran Safety 
Multiple procedures will be in place to minimize psychological risk including (1) participants will be 
reminded that they can choose not to answer any question that they are uncomfortable with, (2) 
participants will be reminded that they can choose to withdraw from the study at any time, (3) on-call 
clinicians (licensed independent providers) will be available to speak with Veterans who report distress 
during any study procedure, and (4) participants will be reminded that they can choose to engage in 
additional mental health services, including specialty PTSD treatment, at any point in the study. All 
referral requests will be promptly facilitated by the PI or on-call clinician and urgent requests will be 
provided with same day access through the facility procedures. This study team has conducted 
numerous studies using similar methods and there have been very few issues. We do not anticipate any 
serious or significant risk with these procedures.  
A number of procedures will be in place for participants who have more urgent needs including needs 
for immediate medical or mental health care. If participants should require medical attention, they will 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
5 
be directed to contact VA medical services, local community hospital, and/or 911 as appropriate. For 
Veterans who are unable to contact required medical services for themselves, research staff will assist 
with connecting Veterans with required services. For Veterans who report urgent need of mental health 
services, they will be evaluated by the on-call clinician and connected with appropriate emergency 
mental health services as needed. For Veterans deemed at imminent risk of harm to self or others, they 
will be connected with the on-call clinician who will facilitate emergency services as necessary (e.g., 
police, Suicide Prevention Team, etc.). The PI and co-Is are licensed clinical psychologists with 
experience in crisis evaluation and management, and research staff will also have access to a list of on-
call clinicians to contact for the study including other licensed psychologists and social workers at the 
Center. Research staff will have detailed training in these protocols for managing urgent needs including 
imminent suicidal/homicidal risk. If Veterans enrolled in the study demonstrate non-imminent suicide 
risk (e.g., ongoing ideation with no plan or intent), additional suicide risk assessments will be conducted 
by study staff and the intervention provider as needed. 
Potential Benefits.  
The potential benefits of the proposed project outweigh the minimal risks. Risks are non-invasive and 
consist primarily of the possibility of mild psychological distress. There are several potential direct 
benefits for participants. The interviews, telephone screenings, and assessment sessions may provide 
the opportunity for Veterans to thoughtfully reflect on their current situation which may increase insight 
and prompt change (e.g., behavior changes or seeking additional treatment). Veterans will also receive 
monetary compensation for all assessments completed. 
Additionally, all participants will receive the peer-delivered Whole Health Coaching intervention, which 
may increase progress toward health and wellness goals and other improvements in other outcomes 
(e.g., PTSD symptom reduction, functional outcome improvement, patient activation). 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. Overall, the risk to benefit ratio seems favorable. The protocol outlines procedures for 
minimizing risk, and the benefits of evaluating peer-delivered Whole Health Coaching are high. We 
believe the potential benefit of this research outweighs the limited risk to research participants. 
3 
STUDY DESIGN  
This is a quantitative project with a minor qualitative component. This project will use a multiple-
baseline design across participants with non-concurrent replications to measure the impact of Whole 
Health Coaching on Veterans’ progress toward health and wellness goals. In this design, outcomes are 
monitored over time prior to the onset of an intervention, to establish a baseline, and after the onset of 
an intervention to evaluate changes in outcomes for each participant.32 In addition, the start of the 
intervention is staggered across participants to demonstrate experimental control (i.e., that the 
intervention and not some other extraneous variable was responsible for any changes that were 
observed). Data from each participant's intervention phase are compared to that person's baseline phase 
(within-series comparisons) and to the overlapping portions of other participants' baseline phases who 
have not yet begun the intervention (between-series comparisons). We plan to recruit so that Veterans 
start baseline in groups of 2-3 and move through the study concurrently. Participants who start baseline 
concurrently will be randomized to different baseline lengths to establish temporal precedence of 
change and control for history effects.32 The minimum baseline length of 4 weeks (eight possible 
assessment points) allows for sufficient assessments for the statistical model. Intervention will be 
introduced when each participant meets a baseline stability criterion defined as at least four data points 
total, the final two of which fall within the range of the previous data points (i.e., no increasing slope or 
trend over the final three baseline data points). There will be flexibility to extend baseline by one week if 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
6 
participants have not met the stability criterion. The maximum possible baseline will be 13 weeks. 
Following the baseline period, participants will complete ongoing twice weekly assessments throughout 
the 8 week peer-delivered Whole Health Coaching phase, and 3-12 week post-intervention phase for 
the remainder of the 24-week study period. 
4 
STUDY POPULATION 
We will enroll 50 participants aiming to have 25 eligible participants and 8-10 study completers.  
Study completers are defined as Veterans who complete sufficient research tasks to conduct visual 
analysis for the multiple baseline design (i.e., at least 4 baseline data points that meet the stability 
criterion, initiate intervention within 2 weeks of scheduled intervention start date, and complete at least 
4 intervention phase assessments) and complete the intervention (i.e., completed the Personal Health 
Inventory with the peer as the basis of Whole Health Coaching, defined a focus for coaching (Whole 
Health Coaching Stage II Phase II), set a goal  (Whole Health Coaching Stage III Phase I), established an 
action step (Whole Health Coaching Stage III Phase II), and assessed the action taken (Whole Health 
Coaching Stage IV Phase I).  
4.1 
ELIGIBILITY CRITERIA 
Criteria 
Methods for Determining Eligibility 
Inclusion 
 
Veteran status (Non- 
Veterans will not be 
included) 
EMR data (either though datapull or chart review) 
Enrolled in primary care at 
the Syracuse VA (and 
affiliated CBOCs) and seen 
in primary care within the 
past year 
EMR data (either through datapull or chart review) 
Age over 18 
EMR data (either through datapull or chart review) 
Probable PTSD 
1. 
Criterion A is met 
2. 
Score above the 
specified cutoff 
PCL-5 
1. LEC + Criterion A screener positive  
2. PCL-5 ≥ 33 
Exclusion 
 
Unable to communicate in 
spoken and written English 
Research staff assessment. Exclude if ANY of the following are 
present: 
• 
Unable to verbally respond to informed consent items 
• 
Unable to engage in meaningful coherent back-and-forth 
dialogue with researcher to the extent that this interferes with 
research procedures 
• 
Unable to read study materials and complete written 
tasks required for research participation 
Research staff will bring any concerns to the PI for PI discretion and 
clinical judgment of communication concerns. 
Gross cognitive impairment 
Blessed Orientation Memory Concentration (BOMC) > 15. 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
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All Veterans scoring BOMC above 10 and below 16 will be referred 
to the PI for PI determination of likely cognitive impairment based on 
participant's cognitive screening responses, direct evaluation of 
Veteran, and/or EMR review 
Current symptoms of 
mania/psychosis 
EMR data (either through datapull or chart review) and Research staff 
assessment of inability to engage in the consent or research process. 
All research staff concerns will be reviewed with the PI for evaluation 
of likely impairment due to mania/psychosis and PI discretion for 
enrollment. 
At risk for suicide 
Measured by the P4 screener, defined as any Veteran with “higher” 
risk on the P4 Screener or Veterans with “lower” risk on the P4 and 
evaluated by the PI or another clinician to be clinically unstable or at 
risk. 
UNTIL 
Referral to suicide prevention is complete AND connected with 
ongoing services from a licensed independent provider who agrees 
to monitor safety concerns, be a point of contact for the peer support 
specialist, and determines the Veteran is stable for enrollment. Given 
subsequent eligibility requirement that the Veteran not be receiving 
psychotherapy in a non-primary care setting, if a Veteran is to be 
enrolled in the study with LIP monitoring, the LIP would need to be a 
primary care staff member, ongoing psychiatrist (for medication 
management only), or PCMHI provider. 
Engaged in psychotherapy 
in a non- primary care 
setting in the last 2 months 
EMR data (either through datapull or chart review) and self-report 
Changes to psychotropic 
medications for PTSD 
within the last 2 months 
EMR data (either through datapull or chart review) and self-report 
Preference for direct 
referral to specialty 
mental healthcare 
Veteran self-report 
4.2 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Patients who screen positive on the PC-PTSD screen (which is delivered as part of standard practice), 
who have PTSD chart diagnoses, and/or are deemed clinically appropriate for referral will be referred by 
their PCPs, PC-MHI providers, or OEF/OIF/OND case managers. To help identify potential referrals, 
research staff will create a list of these patients monthly and then ask their providers to refer these 
patients to the study. This list may be developed using the Veterans Affairs (VA) electronic medical 
record, or via the VA Informatics and Computing Infrastructure (VINCI). VINCI is a VA HSR&D resource 
center that provides a secure, central analytic platform for performing research 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 servers for securely 
hosting databases from VA data sources. VINCI servers are physically located at the VA Austin 
Information Technology Center (AITC), located in Austin, Texas, which has multiple layers of security and 
disaster recovery to prevent data loss. Only designated members of the study team are granted access 
to study-specific data through a certified VHA network computer within the VA or approved Virtual 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
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Private Network (VPN) and Remote Desktop application. The recruitment lists are generated through 
VINCI with an IRB-approved request from individual VistA systems to the VA Corporate Data Warehouse 
where it is prepared and placed into a secure database for use by the study team. 
 
Once the names are identified from the VA electronic medical record and/or received from VINCI and 
the primary care provider has signed-off, research staff will send an IRB approved letter that is signed by 
the P.I. to all referred Veterans with the purpose of introducing the study. Study staff will then contact 
referred patients by phone or in person to assess their interest in participation and administer an initial 
screen. Additionally, referral interactions with study staff may occur in person at the Syracuse VAMC or 
Behavioral Outpatient Center. 
 
We also plan to engage in multiple direct recruitment strategies. Research staff will set up an 
information table in the common areas at the VAMC. Research study staff will be present at the table 
and will distribute IRB approved brochures and/or flyers containing information about the study. IRB 
approved flyers may also be placed around the Syracuse VAMC and other community locations (e.g., the 
Vet Center), where appropriate. Approved electronic flyers will also be posted electronically at the VA 
medical center and other electronic venues (e.g., the Syracuse VA facebook page).  The IRB approved 
flyers and brochures include research staff contact information, allowing potential participants to 
directly contact staff via phone. Interested and potentially eligible patients will be scheduled for a 
baseline research appointment within their PC clinic where study inclusion will be determined. 
 
5 
STUDY INTERVENTION 
5.1 
STUDY INTERVENTION(S) ADMINISTRATION 
5.1.1 STUDY INTERVENTION DESCRIPTION 
Whole Health Coaching will be implemented as designed by the VHA OPCC&CT and delivered by a peer 
specialist who has completed the OPCC&CT Whole Health Coaching training. Whole Health Coaching is 
explained in detail in the background. Veterans will meet weekly with a peer specialist for 30-50 
minutes. The service is designed to accommodate varying patient readiness for change and system 
barriers, but 8 weeks is a typical length. For this project, the peer support specialist will adjust the time 
frame and frequency as needed to help Veterans achieve progress on wellness goals. Although typical 
primary care interventions are briefer, peers in primary care are not bound by the same guidelines 
typically recommended for PC-MHI providers. Unlike the model for PC-MHI which focuses on facilitating 
increased access through population-based care (i.e., providing a small amount of services to many 
patients), the peer support model focuses on improving the patient experience of care. This allows the 
peers to spend more time with Veterans. 
 
6 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
6.1 
INVESTIGATOR DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants may be removed at PI discretion for research integrity (e.g., if participants are not 
completing study expectations such as engaging with the peer support provider) or safety purposes 
(e.g., if a participant demonstrates elevated risk and would benefit from removal from the study). 
 
6.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
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Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
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7 
STUDY ASSESSMENTS AND PROCEDURES 
7.1 
ASSESSMENTS & ASSESSMENT SCHEDULE 
Screening Measures. The Blessed Orientation-Memory-Concentration test (BOMC) is a 6-item interview 
of cognitive impairment that will be administered prior to any other measures. Scores range from 0 (all 
items correct) to 28 (all items incorrect). This measure has sound psychometric properties.35 The P4 
Screener will be administered by research staff to assess risk for suicide. It assesses the 4 P’s: past 
history, plan, probability, and preventive factors and then classifies respondents as minimal, lower, or 
higher risk for suicide. The P4 will be re-administered at the follow-up assessments as needed to 
evaluate risk. The P4 has been validated in several large studies of medical patients enrolled in 
depression studies and has sound psychometric properties.36 The PCL-5 will be used to screen for 
presence of PTSD symptoms. The PCL-5 includes assessment of Criterion A traumatic events. To confirm 
the absence of non-VA mental healthcare, a short questionnaire titled Non-VA Service Utilization Screen 
will be administered. Screening for mania, psychosis, non-PC-MHI psychotherapy, and changes to PTSD 
medications in the past 2 months will be via chart review of VA records and self-report of non-VA 
services. A Demographics and Military Background questionnaire will be used to assess basic 
demographic information (e.g. sex, age, education, employment, and income) as well as military 
background including deployment history (e.g., length, number, and locations), military rank/positions, 
branch, active/reserve status, and dates of service. This self-report measure is modeled after one used 
in CIH studies of Veterans with PTSD. 
 
Primary Outcome. The primary outcome directly evaluates the target of Whole Health Coaching: 
progress toward health and wellness goals. Progress toward health and wellness goals will be measured 
by Goal Attainment Scaling (GAS), one of the most established applied methods for evaluating 
individualized progress toward rehabilitation goals.37-40 GAS has strong psychometrics as an outcome 
measure in rehabilitation and mental health.38,40 In rehabilitation, recent reviews show strong inter-rater 
reliability, convergent validity, and sensitivity as an outcome measure.38,40 In mental health, fewer 
studies were reported in the review, but available psychometric data are consistent with rehabilitation 
findings.40 Additionally, GAS demonstrated sensitivity to change in a recent peer-delivered coaching 
intervention.41 GAS is a measurement technique designed to be adapted to meet the needs of individual 
patients, settings, and studies; we have adapted a version with specified behavioral anchors42 to 
evaluate the domains targeted by Whole Health Coaching. We selected this version to (1) reduce burden 
in establishing individualized rating criteria and (2) increase transparency, reproducibility, and validity. 
We also plan to follow other recommended guidelines to further enhance validity, reproducibility, 
transparency, and rigor.39  
 
Secondary Outcomes.  
The Inventory of Psychosocial Functioning (IPF) consists of 80 items on a 7 point scale measuring 
functioning in romantic relationships, family relationships, work, friendships and socializing, parenting, 
education, and self care.49 The IPF was developed to evaluate functional impairment in Veterans with 
PTSD and demonstrates good reliability, internal consistency, and convergent validity.49  
 
The PTSD Checklist for DSM-5 (PCL-5), a 20-item scale, measures diagnostic criteria of PTSD on a 0-4 
scale.50 The PCL-5 demonstrates good reliability and validity.50 
 
The 8-item Client Satisfaction Questionnaire (CSQ) is designed to measure patient satisfaction with 
services and demonstrates good reliability.51 

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Table 2. Assessment Schedule 
Administration Time Points 
Measure 
Baseline 
Assessment 
Pre & Follow-
up 
Assessments 
Post 
Assessment 
Twice Weekly 
Assessments 
(All Phases) 
Blessed Orientation-Memory-
Concentration (BOMC) 
X 
 
 
 
P4 Suicide Screener 
X 
 
 
 
Non-VA Service Utilization Screen 
X 
 
 
 
Demographics & Military 
Background 
X 
 
 
 
PTSD Checklist-5 (PCL-5) 
X 
X 
X 
 
Inventory of Psychosocial 
Functioning (IPF) 
X 
X 
X 
 
Client Satisfaction Questionnaire 
(CSQ) 
 
 
X 
 
Goal Attainment Scaling (GAS) 
X 
 
 
X 
*Note. Additional suicide risk evaluations will be conducted as needed to monitor for suicidality. 
 
7.2 
PAYMENT 
Participants will be paid $20 each for completing the one-time baseline (including ineligible 
participants), pre, and follow-up assessments and $30 for completing the post assessment. For the twice 
weekly assessments, participants will be reimbursed on a payment schedule similar to one used in a 
previous study including $5 for each completed assessment with bonuses for high compliance rates.34 
Participants will not be reimbursed for intervention sessions. 
 
8 
STATISTICAL ANALYSES  
To analyze the primary outcome, GAS, we will use a variation of multi-level modeling (MLM) tailored to 
analyze single- case experimental design data.58 The appropriateness of the model will be evaluated and 
adapted as needed to fit the data including evaluating and implementing covariance structures to 
accommodate autocorrelation such as an auto- regressive error structure. We will evaluate alternative 
models to assess model assumptions and robustness of treatment effects. These analyses will be 
supplemented with visual inspection by graphing participants’ outcomes in a multiple- baseline design 
format throughout the study.59 Graphs will be aligned across participants in order to establish temporal 
precedence of symptom change and intervention onset and demonstrate replication across participants 
within the sample. MLM and visual analysis of the primary outcomes will be supplemented with a non-
overlap of all pairs effect size.60 Other quantitative outcomes will be analyzed through descriptive 
statistics, and will be used to generate pre-post effect size estimates for Veteran outcomes to establish 
initial estimates of efficacy for power estimates. 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS  
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
9.1.1 INFORMED CONSENT PROCESS 
At the one-time in-person baseline assessment, Veterans will be provided with comprehensive oral and 
written information about the study procedures, anticipated risks and benefits, and rights as a research 
participant (including the right to refuse participation or withdraw from the study at any time). Veterans 

Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans with PTSD 
PI: Johnson 
Abbreviated Final Version for Public Dissemination on ClinicalTrials.gov 
30 October 2020 
NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
11 
will be informed that participation (or lack of participation) in the research study will not affect their 
eligibility for care at the VA. Veterans will be asked to provide written informed consent and will be 
offered a copy of their signed informed consent document for their records. Limits of confidentiality and 
importance of Veterans’ safety will be outlined. 
9.1.2 DATA AND SAFETY MONITORING PLAN 
The PI along with co-Is Drs. Possemato and Maisto, will oversee data and safety monitoring to ensure 
the safety of participants and integrity of data collected. The study is non-invasive and involves 
interviews, self-report questionnaires, and attendance at intervention sessions. The interventionist is a 
certified peer support specialist with previous experience implementing research protocols at the 
Syracuse VAMC and training in crisis management. The PI, a licensed clinical psychologist, will be on-call 
and a back-up list of on-call clinicians will be available for the interventionist and other research staff 
working on the project.  
Coded self-report survey data will be collected via paper and pen or using PsychData, an online data 
collection tool. No identifiable information will be entered into PsychData. Some data will temporarily 
be stored on the PsychData system but all data entered by participants will be downloaded by research 
staff to secure VA systems regularly. See PsychData Security Statement in Appendix 2. In instances 
where PsychData is used participants will complete online surveys via PsychData, but VA research staff 
will download and store all data in secure VA drives. Only coded data will be entered. 
Identifiable data will be stored in locked filing cabinets and password protected computer files.  
All protocol deviations, adverse events, serious adverse events, and other problems will be identified 
and reported to the IRB and other appropriate individuals/offices as stipulated by VA regulations. All 
study records and files will undergo periodic internal audits to ensure protocol compliance, as well as 
additional audits per VA policy. All paper and electronic data will be stored according to the methods 
described above, which are compliant with data security VA policies.  
Recruitment, intervention, and assessment procedures will be monitored by the PI on a weekly basis to 
ensure we are meeting our goals and complying with all policies. In addition, the PI supervises periodic 
internal audits of data safety and security of all ongoing projects to ensure data integrity and 
management in accordance with VA guidelines.  
We plan to send fully anonymous data from the anonymous online survey to a statistical consultant via 
Safe Access File Exchange (SAFE) for the consultant to analyze the data off the VA network using his own 
equipment. No sensitive data or identifiable records will be sent, all survey responses are fully 
anonymous. All original copies of the data will remain on secure VA drives. 
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NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 
 
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