Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
Study Protocol 
Teaching Loved Ones to Help Veteran Optimize their PTSD Care and Healing (COACH) 
Funding Agency: VA RR&D 
Principal Investigator: Laura A Meis, PhD 
Version 11: February 24, 2022 
 
 
 
 

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Tool Revision History 
 
Version number 1 
Version date: June 8, 2020 
Initial protocol version first submitted to IRB for project PI/SC. 
 
Version number 2 
Version date: October 27, 2020 
Summary of revisions made: Amendment 1; Putting study surveys on the online version on VA 
approved Qualtrics FedRAMP software; using email correspondence to send survey links to 
participants; providing a telemedicine option for treatment; modifying our inclusions/exclusions 
to requiring patients be seen via telehealth when in-person treatment options aren’t available. 
 
Version number 3 
Version date: January 27, 2021 
Summary of revisions made: Amendment 2; revising our study materials document; finalizing 
the study surveys, including survey timelines and survey measures; increasing compensation 
for patient compensation for study survey completion; adding study brochures and flyer. 
 
Version number 4 
Version date: February 19, 2021 
Summary of revisions made: Amendment 3; revising the Loved One screener; adding new 
inclusionary criteria that couples must live in state; adding the CSI-16. 
 
Version number 5 
Version date: March 24, 2021 
Summary of revisions made: Amendment 4; updating the inclusions/exclusions to exclude or 
delay individual's entry to the study on a case-by-case basis based on their clinical presentation; 
updating HIPAA form; ability to respond to emails from potential participants. 
 
Version number 6 
Version date: April 19, 2021 
Summary of revisions made: Amendment 5; adding monthly survey emails; increasing 
enrollment goal; creating Facebook study group and Facebook study post; adding study 
therapists; remove requirement that couples must live in state. 
 
Version number 7 
Version date: June 9, 2021 
Summary of revisions made: Amendment 6; addition of Docusign as a manner of signing 
informed consent forms and HIPAA authorization electronically; addition of a final contact letter. 
 
Version number 8 
Version date: June 24, 2021 
Summary of revisions made: Amendment 7; requiring participants to retake baseline surveys or 
assessments if they expire more than 2 months (60 days). 
 
Version number 9 
Version date: August 3, 2021 
Summary of revisions made: Amendment 8; updating incentive amounts; removing payment for 
symptoms assessments given weekly; reducing baseline survey amount to $40. 
 

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Version number 10 
Version date: October 13, 2021 
Summary of revisions made: Amendment 11; request to use Keystrokes transcription services 
to obtain transcriptions of patient recorded interviews. 
 
Version number 11 
Version date: February 24, 2022 
Summary of revisions made: Amendment 14; adding a 3-month follow-up survey. 
 
 
 
 

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Abstract 
Impacts. We aim to improve the mental health, family functioning, and well-being of veterans 
with posttraumatic stress disorder (PTSD) through developing and evaluating a trauma-focused, 
couple therapy for PTSD. We will use strategies from Integrative Behavioral Couple Therapy 
(ICBT) to help loved ones support veterans during exposure therapy for PTSD (Prolonged 
Exposure; PE). We anticipate this approach will increase veterans’ engagement in PE, but also 
improve relationship functioning, family functioning, and social functioning. Family involvement 
has been highlighted as a fertile avenue for improving the outcomes for patients with PTSD, yet 
families are infrequently integrated into evidence-based psychotherapies (EBPs). Our goals are 
highly is consistent with RR&D’s mission to promote research that leverages family support as a 
pathway to reintegration and optimizes meaningful recovery and functioning. 
 
Background. PTSD occurs in as many as 17% of US military veterans and is associated with 
a host of negative, long-term consequences to the individual, their families, and society at large. 
EBPs, such as PE, result in clinically significant symptom relief for many. Yet, these therapies 
have proven less effective for military personnel and veterans and treatment dropout rates are 
high. Our team surveyed veterans initiating EBPs for PTSD and a family member across four 
VA medical centers (N = 598; Project HomeFront). We found that veterans were more than 
twice as likely to complete EBPs when loved ones encouraged them to confront distress and 
that veterans experienced greater treatment gains when they shared more with their loved ones 
about their treatment. A couples-based, exposure therapy for PTSD that integrates loved ones 
into every session of PE could provide the opportunity to mobilize the whole household in the 
service of EBP engagement, while extending the goals of therapy beyond symptom reduction to 
family functioning. We anticipate this intervention will teach couples to embrace a lifestyle that 
supports confronting trauma-related distress, so the veteran and his/her family can achieve 
optimal functional outcomes.  
 
Objectives. We will complete stages 1A and 1B of the Stage Model of Treatment Development. 
Specifically, we will: (1) Expand our treatment outline using content experts and feedback from 
key stakeholders (veterans, loved ones, providers, and VA mental health leadership). (2) 
Conduct a pilot open trial to assess (a) the acceptability of treatment components, structure, and 
materials, (b) the feasibility of the intervention (retention and intervention fidelity), and (c) the 
study approach (screening, recruitment, and assessment process). (3) Explore the preliminary 
effects of the intervention on select outcomes including overall functioning, mental health 
functioning, social functioning, family functioning, and potential mechanisms (social control, 
subjective norms, and the degree to which veterans rely on their partners for support). 
 
Methods: To accomplish Aim 1, we will expand the outline for the intervention into an initial 
treatment manual through meetings with content experts and stakeholder feedback. Next, we 
will develop fidelity checklists and revise the treatment manual through conducting the 
intervention with 2-3 couples. To accomplish Aims 2 and 3, we will evaluate the intervention in a 
non-randomized, open trial with 12 veterans diagnosed with PTSD and their loved ones. 
Veterans will complete baseline and posttreatment structured diagnostic interviews. Both 
members of the couple will complete baseline surveys, surveys during treatment, posttreatment 
surveys, and posttreatment qualitative exit interviews. Using data obtained from the open trial, 
we will assess the intervention’s acceptability, feasibility, mechanisms, and outcomes. Upon 
completion of this proposal, we will be well positioned to apply for Merit funding for a 
randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this 
innovative, exposure based, couple therapy. 
 

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List of Abbreviations, Acronyms, and Symbols 
 
BFT  
 
Behavioral Family Therapy  
CAPS-5  
Clinician-Administered PTSD Scale for DSM-5  
CCDOR  
Center for Care Delivery & Outcomes Research  
CES   
Credibility Expectancy Scale  
CE  
 
Studio Community Engagement Studio  
Co-I  
 
Co-Investigator  
COACH  
Teaching Loved Ones to Help Veterans Optimize their PTSD Care and Healing  
CPT   
Cognitive Processing Therapy  
CSQ-8  
Client Evaluation of Services Questionnaire  
DSM-5  
Diagnostic and Statistical Manual of Mental Disorders  
DoD   
Department of Defense  
EBP   
Evidence Based Psychotherapy  
FES 
 
Family Environment Scale  
HSR&D  
Health Services Research and Development  
HW  
 
Homework  
IPF  
 
Inventory of Psychological Functioning  
IIR  
 
Investigator-Initiated Research  
IRB  
 
Institutional Review Board  
ICBT   
Integrative Behavioral Couples Therapy  
LO  
 
Loved Ones  
MI  
 
Motivational Interviewing  
MH  
 
Mental Health  
N/A  
 
Not Applicable  
OCD   
Obsessive Compulsive Disorder  
OEF   
Operation Enduring Freedom  
OIF  
 
Operation Iraqi Freedom  
OMHS  
Office of Mental Health Services  
PEAS   
Patient Exposure and Response Prevention Adherence Scale  
PCL   
Posttraumatic Stress Disorder Checklist (DSM-IV)  
PCL-5   
Posttraumatic Stress Disorder Checklist (DSM-5)  
PE  
 
Prolonged Exposure  
PHQ-9  
Patient Health Questionnaire  
PI  
 
Principal Investigator  
PTSD   
Posttraumatic Stress Disorder  
RCT   
Randomized Controlled Trial  
SCID-5-CT  
Clinical Trials Version of the Structured Clinical Interview for DSM-5  
VA  
 
Veterans Affairs  
VAHCS  
Veterans Affairs Health Care System  
VHA   
Veterans Health Administration  
 

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Table of Contents 
Protocol Title:  Teaching Loved Ones to Help Veteran Optimize their PTSD Care and Healing 
(COACH) ....................................................................................................................................... 8 
1.0 
Study Personnel ................................................................................................................. 8 
2.0 
Introduction ........................................................................................................................ 8 
2.1 Preliminary Studies. .......................................................................................................... 10 
2.2 Significance. ...................................................................................................................... 11 
3.0 
Specific Aims .................................................................................................................... 11 
4.0 
Resources and Personnel ................................................................................................ 13 
4.1 Research Site .................................................................................................................... 13 
4.2 Principal Investigator. ........................................................................................................ 13 
4.3 Co-Investigators. ............................................................................................................... 13 
4.4 Study Personnel. ............................................................................................................... 13 
5.0 
Study Procedures ............................................................................................................. 15 
5.1 Study Design ..................................................................................................................... 15 
5.2 Delivery by Telemedicine .................................................................................................. 15 
5.2 Initial Treatment Manual. ................................................................................................... 15 
5.2A. Intervention Overview. ................................................................................................ 15 
5.2B. Manual Expansion ...................................................................................................... 16 
5.2C. Stakeholder Feedback. .............................................................................................. 16 
5.2D. Identifying Stakeholders. ............................................................................................ 16 
5.2E. Manual Refinement .................................................................................................... 17 
5.3 Open Trial. ......................................................................................................................... 17 
5.3A. Sample Identification & Recruitment .......................................................................... 17 
5.4 Limitations and Design Considerations ............................................................................. 18 
5.5 Project Management. ........................................................................................................ 19 
5.6 Human Subjects ................................................................................................................ 19 
5.6A. Risk to Subjects .......................................................................................................... 20 
5.6B. Protection Against Risk .............................................................................................. 21 
5.6C. Potential Benefits of the Proposed Research to the Subject and Others ................... 24 
5.6D. Importance of Knowledge to be Gained ..................................................................... 24 
5.6E. Data and Safety Monitoring Plan ................................................................................ 25 
5.6F. Inclusion of Women and Minorities. ............................................................................ 27 
5.6G. Inclusion of Children. ................................................................................................. 27 

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5.7 Recruitment Methods ........................................................................................................ 27 
5.7A. Study Setting .............................................................................................................. 27 
5.7B. Recruitment Training .................................................................................................. 27 
5.7C. Referral Sources. ....................................................................................................... 27 
5.7D. Veteran Recruitment Processes ................................................................................ 28 
5.7E. LO Recruitment Processes .......................................... Error! Bookmark not defined. 
5.8 Informed Consent Procedures .......................................................................................... 30 
5.8A. Veteran Informed Consent. ........................................................................................ 30 
5.8B. LO Informed Consent ................................................................................................. 31 
5.8C. Incentives ................................................................................................................... 32 
5.9 Inclusion/Exclusion Criteria ............................................................................................... 32 
6.0 
Data Collection & Study Evaluations ................................................................................ 34 
6.1 Data Collection. ................................................................................................................. 34 
6.2 Fidelity Checklists and Provider Training. ......................................................................... 35 
6.3 Final RCT Manual. ............................................................................................................ 35 
6.4 Qualtrics Online Surveys ................................................................................................... 36 
7.0 
Data Analysis ................................................................................................................... 39 
7.1 Qualitative Data Analysis. ................................................................................................. 39 
7.2 Quantitative Data Analysis. ............................................................................................... 39 
7.3 Withdrawal of Subjects ...................................................................................................... 40 
8.0 
Reporting .......................................................................................................................... 41 
9.0 
Privacy and Confidentiality ............................................................................................... 42 
9.1 Confidentiality .................................................................................................................... 42 
9.2 Data Security ..................................................................................................................... 42 
9.2A. Maintaining Secure Servers. ...................................................................................... 43 
9.2B. Data Used for Analysis. .............................................................................................. 44 
10.0 
 Communication Plan ....................................................................................................... 45 
11.0 
References ....................................................................................................................... 46 
 
 
 

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Protocol Title:  Teaching Loved Ones to Help Veteran Optimize their PTSD Care 
and Healing (COACH) 
 
1.0 
Study Personnel 
 
Principal Investigator/Study Chair:  
1. Laura Meis, PhD; laura.meis@va.gov, 612-467-4516; VA employee Minneapolis VAHCS 
 
Co-Investigators:  
2. Shannon Marie Kehle-Forbes, PhD; Shannon.kehle-forbes@va.gov, 612-467-4772; VA 
employee Minneapolis VAHCS 
3. Chris Erbes, PhD; Christopher.erbes@va.gov, 612-467-5868; VA employee Minneapolis 
VAHCS 
4. Shirley M. Glynn, PhD; Shirley.glynn@va.gov, 310-268-3939; VA employee Los Angeles 
VHAGLA 
5. Afsoon Eftekhari, PhD; Afsoon.eftekhari@va.gov, (650) 493-5000 ext. 22393, VA 
employee, Palo Alto VA 
 
Study Personnel:  
1. Erin Linden, MPH; Erin.Linden@va.gov, 612-467-5868; VA employee Minneapolis 
VAHCS 
2. Ann Bangerter, BS; ann.bangerter@va.gov, 612-467-1384; VA employee Minneapolis 
VAHCS 
3. Emily Hagel Campbell, MS; emilyhagelcampbell.@va.gov, 612-725-2000 x7451; VA 
employee Minneapolis VAHCS 
4. Andrea Cutting, MS; andrea.cutting@va.gov, 612-467-1881; VA employee Minneapolis 
VAHCS 
5. Emily Campbell, MS; Emily.Campbell5@va.gov, 612-629-7381; VA employee 
Minneapolis VAHCS 
6. Camryn Kostick, BA, Camryn.Kostick@va.gov; (651) 325-7025; VA WOC, Minneapolis 
VAHCS 
7. Marianne Schumacher, Marianne.Schumacher@va.gov; 612.725.2000 x3985; VA 
employee, Minneapolis VAHCS  
 
Study Therapists: 
1. Elizabeth Robison-Andrew, PhD, Elizabeth.Robison-Andrew@va.gov; 612.725.2000 
x1463; VA employee, Minneapolis VAHCS 
2. Christopher Chuick, PhD, Christopher.Chuick@va.gov; 612-467-1703; VA employee, 
Minneapolis VAHCS 
2.0 
Introduction 
PTSD is a prevalent and potentially debilitating condition associated with a host of negative, 
long-term consequences and functional impairment.2,3,5,6,28 In response, the VA has made two 
EBPs widely available, PE and CPT. The evidence for the effectiveness of these therapies is 

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strong.8 In randomized controlled trials, these and other trauma-focused EBPs yield large 
symptom improvements, and most patients recover or improve29. However, residual 
symptoms are common,29 treatment response for military personnel lags behind other 
populations,12 and dropout rates are high.30 For example, among a large sample of post-9/11 
veterans who initiated PE or CPT with a VA clinic over a 15-year period, 60% failed to 
complete an adequate dose of treatment.30 PE and CPT are intensive treatments that require 
weekly, sustained attendance (10-12 weeks) and frequent, ideally daily, practice of the skills 
learned. In PE, this home practice is designed to break destructive habits of avoidance through 
repeated and sustained revisiting of traumatic memories (imaginal exposure) and approach of 
avoided activities in real life (in vivo exposure). Greater engagement in these activities predicts 
a two-fold increase in the odds of patients achieving good end state functioning and remission.14 
However, patient engagement in these activities can be poor.13 Among HomeFront veterans 
who completed PE or CPT, only 38.7% finished most of their homework, and an important 
minority (20.3%) finished 25% or less of these assignments. Efforts to optimize the quality of 
veteran engagement in PE may hold promise as a pathway for maximizing the gains a given 
patient can reach.  
Teaching family members to support and coach veterans through these difficult activities 
provides one innovative approach to increasing engagement. Our prior work shows intimate 
relationships play a critical role in influencing OIF veterans’ treatment seeking22 and that 
veterans themselves are highly motivated to involve their partners in their PTSD care. 21 
Generally, family involved psychotherapies result in comparable or better outcomes than 
patient-only treatments for a number of mental health conditions.31–33 Ongoing efforts to 
integrate family members into PTSD treatment fall into two categories: (1) novel couple 
therapies designed to treat both relationship strain and PTSD34,35 and (2) brief family-
engagement strategies that educate families early in treatment (Improving Veteran Adherence 
to Treatment for PTSD Through Partnering with Families; PI: Meis; An Adjunctive Family 
Intervention for Individual PTSD treatment; PI: Thompson-Hollands). Novel couple therapies 
demonstrate promise,34,35 but their efficacy compared to EBPs for PTSD is not established. 
Brief family-engagement strategies for EBPs are under evaluation, including our own 
(Improving Veteran Adherence to Treatment for PTSD through Partnering with Families; Partner 
Enhanced PE; PE2; PI: Meis). These approaches aim to increase family support for treatment 
and decrease family behaviors that may undermine treatment in one to three family-member 
sessions.  
 
For some, one to three sessions with a family member may be insufficient. Relationship 
strain predicts poorer response to PTSD treatment,36,37 and HomeFront findings indicate 
family encouragement to confront distress may be less effective in strained relationships. 24 
Ingrained and complex patterns of family interaction may stymie loved ones’ (LOs’) 
effectiveness in supporting veterans, and these patterns are difficult to adequately identify, 
challenge, and shape quickly. Lastly, the brief family-engagement strategies described end 
family members’ session attendance before initiating imaginal exposure. This is when most 
of the difficult work of PE begins. Without weekly interaction, therapists cannot help couples 
manage unanticipated challenges like symptom exacerbation, interpersonal conflict, or 
partners’ frustrations with the veterans’ pace of change. We propose to adapt strategies from 

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Integrative Behavioral Couples Therapy (ICBT),38 an efficacious, evidence-based martial 
therapy intervention, to help couples support each other during this intensive therapy. The 
ICBT techniques we are adapting are most relevant to romantic couples and may look different 
for other veteran-LO relationships. If effective, we will explore how these approaches extend to 
other family constellations in future research. 
2.1 Preliminary Studies.  
Using strategies from ICBT and our ongoing trial (PE2), we plan to target three mechanisms that 
we anticipate will help couples lean into PE: social control efforts, subjective norms supporting 
PE participation, and greater veteran reliance on LOs as supports during treatment (Figure 1). 
By altering these mechanisms, we anticipate veterans will complete at-home exercises with 
greater quantity and quality than they are likely to do alone and better embrace the PE 
philosophy of approaching trauma-related distress. This will yield optimal symptom reductions 
and a corresponding improvement in general mental health and overall functioning. Through 
tackling this treatment together using ICBT strategies, we also anticipate couples will grow in 
their communication skills and acceptance of each other, improving their overall relationship 
functioning. A healthier intimate relationship and optimized PTSD symptom response should 
translate into healthier overall family functioning. In follow-up HomeFront surveys, we found that 
greater reductions in PTSD symptoms from baseline to follow-up predicted greater 
improvements in veteran-child relationships (β = -.23, p = .019) and greater reductions in LO 
reported caregiver burden (β = .18, p = .004). Lastly, many standard in vivo exercises are 
designed to improve veterans’ comfort in social situations (e.g., go to restaurants, family 
gatherings, concerts, the mall). Completing more of these exercises with greater skill may lead 
to greater comfort with and enthusiasm for social activities, improving social functioning.  
Data from HomeFront support our proposed mechanisms. First, we found that veterans were 
more than twice as likely to complete an EBP when a LO encouraged them to confront 
distress.24 This is a form of social control, which includes overt efforts by a LO to urge or 
encourage a person to change a targeted behavior.39,40 Initial HomeFront findings examining 
treatment response found that, when veterans indicated their families supported PE/CPT 
participation (i.e., subjective norms), veterans reported lower symptom severity in follow-up 
surveys (β = -.16, p = .013, controlling for baseline PTSD symptoms). Additionally, when 
veterans relied more on their LOs for support during treatment through talking with them more 
about their mental health treatment (β = -.14, p = .002) and discussing their homework (β = -.13, 
p = .004), veterans reported lower follow-up PTSD symptom severity, controlling for baseline.  
  
  
Outcomes 
Overall and MH Functioning 
Family Functioning 
Social Functioning 
LO Reliance 
Subjective Norms 
Social Control 
LOVED ONE 
VETERAN 
Lean Into  
1. PE 
2. Approaching 
Distress 
Integrative Behavioral 
Couple Therapy 
Partner Enhanced PE 
Strategies from 
Figure 1. COACH Conceptual Model 

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2.2 Significance.  
The influence of a successful course of PTSD treatment on a veteran’s life is considerable. In 
addition to reducing symptoms of PTSD and associated mental health problems (e.g., 
depression), successful PTSD treatment improves, reduces, and may even reverse the negative 
physical health effects associated with PTSD.10,41 Family involvement has been highlighted as 
a fertile avenue for improving the outcomes for patients with PTSD.7,27 Yet, despite 
congressional legislation and national mandates within VA/DoD for family involvement in PTSD 
care,7,8,42,43 family inclusion in PE and CPT is infrequent (17% among HomeFront veterans). 
Concordant with the Behavioral Health & Social Reintegration Program, this proposal will 
support work on an intervention intended to promote higher rates of recovery from PTSD, better 
overall functioning, greater family functioning, and greater social functioning. These outcomes 
are consistent with those patients likely find meaningful.27 Our stakeholder engagement 
strategies, described below, provide an additional pathway to ensuring COACH aligns with what 
LOs, providers, and VA leadership need in a family intervention for PTSD, building a more 
patient-centered approach to treating PTSD. Overall, this work is highly consistent with the 
explicit goals of the Behavioral Health & Social Reintegration Program to promote research that 
uses “family support as a means to reintegration” and leads veterans to “function more fully in 
society” and “embrace social situations”.  
3.0 
Specific Aims 
Posttraumatic stress disorder (PTSD) occurs in as many as 17% of US military veterans 1 and 
is associated with long-term functional impairment, poor quality of life, family problems, 
unemployment, and suicidality.2–6 Evidence-based psychotherapies (EBPs) such as 
Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) result in clinically 
significant symptom relief for many,7,8 improving physical health, social and work functioning, 
and quality of life.9–11 Yet, these therapies are less effective for military personnel and 
veterans, with up to one-half of patients failing to achieve meaningful recovery.12 Efforts to 
optimize veteran engagement in PE and CPT may hold promise as a pathway for maximizing 
gains. PE and CPT are intensive treatments requiring weekly, sustained attendance (10-12 
weeks) and frequent, ideally daily, practice of the skills learned. Engagement in these activities 
can be highly variable.13,14 Yet, they are an important predictor of treatment response.13–18  
Partnering with veterans’ significant others may provide a powerful method for helping 
veterans get more out of their PTSD treatment. Even with high rates of intimate 
relationship difficulties and divorce among veterans with PTSD,19 many are (a) married or 
living with an intimate partner20 and (b) interested in including their partners in their care.21 
Family members can help patients with PTSD initiate22,23 and stay in mental health care.24 Our 
team surveyed veterans initiating EBPs for PTSD and a family member across four VA medical 
centers (N = 598; Project HomeFront). We found that veterans were more than twice as likely to 
complete an EBP when a loved one encouraged them to confront distress24 and that veterans 
experienced greater treatment gains when they share more with their loved ones about their 
treatment.  

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Creating a couple-therapy approach to exposure therapy provides an opportunity to mobilize the 
whole household in the service of EBP engagement, while providing an opportunity to further 
extend the goals of therapy beyond symptom reduction. Through integrating a loved one in PE, 
we can simultaneously address relationship functioning and family functioning. We could also 
improve social functioning through increasing the quality and quantity of participation ‘in real life’ 
(in vivo) exposure exercises by asking couples to confront avoided social situations together. 
Our overall goal is to develop and pilot a couple-therapy approach to Prolonged 
Exposure that integrates loved ones into every session of PE. We will combine techniques 
from Integrative Behavioral Couples Therapy and a brief, three-session approach to involving 
family in PE (Partner Enhanced Prolonged Exposure). We anticipate this intervention will teach 
couples to embrace a lifestyle that supports confronting trauma-related distress, so the veteran 
can achieve optimal functional recovery, while improving both social and family functioning. We 
will complete stages 1A and 1B of the Stage Model of Treatment Development.25 This includes 
the following aims:  
Aim 1: Expand our treatment outline using content experts and feedback from key 
stakeholders (veterans, loved ones, providers, and VA mental health leadership).  
Aim 2: Conduct a pilot open trial to assess (a) the acceptability of treatment components, 
structure, and materials, (b) the feasibility of the intervention (retention and intervention fidelity), 
and (c) the study approach (screening, recruitment, and assessment process).  
Aim 3: Explore the preliminary effects of the intervention on select outcomes including overall 
functioning, mental health functioning, social functioning, family functioning, and potential 
mechanisms (social control, subjective norms, and the degree to which veterans rely on their 
partners for support). 
Impact: PTSD treatments (including PE and CPT) have been criticized for a narrow focus on 
symptom gains over goals that may be more meaningful to veterans, such as greater quality of 
life, interpersonal connections, and social functioning.26,27 Our proposal aims to expand the 
explicit targets of PE to these patient-centered outcomes. If our approach to a couple-based 
exposure therapy demonstrates promise, this proposal could provide the first step in a series of 
studies that feed the evolution of one-on-one symptom-focused psychotherapies into 
family-based interventions designed to lift the whole household. Our approaches could 
inform adaptations to interventions for a myriad of problems including suicide prevention, TBI 
rehabilitation, and pain management, contributing to a broader evolution towards evidence-
based, family-inclusive care focused on outcomes with meaning to veterans.  
 
 

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4.0 
Resources and Personnel 
4.1 Research Site 
1. 
Center for Chronic Disease Outcomes Research, Minneapolis VA, Minneapolis, 
MN. Activities that take place include the following: 
a. Data extraction  
b. Recruitment, obtaining informed consent, and data collection, 
including interviews by trained staff, who are the study coordinator 
and study manager  
c. Intervention administration/delivery 
d. Data analysis  
 
4.2 Principal Investigator. 
Laura Meis, PhD, LP 
a. Will have access to protected health information  
b. Will be involved in recruiting subjects; obtaining informed consent; 
supervising and administering interview procedures/conduct of interviews,  
training and supervising providers in intervention delivery, and performing 
data analysis  
4.3 Co-Investigators. 
1. Shannon Marie Kehle-Forbes, PhD; Shannon.kehle-forbes@va.gov, 612-467-4772; VA 
employee Minneapolis VAHCS 
a. Role: Co-Investigator; She will serve on the Implementation/Dissemination, Trial, 
and Qualitative Subgroups. She will be involved in supervising and conducting 
interviews; and performing data analysis and manuscript writing 
b. Will have access to protected health information  
2. Christopher Erbes, PhD; Christopher.erbes@va.gov, 612-467-5868; VA 
employee Minneapolis VAHCS 
a. Role: Co-Investigator;  
b. Will have access to protected health information 
3. Shirley M. Glynn, PhD; Shirley.glynn@va.gov, 310-268-3939; VA employee Los Angeles 
VHAGLA 
a.  Role: Co-Investigator;  
b. Will have access to protected health information 
4. Afsoon Eftekhari, PhD; Afsoon.eftekhari@va.gov, (650) 493-5000 ext. 22393, VA 
employee, Palo Alto VA 
a. Role: Co-Investigator;  
b. Will have access to protected health information 
 
4.4 Study Personnel. 
1. Erin Linden, MPH; Erin.Linden@va.gov, 612-467-5868; VA employee Minneapolis 
VAHCS 
a. Role: Project Manager; She will oversee and manage project activities. 

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b. Will be involved in recruiting subjects; obtaining informed consent; 
supervising and administering interviews and surveys, fidelity coding, 
data collection  
c. Will have access to protected health information 
2. Ann Bangerter, BS; ann.bangerter@va.gov, 612-467-1384; VA employee Minneapolis 
VAHCS 
a. Role: programmer 
b. Will have access to protected health information 
c. Will not have contact with research participants 
3. Emily Hagel Campbell, MS; emilyhagelcampbell.@va.gov, 612-725-2000 x7451; VA 
employee Minneapolis VAHCS 
a. Role: statistician 
b. Will not have access to protected health information 
c. Will not have contact with research participants 
d. Will be involved in performing data analysis of de-identified quantitative data 
4. Andrea Cutting, MS; andrea.cutting@va.gov, 612-467-1881; VA employee Minneapolis 
VAHCS 
a. Role: programmer 
b. Will have access to protected health information 
c. Will not have contact with research participants 
5. Emily Campbell, MS; Emily.Campbell5@va.gov, 612-629-7381; VA employee 
Minneapolis VAHCS 
a. Role: Project Coordinator 
b. Will assist with recruiting subjects; obtaining informed consent; 
administering interviews and surveys, fidelity coding, data collection  
c. Will have access to protected health information 
6. Camryn Kostick, BA, Camryn.Kostick@va.gov; (651) 325-7025; VA WOC, Minneapolis 
VAHCS 
a. Role: Research Assistant Intern 
b. Will assist with recruiting subjects; obtaining informed consent; 
administering interviews and surveys, fidelity coding, data collection  
c. Will have access to protected health information 
7. Marianne Schumacher, Marianne.Schumacher@va.gov; 612.725.2000 x3985; VA 
employee, Minneapolis VAHCS  
a. Role: Study assessor 
b. Will have access to protected health information 
c. Will have contact with study participants 
 
 
 
 

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5.0 
Study Procedures 
5.1 Study Design 
First, we will expand the treatment outline for COACH (see Appendix 1) into an initial treatment 
manual through meetings with content experts and stakeholder feedback. Next, we will develop 
fidelity checklists and revise the treatment manual through a ”test run” with 2-3 couples. The 
resultant intervention will then be evaluated in an open trial with 12 veterans diagnosed with 
PTSD and their loved ones. During the course of the open trial, we will refine fidelity checklists 
and develop a provider training program. Using data obtained from the open trial, we will assess 
the intervention’s acceptability, feasibility,44 mechanisms, and outcomes. Lastly, using clinical 
observations, participant feedback from qualitative exit interviews, and additional stakeholder 
feedback, we will make final edits to the manual, yielding a manual suitable for a future RCT 
(Stage II Manual).25 Upon completion of this proposal, we will be well positioned to apply for 
Merit funding for a randomized controlled efficacy trial.25 
5.2 Delivery by Telemedicine 
We will recruit participants and offer to provide treatment within the study using telemedicine. 
The telemedicine option would use VA approved electronic communication methods (e.g., VA 
Video Connect, Webex, Teams) and information technology to provide the COACH therapy 
to patients by study clinicians. This option would greatly benefit participants. A telemedicine 
option is necessary during COVID-19. For the safety of both staff and patients, staff are 
teleworking. Because of this, a telemedicine option will allow Veterans to still participate in 
the study treatment during COVID-19 restrictions. Psychotherapy is currently widely available 
within VA by telemedicine to improve Veteran access to care. The major benefit of 
telemedicine is that it eliminates travel that may be unsafe or costly to patients. Allowing a 
telemental health option for PE therapy would ease these burdens by making services more 
accessible to patients, especially during the current COVID-19 directives.  
 
Furthermore, many individuals in need of specialized PTSD services live in geographically 
remote regions. Additionally, individuals needing mental health services may have physical 
limitations or disabilities. Providing therapy to these individuals solely in medical centers can 
impose a tremendous financial, travel, or personal burden. Allowing a telemental health 
option for PE therapy will ease these burdens by making services more accessible to 
patients. 
 
Our study site has robust telemedicine programs that provide PE by telemedicine. We will 
follow all procedures and regulations that are currently in place at their VA hospital and 
surrounding CBOCs to ensure services provided to Veterans are safe and accurate. 
Additionally, all practitioners treating patients using telemedicine will be qualified to deliver 
the level of consultation, care, and treatment involved. Lastly, if during the course of the 
study, it becomes safe to deliver the intervention in person, we will offer in-person delivery as 
well. Any in-person visits will follow the Minneapolis VA’s guidelines and Team L’s (trauma 
mental health clinic) procedures for providing in-person care safely.  
 
5.2 Initial Treatment Manual.  
5.2A. Intervention Overview. COACH is a flexible length loved one-assisted treatment for 
PTSD that draws from PE, ICBT, and PE2. Sessions take place weekly and are 90 minutes 

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each. Treatment is typically between 13 and 15 sessions, but can be fewer or more based on 
patient need and symptom response. Consistent with IBCT, the treatment will take place in 
phases. The first phase focuses on gathering information from both the veteran and his/her 
loved one and creating a treatment frame that conceptualizes struggles in a fashion that is 
acceptable to both partners and that highlights ineffective change strategies. In COACH, this 
treatment frame also incorporates 1) the role of PTSD in disrupting relationships and intimacy, 
2) the role of avoidance in maintaining PTSD and couple conflict, and 3) existing strengths or 
coping strategies that can be capitalized on in PE. In this way, the treatment frame serves as a 
contextualized and focused introduction to both key PE principles and key couples dynamics 
that will be challenged in treatment. In the ‘active treatment’ phase, sessions will focus on (1) 
reviewing in vivo exposure exercises completed at home, (2) shaping the couple’s support for 
each other’s efforts to practice a lifestyle of approach, and (3) imaginal exposure and emotional 
processing. The final session includes reflection on the therapy experience and building an 
action plan for continued work at home.  
5.2B. Manual Expansion. In months 1-5, we will expand the treatment outline into an initial 
manual through weekly meetings with the investigator team (Meis, Erbes, Kehle-Forbes, Glynn, 
Eftekhari). Our team is comprised of content experts in delivering and implementing PE (Kehle-
Forbes; Glynn’ Eftekhari) and couple therapy (Meis, Glynn, Erbes). The team will review, 
discuss, and revise intervention materials for each treatment session, led by Dr. Meis. This work 
will generate key questions for the first stakeholder meetings described below.  
5.2C. Stakeholder Feedback. To elicit feedback from the end users of COACH, we will employ 
a model of stakeholder engagement that Dr. Meis has adapted and implemented at the 
Minneapolis VA (Community Engagement Studios; CE Studios).45 The model guides the 
structure and conduct of meetings between researchers and stakeholders to ensure the 
experience is successful, focused, and effective. Studios begin with a presentation from the PI 
that cumulates in two to three key questions (e.g., “How can we help veterans feel more 
comfortable reaching out to their spouses for support when PE feels hard?”). Presentations will 
be prepared in consultation with a veteran moderator to maximize the clarity and focus of the 
presentation with the stakeholder audience in mind. Notes are taken during the meeting, 
reviewed immediately following the meeting, and later summarized. Summaries will be 
distributed to investigators and stakeholders. Feedback will be used by the investigator team to 
identify issues with the intervention to resolve or expand upon.  
5.2D. Identifying Stakeholders. Our key stakeholders include patients (veterans), LOs, 
providers, and leadership. Veteran and LO groups will meet separately to optimize the depth of 
feedback received from these two groups.46,47 Dr. Meis is currently leading CCDOR’s efforts to 
create a standing panel of veterans with lived-experience with PTSD to consult with researchers 
at the Minneapolis VA. We will work with this group of veterans to obtain stakeholder feedback. 
In months 1-3, using CCDOR’s established stakeholder recruitment processes, including 
posting fliers at strategic Minneapolis VA locations, snowball sampling through existing 
stakeholder panel members, and distributing fliers through social media and local relevant 
advocacy groups and non-profit organizations. Veteran and LO stakeholders will be 
compensated $100 for each meeting. 

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Provider stakeholders will include Minneapolis VA providers who deliver marital and family 
therapy (n = 3-4) or PE (n = 3-4). Dr. Meis will reach out by email to PE and family therapy 
providers at the Minneapolis VA. Dr. Meis has used similar strategies to recruit providers for 
focus groups, qualitative interviews, and to serve as study therapists for her ongoing PE2 trial. 
Leadership stakeholders will include the coordinator of the PTSD clinical team (Kaler), director 
of the family therapy training clinic (Chuick), and the chief of psychology (Leskla). Provider and 
leadership interviews will take place in smaller groups and in one-on-one meetings, as 
schedules allow. These interviews will include a discussion of provider training needs and 
challenges to conducting COACH in a VA setting (e.g., “Are there pre-existing skillsets providers 
need to be successful delivering this treatment?”, “How can we address challenges with 
scheduling sessions given providers have limited openings and couples have limited 
availability?”). 
5.2E. Manual Refinement. For any psychosocial intervention, critical insight is gained through 
actual delivery of the treatment. we will conduct a “test run” of the treatment manual with 2-3 
cases. Early experience with these test cases will help identify sections of the treatment manual 
that prove difficult to implement or are unclear. The PI (Meis) and study Co-Investigator (Erbes) 
will serve as the study providers. Of note, while Dr. Meis is a licensed psychologist, she is a 
Research Service employee and does not currently have Minneapolis VA privileges.  She will 
treat cases under this IRB protocol and under the supervision of a privileged VA provider. After 
completing each of the sessions, Drs. Meis and Erbes will compose a memo for the larger team 
that identifies (1) what went well and why, (2) what proved more challenging and why, and (3) 
time stamps from session recordings that correspond to these observations. Memoranda will be 
sent out to the team of investigators in advance and discussed in weekly intervention refinement 
meetings. The team will brainstorm solutions to problems and identify expansions needed to the 
manual to capture clinical observations. This work will generate the key questions for veteran 
and LO stakeholder meetings. These meetings will focus on problems with implementing ideas 
within the manual (e.g., “How can we help couples do a given at-home exercise more 
effectively?”). The study PI will draft manual revisions and distribute revisions to the team to 
review. During this time, Dr. Glynn will also draft initial fidelity checklists, which will be reviewed 
and refined in team meetings.  
 
5.3 Open Trial. 
5.3A. Sample Identification & Recruitment. Participants will be ten veterans with PTSD at the 
Minneapolis VA and their loved ones. Although the Stage Model of Treatment Development 
does not recommend a sample size for stage 1B activities, published accounts of 
psychotherapy treatment development frequently report on samples of ten to twelve 
participants.48–51 Veterans must meet full criteria for PTSD on the CAPS-552 and have been in 
an intimate relationship for the last six months. Both members of the couple must be willing to 
participate together in therapy and deny any episodes of severe relationship violence in the past 
year. We will exclude veterans who are typically excluded from trauma-focused treatment due to 
counter-indications, including severe substance use, uncontrolled psychosis or mania, and 

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active suicidal or homicidal ideation, which should be the focus of clinical attention. Lastly, we 
will exclude dyads in which the loved one also screens positive for PTSD. 
Clinic referrals, announcements to veteran groups, and strategically placed study fliers in 
appropriate clinic locations will provide our first-line recruitment source. We are proposing to 
enroll one couple per month over 10 months (months 9-18). Using similar inclusion/exclusion 
criteria and strategies in PE2, our team has received 72 referrals over the past 10 months 
and randomized 18 dyads at the Minneapolis VA. Eleven of these cases have been in 
intimate relationships (M = 1.10 per month). Of note, we are proposing to start recruitment for 
COACH after PE2 recruitment efforts are planned to end.  
Veterans identified through the above-mentioned means will be sent a brochure describing the 
study and a cover letter, informing them they will be contacted and how to decline participation. 
They will then be contacted by telephone by a trained interviewer to discuss the study, for 
consent, and for initial screening including an assessment of the status of their intimate 
relationship. With permission, their loved one will be recruited and consented by telephone. 
Veterans remaining eligible (i.e., partner agrees to participate, denies intimate partner violence 
(IPV), and screens negative for PTSD) will be scheduled for a diagnostic interview (Clinician-
Administered PTSD Scale for DSM-5, CAPS-552; Clinical Trials Version of the Structured 
Clinical Interview for DSM-5, SCID-5-CT).53 Diagnostic interviews will be conducted by a study 
staff member with a master’s degree in clinical or counseling psychology under the supervision 
of a licensed clinical psychologist from the study team. To ensure our sample is representative 
of those receiving PE, we will enroll at least three women and three OEF/OIF Veterans. To ease 
anticipated barriers to couples attending therapy sessions, we will offer compensation for costs 
for childcare and travel and offer participation through telemedicine. 
5.4 Limitations and Design Considerations.  
Due to the open trial design, we will be unable to evaluate COACH next to a comparator 
condition. However, others have cautioned against using pilot studies to inferentially compare 
interventions as small sample sizes lead to imprecise effect size estimates.44 A design with a 
comparator would offer the opportunity to evaluate the feasibility and acceptability of a 
comparator arm in preparation for a RCT. However, this would require reducing the sample size 
for the COACH-arm or an infeasible sample size for both arms. A second limitation is the pre-
post treatment design. A longer follow-up may increase the chances of detecting improvements 
in functional outcomes. However, a longer-term follow-up would come at the expense of sample 
size, reducing the feedback we will obtain from delivering COACH with more couples. It is 
important to note that our approach to family inclusion could also prove viable for CPT. We 
elected to start with PE as veterans may find it more challenging, given some evidence drop out 
may be worse for PE than CPT.65 Additionally, Cognitive Behavioral Conjoint Therapy, one of 
the novel couple therapies described above,34 incorporates many of the cognitive restructuring 
strategies of CPT. Consequently, we perceive a greater need for couple adaptation for PE. 
Lastly, whenever one seeks to add a family member to the process of mental health care, one 
adds a layer of challenges. For example, for every one individual interested in treatment, you 
must identify, recruit, and schedule two individuals. The second individual may be less 
interested or pose any myriad of additional challenges. Our team is prepared to manage these 

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complications. Team members include VA central leadership in implementing family therapies 
(Glynn) and investigators with long histories of navigating these challenges (Meis, Erbes, 
Glynn). We also have first-hand experience with the potential for transformative change when 
you extend the therapy circle beyond the patient to mobilize her most important LOs in the act of 
change. This is the very spirit of the high risk-high reward research for which this funding 
mechanism is designed.  
 
5.5 Project Management.  
Study activities are detailed in Table 2. Dr. Meis will be responsible for the overall conduct and 
integrity of the project, facilitating stakeholder meetings, writing and implementing revisions to 
the provider manual, delivering the intervention, and qualitative and quantitative analysis. Dr. 
Erbes will lead efforts to develop the provider training program, deliver the intervention, assist 
with quantitative data analysis, and provide expertise in ICBT. Dr. Glynn will lead efforts to 
develop the fidelity rating instrument and provide expertise in implementing family therapy in 
VA. Dr. Kehle-Forbes will provide oversight for qualitative data collection and analysis and 
provide clinical 
and academic 
expertise in PE. 
All investigators 
will participate 
in intervention  
development 
and refinement, 
data 
interpretation, 
and 
dissemination. Our team is well-positioned to take on this effort. Team members have served as 
PI, Site PI, or Co-I for 13 different ongoing or completed randomized controlled trials of 
behavioral interventions for patients with mental health conditions and their families, including 
11 multisite trials. This includes enrolling and randomizing over 1300 participants. 
5.6 Human Subjects 
For all research activities involving human subjects, we will obtain approvals from the VA’s 
Central Institutional Review Board (IRB) with local approvals from the Minneapolis VA as 
required through the Central IRB process.  
Table 2. Timeline of Major Tasks 
Activity             Months  
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 
Recruit LO stakeholders 
X X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Initial treatment manual 
X X X X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stakeholder meetings 
 
 
 X  
 X  
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Test cases 
 
 
 
 
 X X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refine treatment manual 
 
 
 
 
 X X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
 X X X X X X X X X X X 
 
 
 
 
 
 
Open trial enrollment 
 
 
 
 
 
 
 
 1 2 3 4 5 6 7 8 9 10  
 
 
 
 
 
Treatment delivery 
 
 
 
 
 
 
 
 X X X X X X X X X X X X X 
 
 
 
Posttreatment assessments  
 
 
 
 
 
 
 
 
 
 
X X X X X X X X X X 
 
 
 
Qualitative analyses  
 
 
 
 
 
 
 
 
 
 
 
 
X X X X X X X X X X 
 
 
Quantitative analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X 
 
 
Finalize stage II manual  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X X X X 
Table 1.  Abbreviated Measures (see Materials document for exhaustive list 
of measures and items) 
 
Reporter 
Source 
Measure 
Domain 
V 
LO 
S 
I 
A 
Acceptability 
 
 
 
 
 
 
Treatment Structure 
X 
X 
X 
X 
 
CES56; CSQ-857 
Materials 
X 
X 
 
X 
 
N/A 
Feasibility 
 
 
 
 
 
 
Treatment Retention 
X 
X 
 
X 
X 
N/A 

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5.6A. Risk to Subjects 
A.1. Human Subjects 
Involvement and Characteristics 
We aim to enroll 12 Veterans 
with PTSD at the Minneapolis 
VA and their loved ones. 
Veterans must (1) meet full 
criteria for PTSD on the CAPS52 
and (2) have been in an 
intimate relationship for the last 
six months. Both members of 
the couple must be (3) willing to 
participate together in therapy, 
and (4) deny any episodes of 
severe relationship violence in the past year. We will exclude veterans who are typically 
excluded from trauma-focused treatment due to counter-indications, including (1) severe 
substance use, (2) uncontrolled psychosis or mania, and (3) active suicidal or homicidal 
ideation, which should be the focus of clinical attention. Lastly, (4) we will exclude dyads in 
which the loved one also screens positive for PTSD. See below for exhaustive list of 
inclusions/exclusions. 
A.2. Data Sources 
Data sources will include surveys, semi-structured qualitative interviews, and administrative 
data. Veterans and their LOs will complete surveys prior to treatment (baseline), during 
treatment, after their final COACH session, and 3-months after their final COACH session. 
Those who do not attend their final session will receive their survey by mail or email (Qualtrics 
link) using CCDOR’s modified-Dillman protocol.54  
Veterans will also complete a posttreatment structured clinical interview for PTSD symptoms.52 
Veterans and LOs will also complete 90-minute semi-structured qualitative exit interviews. All 
interviews will be conducted in person or by phone, based on the interviewee’s preference, and 
will be audio-recorded. Qualitative exit interviews (Appendix 2) will assess (1) attitudes about 
intervention components, structure (e.g., level of therapist contact), and materials (e.g.,  
handouts), (2) acceptability and efficacy of COACH, including suggestions for intervention 
improvement, (3) engagement with COACH, including retention and barriers/facilitators to  
engaging with the program, (4) perceptions of the impact of the program on the intervention 
targets (e.g., functioning, social control, subjective norms, and LO reliance) and exploration of 
unexpected domains impacted by the program, and (5) the completeness and time burden of 
the survey battery. We will also extract the following administrative data: (1) the number of 
sessions attended (from electronic medical record; retention), (2) the number of participants 
screened each month (screening), and (3) the number of eligible Veterans and LOs who 
declined participation (recruitment), and therapists ratings of homework compliance using two 
Treatment Fidelity 
 
 
 
 
X 
Fidelity instrumentb 
Screening Approach 
 
 
 
 
X 
N/A 
Recruitment Approach 
 
 
 
 
X 
N/A 
Assessment Process 
X 
X 
X 
X 
 
All survey measures 
Outcomes: Functioning 
 
 
 
 
 
 
Overall functioning 
X 
X 
X 
 
 
Short Form Survey58 
MH functioning 
X 
X 
X 
X 
 
CAPS52, PCL-559;PHQ-9;60 
Self-care functioning 
X 
X 
X 
 
 
IPF55 
Family functioning 
X 
X 
X 
 
 
IPF55 
Romantic functioning 
X 
X 
X 
 
 
IPF55 
Communication 
X 
X 
X 
 
 
Prepare/Enrich61 
Conflict Resolution 
X 
X 
X 
 
 
Prepare/Enrich61 
Parenting 
X 
X 
X 
 
 
IPF55 
Social functioning 
X 
X 
X 
 
 
IPF55 
Outcomes: Mechanisms 
 
 
 
 
 
 
Session Attendance 
 
 
 
 
X 
N/A 
HW Compliance 
 
 
 
 
X 
PEAS62 
Social control 
X 
X 
X 
 
 
Emotional and Problematic 
Support63 
Subjective Norms 
X 
X 
X 
 
 
Subjective Norms-PTSDa 
LO Reliance 
X 
X 
X 
 
 
Treatment Discussionsa 
aUnpublished scale from Project HomeFront.bDeveloped during the study 
V = Veteran; LO = Loved One; A = Administrative data; S = Survey; I = Interview.  

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items adapted from the Patient Exposure and Response Prevention Adherence Scale (PEAS) 
for Obsessive Compulsive Disorder (also a cognitive-behavioral exposure therapy).62  
 
Table A. Data Sources 
 
Reporter 
Baseline 
During Treatment 
Posttreatment 
3-month follow-up 
Veteran 
Structured Interview 
Surveys assessing 
symptoms, weekly 
questions in 
preparation for 
therapy sessions for 
therapists, and 
treatment 
mechanisms 
 
Structured Interview 
Online measures 
Online survey 
measures 
Online survey 
measures 
Qualitative Interview 
LO 
Online survey 
measures 
Surveys assessing 
symptoms, weekly 
questions in 
preparation for 
therapy sessions for 
therapists, and 
treatment 
mechanisms 
 
Online survey 
measures 
Online measures 
Qualitative Interview 
 
A.3. Potential Risks 
This study involves minimal risk. COACH is a flexible length cognitive-behavioral, loved one-
assisted, treatment for PTSD that draws from PE, ICBT, and PE2. Treatment is typically 
between 13 and 15 sessions, but can be fewer or more based on patient need and symptom 
response. There are no anticipated physical risks in this study. Economic risks include potential 
loss of wages when traveling to and participating in the research intervention. The 
questionnaires ask questions consistent with those included in routine clinical care, and 
participants can refuse to answer any question(s). Individuals may experience some 
psychological or social discomfort during the course of the study; however, the intervention is 
likely to increase their well-being. Additionally, the risks are no greater than those encountered 
in routine clinical care.  
5.6B. Protection Against Risk 
B.1. Social and Psychological   
Appropriate safeguards will be in place if screening interviews, assessments, interviews, or 
therapy sessions cause any psychological distress, a psychiatric emergency emerges among 
participants, or severe interpersonal violence (SIV) is reported. Severe violence will be defined 
as one or more episodes of severe violence in the past year (e.g., beating up, threatening with a 
knife or gun). The PI has expertise in assessing and managing risk for SIV, including within a 
clinical trial, and will closely train and supervise study staff in assessing and managing risk for 
SIV. 
All surveys will be screened upon receipt by study staff. If a psychiatric emergency is reported 
on surveys (i.e., expression of risk for suicide or homicide), veterans MH providers will be 
notified. MH providers will follow-up as they deem clinically indicated. If the participant does not 

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have a MH provider or this provider cannot be reached, the site PI, or in case of her 
unavailability, a Co-I will contact the disclosing participant by phone, assess for risk and safety, 
and provide the participant with appropriate referrals. We will utilize access to local and national 
mental health resources available through the VA, including the suicide prevention hotline, risk 
assessments through Mental Health during regular business hours (Psychiatry Urgent Care), or 
the facility’s Emergency Room during off hours. In the unusual event of an on-site psychiatric 
emergency involving a participant who is not a Veteran, including threats of or acute risk for SIV, 
the participant will be triaged within VA facilities. If indicated based on psychiatric evaluation, 
non-Veterans will be transferred for appropriate care in community. Once stabilized, they will be 
eligible to enter or re-enter the study.  
All staff with contact with study participants will be trained on how to recognize, assess, and 
intervene, in a manner appropriate to their training backgrounds, in the case of a psychiatric 
emergency. They will be trained and supervised by an on-site licensed clinical psychologist and 
study team member (Co-I or PI).  
If IPV is directly reported to a study staff member (e.g., during a screening call), the study staff 
member will (1) ensure the participant is speaking privately (e.g., if disclosed by phone), (2) ask 
if the participant currently feels safe, (3) offer immediate assistance (i.e., warm transfer to the 
national domestic violence hotline or contact the police), (4) offer to have a MH provider from 
the study reach out, and (5) offer local and national resources for IPV.   
MH providers on the study will receive training on how to assess and intervene when IPV is 
reported.  This includes training on assessing IPV severity and intervening on IPV, including 
safety plans, no aggression contracts, and time out procedures. When IPV is reported to a study 
MH Provider, they will discuss it privately with the reporter and intervene as clinically indicated, 
keeping the safety of the reporter of paramount concern. Providers will not breech the reporter’s 
confidentiality unless they have the reporter’s verbal permission or are concerned they must do 
so to prevent imminent harm.  
All potential collaborators and study therapists on these research activities will have completed 
comprehensive training in the areas of research ethics, protection of human subjects, and 
suicide prevention. They will also have completed all VA required trainings pertinent to cyber 
security, VHA privacy policy (HIPAA), research data security and privacy, ethical principles of 
human subjects’ protection, good clinical practice, and suicide prevention. In addition, Dr. Meis’s 
graduate coursework included a three-credit course on ethics. 
IPV reports on surveys. Surveys ask about intimate partner violence (IPV). IPV reports are not 
routinely considered psychiatric emergencies that warrant breaching participants’ confidentiality. 
Additionally, reaching out to all those who endorse IPV may have unintended negative 
consequences. Reaching out when uninvited to ask IPV victims to further discuss their IPV may 
be distressing and bring up traumatic memories. The outreach may be unwelcome, perceived 
as intrusive, and discourage future reporting. Discussing violence over the phone may also 
place the victim at risk to be overheard by the abuser, other loved ones, or children in the home. 
Consequently, a list of resources will be provided to participants, including for IPV. 
Correspondence accompanying surveys will encourage respondents to contact study staff if 
they would like to discuss any of their survey responses. We will rely on participants to contact 
study staff if they wish to discuss their IPV experiences further. If participants are excluded due 

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to IPV, the staff member notifying the reporter of their exclusion will offer local and national 
resources for IPV. 
 
Managing risk from CBOCs and in-home video telehealth sessions. Due to the nature and 
distance between the Veteran and telemental health provider incurred in telemedicine 
practice, additional measures will be taken to ensure patient safety. These procedures will be 
in place during all telemedicine sessions:  
a. Study providers will follow the guidelines detailed in the 2017 Department of Veteran 
Affairs National Telemental Health Supplement and the 2012 Telemental Health 
Suicide Prevention and Emergency Care manual. 
b. All study providers will follow the Minneapolis VA’s local telemental health policies 
and emergency procedures at each facility and clinic. 
c. Telemental health provider will have detailed contact information from the patient with 
particular attention to who could be contacted in the event of an emergency. All 
emergency contact information, local police phone numbers and local emergency 
room contact information should be readily retrievable during all sessions. 
d. Providers will use the National Telehealth Help Desk when necessary: 1-866-651-
3180. 
 
Additional manners to manage risk from CBOCs.  
a. For all telemental health sessions at CBOC locations, a CBOC staff person will be 
available to assist Veteran should the need arise. 
b. CBOC staff will be available by telephone for the remote telemedicine study provider 
should they need to emergently contact an on-site VA staff. 
c. If a patient becomes suicidal, homicidal, psychotic, or agitated, the Telehealth 
provider will ask for assistance from the CBOC staff who would help in deescalating 
the patient and/or initiating commitment.   
Additionally, the study will abide by the requirements contained in the VHA Handbook for the 
credentialing of VHA practitioners who provide clinical services using telemedicine. All 
practitioners treating patients using telemedicine will be qualified to deliver the level of 
consultation, care, and treatment involved. 
B.2. Economic:  
Participants may choose to take time off work or may incur transportation costs because of 
participating in this study. Every effort will be taken to schedule assessments and therapy 
sessions at times convenient to participants to minimize loss of wages.  
 
B.3. Loss of Confidentiality 
DATA SECURITY. All data will be stored on the servers of the Center for Chronic Diseases 
Outcomes Research (CCDOR) at the Minneapolis VAHCS. CCDOR has well-established 
procedures to protect the privacy of research participants. Names, social security numbers, and 
contact information will not appear on any study materials. Instead, only unique study 
identification numbers randomly assigned to each unique record will be used. Only lead 
investigators, project coordinators, and study programmers (when extracting data to obtain 
treatment adherence and compare survey responders to non-responders for the survey) will 
have access to an encrypted crosswalk table linking study identification numbers to identifying 
information. The CCDOR Statistical and Data Management (SDM) team, in partnership with 
IRM staff, maintain several secure servers, access to which is granted only to SDM members 
who have been screened and assigned appropriate security clearance to work with patient data. 

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One common-access server contains individual project data. Access to individual project data 
on this server is granted only to project staff by an SDM team member, as authorized by the 
study investigator. Identifiers will be destroyed as quickly as possible. Audio and video 
recordings will be stored digitally on CCDOR servers and only accessible to the principal 
investigator and project coordinator. Participants will be asked not to use last names or provide 
identifying information during recorded interviews.  
CONFIDENTIALITY. For all projects, strict confidentiality procedures will be maintained to 
minimize the potential risk of loss of confidentiality. Participant privacy will be further assured by 
conducting interviews in a private office and by assigning arbitrary identifiers in place of 
individual names in the field notes. Data analysis, interpretation, and reporting will be based on 
these de-identified field notes and transcriptions. Since subject responses will not be linked to 
identifying information, participant confidentiality will be assured. The time commitment will be 
explained to all participants prior to their participation in the study. Every effort will be made to 
minimize the length of time and maximize the convenience of the interviews. Participants will be 
assured that participation is completely voluntary and that they have the right to stop 
participation, decline answering any questions, or change the course of the interviews for any 
reason, including potential feelings of discomfort. 
5.6C. Potential Benefits of the Proposed Research to the Subject and Others 
Participants will receive $40 for participating in Baseline surveys, $50 for baseline diagnostic 
interviews (Veterans only), $60 for posttreatment surveys, $60 for posttreatment diagnostic 
interviews (Veterans only), and $60 for one-time qualitative exit interviews. Both veterans and 
intimate partners will complete monthly surveys for outcomes and treatment mechanisms. They 
will receive $25 for each of these surveys. Additionally, participants receive $70 for completing a 
3-month follow-up survey. A possible total of $415 for veterans and $305 for loved ones. 
5.6D. Importance of Knowledge to be Gained 
The influence of a successful course of PTSD treatment on a Veteran’s life is considerable. In 
addition to reducing symptoms of PTSD and associated mental health problems (e.g., 
depression), successful PTSD treatment improves reduces, and may even reverse, the negative 
physical health effects associated with PTSD.10,41 Family involvement has been highlighted as 
a fertile avenue for improving the outcomes for patients with PTSD.7,27 Yet, despite 
congressional legislation and national mandates within VA/DoD for family involvement in PTSD 
care,7,8,42,43 family inclusion in PE and CPT is infrequent (17% among HomeFront veterans). 
Concordant with the Behavioral Health & Social Reintegration Program, this proposal will 
support work an intervention intended to promote higher rates of recovery from PTSD, better 
overall functioning, greater family functioning, and greater social functioning. These outcomes 
are consistent with those patients likely find meaningful.27 Our stakeholder engagement 
strategies, described below, provide an additional pathway to ensuring COACH aligns with what 
LOs, providers, and VA leadership need in a family intervention for PTSD, building a more 
patient-centered approach to treating PTSD. Overall, this work is highly is consistent with the 
explicit goals of the Behavioral Health & Social Reintegration Program to promote research that 
uses “family support as a means to reintegration” and leads veterans to “function more fully in 
society” and “embrace social situations”.  

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5.6E. Data and Safety Monitoring Plan 
This project will operate under the oversight of the Minneapolis VA Health Care System’s IRB 
for Protection of Human Subjects. The IRB reviews research projects which involve human 
subjects to ensure that two broad standards are upheld: first, that subjects are not placed at 
undue risk; second, that they give uncoerced, informed consent to their participation.  After 
initial review, each approved project is re-evaluated annually. The Minneapolis VA Health Care 
System’s IRB works with investigators to modify projects to ensure adequate protection for its 
subjects' welfare and right of self-determination. VA regulations require that all investigators and 
individuals who work on the study undergo comprehensive training annually in research integrity 
and protection of human subjects.  
E.1. Privacy Protections:  
CCDOR protects data collected for the purpose of conducting research projects at a level higher 
than that provided for clinical encounters. We use “stand-alone,” secure data servers that are 
accessible only to designated, security-cleared, and trained personnel and data are de-identified 
as quickly as is feasible. Details about CCDOR’s specific data privacy assurance procedures to 
be employed for this study are provided below. 
E.2. Maintaining Secure Servers:  
CCDOR maintains three secure computer servers that are protected under the Minneapolis VA 
Windows 2000 network. All individuals with administrative access privileges to CCDOR’s 
servers, including IRM personnel and the CCDOR Statistical & Data Management Team, have 
been screened and assigned a security clearance putting them in trusted positions of the 
hospital with clearances to work with patient level data. These individuals and their access to 
the CCDOR servers is ultimately monitored and controlled by Sean Nugent, Senior Program 
Analyst for the CCDOR Statistical & Data Management Team. IRM’s access to the data is 
strictly limited to backing up server data, which prevents catastrophic loss of data. Backups are 
written to tapes that are stored in a secure location accessible only to IRM personnel. CCDOR’s 
Statistical & Data Management Team members maintain permissions, data storage, and all 
server applications.  
ORGANIZATION AND ACCESS TO RESEARCH DATA: With the exception of one server, 
named the “CCDOR Server,” only the CCDOR Statistical & Data Management Team has 
access to remaining Center servers. Data on the “CCDOR Server” are organized by projects 
within folders designated by each investigator. Only members of a given project have access to 
a specific project folder on the “CCDOR Server.” Even then, access to project data is obtained 
through Windows authentication (i.e., user’s name and password to the network). It is virtually 
impossible for any person without a login name and password to the VA hospital’s domain 
network to access data on the Center’s servers. Thus, all data housed on the “CCDOR Server” 
are extremely secure, and access by unauthorized persons highly unlikely. Data containing 
patient identifying information are not stored on the CCDOR Server but are stored on the 
servers accessible only to CCDOR Statistical & Data Management Team members who are 
directly involved in the project. Thus, not even the PI can link individual names to their PHI 
without first obtaining permission to do so from the Statistical & Data Management Team. These 
protections exceed the usual protections provided PHI by the VA system.  

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SECURING CONFIDENTIAL RESEARCH DATA: Data collected for individual Center projects 
are often obtained through primary (e.g., surveys) or secondary (e.g., VISTA and Austin 
databases) sources. All extractions of secondary data collection are stored on servers 
accessible to the CCDOR Statistical & Data Management Team only. Secondary data used for 
a study are de-identified according to HIPAA criteria and provided a random study identification 
number. A crosswalk table is created linking the study id with the primary key of the secondary 
data source. These data are only accessible to those employees of the Statistical & Data 
Management Team who have undergone the necessary security background checks, received 
appropriate security clearances, and are an integral part of an IRB-approved study. Primary 
data that involves surveys contain only the coded study identification number to identify study 
participants. The paper version of these forms/surveys is kept in locked cabinets within a locked 
room. Data from these surveys/forms are scanned or data entered by project staff or CCDOR 
Statistical & Data Management Team members to a secure folder. This secure folder is on a 
server accessible only to the CCDOR Statistical & Data Management Team members directly 
involved in the study. This protects the integrity of the data as well as its confidentiality. Primary 
data collection involving direct data entry is performed through a custom application written by a 
CCDOR Statistical & Data Management Team programmer. This ensures that data is in a 
secure environment and accessible to only those individuals with permission to access the data. 
Only individuals with a need to access the data, as vetted by the project’s Principal Investigator 
are granted access. Even then, only the absolute minimum number of data elements is 
released. 
E.3. Data Used for Analysis:  
For all projects conducted in CCDOR, the final data is constructed in Statistical Analysis 
Software (SAS) data sets. Analyses are mostly conducted by statisticians assigned to the 
project or by other members of the project (e.g. Principal Investigators). All data collected are 
stored in individualized SAS data sets pertaining to the specific type of analyses to be 
performed. These SAS data sets will be de-identified according to HIPAA criteria, using only 
subjects’ coded identification number as the primary key. The de-identified data set will be made 
accessible to those project members who are conducting analyses. Only the data elements 
required for the analysis under consideration are released. In summary, a separate workspace 
on a server accessible only to project Statistical & Data Management Team members will be 
created to work with administrative data. Any of the administrative data containing patient level 
data will be encrypted when not being used by a project programmer. All patient-identifying 
information will be removed from the administrative records. Upon completion of all study data, 
de-identified analysis data sets will be created in SAS that will use the subjects’ coded study 
identification numbers as the only key. 
E.4. Transcriptions 
We will use Keystrokes Transcription services to obtain transcriptions of patient recorded 
interviews. Recorded individual patient interviews will be identified only by a coded facility 
identification number. Interviews will be conducted by telephone and will be recorded directly to 
a password protected project file on a center server. Recordings will be transferred using a 
secure portal (Reflection FTP Client) to the identified transcription company (Keystrokes). Once 
recordings have been transcribed, the recordings will be deleted by the transcription company. 

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For all projects conducted in CCDOR, the final quantitative data is constructed in Statistical 
Analysis Software (SAS) data sets. Qualitative data includes audio recordings of interviews that 
are transcribed and then stripped of all identifiers. De-identified transcripts are then coded by 
study staff and/or uploaded into qualitative analysis software (NVIVO). Quantitative analyses 
are mostly conducted by statisticians assigned to the project or by other members of the project 
(e.g. Principal Investigator or Project Manager). Qualitative analyses are conducted by study 
investigators with qualitative expertise. All data sets and qualitative transcripts will be de-
identified according to HIPAA criteria, using only subjects’ coded identification number as the 
primary key. The de-identified data set will be made accessible to those project members who 
are conducting analyses. Only the data elements required for the analysis under consideration 
are released.  
5.6F. Inclusion of Women and Minorities. 
Women and minorities will be represented in our study sample. Any patient who enters the 
Minneapolis, Ann Arbor, or Atlanta outpatient PCT clinics during the study period and meets 
inclusion criteria will be eligible for participation regardless of gender or race.  
5.6G. Inclusion of Children. 
All study subjects are expected to be 18 years of age or older. 
 
 
5.7 Recruitment Methods 
5.7A. Study Setting 
The study will be based in the Center for Chronic Disease Outcomes Research (CCDOR). All 
data collection will take place at the Minneapolis VAHCS. 
5.7B. Recruitment Training 
Given the importance of recruitment to the success of any study, staff will be trained in 
established best-methods for recruiting for behavioral intervention trials (e.g., Leonard, Lester, 
Rotheram-Borus, Mattes, Gwadz, & Ferns, 2003). Staff will know how to handle difficult 
situations while maintaining boundaries, establish and maintain rapport while not antagonizing 
or alienating participants, and handling reports of IPV or other risk issues. Regular recruitment 
supervision meetings will occur. Given the importance of establishing rapport to successful 
participant recruitment107 and plans for careful training and supervision, staff will be trained in 
the use of scripts as guides to avoid impersonal or alienating recitation of scripts. Reading 
scripts verbatim may interfere with establishing rapport, adaptive social norms that promote 
asking questions, and a safe environment for individuals share when they do not understand or 
have concerns about the study. See Study Materials for example scripts. 
5.7C. Referral Sources.  
We will rely on three methods of identifying potentially eligible Veterans: 1) provider referral, 2) 
self-referral, and 3) identification from hospital records. 

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Provider Referral. Provider referral will provide our first-line recruitment source, as this will 
mirror how the intervention is delivered in typical clinic care. We will make announcements 
about the study in multiple settings and forums (e.g., announcements at team meetings, 
presentations at grand rounds). We will provide flyers and brochures to providers and 
discuss the study with them to inform them about the study. As providers and 
patients/significant others (e.g., caregivers) may prefer to discuss the study together, prior to 
referring the patient/caregiver to our team, fliers and brochures with assist in these efforts. 
Providers may or may not choose to discuss the study with the Veteran or caregiver first. We 
will then receive contact information for potentially eligible participant (i.e., veterans interested 
in PTSD care or trauma-focused treatments; caregivers of with trauma-related mental health 
concerns) by (1) providers or by (2) team-leads in specialty clinics notifying study staff as 
patients are referred for evidence based PTSD treatment. Study staff will be provided with 
the potential participant’s contact information through secure email, verbally, or through a 
cosigned CPRS note that an individual is interested in trauma-focused care (with subsequent 
communication verbally or through secure messaging).  
 
Self-Referral. To facilitate self-referral, we will use study fliers and brochures strategically 
placed in appropriate clinic locations and make announcements to inform others about the 
study. We will also distribute fliers and brochures, make announcements, and provide 
presentations to community organizations to facilitate self-referral. Individuals who are self-
referred to the study will reach out to study staff to express their interest directly. We will also 
distribute study fliers and brochures through social media groups and listservs (e.g., 
Facebook groups for veterans, emails to community groups). If potentially interested 
participants reach out to us via email, we will respond back thanking them for their email and 
interest in the study and asking them to talk by phone to protect their privacy. Distributing 
advertisements through social media and electronically is especially important given the 
ongoing pandemic. 
 
Identification from Hospital Records. If approaches self and provider referral prove 
insufficient to reach recruitment goals, we will identify potentially eligible Veterans who have 
a diagnosis of PTSD through an administrative data pull and recruit these Veterans through 
the mail and telephone, using the same methods employed for provider referral participants. 
5.7D. Recruitment Processes  
Provider Referral.  
Referral sources (e.g. providers) can talk about the study with their patients, their significant 
others/caregivers and provide them with a study brochure detailing the project. During this time, 
providers will ask if the individual is interested in being contacted about a research study for 
PTSD. This will give the individual an opt out option. If the individual responds “no”, clinic staff 
will not contact study staff members. If the individual responds “yes” and would like to be 
called regarding a research study, the provider/staff will notify study staff. When a provider or 
off-team staff member refers an individual who has expressed an interested in being called 
regarding a research study, study staff will mail the individual information about the study and 
call the individual as soon as possible to give them information about the study.. This eliminates 
a delay in getting couples into care and follows the current clinic mandates regarding minimum 

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wait times for evidence-based treatment for PTSD. Off-team individuals will not make any 
efforts to recruit the individual and will refer the individual to study staff with any questions.   
 
Alternatively, individuals’ who have not been asked if study staff can contact them will be sent 
a letter in the mail and brochure about the study, informing them they will be contacted and 
how to decline study recruitment efforts. In this case, staff will attempt to reach the individual 7 
days after the letter is sent. 
 
Prior to initiating contact with the individual, study staff will review the veteran’s hospital records 
to determine the presence of any study exclusionary criteria (e.g., the patient is currently 
hospitalized for a psychiatric emergency or reporting active psychotic symptoms).  
 
Individuals will then be contacted by telephone by a trained interviewer to discuss the study and 
for initial screening. We will make up to 3 calls a week for 3 weeks, unless the individual 
declines recruitment or requests an alternative schedule (e.g., if he/she asks us to call more 
often to try to catch them at a time when they aren’t busy or are somewhere in private). We will 
leave up to one message per week, unless the individual requests no voicemails or requests an 
alternative schedule.  See Materials for an example voicemail script. 
 
Upon contact with the individual, with their permission, a trained interviewer will then discuss the 
study and complete an initial screening, including for the presence of a significant other with 
whom they have been in a relationship with for at least 6 months, willingness to include the LO 
in treatment, presence of moderate intimate partner violence (SF CTS-2), and (for veterans) the 
presence of symptoms of PTSD on the PC-PTSD-5 (see inclusion/exclusion criteria for further 
detail). 
 
The study procedures (assessment data gathering, intervention, session recording) and study 
design (including the nature of randomization to condition) will be fully described to the 
participant at the time of the initial contact (and again at the time that consent is documented). 
See script for initial screening call in Materials. For interested and eligible individuals, we will 
begin recruitment efforts for their significant other and begin or schedule the over-the-phone 
informed consent meeting with the significant other to complete enrollment. 
 
For individuals who have expressed interest in the study (i.e., study staff spoke with them over 
the phone, completed screener, and/or completed informed consent), if at any time during the 
recruitment process study staff are unable to reach them, we will send them one final letter. The 
letter will inform the participant that we have been unable to reach them and that without contact 
within 2 weeks, we will have to close their case from our study records. The letter informs the 
individuals that we will no longer attempt to contact them and gives them the opportunity to 
reach out to study staff if they still have interest in participation in the study. 
 
Self-referral and Referral through Identification from Hospital Records.  
Procedures will follow the same general process as above with a few exceptions. For self-
referrals, these individuals will be contacting study staff first, so we will immediately initiate 

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efforts to return their calls while also sending them an introductory letter and study brochure.  
See Materials for Introductory Letter.  
 
For individuals identified through hospital records, the volume of mailings anticipated makes 
individual review of patients’ records prior to their initial mailing impractical, so this component of 
the process will not take place prior to mailing for individuals referred through this channel. 
Additionally, as these individuals are not necessarily seeking treatment, we will wait 7 days after 
the initial mailing before attempting to contact them by telephone. 
 
5.8 Informed Consent Procedures 
5.8A. Veteran Informed Consent.   
After completing the recruitment steps described above, Veterans will participate in informed 
consent procedures. Veteran participants will participate in informed consent over the telephone 
with a study staff member. Subjects can meet with a study staff member for in-person informed 
consent if they prefer.  
 
Veteran participants will receive all of the information contained within informed consent by mail 
or electronically through Docusign. The mailing will contain an opt-out option for those who do 
not want to be contacted any further along with 1) information explaining the risks and benefits 
of study participation, 2) their rights as study participants and their privacy rights and 3) required 
elements of informed consent  4) HIPAA authorization. This material will then be reviewed by 
telephone prior to participation. When the telephone consent is obtained, they will have already 
had the opportunity to review study details, consider their participation, and consult with loved 
ones about participation. Discussing this material with a staff member over the phone will 
provide greater time and freedom to consider or decline study participation, prior to investing 
more time and energy in the study.   Staff will solicit and answer all questions, and they will also 
ask the participants questions to ensure participant comprehension of the informed consent 
document including, but not limited to, what their understanding is of the risks and benefits of 
participation, when assessments will occur and what topics they will cover. The team is 
sensitive to the importance of the informed consent process and will make every effort to ensure 
that participants give their consent voluntarily and fully informed about the potential risks and 
benefits. If a participant agrees to participate in the study, an informed consent form and HIPAA 
authorization form will be signed by hand or electronically via Docusign by the participant. If signed 
by hand, the participant will mail the form back to study staff.All signed forms will be kept locked in 
staff file cabinets in a locked office. When signed electronically using Docusign, staff can access the 
signed form in the online Docusign sharepoint space and will export the document to study files. 
 
If a participant requests to have an informed consent meeting face-to-face with a study staff 
member, this will be permitted. Some participants may prefer to coincide other appointments at 
the VA with an in-person consent meeting with our study staff. Participants meeting in-person 
for informed consent will also be required to sign an official informed consent form, and a HIPAA 
authorization form. 
 

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Informed consent will be obtained before obtaining any Baseline self-reports or Baseline clinical 
interviews. As these Baseline procedures are also necessary for establishing final eligibility 
(SCID-5-CT and CAPS-5; IC: PCL-5, PHQ-9, AUDIT, DAST), Veterans will be notified that the 
baseline procedures are necessary for establishing final eligibility and they may be deemed 
ineligible for the study after these procedures. They will receive notification of their edibility and 
contacted by staff to schedule their first therapy appointment. Individuals deemed ineligible will 
be told by telephone and Veterans referred back to their referring providers.  
 
When Veterans are deemed ineligible by a study assessor after completion of the Structured 
Clinical Interview (i.e., positive screens for psychosis, substance use, suicidality, homicidally, 
etc.), study staff will communicate the assessment results of these ineligible subjects back to 
the treatment team (non-study clinical staff) for purposes of patient treatment planning and 
continuity of care. Conveying a patient’s assessment results to the treatment team allows 
patients to be referred to appropriate treatment in a timely manner, while also eliminating any 
inconvenient and redundant reassessments. This will be proposed to participants during 
informed consent, and patients will have the ability to decline this request 
 
5.8B. LO Informed Consent 
Loved ones will be sent a letter and brochure describing the study, an informed consent form, 
and a HIPAA authorization form. The letter will inform them that they will be contacted and how 
to decline study recruitment efforts. They will then be contacted by telephone by a trained 
interviewer to discuss the study, their interest, and assess the presence of severe relationship 
violence. The study procedures (assessment data gathering, intervention, audio/videotaping) 
will be fully described to the participant at the time of the initial phone call. Participants will be 
informed of the study design (including randomization to condition) before they decide to 
participate. If the participant agrees to take part in the study, they will sign the informed consent 
form and HIPAA authorization by hand or electronically via Docusign. If signed by hand, the 
participant will mail the form back to study staff. All signed forms will be kept locked in staff file 
cabinets in a locked office. When signed electronically using Docusign, staff can access the signed 
form in the online Docusign sharepoint space and will export the document to study files. 
If Veterans are deemed ineligible due to inclusion/exclusion criteria or lack of interest, LOs will 
be informed that full inclusion/exclusion criteria were not met for the Veteran and thus the dyad 
is no longer eligible for enrollment.  Specific details on which inclusion/exclusion criteria 
(including level of interest in the study) will not be disclosed. The same approach will be used 
for LOs who decline participation or report severe relationship aggression (i.e., Veterans will be 
informed that full inclusion/exclusion criteria were not met for the Veteran and thus the dyad is 
no longer eligible for enrollment). Appropriate alternative referrals to mental health treatment, 
including substance use treatment or psychotherapy, or to address relationship aggression will 
be made as upon request and when clinically indicated (i.e., positive screens for psychosis, 
substance use, suicidality, homicidally, etc.).  

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5.8C. Retaking Baseline Assessments 
For safety and risk implications, we will require Veteran and SP participants to retake the 
baseline survey and preclinical assessment if the therapy start date would occur 2 months after 
their baseline data was collected. Time gaps between baseline data and therapy start dates can 
occur for various reasons, including scheduling issues, provider availability, patient travel 
arrangements, etc. It is important that patient baseline data is as close to therapy start dates as 
possible, as clinical data can change over several weeks. For example, in the gap between 
assessment and therapy start, patients could have a serious substance use relapse or a suicide 
attempt that would then make it clinically inappropriate for them to begin a trauma-focused 
therapy, prior to addressing their more pressing concerns around establishing their safety or 
sobriety. Additionally, we expect many of the constructs we assess to naturally change with time 
(e.g., family functioning, relationship satisfaction). So, baseline assessments that are more than 
2 months old at the time of therapy start may no longer truly represent the patient, support 
person, or family functioning at the beginning of treatment, confounding study results. 
Subjects will be informed of this requirement during the informed consent process and on the 
information packet or informed consent form. Participants would get paid again for retaking 
these assessments ($50 for the baseline survey; $60 for the preclinical interview). 
 
5.8D. Incentives.  
Participants will receive $40 for participating in Baseline surveys, $50 for baseline diagnostic 
interviews (Veterans only), $60 for posttreatment surveys, $60 for posttreatment diagnostic 
interviews (Veterans only), and $60 for one-time qualitative exit interviews. Both veterans and 
intimate partners will complete monthly surveys for outcomes and treatment mechanisms. They 
will receive $25 for each of these surveys. Additionally, participants receive $70 for completing a 
3-month follow-up survey.  A possible total of $415 for veterans and $305 for loved ones. 
Participants will receive payment by direct deposit or debit card after completion of their 
baseline assessment and interview, post treatment assessment and interview, and exit 
interview.  
 
5.9 Inclusion/Exclusion Criteria 
See Table X. With the exception of criteria relevant to LO inclusion (criteria 3, 4, 10, & 11), 
inclusion/exclusion criteria reflect those consistent with PE delivery within VA. Participants 
must meet diagnostic criteria for PTSD,91 assessed using the gold-standard Clinician-
Administered PTSD Scale for DSM-5 (CAPS-5; Item 2).3 Structured clinical interview for 
inclusion/exclusion criteria will be administered by trained and supervised assessors (Items 10, 
11, 12).  
Table x. Inclusion/exclusion criteria 
Inclusions 
Measure 
Exclusions 
Measure 
1. Male or female Veterans at least 18 
years old. Enrolled in VHA care. 
CPRS 
9. Recent suicidal or homicidal ideation with intent 
and/or plan that, in the judgment of the 
investigator, should be the focus of treatment 
SCID-5-CT12 

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Relationship violence will be assessed by telephone from both Veteran and LO-report (Item 13). 
We will exclude Veteran participants if he/she has an underlying medical condition or a medical 
procedure (item 15 and 16) planned that would greatly impair their ability to participate in a 
weekly psychotherapy (i.e., a severe seizure disorder making weekly attendance difficult or a 
planned major surgery within a month of beginning treatment). This item will be assessed during 
the initial phone screening. Items 3, 4, 8, and 14 will also be assessed by phone screen.  See 
materials document for screening items. We will administer a PTSD screen including the PCL-5, 
PHQ9, and questions regarding prior hospitalizations for MH concern, by telephone. If the loved 
one has (1) a PCL score above a 32, (2) a PHQ9 score of 9 or 10, and (3) they have ever had a 
hospitalization for MH or SUD concerns, a further case review will be conducted by a 
psychologist on the team. LOs and Veterans will be required to complete a baseline survey 
assessment before they can be randomized to a study arm. Failure to complete the baseline 
survey will result in study ineligibility (item 18).  
 
We will exclude dyads in which either the Veteran or LO report moderate relationship violence 
(item 12), defined as one or more episodes of severe violence in the past year (e.g., kicked or beat 
up) on the IPSVS Adapted Scale106. It would be counter-indicated for providers to proceed with 
PTSD treatment, without addressing ongoing significant relationship violence first. This is similar 
to the requirement that the patient must not be actively psychotic, manic, suicidal, or dependent 
on substances. Consequently, the reporting dyad member(s) will be provided with resources 
and referrals for IPV (see IPV risk algorithm). The dyad may be re-evaluated for eligibility when 
this exclusionary criteria has been resolved (i.e., one year has passed without an episode of 
severe violence). Finally, we can delay or end treatment, when clinically indicated, based on 
case review. For example, if the veteran is new to mental health care at the Minneapolis VA and 
2. Participant meets full DSM-5 diagnostic 
criteria for PTSD. 
CAPS-5 
10. Hospitalized or meets DSM-5 criteria for a 
manic, hypomanic, or psychotic episode in the 
past 3 months  
SCID-5-CT12 
3. Has an intimate partner with whom 
they've been in a committed 
relationship with for the last 6 months 
and have some form of contact with at 
least 5 days a week. 
 
Self-report item 11. Meets DSM-5 diagnostic criteria for a severe 
substance use disorder in the past 3 months. 
Of note, subjects can be abusing or dependent 
upon nicotine or marijuana and still be included 
in the study 
SCID-5-CT12 
4. Interested in participating weekly 
psychotherapy for PTSD with this 
person.  
Self-report item 12. Moderate relationship violence between the 
identified partner and the Veteran, defined as 
one or more episodes of severe violence in the 
past year (e.g., punched, kicked, or beat up). 
IPSVS 
Adapted108 
5. Provides informed consent. 
Self-report item 13. Partner screens positive for PTSD on a self-
report instrument (PCL). 
PCL-5 
6. Speaks and reads English. 
Self-report item 14. Having an ongoing medical condition that 
would interfere with ability to attend weekly 
treatment sessions. 
Self-report 
item 
7. Willing to have their therapy sessions 
recorded. 
Self-report item 15. Having any planned upcoming major medical 
procedure or personal event over the next 
several months that would prevent them from 
attending weekly treatment sessions. 
Self-report 
item 
8. Willing and able to be seen via 
telehealth when in-person treatment 
options aren’t available. 
Self-report item 16. Severe cognitive impairment 
CPRS 
17. Fails to complete baseline survey. 

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has a history of suicidal ideation, the team can elect to delay entry into the study until the patient 
has established mental health care with the Minneapolis VA (e.g., assignment of an mental 
health treatment coordinator and a treatment plan) to determine if the patient needs a higher 
level of treatment than is provided by the limited services in the study before proceeding. 
6.0 
Data Collection & Study Evaluations 
6.1 Data Collection.  
Data collected will include surveys, semi-structured qualitative interviews, and administrative 
data. The outcomes of interest for Aims 2 & 3 (acceptability, feasibility, functioning, and 
mechanisms), their source, and the specific measure (as applicable) are presented in Table 1. 
Couples will complete surveys prior to treatment (baseline), during treatment, and within four 
weeks of their final COACH session. Those who do not attend their final session will receive 
their survey by mail using CCDOR’s modified-Dillman protocol.54  
Consistent with recommendations, we will obtain collateral reports on veteran functioning by 
asking LOs to report on the veterans’ functioning on the Inventory of Psychological Functioning 
(IPF).55 Veterans will also complete a posttreatment structured clinical interview for PTSD 
symptoms.52 Lastly, veterans and LOs will complete 90-minute semi-structured qualitative exit 
interviews.  
All interviews will be conducted in person or by phone, based on the interviewee’s preference, 
and will be audio-recorded. Qualitative exit interviews (Appendix 2) will assess (1) attitudes 
about intervention components, structure (e.g., level of therapist contact), and materials (e.g., 
handouts), (2) acceptability and efficacy of COACH, including suggestions for intervention 
improvement, (3) engagement with COACH, including retention and barriers/facilitators to  

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engaging with the program, 
(4) perceptions of the impact 
of the program on the 
intervention targets (e.g., 
functioning, social control, 
subjective norms, and LO 
reliance) and exploration of 
unexpected domains 
impacted by the program, and 
(5) the completeness and time 
burden of the survey battery. 
We will also extract the 
following administrative data: 
(1) the number of sessions 
attended (from electronic 
medical record; retention), (2) 
the number of participants 
screened each month 
(screening), and (3) the 
number of eligible veterans 
and LOs who declined 
participation (recruitment), 
and therapists’ ratings of homework compliance using two items adapted from the Patient 
Exposure and Response Prevention Adherence Scale (PEAS) for Obsessive Compulsive 
Disorder (also a cognitive-behavioral exposure therapy).62  
 
6.2 Fidelity Checklists and Provider Training.  
Over the course of the open trial, Dr. Glynn will lead efforts to finalize fidelity checklists, and Dr. 
Erbes will lead efforts to develop the provider training program. We anticipate the provider 
training program will follow a structure similar to that of the VA’s national PE and ICBT trainings. 
These include an initial didactic training with role plays (PE is 4 days; ICBT is 2.5 days) followed 
by two training cases with individual feedback and weekly case consultation. Additional 
materials needed for the training program (e.g., powerpoint, clinical vignettes, role play 
exercises) will be included in the final RCT manual for COACH. Each therapy session will be 
recorded. We will apply the fidelity checklists to one randomly selected session for each couple. 
We will identify gaps in content covered by checklist items and items that are unclear, difficult to 
rate, or not consistently applicable. Items will be revised and finalized for the final Stage II 
Manual.25  
 
6.3 Final RCT Manual.  
During the conduct of the open trial, Drs. Meis and Erbes will meet weekly and the larger team 
will meet monthly to discuss new observations, successes, and challenges. They will identify 
Table 1. Select 
Measures. See 
materials document for 
full list. 
Reporter 
Source 
Measure 
Domain 
V 
LO 
S 
I 
A 
Acceptability 
 
 
 
 
 
 
Treatment Structure 
X 
X 
X 
X 
 
CES56; CSQ-857 
Materials 
X 
X 
 
X 
 
N/A 
Feasibility 
 
 
 
 
 
 
Treatment Retention 
X 
X 
 
X 
X 
N/A 
Treatment Fidelity 
 
 
 
 
X 
Fidelity instrumentb 
Screening Approach 
 
 
 
 
X 
N/A 
Recruitment Approach 
 
 
 
 
X 
N/A 
Assessment Process 
X 
X 
X 
X 
 
All survey measures 
Outcomes: Functioning 
 
 
 
 
 
 
Overall functioning 
X 
X 
X 
 
 
Short Form Survey58 
MH functioning 
X 
X 
X 
X 
 
CAPS-552, PCL-559;PHQ-9;60 
Self-care functioning 
X 
X 
X 
 
 
IPF55 
Family functioning 
X 
X 
X 
 
 
IPF55 
Romantic functioning 
X 
X 
X 
 
 
IPF55 
Communication 
X 
X 
X 
 
 
Prepare/Enrich61 
Conflict Resolution 
X 
X 
X 
 
 
Prepare/Enrich61 
Parenting 
X 
X 
X 
 
 
IPF55 
Social functioning 
X 
X 
X 
 
 
IPF55 
Outcomes: Mechanisms 
 
 
 
 
 
 
Session Attendance 
 
 
 
 
X 
N/A 
HW Compliance 
 
 
 
 
X 
PEAS62 
Social control 
X 
X 
X 
 
 
Emotional and Problematic 
Support63 
Subjective Norms 
X 
X 
X 
 
 
Subjective Norms-PTSDa 
LO Reliance 
X 
X 
X 
 
 
Treatment Discussionsa 
aUnpublished scale from Project HomeFront.bDeveloped during the study 
V = Veteran; LO = Loved One; S = Survey; I = Interview; A = Administrative Data.  

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portions of session recordings to review to illustrate examples. These discussions will be used 
to refine and expand the manual and to identify key questions for stakeholder meetings. We will 
meet with veteran and LO stakeholder groups once during the conduct of the open trial. Final 
stakeholder meetings, with all stakeholder groups, will take place during month 23 to review 
preliminary findings and obtain feedback on the Stage II manual. 
 
6.4 Online Surveys 
Survey administration format will take place on Qualtrics FedRAMP electronic survey software 
accessed via the VA cloud OR the VA mPRO (mobile Patient-Reported Outcomes) mobile 
application. This will support data collection during the COVID 19 pandemic. Social distance 
guidelines and pandemic related challenges have made routine paper survey mailings 
unreliable. Participants can complete surveys over-the-phone with study staff if they prefer. 
Paper versions will also be available, if requested. 
 
Qualtrics FedRAMP has been approved for use from the VA OIT Security standpoint (Authority 
to Operate or ATO). The ATO status is currently approved for 1 year and a full 3-year ATO is in 
the works. Qualtrics FedRAMP surveys will contain a study ID number, time of data entry and 
limited individually identifiable information.  Within the VA firewall, the study team at the VA will 
create a custom- built tracking app that will track each participant’s enrollment and study status. 
Data will be routinely extracted from Qualtrics FedRAMP in the VA cloud and stored on secure 
CCDOR servers, using SQL database connections. All data will be stored and utilized within 
secure CCDOR servers that are part of the Minneapolis VAMC network and which operate 
behind the VA firewall. All data is tracked using a SQL database, with a GUI-front end system 
that restricts access to only those with approval to study data.    
 
Participants will be sent Qualtrics surveys via a generic email to their personal email address, if 
the patient opts in for email usage. Prior to emailing participants, we will contact them by phone 
to ask permission to use their email for this purpose. If the participant does not opt in for email 
usage, they will be given the Qualtrics survey URL verbally over-the-phone or written on the 
recruitment and/or follow-up letters sent to them in the mail. All emails to participants will be 
extremely generic and will follow VA guidelines; they will not mention details of the study in the 
body of the email, participant names and PHI will not be used. For emailed survey links, we will 
use CCDOR’s well-established modified-Dillman protocol with repeated mailings and an 
incentive to boost response rates (see example of Dillman protocol chart below). 
 
MPRO. The mPRO mobile app is designed to deliver research and quality improvement surveys 
to Veterans and their family members. The app allows VA researchers to select and create 
assessments and assign them to participants using fully deidentified invite codes. Participants 
then use their invite codes to sign into the mPRO mobile app.  
 
To manage the risk of app-related information being intercepted by a third party, the following 
steps will be taken. First, the mPRO app will not be used (cannot be used) to collect any 
personally-identifying information and does not contain any open text fields that would allow a 
user to enter personally-identifying information. Second, any app usage data that is transmitted 
from a participant's phone to the research team will be linked only with a non-identifying subject 
identification code. In order to mitigate privacy risks that are inherent to using mobile phones or 
websites, we will be implementing several strategies. Participants will receive a unique invitation 
code that can be used to download and unlock the mPRO study app, and this unique code will 
be used to examine patient-reported outcomes. App usage data will be fully de-identified. 

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Qualtrics FedRAMP and mPRO surveys will contain minimal individually identifying information. 
The only identifying information will be information that is self-reported by the participants (e.g. 
name, phone, email, which is best method of contact). No sensitive data will be stored outside 
of the VA protected environment. Once data are transferred for data analysis, data will be 
maintained on password-protected VA computers in the VA environment and on secure VA 
servers. Study staff will monitor the functioning of the Qualtrics FedRAMP and mPRO 
applications. Only staff affiliated with this research protocol will have access to Qualtrics 
FedRAMP and mPRO data collected for this study. The PI or her designee will be responsible 
for monitoring data storage location and transfer of data between the VA cloud and VA server. 
 
Study providers will also use email to contact participants using Mpls VA approved email 
protocol when patients opt in for personal email usage. 
 
 
Table 1. Multi-modal follow-up protocol for baseline surveys for both Veterans and LOs. 
 
 
Day 
A) US Postal 
Mail 
B) Email Contact 
C) Phone Contact 
1: Recruitment 
Package 
Delivery of info 
sheet, opt-out, 
Letter 1 (B1.V.L or 
B1.LO.L) 
 
 
2: Day 0 – 
Phone 
screening 
(participant opts 
in or out of 
email usage)  
Give participant 
personal code 
after consent; tell 
them to use URL 
from recruit letter. 
Email (B2.V.E or B2.LO.E) with link 
to survey after email address and 
consent is obtained 
Call participant, discuss study using script 
(see study materials), obtain consent, 
screening, obtain verbal permission to send 
emails, provide link to survey and pin 
verbally. 
3: Day 3 
 
First email reminder with survey link 
to non-responders (B3.E.) 
 
4: Day 7 
 
Second email reminder with survey 
link to non-responders (B4.E.) 
First weekly outreach call to non-responders.  
Provide link to survey and pin verbally. (no 
script) 
5: Day 14 
 
 
Second weekly outreach call to non-
responders. Provide link to survey and pin 
verbally. (no script) 
6: Day 21 
 
Third and final reminder email with 
survey link to non-responders 
(B6.E.) 
Third weekly outreach call to non-responders.  
Provide link to survey and pin verbally. (no 
script) 
*Day of survey 
completion 
 
 
Thank you phone call and schedule 
assessment when applicable (veterans only) 
Table 2. Multi-modal protocol for monthly surveys for both Veterans and LOs. 
 
 
Day 
A) US Postal 
Mail 
B) Email Contact 
C) Phone Contact 

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1: Day 0 
 
Email (M1.E) with link to monthly 
survey. 
Call participant to inform them of fup survey; 
inform them of survey link email OR provide 
link to survey and pin verbally. 
2: Day 3 
 
First email reminder with monthly 
survey link to non-responders 
(M2.E.) 
 
3: Day 7 
 
Second email reminder with 
monthly survey link to non-
responders (M3.E.) 
First weekly outreach call to non-responders. 
Inform them of survey link email OR provide 
link to survey and pin verbally. (no script) 
4: Day 14 
 
 
Second weekly outreach call to non-
responders.  Inform them of survey link email 
OR provide link to survey and pin verbally. 
(no script) 
5: Day 21 
 
Third and final reminder email with 
monthly 1 survey link to non-
responders (M5.E.) 
Third weekly outreach call to non-responders.  
Inform them of survey link email OR provide 
link to survey and pin verbally. (no script) 
Table 3. Multi-modal follow-up protocol for fup surveys for both Veterans and LOs. 
 
 
Day 
D) US Postal 
Mail 
E) Email Contact 
F) Phone Contact 
1: Prenotice 
Fup prenotice 
letter to 
dropout 
dyads only 
(FU1.V.L or 
FU1.LO.L)  
Fup prenotice emails to dropout 
dyads only (FU1.V.E or 
FU1.LO.E) 
 
2: Day 0 
 
Email (FU2.V.E or FU2.SP.E) with 
link to fup 1 survey. 
Call participant to inform them of fup survey; inform 
them of survey link email OR provide link to survey 
and pin verbally. 
3: Day 3 
 
First email reminder with fup 
survey link to non-responders 
(FU3.E.) 
 
4: Day 7 
 
Second email reminder with fup 
survey link to non-responders 
(FU4.E.) 
First weekly outreach call to non-responders. Inform 
them of survey link email OR provide link to survey 
and pin verbally. (no script) 
5: Day 14 
 
 
Second weekly outreach call to non-responders.  
Inform them of survey link email OR provide link to 
survey and pin verbally. (no script) 
6: Day 21 
 
Third and final reminder email with 
fup 1 survey link to non-
responders (FU6.E.) 
Third weekly outreach call to non-responders.  
Inform them of survey link email OR provide link to 
survey and pin verbally. (no script) 
Table 4. Multi-modal follow-up protocol for 3M fup surveys for both Veterans and LOs. 
 
 

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7.0 
Data Analysis 
7.1 Qualitative Data Analysis.  
We will utilize an efficient, rapid turn-around analytic approach well-suited to short-term projects, 
interviews that use targeted guides, and projects that lend themselves to straightforward 
explanatory analyses.64 This approach uses data reduction, rather than coding, as the first step 
of analysis. Qualitative interviews will be transcribed verbatim. Following transcription of the first 
three interviews, Dr. Kehle-Forbes (with feedback from co-investigators) will develop a draft 
template that will be used to summarize each transcript. The template will include sections for 
each main topic of inquiry, unexpected findings, and exemplary quotes. After fielding the 
template and making any necessary revisions, Dr. Meis and the project manager (trained by Dr. 
Kehle-Forbes) will carry out the data reduction process. After all transcripts have been 
summarized, the project manager will transfer the summary points to a data matrix that 
organizes the summary points along each of our domains (acceptability, feasibility, and 
outcomes). Finally, following discussion of the matrix with the investigator team, Dr. Meis will 
create a memorandum summarizing findings and key themes.  
 
7.2 Quantitative Data Analysis.  
To evaluate acceptability of COACH, we will calculate the percentage of participants who report 
neutral or better treatment credibility and expectancy on the Credibility-Expectancy scale 
(CES)56 and examine the distribution of scores on the Client Satisfaction Scale (CSQ-8).57 To 
assess feasibility, descriptive statistics and graphical representations depicting intervention 
Day 
D) US Postal 
Mail 
E) Email Contact 
F) Phone Contact 
1: Prenotice 
 
3M fup prenotice emails (3M1.E) 
 
2: Day 0 
 
Email (3M2.E) with link to 3M fup 
1 survey. 
Call participant to inform them of 3M fup survey; 
inform them of survey link email OR provide link to 
survey and pin verbally. 
3: Day 3 
 
First email reminder with 3M fup 
survey link to non-responders 
(3M3.E.) 
 
4: Day 7 
 
Second email reminder with 3M 
fup survey link to non-responders 
(3M4.E.) 
First weekly outreach call to non-responders. Inform 
them of survey link email OR provide link to survey 
and pin verbally. (no script) 
5: Day 14 
 
 
Second weekly outreach call to non-responders.  
Inform them of survey link email OR provide link to 
survey and pin verbally. (no script) 
6: Day 21 
 
Third and final reminder email with 
3M fup 1 survey link to non-
responders (3M6.E.) 
Third weekly outreach call to non-responders.  
Inform them of survey link email OR provide link to 
survey and pin verbally. (no script) 

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fidelity, screening, and treatment retention will be generated. We will calculate rates of survey 
non-response and item missingness for assessment feasibility. To preliminarily evaluate 
outcomes, we will calculate and graphically display the direction and magnitude of change from 
baseline to follow-up for outcomes outlined in Table 1. We will also calculate the percentage of 
participants who improved, worsened, and experienced no change for each of these measures. 
We will calculate descriptive statistics and pre-to-post treatment effect sizes. Lastly, we will 
triangulate our quantitative data with qualitative themes through matrices with exemplary 
quotations. Themes that emerge from the interviews will be stratified by participants’ scores on 
relevant quantitative scales (e.g., participants’ acceptability themes stratified by their Credibility-
Expectancy and Satisfaction scores; feasibility themes stratified by number of sessions 
attended). 
 
7.3 Withdrawal of Subjects 
Participants can withdraw from the study at any point in time and for any reason by contacting 
study personnel in person, by telephone, or by mail, and requesting to withdraw. We anticipate 
termination of participation if: 
1. The participant becomes ineligible to participate. 
2. The participant does not follow instructions from the researchers. 
3. The study is unexpectedly suspended or canceled. 
 
 

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8.0 
Reporting 
We will follow the VA Central IRB Table of Reporting Requirements for all issues that must be 
reported (i.e. summary of adverse events, unexpected problems and any actions or changes 
with respect to the protocol).   
Adverse events (AE) include any untoward medical occurrence in a patient or clinical 
investigation subject administered an intervention and which does not necessarily have a causal 
relationship with this treatment. We will collect the following safety information (adverse events) 
that occurred within 7 days leading up to the final assessment.  
1. Suicide attempts 
2. Hospitalizations for mental health  
3. Episodes of severe IPV 
 
Therapists will be instructed to notify study staff immediately when such events occur during 
treatment delivery. Staff will report directly to the PI regarding any events. Therapists will also 
meet regularly for case consultation, where the occurrence of any of these events will be further 
discussed and tracked.  Questions regarding the occurrence of each of these three events will 
be included in posttreatment assessments. Data obtained from participants will be reviewed for 
safety concerns. In the case of problems, the staff will discuss this with the PI.  
 
Of note, survey reports of IPV on posttreatment and follow-up surveys will be reported when 
respondents endorse items consistent with severe violence. This includes the following: (1) hit 
my partner with a fist or something hard, (2) kicked my partner, (3) slammed my partner against 
something, (4) beat my partner, (5) burned my partner on purpose, (6) tried to hurt my partner 
by choking or suffocating him/her, or (7) used a knife or gun on my partner. Examples of serious 
adverse effects, according to the FDA, include death, life- threatening adverse events, suicide 
attempts, and hospitalization. Consequently, endorsement of items 6 or 7 will be considered a 
SAE. Given the population, some incidents of severe IPV are expected. Reports of moderate to 
severe IPV on baseline surveys are part of our exclusionary criteria (see inclusions/exclusions). 
Thus, severe IPV in reported in baseline surveys will not be reported as adverse events. 
 
The PI and Co-Is are all licensed clinical psychologists. Events will be immediately 
communicated to the study PI. The team will in turn will report any problems to the IRB. Once 
the PI learns of any SAEs, UAP, compliance issues, RCO, and/or protocol deviation, the team 
will report these events. If there are modifications or amendments to the study the study PI will 
also submit appropriate amendments and wait for approval prior to implementation.   
   
 
 

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9.0 
Privacy and Confidentiality 
Protected Health Information will need accessed for the conduct of this study, but PHI will not be 
disclosed. Steps to ensure confidentiality and secure data are described below. 
9.1 Confidentiality 
For all participants, strict confidentiality procedures will be maintained to minimize the potential 
risk of loss of confidentiality. Participant privacy will be further assured by conducting interviews 
in a private office and by assigning arbitrary identifiers in place of individual names in the field 
notes. Data analysis, interpretation, and reporting will be based on these de-identified field 
notes and transcriptions. Since subject responses will not be linked to identifying information, 
participant confidentiality will be assured. The time commitment will be explained to all 
participants prior to their participation in the study. Every effort will be made to minimize the 
length of time and maximize the convenience of the interviews. Participants will be assured that 
participation is completely voluntary and that they have the right to stop participation, decline 
answering any questions, or change the course of the interviews for any reason, including 
potential feelings of discomfort. 
 
9.2 Data Security 
All data will be stored on the servers of the Center for Chronic Diseases Outcomes Research 
(CCDOR) at the Minneapolis VAHCS. CCDOR has well-established procedures to protect the 
privacy of research participants. Names, social security numbers, and contact information will 
not appear on any study materials. Instead, only unique study identification numbers randomly 
assigned to each unique record will be used. Only study team members and study programmers 
(when extracting data to obtain treatment adherence and compare survey responders to non-
responders for the survey) will have access to an encrypted crosswalk table linking study 
identification numbers to identifying information. The CCDOR Statistical and Data Management 
(SDM) team, in partnership with IRM staff, maintain several secure servers, access to which is 
granted only to SDM members who have been screened and assigned appropriate security 
clearance to work with patient data. One common-access server contains individual project 
data. Access to individual project data on this server is granted only to project staff by an SDM 
team member, as authorized by the study investigator. Identifiers will be destroyed as quickly as 
possible. Audio and video recordings will be stored digitally on CCDOR servers and only 
accessible to the principal investigator and project coordinator. Participants will be asked not to 
use last names or provide identifying information during recorded interviews.  
 
CCDOR protects data collected for the purpose of conducting research projects at a level higher 
than that provided for clinical encounters. We use “stand-alone,” secure data servers that are 
accessible only to designated, security-cleared, and trained personnel and data are de-identified 
as quickly as is feasible. Details about CCDOR’s specific data privacy assurance procedures to 
be employed for this study are provided below. 
 

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9.2A. Maintaining Secure Servers.  
CCDOR maintains three secure computer servers that are protected under the Minneapolis VA 
Windows 2000 network. All individuals with administrative access privileges to CCDOR’s 
servers, including IRM personnel and the CCDOR Statistical & Data Management Team, have 
been screened and assigned a security clearance putting them in trusted positions of the 
hospital with clearances to work with patient level data. These individuals and their access to 
the CCDOR servers is ultimately monitored and controlled by Sean Nugent, Senior Program 
Analyst for the CCDOR Statistical & Data Management Team. IRM’s access to the data is 
strictly limited to backing up server data, which prevents catastrophic loss of data. Backups are 
written to tapes that are stored in a secure location accessible only to IRM personnel. CCDOR’s 
Statistical & Data Management Team members maintain permissions, data storage, and all 
server applications.  
 
9.2A.1 Organization and Access to Research Data. With the exception of one server, named the 
“CCDOR Server,” only the CCDOR Statistical & Data Management Team has access to 
remaining Center servers. Data on the “CCDOR Server” are organized by projects within folders 
designated by each investigator. Only members of a given project have access to a specific 
project folder on the “CCDOR Server.” Even then, access to project data is obtained through 
Windows authentication (i.e., user’s name and password to the network). It is virtually 
impossible for any person without a login name and password to the VA hospital’s domain 
network to access data on the Center’s servers. Thus, all data housed on the “CCDOR Server” 
are extremely secure, and access by unauthorized persons highly unlikely. Data containing 
patient identifying information are not stored on the CCDOR Server but are stored on the 
servers accessible only to CCDOR Statistical & Data Management Team members who are 
directly involved in the project. Thus, not even the PI can link individual names to their PHI 
without first obtaining permission to do so from the Statistical & Data Management Team. These 
protections exceed the usual protections provided PHI by the VA system.  
 
9.2A.2 Securing Confidential Research Data. Data collected for individual Center projects are 
often obtained through primary (e.g., surveys) or secondary (e.g., VISTA and Austin databases) 
sources. All extractions of secondary data collection are stored on servers accessible to the 
CCDOR Statistical & Data Management Team only. Secondary data used for a study are de-
identified according to HIPAA criteria and provided a random study identification number. A 
crosswalk table is created linking the study id with the primary key of the secondary data 
source. These data are only accessible to those employees of the Statistical & Data 
Management Team who have undergone the necessary security background checks, received 
appropriate security clearances, and are an integral part of an IRB-approved study. Primary 
data that involves surveys contain only the coded study identification number to identify study 
participants. The paper version of these forms/surveys is kept in locked cabinets within a locked 
room. Data from these surveys/forms are scanned or data entered by project staff or CCDOR 
Statistical & Data Management Team members to a secure folder. This secure folder is on a 
server accessible only to the CCDOR Statistical & Data Management Team members directly 
involved in the study. This protects the integrity of the data as well as its confidentiality. Primary 
data collection involving direct data entry is performed through a custom application written by a 
CCDOR Statistical & Data Management Team programmer. This ensures that data is located in 

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a secure environment and accessible to only those individuals with permission to access the 
data. Only individuals with a need to access the data, as vetted by the project’s Principal 
Investigator are granted access. Even then, only the absolute minimum number of data 
elements is released. 
 
9.2B. Data Used for Analysis.  
For all projects conducted in CCDOR, the final quantitative data is constructed in Statistical 
Analysis Software (SAS) data sets. Qualitative data includes audio recordings of interviews that 
are transcribed and then stripped of all identifiers. De-identified transcripts are then uploaded 
into qualitative analysis software (NVIVO). Quantitative analyses are mostly conducted by 
statisticians assigned to the project or by other members of the project (e.g. Principal 
Investigator). Qualitative analyses are conducted by study investigators with qualitative 
expertise (e.g., Kehle-Forbes and study PI).  
 
SAS data sets and qualitative transcripts will be de-identified according to HIPAA criteria, using 
only subjects’ coded identification number as the primary key. The de-identified data set will be 
made accessible to those project members who are conducting analyses. Only the data 
elements required for the analysis under consideration are released. In summary, a separate 
workspace on a server accessible only to project Statistical & Data Management Team 
members will be created to work with administrative data. Any of the administrative data 
containing patient level data will be encrypted when not being used by a project programmer. All 
patient-identifying information will be removed from the administrative records. Upon completion 
of all study data, de-identified analysis data sets will be created in SAS and NVIVO that will use 
the subjects’ coded study identification numbers as the only key. 
 
 
 

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10.0  Communication Plan 
P.I. Dr. Laura Meis will meet regularly with Erin Linden, the project manager.  At these 
meetings, Dr. Meis will check in with Ms. Linden to ensure that the following key 
communications occur: 
1. Ensure that required approvals are obtained  
2. IRB of any Serious Adverse Events, Unanticipated Problems, or interim results 
that may impact conduct of the study. 
3. Notify facility directors when the study reaches the point that it no longer requires 
engagement of the local facility  
The study team will also review relevant sections of the protocol periodically, so that we 
can make sure that the phases of the study are conducted according to the IRB-
approved protocol. 
 
 
 

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11.0 References 
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16. Mausbach BT, Moore R, Roesch S, Cardenas V, Patterson TL. The relationship 
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