The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility
Conditions: PTSD, Depression, Chronic Pain, Alcohol Use Disorder, Traumatic Brain Injury
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Impact of Modifiable Psychosocial Factors on Veterans' Long-term 
Trajectories of Functioning and Quality of Life: Promoting Recovery by 
Targeting Mindfulness and Psychological Flexibility  
(Study Evaluating Returning Veterans Experienced: Post-Deployment 
Functioning (Project SERVE)) 
 
NCT03615222 
 
v. 06/13/2023  
 

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RESEARCH PROTOCOL FOR 
PROJECT SERVE: POST-DEPLOYMENT FUNCTIONING (Project SERVE: FX) 
 
SPECIFIC AIMS 
 
Understanding the process of functional recovery among returning Operation Enduring (OEF) and Iraqi 
(OIF) Freedom and New Dawn (OND) Veterans is of the utmost importance, both to VA and to the national 
economy. Although most returning OEF/OIF/OND soldiers are resilient, concerning rates of PTSD (12-20%) 
and depression (14-15%) have been found, and as many as 24-35% report drinking more alcohol than they 
intended (Hoge et al., 2004). Notably, these figures are likely underestimates due to stigma associated with 
mental health services in military culture (Wright et al., 2009). Certainly, the course and impact of mental health 
conditions among returning OEF/OIF/OND Veterans are not well established, with most studies being cross-
sectional and retrospective in nature. It is critical to understand the long-term trajectories and functional impact 
of exposure to war zone stressors and associated mental health disorders, particularly in the context of the 
current economic environment, which differs considerably from past eras of war zone service. 
 
The purpose of the proposed longitudinal project is to better understand the functional impairment and 
recovery of returning OEF/OIF/OND Veterans and to identify potentially-malleable risk and resilience factors 
that predict level of functioning over time. Up to 600 OEF/OIF/OND Veterans will be evaluated over a two-year 
period in Phase III of this project, including as many participants from Phase I and Phase II as possible. 
Veterans will complete a detailed baseline assessment, as well as follow-up assessments. The most recently 
funded continuation Phase (Phase III) will continue and extend the longitudinal assessment study examining 
predictors of post-deployment functioning, referred to as Project SERVE. The specific aims of Phase III are to 
1) identify treatment targets that may predict functional disability and self-directed violence 2) identify gender 
differences in the sample. 
 
STUDY METHODS 
 
Overview of Study Methods. This study will investigate the course of functioning over time among 
returning OEF/OIF/OND Veterans enrolled at CTVHCS. The primary outcome measures will assess multiple 
domains of functioning, including: 1) occupational functioning; 2) social relationships; 3) family functioning; 4) 
physical functioning; and 5) quality of life. Hypothesized predictors of functioning include: 1) level of exposure 
to deployment-related stressors, including potentially traumatic events (PTEs) and head injuries/traumatic brain 
injury (TBI); 2) level of pre-deployment stress and trauma exposure; 3) level of exposure to post-deployment 
stress and trauma, including “everyday” stressors; 4) modifiable psychological factors including coping, 
emotion regulation, self-compassion, attributional style, psychological flexibility, and mindfulness; 5) perceived 
social support; 6) psychopathology including PTSD and depression; 7) substance misuse; 8) physical health 
symptoms including chronic pain; and 9) exposure to morally injurious events. Saliva/blood samples will also 
be collected (on an optional basis) to examine genetic contributions. 
The proposed longitudinal design will include a baseline assessment and follow-up assessments in order to 
examine predictors of functioning during post-warzone readjustment. This design enables us to examine 
mechanisms of action in the development of functional impairment over time. 
    
Participants. In Phase III, we propose to continue following as many of the Phase I and Phase II 
participants as volunteer and to recruit additional participants until we reach the target sample size of 500 
eligible OEF/OIF/OND Veterans. This will increase the total sample size across study phases to approximately 
1,000 depending on how many existing participants transfer into the next Phase versus enrolling more new 
participants. Every effort will be made to represent women and men of all racial and ethnic backgrounds. 
Several of our main hypotheses focus on the influence of psychopathology and other predictors on functioning 
over time as well as gender differences. In addition Veterans experiencing mental health problems require 
higher levels of healthcare service utilization and are at increased risk for maladaptive functional outcomes. 
Therefore, our recruitment strategy will involve over-sampling for participants experiencing mental health 
difficulties and women veterans. 
 

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Inclusion Criteria. In keeping with the nature of a longitudinal assessment study, this project has relatively 
few exclusionary criteria. Potential participants include male and female, English-speaking OEF/OIF/OND 
Veterans, 18 years of age or older, enrolled at CTVHCS or willing to be enrolled for the purpose of participation 
in this study. To be eligible, participants must be: 1) able to comprehend and sign the informed consent form; 
2) able to complete the structured interviews and self-report assessments; 3) willing to be contacted for follow-
up assessments; 4) (for newly enrolled participants), given that we have already recruited a large sample of 
veterans who are reporting relatively little functional impairment, we will require newly enrolled participants to 
self-report global functional impairment on the WHODAS 2.0 12-item self-report version equivalent to a mean 
item score of 0.89, reflecting current research findings. Although we anticipate being able to meet our 
recruitment goals, should recruitment prove more challenging than expected, we will remove this inclusion 
criterion; 5) deemed stable on psychotropic medications (defined as t3 months on a selective serotonin 
reuptake inhibitor or monoamine oxidase inhibitor; >1 month on an anxiolytic or beta-blocker; >1 month 
medication discontinuation or “wash out” for all medications) at the time of the BL assessment; and 6) deemed 
stable in psychotherapy (t3 months stabilization for psychotherapy and 1-month psychotherapy wash-out) at 
the time of the BL assessment. These latter two criteria are instated to ensure that symptoms assessed during 
the baseline assessment are due to any underlying psychiatric condition and not due to the effects of starting 
or stopping medications and/or psychotherapy. Changes in treatment will be permissible during the current 
study, as this reflects real-world practice. All changes in medications will be monitored over time, and 
appropriately covaried, as treatment can have important effects on functioning over time. Individuals with 
current and lifetime psychiatric diagnoses, with the exception of schizophrenia, schizophreniform disorder, 
schizoaffective disorder, delusional disorder, unspecified schizophrenia spectrum/other psychotic disorder, and 
bipolar disorder, will be eligible to participate.     
 
Exclusion Criteria. Veterans will be excluded if they: 1) plan to relocate out of the CTVHCS system within 
four months of protocol initiation; 2) meet criteria for a diagnosis of schizophrenia, schizophreniform disorder, 
schizoaffective disorder, delusional disorder, or a manic/hypomanic episode; 3) report current suicidal or 
homicidal risk warranting crisis intervention; 4) report symptoms consistent with severe traumatic brain injury 
(TBI) that interfere with their ability to complete the consent process or assessment (i.e., due to ethical 
concerns about obtaining informed consent and difficulties with completing the structured assessment); or 5) 
report current non-military related hallucinations or delusions that cause significant distress and/or impairment.  
 
Procedures. In Phase III, assessments occur at 0, 8-, 16-, and 24-month time points. Veterans will 
complete a baseline assessment, lasting approximately 2-3 hours, and a two-year follow-up assessment 
lasting approximately 1-2 hours. Please note that these times are approximated, and could be shorter or longer 
depending on the nature of the interview (e.g., diagnostic complexity, taking breaks, talkative Veteran). The 
baseline and annual assessments include clinical assessments and self-report questionnaires. In addition, 
follow-up questionnaire assessments (~45 minutes) are administered to track functional impairment and 
recovery over time. For those who opt to participate in the genetic component of the study, saliva/blood 
samples will be collected at the baseline and two-year follow-up assessments. Participation in the 
genetic/biomarker component of the study is completely optional and does not affect participation in the study 
as a whole. Self-report data at in-person assessments will be collected either using pencil and paper surveys 
or on VA-issued iPads. These iPads are FIPS-140-2 compliant and will only be used on the VA network behind 
the VA firewall. Interviews will be conducted by trained masters or doctoral-level assessors and research 
assistants, and supervised by licensed clinical psychologists. Participants in the Project SERVE pilot, FX 
Phase I, and FX Phase II studies have tolerated the assessment length well. Those for whom the assessment 
length poses a problem (e.g. due to work, childcare, etc.) will be offered to split the assessment into two days 
(preferably consecutive). We will also make efforts to conveniently schedule the assessment around other 
medical appointments at CTVHCS, which could result in needing to complete two appointments. As needed 
and appropriate, Veterans may also be given the option to complete assessments by VA approved video 
communication technology, telephone or online. Veterans who are scheduled for a video appointment, may be 
sent an encrypted email from study staff with the details of their appointment (i.e., date, time, associated links). 
We will examine outpatient medical records for the SERVE participants to investigate the association between 

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PTSD and other mental health symptoms a range of health-related outcomes, including incident heart failure.  
 
Recruitment. Multiple strategies will be used to recruit new participants for Phase III, which are in keeping 
with previous procedures. Participants in Phase I and Phase II will be invited to participate in Phase III (i.e., 
“transfers”). Newly enrolled participants will participate in Phase III only. Participants will be recruited through 
advertisement at enrollment sites, vet centers, Veteran’s networks and service organizations, through in-
service presentations to primary care staff, mental health staff, and other relevant VA staff (e.g., OEF/OIF/OND 
coordinators, etc.), and through the community (e.g. grocery stores, churches, shopping centers, and so forth). 
In-person recruiting will also be conducted at enrollment and community sites. In these cases, one or more 
research team members will sit at a table/booth in a high visibility area (e.g., a main VA lobby or outside of a 
grocery store) with a sign indicating that OEF/OIF/OND Veterans are being recruited to participate in a 
research study. Staff members will provide interested Veterans with a flyer (see attached flyer and brochure) 
about the study. In addition, Veterans interested in participating in the study will be given the option of 
providing staff members with their contact information so that they can be contacted by phone at a later point in 
time to complete a telephone screen interview. If a private office is available, as a convenience, participants 
may be given the option to complete the screening interview in person. We will also place advertisements in 
local newspapers, local community-based advertisement sources, on local Craigslist pages, and in other 
locally-based media platforms, on relevant VA and other Veteran-oriented websites, and social media outlets, 
pending required approvals from VA public relations office (see attached ad). 
We also request permission to conduct periodic queries to recruit new participants using VISTA, VINCI, the 
corporate data warehouse, or other approved VA methods for accessing Veteran mailing list information 
(frequency approximately 1x/year, to be determined based on the number of names generated; i.e. if there are 
too few or too many names we will adjust the frequency correspondent with staffing so potential participants 
would not need to wait too long for a research assessment appointment; as the list is exhausted, we will 
update the list more frequently; maximum number of names generated = 100,000). We will use these VA 
approved methods to identify OEF/OIF/OND Veterans who meet some of our inclusion criteria (e.g. 
OEF/OIF/OND Veteran status) so that we can reach out to returning Veterans to let them know that the study 
is being conducted. Up to two letters per study phase will be sent to participants (see attached). The second 
letter will be mailed approximately 2 weeks after the first letter, depending on response to the first letter. 
Depending on recruitment flow from these letters, we retain the option to attempt to contact potential 
participants by telephone after the second letter (allowing at least 4 days for them to receive the second letter). 
In the first letter, unique veteran (i.e., those who have not participated in a prior phase) will receive a post-card 
or form with a potage paid envelope to opt-out. If a Veteran returns this opt-out card or says he/she is not 
interested at any point in this process (e.g., after the first letter, second letter, or during the follow-up call), their 
name will be marked on the list and they will not be contacted again during this study phase. We will also send 
a text message to Veterans to let them know that they are invited to participate (see attached for wording of 
text messages). Interested Veterans will complete a telephone screen to determine their eligibility (see below). 
This recruitment procedure requires a waiver of consent and waiver of HIPAA authorization (attached). The 
retrieval of names and addresses to recruit study participants involves no more than minimal risk to subjects, 
and will not adversely affect the rights and welfare of subjects. This research could not practically be carried 
out without the waiver, which enables us to reach out to as many Veterans as possible to make participation in 
the study available to them. The mailing list of contact information generated by the methods detailed above 
will be stored electronically on the secure VA Research drive and/or VINCI project folder for this study, 
depending on the required data storage location associated with the approved method of requesting and 
storing this information. After a Veteran contacts the CoE (or we contact the Veteran per above), a brief 
screening will be conducted by telephone (see below). Every effort will be made to schedule eligible 
participants for the baseline assessment appointment at the enrollment site (CTVHCS campuses and CBOCs) 
of their choice, pending availability of staffing resources and research space at that time. 
Eligible Veterans who participated in Phase I or Phase II will be contacted to determine their interest in 
being a part of Phase III (as indicated in original ICF; see attached recruitment letters). As enrollment for 
Phase I began in 2010 and enrollment for Phase II began in 2014, current SERVE participants will be 

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contacted to invite them to participate for what would approximately mark their 4-year follow-up if they entered 
the study in Phase II and their 8-year follow-up if they entered the study in Phase I. They would then be 
followed for another two-year time-frame, which would culminate with either their 6-year or 10-year follow-up, 
depending on when they entered the research program. A series of two form letters will be sent to “transfer” 
participants (attached). The second letter will be mailed approximately 1-4 weeks after the first letter, 
depending on response to the first letter and to allow flexibility in the recruitment strategy for new vs. transfer 
participants with whom we have an existing relationship. Recruitment letters may include a small token (e.g., 
magnet, pen or pin with SERVE logo). We will attempt to contact potential participants by telephone and/or text 
message at least 4 days after a letter is mailed to allow time for them to receive the letter. Because of the 
priority to recruit transfers for the scientific mission, and addresses may well change during the interval since 
their last contact with us, we retain the option of sending up to two additional letters (e.g., personally-written 
note card) informing them that we have tried unsuccessfully to reach them. In addition, we will utilize the 
contact information form from Phase I and Phase II to call contact person(s) provided by the Veteran in case 
we were unable to reach him/her in order to get updated contact information. If a Veteran says he/she is not 
interested at any point in this process, his/her name will be marked on the list and s/he will not be contacted 
again. Interested Veterans will complete a telephone screen to confirm their eligibility (i.e., to ensure they are 
not actively suicidal, etc.; see attached Telephone Screening Form FX3). This recruitment procedure requires 
a waiver of consent (see attached).  
To facilitate recruitment, the study will have a dedicated phone line. After a Veteran calls about the study 
(or we contact the Veteran), a brief screening assessment will be conducted by telephone or in person. This 
should help minimize participant burden, as those who are not eligible will be saved time and transportation 
costs associated with attending a screening appointment in person. If the Veteran is determined to be ineligible 
based on the telephone eligibility screening procedure, we will not collect any personally identifying 
information. For veterans determined to be initially eligible, we will collect identifying information for the 
purpose of scheduling a baseline assessment appointment. This identifying information will be recorded on an 
electronic telephone screen registry of initially-eligible participants, including Screen ID#, date of screen, 
salutation, name, contact information, whether or not it is ok to leave telephone messages (e.g., for 
appointment reminders), the appointment campus/date/time, indication that telephone note entered in CPRS, 
enrollment date, and reason not enrolled (e.g., unable to schedule, no longer has time to participate). Coded 
hardcopy eligibility screening documents will be stored in separate files for those deemed initially eligible 
versus ineligible. Final eligibility will be determined at the baseline assessment (e.g., from the diagnostic 
evaluation). Telephone screen information will be used in aggregate to report the recruitment process (e.g., 
number screened, number eligible, number ineligible, percentage/reasons for ineligibility, etc.). The telephone 
screen asks about mental health problems, and therefore is possible that a veteran who is screened will 
provide information about a substance use disorder (SUD). The substance data is used to conduct scientific 
research and will be reported in aggregate such that no individual participant is identified. However, should the 
participant desire treatment for SUD or mental health services, appropriate clinical referrals will be made. 
Following the phone screen, for those deemed initially eligible, a cover letter will be mailed to the Veteran 
in advance of the baseline assessment appointment with directions and parking instructions. In addition, a 
copy of the Informed Consent Form (ICF and HIPAA authorization; attached) will be mailed to the Veteran in 
advance of the appointment (time permitting depending on when appointment is scheduled) for the Veteran to 
read and consider participation. Mailing the ICF/HIPAA authorization to the Veteran in advance will benefit 
Veterans in two ways. First, it will provide them with additional information about the study prior to their initial 
appointment. In the event Veterans read the ICF/HIPAA authorization at home and decide they do not wish to 
participate, they will be able to cancel the appointment ahead of time, saving them the time and expense of 
travelling to the appointment unnecessarily. Second, this procedure will reduce participants’ time burden on the 
day of the assessment, as Veterans will have had the time to read and consider the ICF/HIPAA authorization 
prior to coming to the initial intake appointment. Upon arrival, the Veteran will be asked if s/he had a chance to 
read the ICF/HIPAA authorization, and if not, will be asked to read the consent form at that time. It should be 
noted that, regardless of whether or not participants read the ICF/HIPAA authorization ahead of time, the study 
staff member will always explain the nature of the study to participants at the time of the baseline assessment, 

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as well as the potential risks/benefits of participating in the study. In addition, written informed consent will only 
be obtained prior to the baseline assessment and will not be obtained until the researcher is satisfied that the 
participant has a good understanding of the risks/benefits of participating in the study. In situations where a 
Veteran unique to the Project SERVE Phase III study is unable to attend a baseline appointment in person 
(e.g., due to COVID-19), they may enroll remotely by electronically signing an informed consent form via 
docusign. Potential participants will be given the opportunity to ask questions and encouraged to contact the PI 
if they have any additional questions or concerns related to the study. 
In order to recruit as many Phase I and Phase II participants as possible, we will offer the option of signing 
an informed consent form remotely for transfer participants who have moved out of the area. Following the 
phone screen, if the Veteran is interested in participation, he/she will be mailed the informed consent form and 
HIPAA authorization. Participants will be provided clear instructions for signing the forms, and a postage-paid 
envelope for returning them to the study team. Participants will be informed that study procedures will not 
begin until the forms have been received by a study team member. Any potential participant who wishes to 
travel to the VA Medical Center to provide informed consent in person will be allowed to do so, unless it is 
deemed unsafe for the veteran or study staff (e.g., due to COVID-19). Veterans who enrolled in a prior study 
phase and who are unable to attend an in-person appointment due to having moved out of the area or some 
other logistical barrier will have the option of renewing their consent online in order to participate in the current 
study phase. This requires a waiver of documentation of signed informed consent. The elements of informed 
consent will be displayed on the screen along with a button indicating “I consent/agree to participate.” The 
screen displaying the study information will be designed so that the participant is required to take an action to 
signify their acknowledgment of the information before they can proceed. The instruction tells participants that 
pressing the button confirms they have read the study information and that they agree to participate. 
Participants will be informed that they have the option of printing the page for their records, or to request study 
staff to send them a copy of the summary of the elements of informed consent. In addition, these participants 
will already have of copy of the full informed consent form, which has been mailed to them. Potential 
participants will be given the opportunity to ask questions and encouraged to contact the PI if they have any 
additional questions or concerns related to the study. Because these participants are unable to attend in 
person, they will not have the opportunity to participate in the biomarkers component of the study. Their 
participation will be limited to completing an assessment by phone or VA approved video communication 
technology and completing questionnaires online. 
 
Research Setting. Veterans will be recruited from the three primary campuses of CTVHCS (Waco, 
Temple, Austin) as well as CBOCs in order to represent Veterans from different geographic regions within 
CTVHCS. Research interviews will be conducted in Waco, Temple and Austin. In Waco, private offices are 
available in the Center of Excellence Building. In Temple, Research Service Space is available in the 
Domiciliary, Building 146 and Building 205. In addition, interviews will be conducted in private offices available 
on the Temple campus (e.g., swing space through Mental Health/Behavioral Medicine, OEF/OIF program, 
library, etc.). In Austin, only swing space is available at this time, however, we will continue working on other 
available space. As needed, we will also use the CoE’s Mobile Support Vehicle, which includes two sound-
proofed offices and can be relocated as needed (e.g., Waco, Temple, Austin, CBOCs, Vet Centers). The 
Mobile Support Vehicle is VA/CoE-owned and includes two offices. Laptops that are used for the study will not 
be locked up in the Mobile Support vehicle, and will stay with the VA employee as assigned/issued by VA IT. 
The laptops have locking cables and are password protected.  
Every effort will be made to conduct assessments at the site of the Veterans’ choice, pending availability of 
staffing resources and research space at that time. Due to research space limitations, the need may arise to 
invite participants to come to another campus to complete the interviews (i.e., different campus from where 
they usually receive their care). When space is not readily available (and budget dependent), we will offer the 
option to participants to travel to another campus to complete the assessment. In such instances, participants 
will be provided with supplementary compensation to account for extra time and travel expenses. Calculations 
will be made using VA mileage rates at the time (currently: 41.5 cents/mile). For example, based on current 
rates, participants would be paid the following (rounded to nearest 5 or 10): 1) Austin/Temple (142 miles 

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roundtrip) = $60; 2) Austin/Waco (204 miles roundtrip) = $85; 3) Temple/Waco (68 miles roundtrip) = $30. This 
strategy will also be used to appropriately compensate Veterans who have relocated out of the CTVHCS area, 
but are still within reasonable distance to participate at a CTVHCS site (e.g., travel from College Station, 
Dallas, Houston, San Antonio). Rates for these cities will be similarly calculated. This procedure is critical to 
the research mission in order to continue following as many transfer participants as possible (i.e., the 
importance of the Phase I/Phase II to Phase III design is to answer scientific questions over longer periods of 
time). Numerous participants have expressed a preference for driving to the VA to complete the procedures in 
person rather than remotely. Thus, we are requesting to have flexibility on this front. These rates are based on 
federal standards and provide appropriate remuneration to participants (i.e., standard payments do not 
properly compensate Veterans for time and travel when traveling longer distances). Participants will be 
informed that they cannot receive compensation for travel to other appointments and research simultaneously 
(i.e., no double dipping). 
 
Enhancing Retention. In a longitudinal study (Aim 1), retention is as important as recruitment. Every effort 
will be made to establish personal relationships with participants and to help them feel connected to the study 
and to CTVHCS. Appointment reminders will be used to decrease attrition. Research assistants will mail 
appointment confirmation letters to participants and call, text, or email participants prior to their appointment. 
For follow-up assessments, two methods of completing self-report questionnaires will be offered: filling out the 
questionnaires via paper and pencil and returning them through the mail, or filling out questionnaires online via 
a secure web-based survey application. Those who chose the online option will be mailed, texted, or emailed 
instructions, information regarding our procedures for ensuring their confidentiality and privacy, and a web 
address and unique code that they will enter as indication of their consent to this procedure. Veterans who do 
not complete the follow-up assessments will be contacted by telephone and/or letter as a friendly reminder; 
they will be offered to complete the assessment by telephone if they find that to be more convenient than filling 
out the written forms or completing them online. Alternately, if it is deemed safe to do so, participants will be 
offered the opportunity to schedule an appointment to complete the questionnaires in-person, if that is more 
convenient for them (our experience is that some Veterans prefer this option). At each assessment point, 
Veterans will complete (or update) a contact information form. In addition, research staff will also periodically 
contact Veterans to inquire if their contact information is current (e.g. in advance of a follow-up appointment or 
to confirm mailing address for payment purposes). It is possible that some Veterans will relocate between 
assessment points and our contact information will become outdated. In these instances, the Veteran’s 
medical record and contact information form will be used to retrieve his/her updated telephone/address so s/he 
can be contacted to continue to participate in the study. Veterans will also be given the option of completing 
telephone or VA approved video communication technology interviews in the event that they decline or are 
unable to attend a follow-up assessment or decline or are unable to complete the packets by mail or online. 
Additionally, if the Veteran declines or is unable to participate in a telephone/video interview, s/he will be 
offered the option of completing only the self-report measures either via mail, online, or telephone. These 
procedures give flexibility to the Veteran to choose to continue participating in a manner that is feasible given 
life circumstances. 
Several incentive strategies will also be used to decrease attrition and optimize retention. Participants will 
be compensated $75 each for the baseline and annual assessment and $25 for mailed follow-up assessments. 
That is, a Veteran would be compensated a total of $200 for completing all study procedures. The Veteran will 
have the option being compensated at any time-point with either the standard payment or with a gift card from 
a national chain store (e.g. Walmart) should that option become approved for use in VA research. These 
incentives should reduce participant burden related to their time spent, travel costs, and other expenses (e.g. 
childcare coverage). To demonstrate our appreciation for their participation, other incentive strategies will also 
be used. At the baseline and annual assessment, participants will be given small appreciation gifts that make 
them feel part of the study (e.g. water bottle with study logo; Veteran-oriented magnetic poetry, candy with 
logo, baseball cap with study logo). Incentives will be used to encourage participants to mail back their self-
report questionnaires. Specifically, a raffle will be held every 4-6 months (prize ranging from $50-200; e.g. gift 
certificate to canteen, amazon.com, Best Buy, cash/check/direct deposit, etc.). Every participant who mails 
back his/her questionnaires will be entered into the raffle. Raffle tickets will be entered into a drawing and a 

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winner will be randomly selected. The raffle will be announced in a newsletter. Winners will be announced by 
participant number only and we will the participant to notify them that they have won. 
 
Assessment Procedures. The assessment instruments for Phase III are presented in Table 1 (see 
attached). Assessment domains were selected based on the empirical literature to capture biopsychosocial 
variables associated with responses to stressful life events and include: 1) pre-deployment characteristics 
(demographic variables, pre-deployment psychiatric history; pre-deployment stress and trauma); 2) cognitive 
functioning; 3) deployment related stress, trauma, exposure to potentially morally injurious events, and TBI 
(number of deployments, deployment-related PTEs); 4) post-deployment stress and trauma (exposure to PTEs 
following deployment, exposure to everyday/chronic stressors); 5) psychopathology (PTSD, depression, 
alcohol and substance use, abuse and dependence); 6) coping methods (acceptance, self-compassion, 
emotion regulation, attribution style, mindfulness, psychological flexibility, active coping); 7) multi-dimensional 
functioning; 8) response style/validity; and 9) information from VA electronic health records such as diagnoses, 
progress notes, medications, lab or radiology findings, etc.  
 
Table 1. Phase III Assessment Instruments. 
Measures/ 
Proposed 
Indicators 
Purpose 
Assessment 
Time Point 
 
Description/Rationale 
BL 
8 & 
16
mo 
24 
mo 
 
Telephone Screen 
E 
 
 
 
Administered prior to the baseline assessment to determine initial 
eligibility. Assesses inclusion/exclusion criteria.  
Contact 
Information  
Contact 
9 
9 
9 
Collected to verify Veteran status in CPRS, scheduling, send 
appointment confirmation letter, contact for follow-up, etc. 
Demographic 
Questionnaire & 
Military History 
Form (DHMQ) 
Demographic, 
PV 
9 
 
9 
Assesses basic demographic and Veterans-specific characteristics (e.g., 
years of education, years of military service, family history of military 
service). Re-administered at annual to assess changeable demographics 
(e.g. marital status, employment). 
Mini International 
Neuropsychiatric 
Interview (MINI)  
E 
9 
 
 
Modules administered from this widely used screening Interview to 
assess for exclusionary criteria (manic/hypomanic episode and 
psychosis).  
Full Combat 
Experiences 
Scale (FCES) 
PV 
9 
 
9 
Self-report measure of exposure to combat situations (Hoge et al., 2004). 
Re-administered if re-deployed. Items added from the National Vietnam 
Veterans Readjustment Survey to assess potentially morally injurious 
combat events. 
Nash Moral Injury 
Events Scale 
(MIES) 
PV 
9 
 
9 
Self-report questionnaire developed as a measure of exposure to 
potentially morally injurious events (Nash, et al, 2013). Re-administered if 
re-deployed. The MIES has excellent internal consistency, both the 
overall scale and the 2 subscales showed temporal stability, and early 
research found preliminary support for the construct validity (Nash, et al., 
2013).  
Deployment Risk 
and Resilience 
Inventory (DRRI) 
PV 
9 
 
9 
The DRRI (King, King, and Vogt, 2003) is a collection of scales 
assessing pre-deployment, deployment, and post-deployment risk and 
resilience factors. The DRRI was validated for use with OIF Veterans 
(Vogt et al., 2008). Scales administered will include the military sexual 
trauma scale at baseline and the post-deployment social support scale at 
baseline and 24 months.   
Acquired 
Capability for 
Suicide Scale 
PV 
9 
 
9 
Self-report of perceived ability to tolerate fear and pain associated with 
suicide. Has adequate internal consistency in a study that built on 
SERVE (.80). 
Interpersonal 
Needs 
Questionnaire 
(INQ)  
PV 
9 
 
9 
Self-report measure that assess thwarted belongingness and perceived 
burdensomeness (Van Orden et al., 2012). The INQ has demonstrated 
good convergent validity, internal consistency and concurrent validity 
(Van Orden et al., 2012). 
Treatment 
Involvement Form 
(TIF) 
CV 
9 
9 
9 
Form created for the current study that will be used to assess treatment 
involvement during the prior interval, including medical, psychiatric and 
psychological treatment, as well as supportive interventions (e.g. 

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Alcoholics Anonymous, Narcotics Anonymous).  
Columbia Suicide 
Scale 
DV 
9 
 
9 
The Columbia Suicide Scale (Posner et al., 2008) is a state-of-the-art 
suicide assessment for individuals perceived to be at high risk for 
suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 
2011). 
Clinician 
Administered 
NSSI Disorder 
Index (CANDI) 
DV 
9 
 
9 
The CANDI is a clinical interview that diagnoses Nonsuicidal Self Injury 
(NSSI) disorder and type and frequency of NSSI. Demonstrated good 
reliability and validity in prior research, including in Co-I Kimbrel’s VA-
funded study of NSSI in veterans. Administered in tandem with the NSSI 
Screen developed by Co-I Kimbrel. 
Beck Scale for 
Suicide Ideation 
(BSSI)  
DV, Med 
9 
 
9 
Widely-used self-report measure of intensity of thoughts and behaviors 
associated with suicide. Includes 2 additional items that ask about past 
suicide attempts as well as the level of suicidal intent during the most 
recent attempt. Prior research shows that endorsement of suicidal 
thoughts and behaviors can be greater on self-report questionnaires 
compared to interviews. Thus, this measure complements the suicide 
focused interviews. 
Suicide 
Cognitions Scale-
Brief  
DV, Med 
9 
 
9 
Self-report measure of suicide-related thoughts that load onto the 
following subscales: unsolvability, unlovability, and unbearability. Brief 
version was recently validated across 3 chronic pain samples (Bryan et 
al., 2016). 
PTSD Checklist-5 
(PCL-5)  
Med  
9 
9 
9 
Self-report of symptoms of PTSD during the previous month. 
Demonstrates high sensitivity and specificity in relation to a lengthy 
diagnostic interview for PTSD (CAPS), with which it was co-developed. 
Strong psychometric properties, including in numerous Project SERVE 
papers. 
Patient Health 
Questionnaire-9  
Med, DV 
9 
9 
9 
Self-report measure used for screening, diagnosing, and monitoring 
depression. It incorporates DSM-IV diagnostic criteria (Question 9 
screens for suicidal ideation; Kroenke, Spitzer & Williams, 2001). 
Alcohol Use 
Disorders 
Identification Test 
(AUDIT)  
Med 
9 
9 
9 
Self-report measure to screen for alcohol-use disorders (Saunders, 
Aasland, Babor, Fuente, & Grant, 1993). 10-item measures adopted by 
VA as the gold-standard screening for alcohol use disorders in mental 
health and primary care clinics. Good internal consistency (α=.80 - .94) 
and test-retest reliability (r=.86), and strong concurrent validity with the 
MAST and CAGE screening measures (Babor et al., 2001). 
Drug Abuse 
Screening Test 
(DAST)  
Med 
9 
9 
9 
Self-report measure to quantify drug misuse and related psychosocial 
impairment. Good internal consistency and concurrent validity with 
frequency of drug use over 12-months (Skinner, 1982). Moderately 
correlated with denial and social desirability. The instructions will be 
updated to more explicitly assess for misuse of opiates that may have 
been prescribed. 
Substance Use 
Screen 
Med 
9 
 
9 
Form created for the current study that will be used to assess current and 
lifetime substance use (e.g., stimulants, cannabis, etc.) 
TBI—Vasterling 
Assessment 
Interview   
E, Med 
9 
  
 9 
This clinician-administered structured interview developed by Vasterling 
(2008) assesses the number, recency, type of injury, and clinical 
sequelae associated with traumatic brain injury during deployment. Total 
number of lifetime head injuries leading to any symptoms will also be 
assessed. TBI will be assessed at baseline for lifetime history and then 
re-assessed at the annual interview for any new TBIs that may have 
occurred during the past two years. 
Ten-item 
Personality 
Inventory (TIPI) 
PV 
9 
 
 
10-item self-report measure of the Five-Factor Model of personality 
(Gosling, Rentfrow & Swann, 2003). 
Patient Health 
Questionnaire–15 
(PHQ-15) 
Med, DV 
9 
 
9 
Self-report (Kroenke, Spitzer & Williams, 2002) of somatic symptom 
clusters including pain (musculoskeletal, headaches), cardiac, 
gastrointestinal, respiratory, etc. that account for more than 90% of 
outpatient physical complaints (Kroenke, Arrington & Manglesdorff, 
1990). The PHQ-15 had strong internal reliability in the initial validation 
(α=.80) and was associated with functional status and disability (Kroenke 
et al., 2002). 
Chronic Pain 
Screen Quest. 
Med 
9 
  
9 
Self-report of pain type/intensity. Internal consistency in SERVE was .67. 

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Acceptance and 
Action 
Questionnaire 
(AAQ-II)  
PV 
9 
9 
9 
Self-report measure assessing acceptance, experiential avoidance 
(attempting to alter the form or frequency of unwanted internal 
experiences), and taking action despite experiencing unwanted private 
events (Bond, et al, 2011). Strong psychometrics in multiple SERVE 
publications (Meyer et al., 2013; 2018; in press, DeBeer, Meyer, et al., 
2017).  
Brief Experiential 
Avoidance Quest. 
(BEAQ)  
PV 
9 
9 
9 
The BEAQ is a single-factor item that assesses the modifiable construct 
of experiential avoidance (Gamez et al., 2013). 
Self-Compassion 
Scale – Short 
Form (SCS-SF)  
PV 
9 
9 
9 
Self-report measure of self-compassion, consisting of a total scale score 
and six subscale scores: self-kindness, self-judgment, common 
humanity, isolation, mindfulness, and over-identified (Neff, 2003; Raes, 
Pommier, Neff, & Van Gucht, 2011). The SCS-SF is strongly correlated 
with the original long form (r=.97) and has the same 6-factor structure 
with one higher-order factor. Internal consistency was .86 for the whole 
measure, with subscale alphas ranging from .54 to .75 (Raes et al., 
2011). 
Difficulties in 
Emotion 
Regulation Scale 
(DERS-Brief)  
PV 
9 
9 
9 
Self-report measure (Bjureber et al., 2016) of 6 domains of emotion 
dysregulation: nonacceptance of emotional responses, difficulty 
engaging in goal-directed behavior, difficulty with impulse control, lack of 
emotional awareness, poor emotion coping strategies, and lack of 
emotional clarity.  
Five Facet 
Mindfulness 
Questionnaire  
PV 
9 
9 
9 
Self-report measure assessing multiple facets of the modifiable factor of 
mindfulness. The FFMQ has demonstrated good construct validity and 
internal consistency. Good predictive validity in research with veterans. 
World Health 
Organization 
Disability 
Assessment 
Schedule II 
(WHODAS 2.0)  
 
DV 
9 
9 
9 
Self-report assessment of functional disability with total score and 6 
domains of functioning: understanding and communicating, mobility, 
getting along with others, life activities (i.e., work, education, household 
responsibilities), participation in society, and self-care (Üstün et al., 
2010). Both global and specific areas of functioning are crucial in 
thoroughly understanding functional recovery, as Veterans may function 
well in one area and have difficulty in another. Moreover, some domains 
may be affected by contextual factors instead of representing functional 
capacity (e.g., work functioning in a struggling economy independent of 
impairment). 
Inventory of 
Psychosocial 
Functioning (IPF) 
– Brief  
DV 
9 
9 
 
9 
Self-report measure (Co-I Marx et al., 2009; Bovin et al., 2018) of 
Romantic Relationships with a Spouse/Partner, Family, Work, 
Friendships and Socializing, Parenting, Education, and Self-Care. The 
short version has a .90 correlation with the full 80-item instrument (Co-I 
Marx, personal communication). Higher scores indicate greater functional 
impairment.   
Quality of Life 
Scale (QLS)  
DV 
9 
9 
9 
Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in 
areas distinct from health status (mate, physical well-being, relationships 
with others, social, community, and civic activities, personal development 
and fulfillment, recreation, and independence). Good internal consistency 
and high test-retest reliability (Burckhardt et al. 2003).   
Values Tracker  
DV 
9 
9 
9 
Brief self-report measure of value engagement. Good predictive validity 
in research with chronic pain samples. 
Meaning in Life 
Questionnaire  
PV 
9 
 
9 
Brief self-report assesses presence and search for meaning in life 
(Steger et al., 2006). 
Social Connection 
Index  
DV, Med 
9 
 
9 
Self-report measure of frequency of contact with others, number of close 
friends and relatives, level of secure attachment in relationships, 
frequency of problems getting along with friends and family members. 
Brief Loneliness 
Measure  
DV, Med 
9 
 
9 
Brief self-report measure of loneliness for use in large survey studies. 
Highly correlated with lengthier measures such as the UCLA Loneliness 
Scale. 
Interpersonal 
Reactivity Index-
Brief (B-IRI)  
DV, Med 
9 
 
  
Brief self-report measure of disposition to empathic responding; 2 
subscales assess perspective taking and empathic concern. Good 
reliability and validity (Ingoglia et al., 2016).  
Flexible 
Regulation of 
Emotional 
DV, Med 
9 
 
  
Self-report measure of ability to enhance and suppress both positive and 
negative emotions. Good convergent and divergent validity with 
depression, personality, resilience, and laboratory tasks measuring 

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Expression 
(FREE) Scale 
emotion suppression and enhancement (Burton & Bonanno, 2016). 
Perceived Ability 
to Cope with 
Trauma (PACT) 
Scale 
DV, Med 
9 
 
  
Self-report measure of trauma-focused and future-oriented coping. In 
addition, a coping flexibility score indicates greater use of both types of 
coping. 
Differential 
Emotions Scale-IV 
(DES-IV) 
DV, Med 
9 
 
  
Self-report of frequency of emotional responses across 9 types of 
emotions: guilt, shame, fear, anger, shyness, self-hostility, contempt, 
disgust, sadness. Good reliability and associations with personality and 
MH symptoms (Izard et al., 1993). Modified to assess participants’ 
emotional responses to thinking about their most traumatic and 
potentially morally distressing experiences. 
Traumatic Life 
Events 
Questionnaire 
(TLEQ-Lite) 
PV 
9 
 
9 
24 items (Kubany et al., 2000); assesses frequency of exposure to 22 
potentially traumatic events encountered outside of military service, 
resulting in a continuous trauma exposure score. The psychometric 
properties were carefully established in 5 studies, including a sample of 
combat Veterans (Kubany et al., 2000). Modified for this study to no 
longer assess DSM-IV criteria for PTSD Criterion A2, as this is no longer 
required in DSM-5, and to include an item assessing exposure to 
COVID-19 as a potential stressor. 
Multidimensional 
Psychological 
Flexibility 
Inventory (MPFI)  
PV 
9 
 
9 
60-item self-report (Rolffs, Rogge, & Wilson, 2018) used to assess the 
dimensions of the psychological flexibility model that underlies 
Acceptance and Commitment Therapy 
 
Expressions of 
Moral Injury Scale 
(EMIS)  
DV 
 
 
 
17-item self- report (Currier et al., 2018) to assess for problems 
associated with exposure to morally injurious events 
Credibility & 
Expectancy 
Questionnaire  
PV 
 
 
 
Widely-used 6-item self-report measure of the credibility of the treatment 
approach and expectations for positive response to the treatment 
(Borkovec & Nau, 1972). Used in Dr. Meyer’s prior ACT studies 
(Hermann, Meyer et al., 2016; Meyer et al., in press). 
Client Satisfaction 
Questionnaire  
DV 
 
 
 
Widely-used 8-item self-report measure of treatment satisfaction (Larsen 
et al., 1979). Used in Dr. Meyer’s prior ACT studies (Hermann, Meyer et 
al., 2016; Meyer et al., in press). 
Working Alliance 
Inventory  
PV 
 
 
 
Widely-used, brief self-report measure of clients’ perceptions of working 
alliance with therapist on 3 dimensions: goal, task, and bond (Horvath, 
1981).  
Parenting Stress 
Index Short Form 
(PSI-SF) 
PV 
9 
9 
9 
Veterans with a child between birth and 12 will be asked to complete this 
measure on the child they are most concerned about. Thirty-six items are 
divided into three domains: Parental Distress (PD), Parent-Child 
Dysfunctional Interaction (P-CDI), and Difficult Child (DC), which 
combine to form a Total Stress scale. 
Quality of 
Marriage Index 
(QMI)  
PV 
9 
9 
9 
6-item self-report questionnaire used to measure relationship distress 
(Norton, 1983). The measure was developed based on an empirical 
analysis of the functioning and construction of marriage quality variables. 
Saliva sample and 
saliva collection 
questionnaire 
PV, Med 
9 
 
 
DNA and other products will be extracted from saliva samples. A list of 
13 questions will be asked during sample collection related to variables 
that can affect quality of saliva sample and associated biomarkers (e.g., 
time since last meal). Provision of saliva sample is optional. 
Blood sample 
PV, Med 
9 
 
 
DNA and other products will be extracted from blood samples. Provision 
of blood sample is optional.   
BL = Baseline; E = Eligibility; DV = Dependent/Outcome Variable; PV = Predictor Variable; Med = Mediator; CV = Covariate 
 
 
Training of Clinical Interviewers. Clinical interviews will be conducted by trained interviewers familiar with 
the assessment procedures and the culture of military service. The PI and trained doctoral staff members will 
conduct certifications in the proper administration of the clinical interviews and will provide ongoing, weekly 
supervision of interviews conducted. Further, all interviews will be video or audio-recorded through a VA 
computer using a microphone directly onto the secure, approved drive behind the VA firewall or using a FIPS 
140-2 validated digital voice recorder. In any instance in which technical or logistical difficulties interfere with 
video recording, audio recording will be used. All video/audio files will be stored on the secure, approved drive 

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behind the VA firewall. FIPS 140-2 validated digital voice recorders will only be transported by research staff 
who have an approved Authorization to Transport memorandum on file with the Research Office. After being 
uploaded to these secure folders, audio files will be accessible to approved research staff. Approved research 
staff will listen to recordings for training purposes (e.g., practice coding, learn administration procedures), or for 
the purposes of assessing inter-rater reliability. An interviewer training manual has been developed, which 
details the training method, scoring procedures, and process for systematic DRG to ensure consistency across 
interviewers (Meyer, Morissette & Kimbrel, unpublished). Interviews (10% or more if necessary) will be rated 
for inter-rater reliability as an added measure. Recordings will also be coded for observable, clinically relevant 
behaviors. 
 
Biological Markers.  
Overview. Subjects will donate saliva and blood for genetic and biomarker research studies. Both saliva 
and blood will be collected because some biomarkers are known to be present in both blood and saliva. If we 
find a biomarker for PTSD symptoms in blood, and it is also in saliva, that would be a great advantage for 
monitoring. Also, there are species of proteins in saliva that are not carried in the blood, and which change with 
stress. These may also be biomarkers for PTSD symptoms. No clinically validated tests will be performed. The 
genetics/biomarker component of the protocol will be supervised by Dr. Rakeshwar Guleria (CoE Biomarkers 
and Genetics Core; Phase I, II, III), an expert in this area, in collaboration with the PI, Dr. Creech. See 
Appendix for Safety Survey. At the BL assessment, participants will be given the option of consenting to all 
study procedures or all procedures excluding the saliva/blood sample (depending on the phase) and genetic 
research.  
Study participants will be donating their samples for biomarker and genetic-related studies. The samples 
(blood/saliva) will be collected from the study participants and will be analyzed for identifying molecular 
biomarkers for early diagnosis and prevention of traumatic brain injury and PTSD in our returning war 
Veterans. Genetic variation will also be studied between the patient vs. the control group of participants for 
predicting PTSD susceptibility and progression. The study participants will be donating their samples for the 
biomarker and genetics related studies. The process of biomarker identification and validation will be 
conducted in two stages 1) Unbiased approach (discovery) and 2) Targeted approach. 
Stage I (unbiased approach): This is the discovery phase where samples will be analyzed globally to identify 
potential biomarkers (protein, genetic, epigenetic, metabolic, and immunological markers). Protein (proteomics) 
and metabolite (metabolomics) biomarkers will be screened with mass spectrometric analysis at the Mass 
Spectrometry Core facility, Baylor University, Waco, TX (under CTVHCS’s MOU with Baylor). Genetic markers 
(allelic, mutations, CNV’s, SNPs, miRNA) will be screened at the VA by using PCR, Real-Time Quantitative PCR, 
Droplet Digital PCR, and next-generation sequencing. Inflammation and immune biomarkers will be screened 
by flow cytometric analysis at the CoE Biomarkers & Genetics Core laboratory. If de-identified samples are sent 
outside the VA for analysis, we will follow all VA rules and regulations and obtain appropriate Research Service, 
IRB, safety and data monitoring approval. 
Stage II (targeted approach): Once we narrow down the potential biomarkers, we will move to the 
qualification, verification, and validation steps where we will target the specific potential biomarker and proceed 
with a targeted screening approach. Once validated, the markers identified will be segregated according to 
susceptibility, diagnostic, and therapy biomarkers.  
Sample Collection: Participants will donate saliva by passive drool, a method of pooling saliva in the mouth 
and pushing it through a straw or collection device into a collection tube. Staff will be trained to avert their eyes 
when participants are depositing saliva into the test tube to reduce potential embarrassment. Because many 
factors can influence salivary biomarkers, participants will complete a saliva questionnaire (included in Table 3 
and appendices). The saliva samples will be stored in a cooler with an ice pack or in a refrigerator until 
transported to the Center of Excellence (Building 93), processed and stored until assay.  
Subjects can also opt to donate blood by venipuncture by personnel trained in VA procedures for taking 
blood samples. All blood processing will take place at the VA by trained personnel. Compression bandages will 
be used to cover the puncture. Blood will be placed in 1 RNA (Paxgene Red-top), 1 DNA (Paxgene Blue-top), 
2 purple top (plasma) and two red top (serum, activator coated), all coded, and stored in a cooler with an ice 
pack or refrigerator until transported to the Center of Excellence (Waco Building 93) within 4-6 hours of 
collection. If the participants have a fear of needles, blood will not be drawn in Phase III.  

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Tubes will either be frozen (RNA, DNA) or processed (redtop and purple top tubes) for cell protein and 
other constituents in Waco building 93 (2A113, 2A116, 2A117). DNA/RNA extraction from the DNA/RNA tubes 
will be performed by team members using DNA/RNA extraction kits and coded DNA/RNA samples will be 
stored at -20/-80 and in liquid nitrogen until testing. Blood will also be analyzed for immune and inflammatory 
markers (cluster of differentiation (CD) immunomarkers, chemokines, cytokines), as well as for other blood and 
saliva-based biomarkers. Remaining blood product samples will be stored at -20/-800C and in liquid nitrogen 
for future use, with appropriate IRB approval at CoE (Freezer Room 2A13). DNA genotyping and lab work will 
be performed in the wet lab within the CoE (Waco building 93; room 2A113, 2A116, 2A117). The results of any 
biomarker analysis will be saved in a coded, de-identified dataset and stored on VA computers on the secure 
CTVHCS Research Service-approved drives that will only be accessible to study staff.  
 
Data Management: 
Identifiers: A study ID number will be used to identify each participant across assessments. 
 
Identifiers/linking data: A password protected master participant tracking spreadsheet will contain the linking 
information that matches the participant IDs to participant names. This spreadsheet will reside only on the 
secure research drive. Other PHI such as participant addresses and phone numbers (for follow-up contact), 
and date of participation will only be accessible to PI Creech and her research staff that is approved to work on 
the study. The Master tracker will be kept separately from study databases on the secure research drive. 
Paper files will be stored at the VISN 17 Center of Excellence in Waco, TX in Building 93, room 1A-137. 
 
Confidentiality: No participant will be identified in any publications or presentations arising from this study. 
Records will be maintained in accordance with the Department of Veterans Affairs Record Control Schedule 
10-1. It may be necessary or required for the study investigators to break confidentiality and release personal 
identifiers and health information when mandated by law. For example, state law requires health care workers 
to report any suspected abuse or neglect of a child, or person 65 years or older, or an adult with disabilities to 
the Texas Department of Family and Protective Services.  
A Certificate of Confidentiality will be obtained from the National Institutes of Health prior to the 
commencement of research. The purpose of this certificate is to protect the identity of research subjects 
participating in studies that collect sensitive information. No information about participants will be released 
without their permission or where required by law (such as the examples given above).  
All employees who are to handle data will be trained in confidentiality policies and procedures. If theft, loss, 
or other unauthorized access of sensitive data and non-compliance with security controls occur, study staff has 
been instructed to follow the CTVHCS standard operating procedure on incidence reporting. 
 
Delineation of research tasks performed by VA and collaborators: All participant contact activities will take 
place on the Austin, Temple or Waco campuses of CTVHCS. Following approved CTVHCS methods for 
sharing a study dataset with collaborators, some secondary outcomes analyses may be performed by 
approved secondary users within and outside the VA through requests made to the SERVE Data Repository. 
 
Primary users of the study dataset are those individuals listed on the study staff list and are those who will 
conduct pre-specified analyses consistent with the study’s hypotheses and its primary, secondary and 
exploratory aims as described in the aims and analysis plan. 
 
Disposition of the data: Paper files containing identifiers will be kept in locked file cabinets in a locked room at 
the Center of Excellence in Waco, TX. Coded paper files will be kept in separate locked file cabinets. Only 
approved study staff will have access to the files. Electronic data will be stored on the secure VA password-
protected server with access restricted to research staff. These records will be maintained and retained in 
accordance with the Department of Veterans Affairs Record Control Schedule 10-1. 
 
Incident Reporting: Any incidents affecting the security of the data such as theft, loss, or unauthorized access 
of sensitive data will be reported to the ISO and PO per VA regulations. 
Data Use within CTVHCS: Only IRB approved personnel on the study staff list will have access to the data 

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collected in this study. Access to the study data will be terminated when personnel are no longer part of the 
research team. The primary repository of paper files generated by the study is the VHA VISN 17 CoE. Data to 
be transported to the CoE includes: consent documents and measures completed after each appointment. 
Study data collected at the Temple or Austin campus will be transported to the approved data storage location 
at the Waco Campus where it will be uploaded to the secure research drive. Personally-identifying information 
(e.g. Informed Consent Form with name and date of consent) will be kept in a separate locked carrying case 
from the data during transport. 
 
Records destruction information: "All paper AND electronic documentation containing confidential, personally 
identifiable information, protected health information, and any other sensitive information will be 
disposed/destroyed per current VA regulations at the time of disposal/destruction of documentation." 
 
Records retention information:  "The required records, including the investigator's research records, must be 
retained until disposition instructions are approved by the National Archives and Records Administration and 
are published in VHA's Records Control Schedule (RCS 10-1)." All de-identified data will be managed in 
accordance with the VHA Handbook 1605.1 APPENDIX B. All original data will be stored at VA. 
 
Reporting: Any incidents involving theft or loss of data or storage media, unauthorized access of sensitive data 
or storage devices or non-compliance with security controls will be immediately reported to the IRB chair, 
Privacy Officer and Information Security Officer. 
 
Data Analysis Software: Data will be analyzed using the software programs that are already owned by the VA 
(e.g., SPSS, SAS, mPLUS, AMOS) either using local copies of the software or through VA Informatics and 
Computing Infrastructure (VINCI). 
 
Data Collection. Data will be visually inspected for completeness by study interviewers at the time of 
collection. Data will be gathered in two ways: collected and entered using hard-copy assessment measures or 
through the use of Qualtrics, a secure web-based survey application. Qualtrics is a secure, web-based 
application for building and managing online surveys and databases. This system is similar to REDCap and is 
flexible enough to be used for a variety of types of research, and provides an intuitive interface for participants 
to complete surveys. It also offers easy data manipulations with audit trails for reporting, monitoring, and 
querying patient records, and an automated export mechanism to common statistical packages. As with 
REDCap, all web-based information transmission is encrypted. Data from Project SERVE: FX (00390) will be 
stored on VA servers, including data downloaded/exported from Qualtrics. Data will be entered and managed 
using statistical software (SPSS, SAS, Stata, R/S-Plus, and others) and through Research Electronic Data 
Capture (REDCap). REDCap is a service through the VA Information Resource Center (VIReC; for more 
information, please see: http://vaww.virec.research.va.gov/REDCap/Overview.htm). REDCap is a secure, web-
based application for building and managing online surveys and databases. REDCap data collection projects 
rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all 
members of the research team. The iterative development and testing process results in a well-planned data 
collection strategy for individual studies. The REDCap system provides secure, web-based applications that 
are flexible enough to be used for a variety of types of research, provide an intuitive interface for users to enter 
data and have real time validation rules (with automated data type and range checks) at the time of entry. 
These systems offer easy data manipulation with audit trails for reporting, monitoring and querying patient 
records, and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). 
REDCap servers are housed in the secure, VA Information Technology Center on a VINCI server, located in 
Austin, TX. All web-based information transmission is encrypted. REDCap was developed specifically around 
HIPAA-Security guidelines. REDCap has been disseminated for use locally at other institutions and currently 
supports 240+ academic/non-profit consortium partners on six continents and over 26,000 research end-users 
(www.project-redcap.org). Interview and self-report data will be entered continuously by staff members as the 
data are collected. Data entry training will consist of both didactic sessions in which staff members are 
provided with information about the data entry system in place at the CoE as well as actual entry of mock data 
as a validity and accuracy check.  

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Data Sharing With Other Studies Comprising Project SERVE. Project SERVE: FX is one of several studies 
that will comprise the Project SERVE research program. Each study aims to independently contribute to 
scientific understanding of the impact of warzone experiences on OEF/OIF/OND Veterans. A data sharing 
agreement is requested between Project SERVE studies and a SERVE Data Repository has been established 
for future research. Data from Project SERVE will be included in the SERVE Data Repository.  
 
AIMS AND HYPOTHESES.  
Specific Aim 1: Identify treatment targets that prospectively predict functional disability and self-
directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD. 
Hypothesis 1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and 
moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion 
regulation) will prospectively predict functional disability and SDV after accounting for covariates.  
 
Analytical Plan. 
Aim 1: The proposed analyses are grounded in the SERVE conceptual framework (Figure H1a). Our team has 
expertise in a variety of advanced statistical modeling procedures, including latent growth models, growth 
mixture models, longitudinal analyses, and measurement invariance. The design is based on a measurement 
model that collects predetermined, repeated assessments every 8 months over a two-year period. The effect of 
treatment will be examined via dummy variables in all hypotheses. We will use both traditional (e.g., maximum-
likelihood regression) and advanced approaches (e.g., latent growth models, growth mixture models, and 
mediation models with bias-corrected bootstrap confidence intervals) to analyze the data. For example, to test 
Hypothesis 1a (H1a) in a traditional manner, principal component analysis (PCA) will be used to create a 
composite functional impairment factor. This approach will greatly reduce the number of tests conducted and 
provide us with a broad index of functional impairment. Variables used to create this factor score will include 
measures of functional impairment (WHODAS 2.0, IPF), QoL (QLS), and values-based behavior (VT). Change 
scores for these measures will be calculated and regressed onto the hypothesized predictors and covariates 
(including prior level of functional impairment) to test H1a. Latent growth modeling (LGM)—which allows for 
modeling of the change/growth trajectory of different variables assessed on multiple occasions across time—
will also be used to analyze the data. We expect that scores on repeated measures will be correlated. Growth 
models take this dependency into account by treating repeated measures as separate variables, and fitting a 
proposed trajectory shape to the scores across time. Advantages of using LGM over other approaches include 
the flexibility of placing constraints on the model while allowing growth parameters describing participants’ 
trajectories to serve as predictors or outcomes. LGM assumes that individuals come from a homogeneous 
population while Growth Mixture Modeling (GMM) allows multiple subpopulations to be inferred from the data. 
GMM is a general latent class analytical framework that has the capacity to model both random variation of the 
latent growth factors and the unknown heterogeneous subpopulations simultaneously. The proposed mediation 
effects will be examined with bias-corrected bootstrap confidence intervals that have been shown to produce 
the unbiased test with highest statistical power. We will ensure adequate data quality by evaluating normality 
and conducting descriptive, outlier, and psychometric analyses for each data wave. We will use alternative 
robust estimators (e.g., WLSM, WLSMV, MLM, and MLMV) when analyzing non-normal data. All SEMs 
including the LGM and mediation analyses will be evaluated with the chi-square test and commonly used fit 
indices such as RMSEA, SRMR, CFI and TLI. Additionally, for GMM, we will evaluate the results using the 
recommended information criteria (e.g., BIC, BLRT) and other related fit statistics (e.g., entropy). Analyses will 
be registered in the NIH clinical trials online database prior to data collection. 
The statistical power of the hypothesized models was estimated using the Monte Carlo procedure in Mplus. 
For each power analysis, 1000 datasets were simulated following a hypothesized model that included a 
particular effect size of interest for each test. The model(s) of interest were then estimated for each dataset, 
and the proportion of datasets in which the null hypothesis was rejected was taken as the (empirical) power of 
the test. To examine the effect of the novel and established treatment targets on functional impairment over 
time in Hypothesis 1a, we will use LGM with the treatment targets measured at baseline predicting functioning 

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over time (Figure H1a). The statistical power of the target effect, the direct 
arrow from the treatment targets to the slope of functional impairment over 
time, is evaluated. Given the proposed sample size (500 participants with 4 
repeated measures), the power for detecting a medium direct effect (based 
on our preliminary analyses) from the treatment targets to the slope of 
functional impairment is > .90. GMM will be used to test Hypothesis 1b 
(Figure H1b). Based on our preliminary studies, the statistical power for 
detecting a three-class solution is larger than .90 given the proposed 
sample size (500 participants). We calculated statistical power for the 
effects of the novel and established treatment targets on latent class 
membership. Assuming a small to medium effect size (odds-ratio = 1.82, 
which roughly corresponds to Cohen’s d of 0.34), the power of the 
treatment targets on predicting class membership ranged from .72 to .91. 
In Hypothesis 1c, risk for SDV is measured in multiple ways including a 
continuous variable (severity of suicidal thoughts), a frequency/count 
variable (number of instances of NSSI), and a dichotomous variable 
(attempted suicide). A latent factor will be created and analyzed in Mplus 
which uses the MLR estimation to handle non-normally distributed 
variables. The longitudinal property of this latent factor will be examined 
via the longitudinal measurement invariance. Once the risk for SDV factor 
model is confirmed, we will regress it on the latent class membership 
(based on H1b results), hypothesizing that the most severely impaired 
class will predict greater risk of SDV. The proposed mediation model in Hypothesis 1d (i.e., the treatment 
targets mediate the effects of mental and physical wounds on functional impairment and risk for SDV over 
time) will be tested by using Mplus MODEL INDIRECT with bootstrap confidence intervals. By assuming a 
medium mediation effect, the corresponding statistical power is larger than .80 with our proposed sample size. 
We used conditions and parameters that are broadly based on our own data, prior clinical studies, and 
published Monte Carlo studies. Effect sizes estimates were in the small-to-medium range. The number of 
repeated measures is based on the current design. In brief, we are confident that the parameters and 
conditions are very close to our proposed study conditions.  
 
Additional exploratory analyses will focus on the relationship between mental health symptoms and a range of 
health outcomes. As an initial step, we will use multivariable Cox regression to estimate hazard ratios and 95% 
confidence intervals for the development of heart failure by PTSD status. 
 
Missing Data Management: Longitudinal designs pose several challenges with respect to missing 
observations (e.g., length of data collection, multiple assessment points, participant attrition). Based on our 
prior research and multiple methods of maximizing retention, we anticipate low attrition and minimal missing 
data. Nonetheless, we conservatively expect up to 20% missing data. Mplus, which uses full information 
maximum likelihood (FIML) estimation for handling missing data, will be used for analyses. FIML is a principled 
approach that is considered “state of the art” in missing data management. FIML is a maximum-likelihood 
based estimation procedure that directly estimates parameters and their standard errors for the full sample 
from the existing and limited data. Thus, there is no attempt to replace missing data values. Instead, as 
“maximum likelihood” suggests, the parameter estimates are derived in a manner that maximizes the likelihood 
that the data were drawn from the population of interest. FIML is the optimal procedure for handling missing 
data within both SEM and LGM frameworks primarily because it produces relatively unbiased parameter 
estimates and standard errors. In fact, using methods other than FIML in SEM requires justification. 
 
HUMAN SUBJECTS RESEARCH AND PROTECTION FROM RISK 
1. Risks to Subjects 
 
A. Human Subjects Involvement and Characteristics: Up to 600 male and female OEF/OIF/OND Veterans 
enrolled for healthcare at the CTVHCS will be participants in Phase III. Veterans from all races/ethnic 
backgrounds will be recruited. Veterans with mental health conditions will be over-sampled. Participants will be 

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at least 18 years of age. The telephone screen will determine initial study eligibility. Eligible participants will be 
scheduled for a baseline assessment, at the beginning of which participants will complete a written informed 
consent form (ICF) for all Phases. Final eligibility will be confirmed at the baseline assessment. Participation is 
voluntary, with no penalty for withdrawal. Consistent with HIPAA and institutional IRB guidelines, the utmost 
care will be taken to protect the welfare and interests of human subjects. All key personnel are thoroughly 
trained in the conduct of human-subjects research. See also below “Protection Against Risk” and “Data Safety 
and Monitoring Plan.”  
 
B. Sources of Material: The baseline and annual follow-up assessments will be collected by questionnaire, 
clinical interview, and saliva/blood samples. In addition, questionnaire follow-up assessments will be mailed to 
participants 8- and 16-months post baseline; the Veteran will have the option to complete the follow-up 
assessment either by paper and pencil or online through Qualtrics. Participants who prefer to receive email 
reminders via the Qualtrics system will have their email addresses temporarily stored in the secure Qualtrics 
database using the “Contact List” feature. The Contact List is a feature within a PI’s individual, password 
protected, online Qualtrics account. This feature allows the PI and approved study personnel to create a list of 
study participant email addresses. Only through this feature are study personnel able to send a survey link via 
an email from Qualtrics to participant’s who request this method. Only approved study staff will have access to 
this online account and will be able to enter or see participant’s email addresses. No PHI will be sent or 
received using this feature. The Contact List will simply store email addresses and this feature will allow for the 
distribution of survey links to every participant, which will not require participants to provide any identifying 
information. All email addresses will be deleted from the Qualtrics Contact List at the completion of the study. 
For further description of the Qualtrics security structure, please see the “Qualtrics Security White Paper.” All 
data will be collected for research purposes only. The data will be protected as mandated by local IRB 
committees and the national HIPAA guidelines. Face-to-face interview and questionnaire data obtained during 
baseline and follow-up assessments by the research team will be stored in locked files with only code numbers 
to identify participant data. A list linking names with code numbers will be kept to ensure that no participants re-
enter the protocol and to facilitate scheduling for follow-up assessments; this list will be kept electronically on 
the secure research drive. All research staff involved with the study will be made fully conversant with relevant 
ethical principles related to the conduct of human subjects research (including completion of HIPAA training 
and CITI training in human subjects research) and will be trained to be sensitive to the potential need for 
clinical referral.  
In the event that an assessment conducted by members of the research team indicates that a participant is 
severely debilitated and/or needs a clinical referral (e.g., reports suicidality, homicidality, and/or severe 
symptomatology), the assessor will conduct a risk assessment, develop a safety plan (if necessary), and make 
an appropriate clinical referral. The PI will be notified of all such occurrences immediately. All CoE staff have 
been fully trained by a doctoral-level staff member or the local suicide prevention coordinator using the 
Operation SAVE (Signs, Ask, Validate, Encourage) program developed by the Canandaigua CoE. Emergency 
response (i.e. if the Veteran is actively suicidal or homicidal warranting crisis intervention) varies based on the 
campus in which the Veteran is being interviewed. In Waco, during regular business hours, Veterans can be 
escorted to the Mental Health Clinic for further evaluation, stabilization and hospitalization as necessary. After 
business hours, staff is instructed to call 911. In Temple, Veterans in crisis are brought to urgent care for 
evaluation, stabilization and hospitalization as indicated. In Austin, staff is instructed to call 911, as no 
emergency services are available on site. However, Veterans who would like immediate outpatient services 
can be referred to Primary Care Mental Health in Austin for same-day outpatient appointments.  
In the event that a follow-up assessment received in the mail, online, telephone, or by VA approved video 
communication technology indicates that a participant is severely debilitated and/or needs a clinical referral 
(e.g., reports suicidality and/or severe symptomatology), the assessor will contact the PI immediately. The PI 
or trained staff member will then contact the participant to conduct a risk assessment, develop a safety plan (if 
necessary), and provide appropriate local treatment referral(s).  
With respect to connecting Veterans with appropriate mental health services, a system of providing clinical 
referrals across each campus in which Veterans will be interviewed (Waco, Temple, Austin) has been 
established during the Project SERVE pilot study and continued in subsequent Phases. We anticipate that 
some Veterans will refuse referrals, particularly in light of data suggesting strong concerns about stigma 
among returning OEF/OIF Veterans (Hoge et al. 2004). We will make every effort to make Veterans feel 

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connected to the research study, which we hope will serve as an additional point of access to clinical services 
offered at CTVHCS. By establishing a relationship, coupled with data-driven check-ins on an ongoing and as-
needed basis, we hope that Veterans who initially refuse services will eventually feel more comfortable 
accepting referrals. Certainly, study staff will be available at all times to forge a liaison with mental health 
services upon request.  
In addition to interviews and self-report questionnaires, saliva/blood  samples will be collected from 
participants. All specimens will be used strictly for research purposes. Providing a saliva/blood sample is 
optional and declining to provide a saliva/blood sample does not impact participation in the rest of the study.  
With respect to the saliva sample, staff will be trained to avert their eyes when participants are spitting into 
the test tube to reduce the risk for potential embarrassment. The procedure will take approximately 1 minute. 
With respect to the blood draw, risks will be minimized by using personnel trained by the VA who will have a 
fully self-contained phlebotomy kit for each participant. Personnel draw 19 ml (= 4 teaspoons) of blood. The 
procedure will take approximately 10-15 minutes. Samples will be labeled with code numbers only and 
transported by study staff to the Waco VA Campus (Building 93: room 2A 113) for DNA extraction and storage. 
Participants will complete a layered informed consent process in which they will be informed of all procedures 
and will be given the opportunity to participate in the larger observational study while opting out of providing 
saliva/blood samples for later studies. Further, participants may specify that their DNA samples may not 
become part of the shared dataset/tissue repository. 
C. Potential Risks: Potential risks include breach of confidentiality, coercion to participate, and possible 
discomfort from processing and retrieving memories of traumatic events. There is also some concern that a 
seriously impaired Veteran could be identified by the measures included in the interviews or the self-report 
questionnaires. As discussed in greater detail below, we believe that the likelihood of breach of confidentiality 
and coercion are low, given the steps we have taken to obviate these risks (e.g., numeric coding, informed 
consent). This study assesses sensitive information (e.g. alcohol and drug history). To protect confidentiality, 
we have obtained a Certificate of Confidentiality through the NIH for this research program, which will be 
amended to include Phase III. The risk of discomfort from discussion of mental health issues, including 
disclosure of traumatic material is moderate; however, the increased discomfort would be expected to be short-
term and participants expressing severe distress would be referred for evaluation and treatment. The 
identification of a Veteran whose impairment is debilitating is expected to be a low-frequency occurrence. 
However, should an impaired Veterans be identified in the proposed project, appropriate referrals will be made. 
The saliva sample may cause embarrassment for some people. The risks of having blood taken from a vein in 
your arm are pain, bleeding, bruising, and rarely, infection at the site where the needle is inserted. Fainting or 
light-headedness may occur, but they seldom happen. If the Veteran is injured as a result of having blood 
drawn, VA will provide medical treatment for his/her research-related injury at no cost to the Veteran. There is a 
very remote risk that the Veteran’s DNA sample might be obtained by someone who has no right to examine it, 
and enough information might be determined from DNA to identify him/her even if only a code is attached to 
the sample. There might be identity risks involved if this information falls into the wrong hands (e.g., the 
Veteran could be denied insurance coverage or employment because of certain genetic information about 
him/her). Federal laws and policies provide protection from discrimination by health insurance companies, 
group health plans, and most employers based on genetic information. A new federal law, the Genetic 
Information Nondiscrimination Act (GINA), will generally provide protection in the following ways: 1) Health 
insurance companies and group health plans may not request the Veteran’s genetic information obtained from 
this research; 2) Health insurance companies and group health plans may not use the Veteran’s genetic 
information obtained from this research when making decisions regarding his/her eligibility or premiums; and 3) 
Employers with 15 or more employees may not use the Veteran’s genetic information obtained from this 
research when making a decision to hire, promote, or fire you or when setting the terms of employment. 
However, this new Federal law does not protect the Veteran against genetic discrimination by companies that 
sell life insurance, disability insurance, or long-term care insurance.  
 
2. Adequacy of Protection From Risks 
A. Recruitment and Informed Consent: Several recruitment strategies will be used to obtain a broad sample 
of OEF/OIF/OND Veterans. Participants will be recruited from the preceding longitudinal study, as indicated in 
the ICF. New participants will be recruited through advertisement at enrollment sites, vet centers, Veteran’s 
networks and service organizations, through in-service presentations to primary care staff, mental health staff, 

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and other relevant VA staff (e.g., OEF/OIF/OND coordinators, etc.), and through the community (e.g. grocery 
stores, churches, shopping centers, and so forth). In-person recruiting will also be conducted at enrollment and 
community sites. In these cases, one or more research team members will sit at a table/booth in a high 
visibility area (e.g., a main VA lobby or outside of a grocery store) with a sign indicating that OEF/OIF/OND 
Veterans are being recruited to participate in a research study. Staff members will provide interested Veterans 
with a flyer (see attached flyer and brochure) about the study. In addition, Veterans interested in participating in 
the study will be given the option of providing staff members with their contact information so that they can be 
contacted by phone at a later point in time to complete a telephone screen interview.  
In addition, as described in more detail above, we will request that IT/study staff conduct periodic searches 
for OEF/OIF/OND Veterans who meet some of our inclusion criteria (e.g. OEF/OIF/OND Veteran, diagnosis of 
PTSD or depression, no mental health disorder) so that we can reach out to returning Veterans to let them 
know that the study is being conducted.  
 
Interested participants will complete a telephone screen. Eligible participants will be scheduled for a 
baseline assessment appointment, at the beginning of which informed written consent will be obtained. A cover 
letter will be mailed to the Veteran in advance of the baseline assessment appointment with directions and 
parking instructions. In addition, a copy of the Informed Consent Form (ICF) will be mailed to the Veteran along 
with a cover letter in advance of the appointment (time permitting depending on when appointment is 
scheduled) for the Veteran to read and consider participation in advance. Upon arrival, the Veteran will be 
asked if s/he had a chance to read the ICF, and if not, will be asked to read the consent form at that time. It 
should be noted that, regardless of whether or not participants read the ICF ahead of time, the study staff 
member will always explain the nature of the study to participants at the time of the baseline assessment, as 
well as the potential risks/benefits of participating in the study. Participants will be provided with a photocopy of 
signed forms. Related to the saliva/blood sample, the participant will be informed: 1) DNA will be extracted 
from their sample; 2) Researchers may use the participant’s DNA to conduct studies of genetic markers in the 
future; 3) Researchers may conduct DNA studies with new technology in development that is currently 
unknown to the researchers; 4) Gene material and the gene information obtained will be used for research 
purposes only and will not be released to health insurance companies; 5) Researchers will not give the 
participant feedback or information about the results of his/her genetic testing; and 6) Participants can decline 
the saliva/blood sample and still participate in all other study procedures. 
Written informed consent will not be obtained until the researcher is satisfied that the participant has a good 
understanding of the risks/benefits of participating in the study. The Veteran will be informed that s/he may 
discontinue participation at any time or revoke consent to the storage of DNA without any professional or 
personal consequences. We anticipate that participants will be in adequate health to attend and participate in 
all assessments. In order to maximize retention of participants in Phase III, we will offer the option of signing an 
informed consent form remotely for transfer participants who have moved out of the area. Following the phone 
screen, if the Veteran is interested in participation, he/she will be mailed the informed consent form and HIPAA 
authorization. Participants will be provided clear instructions for signing the forms, and a postage-paid 
envelope for returning them to the study team. Participants will be informed that study procedures will not 
begin until the forms have been received by a study team member. Any potential participant who wishes to 
travel to the VA Medical Center to provide informed consent in person will be allowed to do so, unless it is 
deemed unsafe for the veteran or study staff (e.g., due to COVID-19). 
B. Protection Against Risk: Breach of confidentiality is unlikely because of our numeric coding system. 
Assessment procedures will be closely supervised by the PI. Study evaluators may identify a seriously 
impaired Veteran based on the measures proposed in this study. This will be addressed through risk 
assessment, safety planning, and clinical referral.  
Issues related to coercion are unlikely, as Veterans who do not wish to participate in the study will not 
experience any impact on their care as Veterans. We will seek to protect Veterans from the emotional distress 
that might be aroused by the assessments in the following ways: (a) structured training and ongoing 
supervision of all assessment staff; (b) PI availability 24 hours per day, to respond to calls from participants 
who find themselves in crisis, and to assist in any necessary referrals; (c) referrals made for emergency or 
other inpatient or outpatient psychiatric services to identified local clinicians through existing referral 
mechanisms; and (d) Data Safety and Monitoring Plan (DSMP) and Data Safety and Monitoring Board 
(DSMB), described below.  

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To ensure the safety of potentially-impaired Veterans, a study investigator will review all assessments. The 
study investigators will have a roster of treatment providers specializing in the treatment of trauma, depression 
and substance abuse both in the VA and outside the VA. A list linking participant ID numbers to names will be 
on the secure Research and S:\CoE Data\FX drives, which will allow for identification of participants in the 
event that a Veteran evidences serious impairment on the assessment battery, so that an appropriate referral 
for intervention may occur, as needed. Hardcopy assessment information will be kept in a locked office 
(Building 93, 1A-137). Study identifiable information (ICF, HIPAA, payment forms, and contact information) are 
stored separately from coded hardcopy data. 
Informed consent forms and forms with any identifiable information (e.g., payment records) will be kept in a 
locked file cabinet of a locked office (Building 93, 1A-137) with limited access at the Center of Excellence for 
Research on Returning War Veterans. Coded hardcopy phone screen data from both eligible and ineligible 
participants and assessment data will be kept in separate locked file cabinets from identifiable information 
(Building 93, 1A-137). Additionally, coded phone screen information will be placed in separate files to 
distinguish screen eligible/enrolled, screen eligible/not enrolled, and ineligible screens. Data may be 
temporarily (i.e., no more than 7 business days) stored at the Temple research space in locked offices, inside 
locked file cabinets, with identifying information separated from coded data using locked containers. 
Video/Audio recordings will be recorded on FIPS 140-2 validated digital voice recorders that use VA-
approved encryption, stored as .DS2 files, or using VA laptops, recorded directly onto the secure, approved 
drive, and transported by research staff who have an approved Authorization to Transport memorandum on file 
with the Research Office. Video/Audio files will be stored as electronic files in the secure, approved drive and 
on encrypted SD memory cards that are stored as hard copy data in the CoE data rooms (Building 93, 1A-
137). Once video/audio files are transferred to the secure server folders and to the encrypted SD card, they will 
be erased from individual research staff members’ digital voice recorders. Approved research staff will listen to 
video/audio-recordings on site using VA computers; thus, once video/audio files are transferred to storage, the 
only copies will exist on VA-secured servers (electronic) and in locked data rooms (hard copies on SD memory 
cards). 
Coded data collected at other interview sites (Temple, Austin, CBOCs) will be transferred in a locked 
suitcase by a credentialed interviewer/research team member. All data will be marked with code numbers only. 
Informed consent forms, payment forms, and contact information with personally identifiable information 
(name, date of consent, SS#, etc.) will be transferred in a separate carrying case from the coded data (see 
Data Transport Agreements). For online data collection, a unique code will be assigned to participants. IP 
address will be blocked for additional protection, and no email addresses, names, or PHI will be collected. 
Research records will be retained until disposition instructions are approved by the National Archives and 
Records Administration and are published in VHA’s Records Control Schedule (RCS 10-1). Any and all paper 
documentation containing confidential, personally identifiable information, protected health information, and 
any other sensitive information will be disposed/destroyed according to current VA regulations at the time of 
disposal/destruction of documentation. Original data will remain at VA. Only copies of de-identified data will be 
shared outside VA with study collaborators, after approval from the Privacy Officer as de-identified. We will 
request that collaborators share any newly-created variables. However, as the databases are de-identified, 
they will not be required to be returned for destruction.  
Access to identifiable data will be terminated when staff are no longer part of the team. Procedures are in 
place for reporting any incidents (i.e., theft or loss of data or storage media, unauthorized access of sensitive 
data or storage devices or non-compliance with security controls) by reporting to respective parties (i.e., 
privacy officer and/or information security officer, IRB, first line supervisor). 
Every effort will be made to keep information both private and confidential. Study records may only be 
disclosed in accordance with federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its 
implementing regulations. Records may be reviewed by the U.S. Food & Drug Administration (FDA), other U.S. 
government agencies, Institutional Review Boards including the Central Texas Veterans Health Care System 
Institutional Review Board and by staff at these institutions that deal with research as part of their official 
duties. As a result, they may see participant names; however, they are also bound by rules of confidentiality.  
 
3. Potential Benefits of the Proposed Research to Subjects and Others: There are no known benefits for the 
assessment study participants. It is possible that Veterans may benefit from clinical referrals received following 

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the clinical research assessment. In general, Veterans exposed to chronic and potentially-traumatic stress may 
benefit from the findings of this longitudinal project. Specifically, findings from the proposed project will inform 
efforts in the prevention of functional impairment in individuals at increased risk for developing symptoms from 
occupational exposure to chronic and potentially-traumatic stress. The anticipated risks of this project are 
considered reasonable given that this project will expand our knowledge of the effects of potentially-traumatic 
events, stress, and coping on Veterans and potentially lead to advances in the prevention and treatment of 
functional difficulties encountered during the readjustment process post-warzone. 
 
4. Importance of the Knowledge to be Gained: The proposed project results may represent important advances 
in the study of functional recovery and impairment related to commonly-occurring disorders in OEF/OIF/OND 
Veterans, such as PTSD, depression, TBI, chronic pain, and substance-use disorders. Despite important 
epidemiological work in this area, relatively little is known about the specific biopsychosocial factors, including 
clinically relevant and modifiable treatment targets, that predict risk and resilience to these disorders in trauma-
exposed populations. This programmatic line of research will help to elucidate those factors. Longitudinal 
examination of individuals at increased risk psychopathology based on varying levels of trauma exposure is 
essential for advancing our understanding of coping and recovery. This study will contribute to our overall 
understanding of the long-term psychological impact of combat exposure and empirically inform treatment 
development.  
 
5. Data and Safety Monitoring Plan.  
Due to the sensitive nature of the information collected during the observational study and the fact that 
clinical referrals may be made for a number of participants, we have established a DSMP. Given our team’s 
expertise with the behavioral health of Veterans, we have well-established mechanisms for ensuring safety and 
confidentiality of referrals that have been in place during Phases I and II and will continue in Phase III. A final 
measure of governance designed to protect the participants in this project is the following DSMP.  
The DSMP will consist of examination of the accruing study data for indications that participating Veterans 
are being appropriately referred for treatment when necessary. The PI and doctoral-level staff will provide 
ongoing supervision through weekly Diagnostic Review Groups (DRG), which will include discussion of referral 
information for each Veteran who is identified as having mental health difficulties. In addition, self-report data 
will be reviewed by the PI or her staff. Specifically, each time a participant completes the PHQ-9, item 9 
(suicidality) will be visually scanned to make sure that participants are not endorsing suicidal intent. Any 
participants who are identified as at risk for suicidality (i.e., endorse “Several days” or “More than half the days” 
or “nearly every day” on PHQ-9 item #9 asking how often in the last two weeks the Veteran was thinking s/he 
would be better or dead or was wanting to hurt him/herself in some way) will be contacted by the PI or a 
trained clinician to conduct a clinical risk assessment, safety plan (if necessary), and appropriate clinical 
referral. Additionally, each time the participant completes the Treatment Involvement Form (TIF), it will be 
reviewed for serious adverse events occurring during the study period by the PI or trained study staff. The PI 
has the responsibility of reporting adverse events to the IRB, in accordance with federal regulations. If a 
participant is hospitalized in response to a crisis, determination as to continuation in the study will be handled 
on a case-by-case basis. Veterans who feel that participation in the study is overwhelming can certainly 
discontinue. Veterans will also be given the option of skipping an assessment point versus discontinuing. In 
many cases, it may be beneficial for the Veteran to continue, for example: 1) Although not a substitute for good 
clinical care, Project SERVE: FX can serve as an “extra set of eyes” to monitor how Veterans are doing over 
time; and 2) study discontinuation may feel penalizing for Veterans who have reported suicidality, when such 
reporting should be encouraged. Additionally, understanding suicidality over time is a crucial area of scientific 
research that has benefit for our understanding of the adjustment process following deployments, and for 
developing prevention programs for both Veterans and society at large.  
 
Inclusion of Women, Minorities, and Children 
1. Inclusion of Women. Both male and female Veterans who meet inclusion criteria will be recruited for 
participation in this study. We expect that the gender distribution in the proposed study sample will be similar to 
that in deployed samples. In SERVE FX-Phase I, we successfully oversampled women at the level of 33%, 
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oversample to achieve 30% in Phase III. In order to maximize recruitment of women, we will actively recruit 
women through targeted advertisements and outreach efforts to women’s groups within the VA and local 
Veteran’s Service Organizations. 
2. Inclusion of Minorities. We expect that completed response rates among minority participants will be similar 
to the breakdown of minorities in the armed forces residing in Texas (11.6% African-American and 16.4% 
Latino). We plan to collect data from all participants on their ethnic and racial self-identification. As with our 
efforts to maximize recruitment of women, we will actively recruit minority participants within Veterans, 
including outreach meetings with minority Veterans organizations (possibly outside the VA), where available. 
3. Inclusion of Children. Adults ages 18 and older will be included in the current study. 
 
 

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COMPLETED PHASES 
 
Phase I 
A total of 309 VA-service-seeking returning OEF/OIF/OND Veterans were evaluated over a one-year period in 
Phase I. All data collection was completed in June 2014, and data was moved to the SERVE Data Repository 
on November 23, 2021. Primary activities for this study phase are no longer active, and any remaining 
biological samples have been destroyed. 
Specific Aims 
The specific aims of Phase I include: 1) examining the relationship between level of exposure to stressors 
(pre-deployment, deployment-related, and post-deployment) and functioning over time; 2) examining 
whether potentially malleable resilience factors predict higher levels of functioning in returning Veterans 
over time; 3) examining whether psychopathology predicts lower levels of functioning in returning 
Veterans over time; 4) testing the theoretical model that psychopathology partially mediates the effects 
of stress, social support, coping, and neurocognition on functioning over time; 5) examining whether 
changes in the use of healthy coping strategies, social support, post-deployment stress, and 
psychopathology predict changes in functioning over time; and 6) exploring whether stress, social 
support, coping, neurocognition, and psychopathology have differential effects on specific aspects of 
functioning (e.g., occupational, family, social, and physical functioning) over time. 
Study Methods 
This study will investigate the course of functioning over time among returning OEF/OIF/OND Veterans 
enrolled at CTVHCS. The primary outcome measures will assess multiple domains of functioning, 
including: 1) occupational functioning; 2) social relationships; 3) family functioning; 4) physical 
functioning; and 5) quality of life. Hypothesized predictors of functioning include: 1) level of exposure to 
deployment-related stressors, including potentially traumatic events (PTEs) and head injuries/traumatic 
brain injury (TBI); 2) level of pre-deployment stress and trauma exposure; 3) level of exposure to post-
deployment stress and trauma, including “everyday” stressors; 4) modifiable psychological factors 
including coping, emotion regulation, self-compassion, attributional style, psychological flexibility, and 
mindfulness; 5) perceived social support; 6) psychopathology including PTSD and depression; 7) 
substance misuse; 8) physical health symptoms including chronic pain; and 9) exposure to morally 
injurious events. Hair samples will be collected for biochemical validation of drug use. Saliva samples will 
also be collected (on an optional basis) to examine genetic contributions. 
Procedures 
Phase I assessments occur at 0 (baseline), 4-, 8-, and 12-month time points. Veterans will complete an 
in-person baseline assessment lasting approximately 4-6 hours and a one-year follow-up face-to-face 
assessment lasting approximately 3-4 hours. All face-to-face assessments will be conducted in private 
rooms with a white noise machine so that interviews cannot be overheard, although participants may sit 
in a waiting room to complete their questionnaires (any questions that arise will be answered in a private 
area). The baseline and annual assessments include clinical assessments, self-report questionnaires, 
and a hair sample (for biochemical validation of drug use report). Veterans are required to provide a hair 
sample; thus, Veterans who decline to provide a hair sample decline to participate in the study. 
 
 
Validity Checks 
Self-report of substance use will be verified via analysis of hair samples gathered at BL and annual 
assessment. Although only 10% of samples will be analyzed, this sampling has been shown to increase 
accuracy of self-reported substance use (Marlatt & Gordon, 1985). Hair samples will be collected as per 
standard procedures recommended, and kits provided, by Omega Laboratories, Inc. Participants are 
given the option of providing a sample of head hair or from another part of the body (underarm, arm, leg, 
pubic). In the case of pubic hair, participants are instructed in how to take the hair sample and do this 
themselves in the bathroom. Hair (amount approximately the width of a pencil) is cut as closely as 
possible to the root and laid in a piece of tin foil (root in one direction), which is folded. Hair samples are 
then placed in a small sealed envelope, which is placed in a larger sealed envelope with associated 
paperwork marked with a code number only. A total of 10% of the samples will be shipped to Omega 
Laboratories, Inc. for testing. Hair samples are stored with other coded data in locked file cabinets until 
testing. Hair samples will be disposed/destroyed after testing. 

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Phase I Assessment Instruments. [DATA COLLECTION COMPLETED] 
 
Measures/ Proposed 
Indicators 
 
Purpose 
Assessment  
Time Point 
 
Description/Rationale 
BL 
4/8m 
12m 
Telephone Screen 
E 
 
 
 
Assesses inclusion/exclusion criteria.  
Contact Information  
Contact 
9 
9 
9 
Collected to verify Veteran status in CPRS, scheduling, send 
appointment confirmation letter, contact for follow-up, etc. 
Demographic 
Questionnaire & Military 
History Form 
Demographic, 
PV 
9 
 
9 
Assesses basic demographic and Veterans-specific 
characteristics (e.g., years of education, years of military service, 
family history of military service). Readministered at annual to 
assess changeable demographics (e.g. marital status, 
employment). 
Medical History Form 
 
9 
 
9 
Form created for the current study. Medical history will be 
evaluated with respect to participant health and family history. 
Treatment Involvement 
Form 
CV 
9 
9 
9 
Form created for the current study that will be used to assess 
treatment involvement during the prior 4 months, including 
medical, psychiatric and psychological treatment, as well as 
supportive interventions (e.g. Alcoholics Anonymous, Narcotics 
Anonymous). Duration of untreated symptoms will be assessed. 
Mini International 
Neuropsychiatric 
Interview (MINI) - 
Psychosis modules 
E 
9 
 
9  
Screening Interview for exclusionary criteria (bipolar disorder and 
psychosis unrelated to PTSD). Assessment of PTSD related to 
civilian events. 
Clinician Administered 
PTSD Scale (CAPS) 
Med, DV 
9 
 
9 
Interview. Will assess current and lifetime PTSD using DSM-IV 
criteria. Criterion F assesses functional impairment associated 
with PTSD. Both categorical diagnoses and symptom severity 
ratings will be obtained. The CAPS format allows the interviewer 
to link PTSD symptoms to specific Criterion A events (i.e., a 
traumatic event that includes the experience of fear, 
helplessness or horror) and separately assesses for Criterion A1 
(a potentially-traumatic event) and A2. Scoring according to 
criteria established by Weathers et al. (1994) has excellent retest 
and inter-rater reliability, and high sensitivity and specificity for 
PTSD diagnosis.  
Structured Clinical 
Interview for DSM-IV 
(SCID) 
Med, DV 
9 
 
9 
Interview. Widely used. Will assess depression, generalized 
anxiety disorder, alcohol and drug use. 
Wide Range 
Achievement Test 4th 
Edition - Word Reading 
Subtest (WRAT4)  
CV, PV 
9 
 
 
The WRAT4 word reading subtest (Wilkinson and Robertson, 
2007) is a brief (2 minutes) test that provides an estimate of 
native intellectual potential that is considered to be unaffected by 
the onset of mental health problems. This will allow a measure of 
pre-deployment/pre-morbid intellectual potential to serve as both 
a predictor and as a covariate in analyses of neurocognitive 
performance, given previous findings of lower pre-military 
intellectual functioning among individuals diagnosed with PTSD 
(Kremen, et al., 2007; McNally & Shin, 1995; Vasterling, et al., 
1997).  
Neuropsych-ological 
screening 
PV 
9 
 
9 
A brief (35 minutes) neuropsychological assessment will be 
conducted, from which a composite neuropsychological 
functioning index will be computed. The influence of cognitive 
functioning on functional outcomes among returning Veterans is 
not fully understood. Whether influenced by combat exposure, 
TBI, mental health problems, or the complex interactions among 
them, impaired cognitive processing may impact risk, recovery, 
or lead to greater chronicity of functional impairment. Domains 
include: 1) basic processing speed and attentional and memory 
processes frequently observed among individuals with mild TBI, 
as well as psychiatric conditions including PTSD (Brewin, et al., 
2007), substance abuse/dependence, and sleep disturbance; 2) 
working memory, which exhibits a robust relationship with a 
range of functional outcomes in psychiatric populations (Green, 
1996) and may serve as a protective factor against development 
of PTSD (Parslow & Jorm, 2007); and 3) executive functioning, 

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which is associated with impulsivity and PTSD (e.g., Vasterling, 
et al, 1998; Gilbertson et al., 2006).  
Domains will be assessed as follows: 
· Processing speed - Digit Symbol Coding (WAIS-IV), Trail 
Making Test A 
· Attention - Digits Forward and Backward (WAIS-IV)  
· Auditory working memory - Digits Forward and Backward 
(WAIS-IV)  
· Auditory learning and memory - California Verbal Learning Test 
2nd Ed. (CVLT) 
· Executive functioning – Trail Making Test B, Stroop test 
The neuropsychological assessment will be re-administered at 
the annual assessment in order to assess changes in cognitive 
functioning that may have occurred during the past year. 
TBI Assessment 
Interview   
E, PV 
9 
  
 9 
This clinician-administered structured interview developed by 
Vasterling (2008) assesses the number, recency, type of injury, 
and clinical sequelae associated with traumatic brain injury 
during deployment. Total number of lifetime head injuries leading 
to any symptoms will also be assessed. TBI will be assessed at 
baseline for lifetime history and then re-assessed at the annual 
interview for any new TBIs that may have occurred during the 
past year. 
Traumatic Life Events 
Questionnaire (TLEQ) 
PV 
9 
 
9 
23 items (Kubany et al., 2000); assesses frequency of exposure 
to 22 potentially traumatic events encountered outside of military 
service, resulting in a continuous trauma exposure score. The 
psychometric properties were carefully established in 5 studies, 
including a sample of combat Veterans (Kubany et al., 2000).  
Deployment Risk and 
Resilience Inventory 
(DRRI) 
PV 
9 
 
9 
The DRRI (King, King, and Vogt, 2003) is a collection of 13 
individual scales assessing pre-deployment, deployment, and 
post-deployment risk and resilience factors. The DRRI was 
recently validated for use with OIF Veterans (Vogt et al., 2008). 
The full DRRI will be readministered at the annual interview if 
participants have been deployed again. In addition, the social 
support scale of the DRRI will be re-administered to all 
participants at Annual 1 in order to obtain an ongoing 
assessment of social support across time. 
RAND Peritraumatic 
Dissociative Experiences 
Q. 
PV 
9 
 
9 
8 items. Assesses dissociative experiences at the time of a 
military PTE. Demonstrated good retest reliability (r=.85), internal 
consistency (D = .83) and construct validity, and correlated 
moderately with PTSD symptomatology (Marshall et al., 2002). 
Posttraumatic growth 
Inventory 
PV 
9 
 
9 
21 items (Tedeschi & Calhoun, 2005); factors include new 
possibilities, relating to others, personal strength, spiritual 
change and appreciation of life. 
Full Combat Experiences 
Scale 
PV 
9 
 
 
34 items. Newly developed and adapted from the DRRI to 
assess experiences and trauma exposure in land combat 
situations such as OEF/OIF (Hoge et al., 2004). Will be re-
administered if re-deployed. 
PTSD Checklist-5 (PCL-
5) Military and Civilian 
Med  
9 
9 
9 
20 items. Measures symptoms of PTSD during the previous 
month. Demonstrates high sensitivity and specificity for a CAPS 
diagnosis of PTSD. Prior research demonstrates the value of 
including both self-report and clinical interview assessment of 
PTSD (cf. National Vietnam Veteran Readjustment Study; Kulka 
et al., 1988). 
Schedule of Recent 
Exper-iences (SRE) 
PV 
9 
9 
9 
42 items. The SRE (Holmes & Rahe, 1967) will be used to 
assess exposure to common, “everyday” stressful life events 
(e.g., job loss, relationship difficulties, illness or death of a loved 
one).  
Beck Depression 
Inventory-II (BDI-II) 
Med  
9 
9 
9 
21 items; The BDI-II (Beck, Steer, Ball, & Ranieri,1996) is a 
widely-used measure of depressive symptoms with high internal 
consistency (Beck, Steer, Ball & Ranieri, 1996) and test-retest 
reliability (Beck, Steer, & Brown, 1996). 
Depression, Anxiety, 
Stress Scales 
Med 
9 
 
9 
21 items; 3 empirically distinct subscales: depression, anxiety, 
and general stress. Reliable and valid measure of these 
constructs, and discriminates between anxiety and depression 
better than other commonly used indices (Antony et al., 1998; 

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Brown et al., 1997; Lovibond & Lovibond, 1995) 
Columbia Suicide Scale 
DV 
9 
 
9 
The Columbia Suicide Scale (Posner et al., 2008) is a state-of-
the-art suicide assessment for individuals perceived to be at high 
risk for suicidality.  
Daily Drinking Quest. 
Revised (DDQ-R) 
Med 
9 
9 
9 
Yields typical frequency (average number of drinking days per 
week), typical quantity (number of drinks/drinking day), week 
sum (total number of drinks during an average week). Binge 
drinking and tolerance questions added.  
Rutgers Alcohol Problem 
Index (RAPI) 
Med 
9 
 
9 
23-items; measures the frequency of physical (e.g., had 
withdrawal symptoms, passed out or fainted suddenly), 
psychological (e.g., noticed a change in your personality, felt that 
you had a problem with alcohol), and social (e.g., caused shame 
or embarrassment to someone, had a fight, argument, or bad 
feelings with a friend) consequences experienced during the past 
three months (White & Labouvie, 1989). Internal reliability for the 
23-item RAPI is excellent (α= .94; White & Labouvie, 1989).   
Drug Abuse Screening 
Test (DAST) 
Med 
9 
 
9 
20-items to quantify drug misuse. Good internal consistency 
(alpha = 0.92) and concurrent validity with frequency of drug use 
over 12-months (Skinner, 1982). Moderately correlated with 
denial and social desirability. 92% of individuals with drug abuse 
scored greater than 10. 
Fagerstrom Test for 
Nicotine De- pendence 
(FTND) 
DV, Med 
9 
9 
9 
6 items that quantify nicotine dependence that exhibits 
satisfactory internal consistency (α = .61), as well as convergent 
validity with biochemical indices of heaviness of smoking 
(Heatherton et al., 1991). 
Brief COPE  
PV 
9 
 
9 
The widely-used Brief COPE assesses a range of behavioral and 
cognitive coping strategies (Carver, et al., 1989).  
Acceptance and Action 
Questionnaire 
(AAQ-II) 
PV 
9 
9 
9 
10 items; The AAQ-II (Hayes, Bissett, et al, 2004) assesses 
acceptance, experiential avoidance (attempting to alter the form 
or frequency of unwanted internal experiences), and taking 
action despite experiencing unwanted private events. Lower 
scores indicate greater levels of experiential avoidance, whereas 
higher scores indicate greater experiential acceptance and 
willingness. The AAQ-II exhibits a single factor structure, good 
internal consistency (mean α = .83 across multiple samples) and 
test-retest reliability (α = .80 at 3 months, .78 at one year), and 
convergent associations with symptoms of depression (r = -.71), 
anxiety (r = -.58), and global distress (r = -.65).  
Distress Tolerance Scale 
(DTS) –  
Emotional and Physical 
Distress Scales 
PV  
9 
 
9 
16 items (Simons & Gaher, 2005) assessing the extent to which 
participants can tolerate physical (6 items; e.g., “I’ll take fairly 
extreme measures to stop physical discomfort or pain”) and 
emotional (10 items; e.g., “I usually follow through with tasks that 
are emotionally upsetting”) distress. The ability to tolerate 
distress may explain why a disorder develops. For example, if 
one is low on distress tolerance, this may increase risk for 
reliance on other maladaptive coping strategies, particularly 
substance misuse. 
Brief Resilience Scale 
PV 
9 
 
9 
6-item scale measuring resilience (Smith et al., 2008); ability to 
bounce back or recover from stress. Significantly correlated with 
25-item Connor Davidson Resilience Scale. 
World Health 
Organization Disability 
Assessment Schedule II 
(WHODAS II) 
DV 
9 
9 
9 
36 item self-report version assessing functional disability across 
7 domains (understanding and communicating, getting around, 
getting along with people, life activities, work, participation in 
society, self-care) as well as a total score. The WHODAS-II is 
becoming widely used in investigations of functional disability 
with wide-ranging populations and is a primary measure in an 
ongoing VA/DoD study aimed at developing a measure of 
functional impairment in active duty service members and 
Veterans (Marx, PI, Schnurr and Hoge, Co-Investigators).  
Inventory of Functional 
Impairment (IFI) 
DV 
9 
 
9 
87 items (Marx et al, 2009). The IFI yields an overall score and 7 
subscales: Romantic Relationships with a Spouse or Partner, 
Family, Work, Friendships and Socializing, Parenting, Education, 
and Day-to-Day functioning. Higher scores indicate greater 
functional impairment. Preliminary analyses (n = 170) with 
Veterans show strong psychometric properties, including strong 

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internal consistency (Cronbach’s alpha ranging from .76 to .91) 
and construct validity.  
Employment Survey (ES) 
DV 
9 
9 
9 
 12 item self-report version adapted from the measure developed 
by Glynn and colleagues (Mueser, Glynn, and McGurk, 2006) to 
assess employment status, number of hours worked, income, 
reasons for not working or working less than full-time, satisfaction 
with various aspects of current employment, and stability of 
employment (number of jobs held, reasons for leaving previous 
jobs) since discharge from active duty military.  
Quality of Life Scale 
(QLS) 
DV 
9 
9 
9 
16 items (Burkhardt, et al., 1989) assessing how satisfied people 
are in regards to 16 areas distinct from health status (mate, 
physical well-being, relationships with others, social, community, 
and civic activities, personal development and fulfillment, 
recreation, and independence). Good internal consistency and 
(alpha .82 to .92) and high test-retest reliability (r = .78 to .84; 
Burckhardt et al. 2003). Life satisfaction is a central goal of 
recovery and rehabilitation, and diminished quality of life may 
influence suicidality and other key outcomes. 
Strengths and Difficulties 
Questionnaire (SDQ) 
DV 
9 
 
9 
25 items; Administered only to participants with one or more 
children living at home. Measures emotional and behavioral 
disturbance in children aged 4-17 (Goodman, 1997). Consists of 
5 5-item subscales: emotional symptoms, conduct problems, 
hyperactivity/inattention, peer relationship problems, and pro-
social behavior. First 4 scales sum to yield a total difficulties 
score. Strong psychometric properties (Muris et al., 2004), 
concurrent validity (i.e., highly correlated with CBCL; Klasen et 
al., 2000), good convergent validity with structured interviews 
(Goodman & Scott, 1999), and divergent validity (i.e., 
distinguishing psychiatric and community samples; Klasen et al., 
2000). The proposed approach of using the CBCL annually and 
the SDQ at each time point should provide a thorough 
assessment of child psychopathology and functional dimensions 
over time.   
NEO Five-Factor 
Inventory (NEO-FFI) 
PV 
9 
 
9 
60 items (Costa & McCrae, 1989); shortened version of the NEO 
PI-R. Reliable and valid measure of the five-factor model of adult 
personality. Good internal consistency for the five subscales 
(range .74 - .89). 
Pain Disability Index  
 
9 
 
9 
7-item instrument for measuring the impact that pain has on the 
ability of a person to participate in essential life activities. 
Marlow-Crowne Social 
Desirability Scale 
QA 
9 
 
9 
10 item abbreviated version of the original Social Desirability 
Scale (Crowne & Marlowe, 1960) assessing the extent to which 
responses are influenced by social desirability. Measures the 
same construct as the full scale and has good internal 
consistency (Fraboni & Cooper, 1989; Strahan & Gerbasi, 1973). 
Hair Sample 
QA 
9 
 
9 
To verify self-report of drug use, hair samples will be gathered at 
BL and annual assessments. The hair sample is a required 
component of the study. Participants will be told that hair may be 
tested for drug use; however, only 10% of samples will be 
analyzed for use of nicotine, cocaine, marijuana, opiates, 
amphetamines, phencyclidine, hydrocodone, hydromorphone, 
and oxycodone.  
Saliva sample 
PV, Med 
9 
 
 
DNA and other products will be extracted from saliva samples. 
Provision of saliva sample is optional. 
Monetary Choice 
Questionnaire (MCQ) 
PV 
 
 
9 
27-item instrument (Kirby, Petry, & Bickel, 1999) used to 
estimate the rate at which respondents discount the value of 
future rewards. Higher rates of discounting on this measure have 
been associated with both self-reported impulsivity and real-
world engagement in impulsive behaviors. 
BL = Baseline; BI-ANN = Bi-Annual; ANL = Annually; E = Eligibility; DV = Dependent/Outcome Variable; PV = Predictor Variable; 
Med = Mediator; CV = Covariate; QA = Quality Assurance/Validity Check 

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Biological Markers 
In Phase I, subjects will donate DNA/RNA/Saliva for genetic and research studies. No clinically validated 
tests will be performed. The genetics/biomarker component of the protocol will be supervised by Dr. Keith 
Young (CTVHCS Neuropsychiatry Research Program, Building 205, 3R05 and 3R08) and Dr. Rakeshwar 
Guleria (CoE Biomarkers and Genetics Core) experts in this area, in collaboration with the PI. See 
Appendix for Safety Survey. At the BL assessment, participants will be given the option of consenting to 
all study procedures or all procedures excluding the saliva/blood sample (depending on the phase) and 
genetic research.  
For those who consent to that aspect of the study, participants will donate saliva by spitting into a coded 
OragenTM tube at the assessment site. Staff will be trained to avert their eyes when participants are 
spitting into the test tube to reduce potential embarrassment. The saliva samples will be stored at room 
temperature in a locked - cabinet present inside a locked office (Building 93,1A-137) until transported at 
room temperature by team members to Dr. Young’s lab in Temple or Waco Building 93 (rooms 2A 116, 
2A 117), where the samples will be stored until DNA extraction and testing. Phase I genotyping will be 
performed at CTVHCS Temple Building 205 and Waco Building 93. According to the work load, the 
genotyping work will be divided between the two labs (Drs. Guleria & Young).  
Aims and Hypotheses 
Specific Aim 1. Identify whether a dose-response relationship exists between level of exposure to 
stressors and subsequent level of functioning.  
Hypothesis 1a. Greater exposure to pre-deployment stress and trauma will predict lower levels of 
functioning concurrently and over time. 
Hypothesis 1b. Greater exposure to deployment-related stress and trauma will predict lower levels 
of functioning concurrently and over time. 
Hypothesis 1c. Greater exposure to post-deployment stressors will predict lower levels of  
functioning concurrently and over time. 
Specific Aim 2. Examine whether potentially malleable resilience factors predict higher levels of 
functioning in returning OEF/OIF Veterans. 
Hypothesis 2a. Greater use of healthy coping strategies (i.e., acceptance and active coping) will 
predict higher levels of functioning concurrently and over time. 
Hypothesis 2b. Greater levels of social support will predict higher levels of functioning 
concurrently and over time.  
Hypothesis 2c. Higher levels of neurocognition will predict higher levels of functioning concurrently 
and over time. 
Specific Aim 3. Examine whether psychopathology predicts lower levels of functioning.  
Hypothesis 3a. Greater PTSD-Depression symptoms will predict lower levels of functioning 
concurrently and over time. 
Hypothesis 3b. Greater AUD symptoms will predict lower levels of functioning concurrently and 
over time. 
Specific Aim 4. Test the theoretical model that psychopathology partially mediates the effects of stress, 
social support, coping, and neurocognition on functioning concurrently and over time. 
Hypothesis 4a. The hypothesized model (Figure 1) in which PTSD-Depression and AUD 
symptoms fully mediate the effects of pre-deployment stress, post-deployment stress, and active 
coping on functioning and partially mediate the effects of neurocognition, deployment stress, 
acceptance, and social support on functioning will show significantly better fit to the data 
compared to any of the following alternative models: an independent main effects model, a fully 
mediated model, or a full partial mediation model. 
Hypothesis 4b. PTSD-Depression symptoms will fully-mediate the effects of active coping, pre-
deployment stress, and post-deployment stress on functioning and will partially-mediate the 
effects of deployment stress, acceptance, and social support on functioning.  
Hypothesis 4c. AUD symptoms will partially mediate the effects of neurocognition on functioning.  
Specific Aim 5. Examine the influence of changes in coping, social support, post-deployment stress, and 
psychopathology on changes in functioning over time. 

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Hypothesis 5a. Sustained use of healthy coping strategies (i.e., acceptance and active coping), 
or increases in healthy coping strategies, will predict higher levels of functioning over time. 
Hypothesis 5b. Sustained higher levels of social support, or increases in social support, will 
predict lower levels of functioning over time. 
Hypothesis 5c. Sustained higher levels of PTSD-Depression and AUD symptoms, or increases in 
PTSD-Depression and AUD symptoms, will predict lower levels of functioning over time. 
Specific Aim 6. Explore whether stress, social support, coping, neurocognition, or psychopathology have 
differential effects on different facets of functioning (e.g., occupational, family, social, and physical 
functioning). 
Hypothesis 6a. Neurocognition will be most strongly related to occupational functioning. 
Hypothesis 6b. PTSD- Depression and AUD symptoms will be most strongly related to family 
functioning. 
Planned Analyses 
The purpose of the longitudinal design is to better understand the functional recovery of returning 
OEF/OIF/OND Veterans over time and to identify potentially-malleable risk and resilience factors 
associated with functioning. The study design is based on a measurement model that collects 
predetermined, repeated assessments every 4 months over a one-year period beginning with a baseline 
evaluation. Other than these measurement contacts, no experimental manipulations are planned, 
although participants may participate in treatment programs or be appropriately referred to treatment 
programs or other research studies during the course of this study. Treatment will be tracked using the 
Treatment Involvement Form, as this may influence course and outcome.  
This study will provide a rich dataset from which we will be able to conduct numerous analyses as 
proposed here, as well as those that are exploratory in nature in order to maximize the impact of the 
proposed research. Various statistical software programs will be utilized to accomplish the study aims, 
as appropriate (e.g., SPSS, SAS, mPLUS, AMOS). VA software will be used. Licenses are supported by 
the VISN 17 CoE as well as local IT (as indicated in original grant budgets). We will also use access 
software through the secure VA VINCI system (e.g., SPSS). VINCI requires documentation of IRB 
approval before analyzing data on the VINCI system. With respect to the proposed primary hypotheses, 
structural equation modeling (SEM; Jöreskog, 1970, 1993) will be the statistical approach employed to 
examine the relationships among the variables. SEM is essentially a combination of factor analysis and 
path analysis (Kline, 2005). This type of statistical analysis was chosen to test the hypotheses because 
it has several advantages over traditional statistical techniques (e.g., multiple regression). For example, 
SEM corrects for measurement error, which, in turn, improves statistical power. SEM also allows both 
latent and observed variables to be evaluated within the same model, and it is an especially effective 
analytical procedure for studying complex relationships among many variables. However, the two most 
important advantages of SEM over other traditional statistical analyses are: 1) SEM enables users to 
conduct tests of entire models in a single analysis; and 2) SEM allows for entire models to be tested 
against other competing models (Kline, 2005). Given that the one of the primary aims of the current 
proposal is to provide a direct test of our hypothesized model of functional outcomes in returning Veterans 
(Specific Aim 4, Figure 1), SEM appears to be the most appropriate type of statistical analysis to employ 
as it will enable us to: 1) examine the overall fit of our hypothesized model to the data; and 2) statistically 
compare our hypothesized model to other competing models (e.g., a main effects only model).  
A two-step modeling approach will be used to test each aim (Anderson & Gerbing, 1988; Kline, 2005). 
First, a confirmatory-factor analysis (CFA) measurement model will be computed to determine the degree 
to which the underlying latent constructs are statistically accounted for by their corresponding 
hypothesized observed variables. The hypothesized measurement model that we have proposed (see 
Table 3) is based on a combination of findings from our pilot data, previous research, and current theory 
and represents our best estimate of what the measurement model will be. If the hypothesized 
measurement models are supported by CFA, the structural relationships among the latent variables will 
be tested in the second step. If the initial hypothesized measurement model is rejected, the suggestions 
for model respecification offered by Kline (2005, pp 165 - 208) will be followed until an acceptable 
measurement model is found. Once an acceptable measurement model has been identified, the fit of the 
hypothesized structural model will be assessed with multiple goodness-of-fit indices, including the Root 

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Mean Square Error of Approximation (RMSEA), Standardized Root Mean Square Residual (SRMR), 
Comparative Fit Index (CFI), Normed Fit Index (NFI), and the Akaike Information Criterion (AIC). The 
hypothesized models will also be compared with other competing models using either the chi-square 
difference test for hierarchically-related models or the AIC for models that are not nested. Alpha will be 
set conservatively (α = .01) for all analyses in order to minimize the probability of Type I error. 
Specific Aims 1, 2, and 3, which hypothesize that stress, coping, neurocognition, and psychopathology 
will predict functioning in returning Veterans concurrently and over time will be initially tested within the 
context of an independent main effects model in which each of the hypothesized factors will be 
simultaneously regressed onto the functioning factor while accounting for the covariances among the 
predictors. Hypotheses will be considered to be rejected if the regression coefficients are either non-
significant (i.e., > .01) or are in the opposite direction of our predictions. To test these hypotheses over 
time, an identical model will be constructed using level of functioning at 1-year follow-up as the primary 
outcome variable while co-varying for level of functioning at baseline. In addition, a Cross-Lag Panel 
design (Ecob, 1987; Farrell, 1994; King et al., 2000; Williams & Peodsakoff, 1989) will be employed to 
examine the autoregressive associations (i.e., the value of interest is assumed to be a function of the 
previous values plus a random component) and cross-lag associations between the predictors and 
functional impairment across time. For example, Figure 3 illustrates the structural aspects of a Cross-Lag 
Panel design based on two waves of assessments of post-deployment stress and functioning. Within this 
model, we will test the effects of post-deployment stressors from the prior time period on functioning in 
the subsequent time period, while accounting for the effects of functioning from the prior time period. 
Likewise we will test the effects of functioning from the prior time period on post-deployment stressors in 
the subsequent time period, while accounting for the effects of post-deployment stressors from the prior 
time period. The Cross-Lag Panel design will enable us to examine the possibility that there may be 
reciprocal relationships that occur over time involving the predictors of interest and functional impairment. 
Specific Aim 4, which hypothesizes that psychopathology partially mediates the effects of stress, coping, 
and neurocognition on level of functioning in returning Veterans concurrently and over time, will be 
achieved by comparing the hypothesized model with several competing models, which include an 
independent main effects model, a fully-mediated model, and a complete partial mediation model. The 
overall fit of the hypothesized model will initially be assessed with multiple goodness-of-fit indices 
including RMSEA, SRMR, CFI, and NFI. Next, chi-square difference tests and AIC values will be used to 
compare the hypothesized model against the competing models. It is predicted that the hypothesized 
model will show good overall fit to the model (e.g., RMSEA < .05, CFI > .95) and that the hypothesized 
model will fit the data significantly better than the competing models. The regression coefficients for the 
hypothesized indirect pathways will also be examined for statistical significance (i.e., p < .01). The 
hypothesized model will also be tested over time. Specifically, level of functioning at year 1 follow-up will 
be regressed on to PTSD-Depression and AUD symptoms at 8-months, which, in turn, will be regressed 
on to ongoing stress, social support, acceptance, and active coping at 4 months and deployment stress, 
pre-deployment stress, and neurocognitive functioning at baseline. By testing the hypothesized model in 
this manner, we will be able to reduce the possibility that response bias during a particular assessment 
accounts for the hypothesized mediation results. Testing the model in this manner will also take into 
account the hypothesized causal ordering (i.e., stress, coping, social support, and neurocognition predict 
psychopathology, which, in turn, predicts functioning).  
Specific Aim 5, which hypothesizes that changes in the use of healthy coping strategies, social support, 
post-deployment stress, and psychopathology will predict changes in functioning over time, will be 
achieved by using latent growth curve models (LGMs) to test hypotheses 5a – 5c. LGMs characterize 
the trends in growth and change functions for individuals over time (Figure 4). This analytic method 
assumes that individuals change at different rates and that underlying latent variables determine the 
overall level and shape of individual trajectories (Lawrence & Hancock, 1998; McArdle, 1998). LGMs can 
be fit using structural equation models, and are capable of describing the behavior or symptom status of 
individuals in terms of their initial measurement levels and by their trajectories of change from those 
levels. LGM techniques can also analyze variability in initial levels and trajectories across persons, while 
providing means to test the contribution of other predictor variables and constructs as determinants of 
the different levels and trajectories. LGM techniques offer great flexibility for modeling individual growth 

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trajectories and their effects on outcomes, while accounting for multiple covariates. LGM will be used to 
examine the degree to which changes in healthy coping, post-deployment stress, social support, and 
psychopathology predict changes in functioning over time. It is hypothesized that sustained use of healthy 
coping strategies and social support, or increases in healthy coping or social support, will predict higher 
levels of functioning over time, whereas sustained high levels of, or increasing levels of, post-deployment 
stress and psychopathology are hypothesized to predict lower levels of functioning over time.  
Specific Aim 6, which proposes to explore whether the proposed risk and resilience factors have 
differential effects on specific aspects of functioning, will be achieved by testing the hypothesized model 
(or an alternative model found to provide the best overall fit to the data in relation to global functioning) 
in relation to each specific aspect of functioning at both baseline and at 1-year follow-up. That is, separate 
tests of the hypothesized model will be conducted for each specific aspect of functioning (e.g., 
occupational, family, social, physical). We hypothesize that neurocognition will be most strongly related 
to occupational functioning, whereas PTSD-Depression and AUD symptoms will be most strongly related 
to family functioning. 
Power and Sample Size Considerations. SEM will be used as the analytic strategy for testing all 
hypotheses. MacCallum, Browne, & Sugawara (1996) describe a method for estimating the required 
sample size to achieve a given power estimate at specified degrees of freedom (df) for both close fitting 
(i.e., RMSEA = .05) and not close fitting (i.e., RMSEA = .08) models. These RMSEA values are chosen 
as points of estimate, since values below .08 are shown to indicate an acceptable but not necessarily 
close model fit to the data, and values below .05 are shown to indicate an acceptable and close fit to the 
data (Stieger, 1990; Browne & Cudek, 1993; Hu & Bentler, 1993). The method described by MacCallum 
and colleagues can also be employed to provide a power estimate for close and not-close fitting models. 
For the purposes of the current proposal, the software developed by Preacher and Coffman (2006) to 
calculate power from df, RMSEA, N, and alpha using the method described by MacCallum et al. (1996) 
were used to conduct a power analysis for the proposed study. For SEM equations, df are equal to the 
number of observations [i.e., observed variables * (observed variables + 1) / 2] minus the number of free 
parameters in the model. Due to the complexity of the proposed models, the df for our proposed models 
are high and range from 137 to 922 df, with differences among the models being largely accounted for 
by differences in model complexity and the number of observed variables included in each model. Power 
was estimated conservatively by using the model with fewest degrees of freedom to estimate power, as 
power increases with df (MacCallum et al., 1996). Setting alpha conservatively at .01, a final sample size 
of 300 participants (from 400 enrolled) would provide a power estimate of .997 for a close-fitting model 
with 137 df and .988 for a not-close fitting model with 137 df. In addition, in the event that there is even 
greater than expected attrition (i.e., attrition rates are greater than 20%), the proposed study would still 
remain well powered even if as much as 35% of the sample were lost to attrition. For example, leaving 
alpha set conservatively at .01, a sample size of 195 participants (65% of the original sample size) would 
still provide a power estimate of .936 for a close-fitting model with 137 df and .822 for a not-close fitting 
model with 137 df. These results are also consistent with Kline’s (2005) rule-of-thumb that sample sizes 
of 200 or greater are generally well-powered for SEM analyses. Thus, by recruiting an initial sample of 
400 participants, we will be well-positioned to retain a sufficiently large sample to remain well-powered 
throughout the duration of the study, even in the event that attrition rates are higher than expected. 
 
Phase II 
Five hundred and one OEF/OIF/OND Veterans were evaluated over a two-year period in Phase II. All data 
collection for this phase was completed in in June 2018, and data was moved to the SERVE Data Repository 
November 23, 2021. Primary activities for this study phase are no longer active, and any remaining biological 
samples have been destroyed. 
Specific Aims 
The specific aims of Phase II are to identify clinically-relevant, modifiable psychosocial factors that: 1) 
prospectively predict improvements in long-term functioning; (2) predict membership in latent class 
trajectories of functioning; and (3) predict transitions between trajectories of functioning. 
Study Methods 

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This study will investigate the course of functioning over time among returning OEF/OIF/OND Veterans 
enrolled at CTVHCS. The primary outcome measures will assess multiple domains of functioning, 
including: 1) occupational functioning; 2) social relationships; 3) family functioning; 4) physical 
functioning; and 5) quality of life. Hypothesized predictors of functioning include: 1) level of exposure to 
deployment-related stressors, including potentially traumatic events (PTEs) and head injuries/traumatic 
brain injury (TBI); 2) level of pre-deployment stress and trauma exposure; 3) level of exposure to post-
deployment stress and trauma, including “everyday” stressors; 4) modifiable psychological factors 
including coping, emotion regulation, self-compassion, attributional style, psychological flexibility, and 
mindfulness; 5) perceived social support; 6) psychopathology including PTSD and depression; 7) 
substance misuse; 8) physical health symptoms including chronic pain; and 9) exposure to morally 
injurious events. Hair samples will be collected for biochemical validation of drug use. Saliva/blood 
samples will also be collected (on an optional basis) to examine genetic contributions. 
Procedures 
Phase II assessments occur at 0, 8-, 16-, and 24-month time points. Veterans will complete an in-person 
baseline assessment lasting approximately 4-6 hours, and a two-year follow-up face-to-face assessment 
lasting approximately 3-4 hours. All face-to-face assessments will be conducted in private rooms with a 
white noise machine so that interviews cannot be overheard, although participants may sit in a waiting 
room to complete their questionnaires (any questions that arise will be answered in a private area). The 
baseline and annual assessments include clinical assessments, self-report questionnaires, and a hair 
sample (for biochemical validation of drug use report). Veterans are required to provide a hair sample; 
thus, Veterans who decline to provide a hair sample decline to participate in the study. 
 
 
Validity Checks 
Self-report of substance use will be verified via analysis of hair samples gathered at BL and annual 
assessment. Although only 10% of samples will be analyzed, this sampling has been shown to increase 
accuracy of self-reported substance use (Marlatt & Gordon, 1985). Hair samples will be collected as per 
standard procedures recommended, and kits provided, by Omega Laboratories, Inc. Participants are 
given the option of providing a sample of head hair or from another part of the body (underarm, arm, leg, 
pubic). In the case of pubic hair, participants are instructed in how to take the hair sample and do this 
themselves in the bathroom. Hair (amount approximately the width of a pencil) is cut as closely as 
possible to the root and laid in a piece of tin foil (root in one direction), which is folded. Hair samples are 
then placed in a small sealed envelope, which is placed in a larger sealed envelope with associated 
paperwork marked with a code number only. A total of 10% of the samples will be shipped to Omega 
Laboratories, Inc. for testing. Hair samples are stored with other coded data in locked file cabinets until 
testing. Hair samples will be disposed/destroyed after testing. 
 
Phase II Assessment Instruments. [DATA COLLECTION COMPLETED] 
Measures/ Proposed 
Indicators 
 
 
 
Purpose  
Assessment  
Time Point 
 
 
 
Description/Rationale 
BL 
8 & 
16mo 
24 
mo 
 
Telephone Screen 
E 
 
 
 
Administered prior to the baseline assessment to determine initial 
eligibility. Assesses inclusion/exclusion criteria.  
Contact Information  
Contact 
9 
9 
9 
Collected to verify Veteran status in CPRS, scheduling, send 
appointment confirmation letter, contact for follow-up, etc. 
Service Connection 
(SC-S) 
Demographic,  
PV 
9 
 
9 
Assess service-connected disability.  
Demographic 
Questionnaire & 
Military History Form 
(DHMQ) 
Demographic, 
PV 
9 
 
9 
Assesses basic demographic and Veterans-specific 
characteristics (e.g., years of education, years of military service, 
family history of military service). Re-administered at annual to 
assess changeable demographics (e.g. marital status, 
employment). 
Patient Health 
Questionnaire–15 
(PHQ-15) 
Med, DV 
9 
9 
9 
15-item self-report (Kroenke, Spitzer & Williams, 2002) of 
somatic symptom clusters including pain (musculoskeletal, 
headaches), cardiac, gastrointestinal, respiratory, etc. that 
account for more than 90% of outpatient physical complaints 
(Kroenke, Arrington & Manglesdorff, 1990). The PHQ-15 had 

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strong internal reliability in the initial validation (α=.80) and was 
associated with functional status and disability (Kroenke et al., 
2002). 
Treatment Involvement 
Form (TIF) 
CV 
9 
9 
9 
Form created for the current study that will be used to assess 
treatment involvement during the prior interval, including medical, 
psychiatric and psychological treatment, as well as supportive 
interventions (e.g. Alcoholics Anonymous, Narcotics 
Anonymous). Duration of untreated symptoms will be assessed. 
Mini International 
Neuropsychiatric 
Interview (MINI) - 
Psychosis modules 
E 
9 
 
9  
Screening Interview for exclusionary criteria (manic/hypomanic 
episode and psychosis unrelated to PTSD). Assessment of 
PTSD related to civilian events. 
Clinician Administered 
PTSD Scale (CAPS) 
Med, DV 
9 
 
9 
Interview. Will assess current and lifetime PTSD using DSM-5 
criteria. Criterion F assesses functional impairment associated 
with PTSD. Both categorical diagnoses and symptom severity 
ratings will be obtained. The CAPS format allows the interviewer 
to link PTSD symptoms to specific Criterion A events (i.e., a 
traumatic event that includes the experience of fear, 
helplessness or horror) and separately assesses for Criterion A1 
(a potentially-traumatic event) and A2. Excellent retest and inter-
rater reliability, and high sensitivity and specificity for PTSD 
diagnosis. Questions will reflect both DSM-IV for continuity 
across phases and new DSM-5 criteria. 
Structured Clinical 
Interview for DSM-IV 
(SCID) 
Med, DV 
9 
 
9 
Interview. Widely used. Will assess mood disorders and alcohol 
use disorder. Frequency and quantities of drug use will be 
assessed. Questions will reflect both DSM-IV for continuity 
across phases and new DSM-5 criteria.  
Wide Range 
Achievement Test 4th 
Edition - Word 
Reading Subtest 
(WRAT4)  
CV, PV 
9 
 
 
The WRAT4 word reading subtest (Wilkinson and Robertson, 
2007) is a brief (2 minute) test that provides an estimate of native 
intellectual potential that is considered to be unaffected by the 
onset of mental health problems. This will allow a measure of 
pre-deployment/pre-morbid intellectual potential to serve as both 
a predictor and as a covariate in analyses of neurocognitive 
performance, given previous findings of lower pre-military 
intellectual functioning among individuals diagnosed with PTSD 
(Kremen, et al., 2007; McNally & Shin, 1995; Vasterling, et al., 
1997).  
TBI—Vasterling 
Assessment Interview   
E, PV 
9 
  
 9 
This clinician-administered structured interview developed by 
Vasterling (2008) assesses the number, recency, type of injury, 
and clinical sequelae associated with traumatic brain injury 
during deployment. Total number of lifetime head injuries leading 
to any symptoms will also be assessed. TBI will be assessed at 
baseline for lifetime history and then re-assessed at the annual 
interview for any new TBIs that may have occurred during the 
past year. 
Traumatic Life Events 
Questionnaire (TLEQ-
Lite) 
PV 
9 
 
9 
23 items (Kubany et al., 2000); assesses frequency of exposure 
to 22 potentially traumatic events encountered outside of military 
service, resulting in a continuous trauma exposure score. The 
psychometric properties were carefully established in 5 studies, 
including a sample of combat Veterans (Kubany et al., 2000). 
Modified for this study to no longer assess DSM-IV criteria for 
PTSD Criterion A2, as this is no longer required in DSM-5. 
Deployment Risk and 
Resilience Inventory 
(DRRI) 
PV 
9 
9 
9 
The DRRI (King, King, and Vogt, 2003) is a collection of 13 
individual scales assessing pre-deployment, deployment, and 
post-deployment risk and resilience factors. The DRRI was 
recently validated for use with OIF Veterans (Vogt et al., 2008). 
The select scales of the DRRI will be readministered at the 
annual interview if participants have been deployed again. The 
social support scale of the DRRI will be administered to all 
participants at all time points, and the Exposure to Nuclear, 
Biological, or Chemical Agents- Modified (ENBCA-M) scale will 
be administered to all participants at 16 months.  
Full Combat 
Experiences Scale 
(FCES) 
PV 
9 
 
9 
25 items. Newly developed and adapted from the DRRI to 
assess experiences and trauma exposure in land combat 
situations such as OEF/OIF (Hoge et al., 2004). Will be re-

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administered if re-deployed. 
PTSD Checklist-5 
(PCL-5) Military and 
Civilian 
Med  
9 
9 
9 
21 items. Measures symptoms of PTSD during the previous 
month. Demonstrates high sensitivity and specificity for a CAPS 
diagnosis of PTSD. Prior research demonstrates the value of 
including both self-report and clinical interview assessment of 
PTSD (cf. National Vietnam Veteran Readjustment Study; Kulka 
et al., 1988). 
Schedule of Recent 
Experiences (SRE) 
PV 
9 
9 
9 
42 items. The SRE (Holmes & Rahe, 1967) will be used to 
assess exposure to common, “everyday” stressful life events 
(e.g., job loss, relationship difficulties, illness or death of a loved 
one). 
Patient Health 
Questionnaire-9 
Med, DV 
9 
9 
9 
9-item measure used for screening, diagnosing, and monitoring 
depression. It incorporates DSM-IV diagnostic criteria (Question 
9 screens for suicidal ideation; Kroenke, Spitzer & Williams, 
2001). 
Columbia Suicide 
Scale 
DV 
9 
 
9 
The Columbia Suicide Scale (Posner et al., 2008) is a state-of-
the-art suicide assessment for individuals perceived to be at high 
risk for suicidality. Internal consistency ranged from .73 to .95 
(Posner et al., 2011). 
Alcohol Use Disorders 
Identification Test 
(AUDIT) 
Med 
9 
9 
9 
Administered at every time point to screen for alcohol-use 
disorders (Saunders, Aasland, Babor, Fuente, & Grant, 1993). 
10-item measures adopted by VA as the gold-standard screening 
for alcohol use disorders in mental health and primary care 
clinics. Good internal consistency (α=.80 - .94) and test-retest 
reliability (r=.86), and strong concurrent validity with the MAST 
and CAGE screening measures (Babor et al., 2001). 
Drug Abuse Screening 
Test (DAST-20) 
Med 
9 
 
9 
20-items to quantify drug misuse. Good internal consistency 
(alpha = 0.92) and concurrent validity with frequency of drug use 
over 12-months (Skinner, 1982). Moderately correlated with 
denial and social desirability. 92% of individuals with drug abuse 
scored greater than 10. 
Fagerstrom Test for 
Nicotine De- pendence 
(FTND) 
DV, Med 
9 
9 
9 
6 items that quantify nicotine dependence that exhibits 
satisfactory internal consistency (α = .61), as well as convergent 
validity with biochemical indices of heaviness of smoking 
(Heatherton et al., 1991).  
Brief COPE (b-COPE) 
PV 
9 
 
9 
The 28-item measure is widely-used Brief COPE assesses a 
range of behavioral and cognitive coping strategies (Carver, et 
al., 1989).  
Acceptance and Action 
Questionnaire 
(AAQ-II) 
PV 
9 
 
9 
10 items; The AAQ-II (Bond, et al, 2011) assesses acceptance, 
experiential avoidance (attempting to alter the form or frequency 
of unwanted internal experiences), and taking action despite 
experiencing unwanted private events. The AAQ-II exhibits a 
single factor structure, good internal consistency (mean α = .83 
across multiple samples) and test-retest reliability (α = .80 at 3 
months, .78 at one year), and convergent associations with 
symptoms of depression (r = -.71), anxiety (r = -.58), and global 
distress (r = -.65).  
Brief Experiential 
Avoidance 
Questionnaire (BEAQ) 
PV 
9 
9 
9 
15 items; The BEAQ is a single-factor item that assesses the 
modifiable construct of experiential avoidance (Gamez et al., 
2013). 
Self-Compassion 
Scale – Short Form 
(SCS-SF) 
PV 
9 
9 
9 
12-item self-report measure of self-compassion, consisting of a 
total scale score and six subscale scores: self-kindness, self-
judgment, common humanity, isolation, mindfulness, and over-
identified (Neff, 2003; Raes, Pommier, Neff, & Van Gucht, 2011). 
The SCS-SF is strongly correlated with the original long form 
(r=.97) and has the same 6-factor structure with one higher-order 
factor. Internal consistency was .86 for the whole measure, with 
subscale alphas ranging from .54 to .75 (Raes et al., 2011). 
Attributional Style 
Questionnaire (ASQ) 
PV 
9 
  
9 
This 12-item self-report measure assesses attributions for 
positive and negative events along three causal dimensions: 
internal vs. external, stable vs. unstable, and global vs. specific 
(Peterson, Semmel, von Baeyer, Abramson, Metalsky, & 
Seligman, 1982). Internal consistency (α=.72-.75) and test-retest 
reliability (r=.58-.70) are adequate. 
Difficulties in Emotion 
PV 
9 
9 
9 
36-item self-report measure (Gratz & Roemer, 2004) of multiple 

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Regulation Scale 
(DERS)  
domains of emotion dysregulation. Comprised of 6 scales: 
nonacceptance of emotional responses, difficulty engaging in 
goal-directed behavior, difficulty with impulse control, lack of 
emotional awareness, poor emotion coping strategies, and lack 
of emotional clarity. Internal consistency (α=.84 to .93) and test-
retest reliability (r=.57-.89) were strong (Gratz & Roemer, 2004). 
Individual subscale consistencies (range from α=.81 to .92) have 
also been strong (Perez et al., 2012). 
Monetary Choice 
Questionnaire (MCQ) 
PV 
9 
 
 
27-item instrument (Kirby, Petry, & Bickel, 1999) used to 
estimate the rate at which respondents discount the value of 
future rewards. Higher rates of discounting on this measure have 
been associated with both self-reported impulsivity and real-
world engagement in impulsive behaviors. 
Endorsed and 
Anticipated Stigma 
Inventory (EASI) 
Med 
9 
 
 
Three of five 8-item scales that assess a variety of stigma-related 
beliefs within the broader categories of self- and public stigma 
will be used (beliefs about mental illness, mental health 
treatment, treatment seeking). The EASI was developed for use 
with military and Veteran populations. Evidence is available for 
the internal consistency reliability of these scales, with alphas 
ranging from .84 to .93. Scales have strong content validity, 
convergent and discriminant validity, and discriminative validity. 
Confirmatory factor analysis results support the proposed five-
factor structure (Vogt et al., in press). 
World Health 
Organization Disability 
Assessment Schedule 
II (WHODAS 2.0) 
 
DV 
9 
9 
9 
36-item self-report assessment of functional disability with total 
score and 6 domains of functioning: understanding and 
communicating, mobility, getting along with others, life activities 
(i.e., work, education, household responsibilities), participation in 
society, and self-care (Üstün et al., 2010). Both global and 
specific areas of functioning are crucial in thoroughly 
understanding functional recovery, as Veterans may function well 
in one area and have difficulty in another. Moreover, some 
domains may be affected by contextual factors instead of 
representing functional capacity (e.g., work functioning in a 
struggling economy independent of impairment). 
Inventory of 
Psychosocial 
Functioning (IPF) 
[Previously named 
Inventory of Functional 
Impairment, IFI] 
DV 
9 
9 
(Brief) 
9 
87-item self-report measure (Co-I Marx et al., 2009) of Romantic 
Relationships with a Spouse/Partner, Family, Work, Friendships 
and Socializing, Parenting, Education, and Self-Care. The short 
version has a .90 correlation with the full 80-item instrument (Co-
Marx, personal communication). Higher scores indicate greater 
functional impairment. For the 80-item IPF, preliminary analyses 
(n = 236) with Veterans show strong psychometric properties, 
including excellent internal consistency (Cronbach’s α ranging 
from .79 to .90) and concurrent validity with other measures of 
impairment and QoL, as well as PTSD and depressive symptoms 
(McQuaid et al., 2012). A 7-item brief version will be 
administered at 8- and 16-month. 
Community Integration 
Questionnaire (CIQ) 
DV 
9 
9 
9 
This 15-item measure (Willer, Ottenbacher, & Coad, 1994) 
assesses frequency of participation in and ability to 
independently complete home, social, and goal-directed 
activities. The CIQ demonstrates excellent internal consistency 
(α=.83 to .97) and test-retest reliability (r=.91-.97). Although there 
is no gold-standard measure of community integration, this 
measure is recognized by the VA Working Group on Community 
Integration (Resnik et al., 2012). 
Quality of Life Scale 
(QLS) 
DV 
9 
9 
9 
16 items (Burkhardt, et al., 1989) assessing how satisfied people 
are in 16 areas distinct from health status (mate, physical well-
being, relationships with others, social, community, and civic 
activities, personal development and fulfillment, recreation, and 
independence). Good internal consistency and (alpha .82 to .92) 
and high test-retest reliability (r = .78 to .84; Burckhardt et al. 
2003).  
NEO Five-Factor 
Inventory (NEO-FFI) 
PV 
9 
 
 
60 items (Costa & McCrae, 1989); shortened version of the NEO 
PI-R. Reliable and valid measure of the five-factor model of adult 
personality. Good internal consistency for the five subscales 
(range .74 - .89). New participants only. 

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Employment 
Survey (ES) 
Demographic, 
DV 
9 
9 
9 
12 item self-report version adapted from the measure developed 
by Glynnand colleagues (Mueser, Glynn, and McGurk, 2006) to 
assess employment status, number of hours worked, income, 
reasons for not working or working less than full-time, satisfaction 
with various aspects of current employment, and stability of 
employment (number of jobs held, reasons for leaving previous 
jobs) since discharge from active duty military. 
Health-Promoting 
Lifestyle Profile II 
(HPLP-II) 
PV 
9 
 
9 
52-item questionnaire that measures frequency of health-
promoting behaviors in several domains: physical activity, 
spiritual growth, health responsibility, interpersonal relations, 
nutrition, and stress management. The total score (α= .94) and 
each of the subscales (α= .70-.87) demonstrate good internal 
consistency.  
Interpersonal Needs 
Questionnaire (INQ) 
DV 
9 
 
 
18-item self-report measure that assess thwarted belongingness 
and perceived burdensomeness (Van Orden et al., 2012). The 
INQ has demonstrated good convergent validity, internal 
consistency and concurrent validity (Van Orden et al., 2012). 
Modified Habits 
Questionnaire 4 
(MHQ-4) 
DV 
9 
 
 
4-item questionnaire assessing self-injurious behavior  
Nash Moral Injury 
Events Scale (MIES) 
PV 
 
9 
9 
9-item self-report questionnaire developed as a measure of 
potentially morally injurious events (Nash, Carper, Mills, Au, 
Goldsmith, & Lizt, 2013). The MIES has excellent internal 
consistency, both the overall scale and the 2 subscales 
showed temporal stability, and early research found preliminary 
support for the construct validity (Nash, et al., 2013). 
Moral Injury 
Questionnaire- Military 
Version (MIQ-M) 
PV 
 
9 
9 
20-item self-report measure for assessing morally injurious 
experiences or MIEs among military populations (Currier, 
Holland, Drescher, & Foy, 2013). Research supports the 
factorial, concurrent, and incremental validity of the MIQ-M for 
use in both clinical and research contexts (Currier, et al., 2013). 
Family Assessment 
Device 12 (FAD) 
PV 
 
9 
9 
12-item self-report questionnaire, widely used as a measure of 
general family functioning (Epstein, Baldwin, & Bishop, 1983). 
Measure is noted to have adequate test-retest reliability and cut-
off scores which differentiate between clinician –rated healthy 
and unhealthy families (Miller, Epstein, Bishop, & Keitner, 1985). 
Quality of Marriage 
Index (QMI) 
PV 
 
9 
9 
6-item self-report questionnaire used to measure relationship 
distress (Norton, 1983). The measure was developed based on 
an empirical analysis of the functioning and construction of 
marriage quality variables. 
State Shame and Guilt 
Scale (SSGS) 
PV 
 
9 
9 
10-item self-report questionnaire used to assess 
phenomenological aspects of shame and guilt (Marschall, 
Saftner, & Tangney, 1994).  
Gratitude 
Questionnaire-6 (GQ-
6) 
PV 
 
 
9 
6-item self-report measure of trait gratitude. Items are rated on a 
7-point scale from 1 = strongly disagree to 7 = strongly agree. 
(GQ-6; McCullough, Emmons, & Tsang, 2001) 
Hair Sample 
QA 
9 
 
9 
To verify self-report of drug use, hair samples will be gathered at 
BL and annual assessments. The hair sample is a required 
component of the study. Participants will be told that hair may be 
tested for drug use; however, only 10% of samples will be 
analyzed for use of nicotine, cocaine, marijuana, opiates, 
amphetamines, phencyclidine, hydrocodone, hydromorphone, 
and oxycodone.  
Saliva sample 
PV, Med 
9 
 
9 
DNA and other products will be extracted from saliva samples. 
Provision of saliva sample is optional. 
Blood sample 
PV, Med 
9 
 
9 
DNA and other products will be extracted from blood samples. 
Provision of blood sample is optional.   
BL = Baseline; E = Eligibility; DV = Dependent/Outcome Variable; PV = Predictor Variable; Med = Mediator; CV = Covariate; QA = 
Quality Assurance/Validity Check 
 
Biological Markers 
Subjects will donate saliva and blood for genetic and biomarker research studies. Both saliva and blood 
will be collected because some biomarkers are known to be present in both blood and saliva. If we find 
a biomarker for PTSD symptoms in blood, and it is also in saliva, that would be a great advantage for 

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monitoring. Also, there are species of proteins in saliva that are not carried in the blood, and which change 
with stress. These may also be biomarkers for PTSD symptoms. No clinically validated tests will be 
performed. The genetics/biomarker component of the protocol will be supervised by Dr. Keith Young 
(CTVHCS Neuropsychiatry Research Program, Building 205, 3R05 and 3R08) and Dr. Rakeshwar 
Guleria (CoE Biomarkers and Genetics Core) an experts in this area, in collaboration with the PI. See 
Appendix for Safety Survey. At the BL assessment, participants will be given the option of consenting to 
all study procedures or all procedures excluding the saliva/blood sample and genetic research. 
Subjects will donate saliva in a coded Oragen tube at baseline and in a 1ml test tube at follow-up. Staff 
will be trained to avert their eyes when participants are spitting into the test tube to reduce potential 
embarrassment. The Oragen saliva test tubes will stored in Building 93 (2A 113) until transported by 
team members to Dr. Young’s lab in Temple and the small tube collected at follow-up will be frozen at -
80* in Waco Building 93 (2A 113). Subjects can also opt to donate blood by venipuncture by personnel 
trained in VA procedures for taking blood samples. Compression bandages will be used to cover the 
puncture. Blood will be placed in one yellow top, one red top (no additives), one purple top, 1 RNA 
(Paxgene Red-top) and 1 Green-top tubes (Plasma-lithium-heparin), all coded, and stored at 4 degrees 
on ice until separation (green top) or frozen (RNA and Yellow top). The original green top tube will be 
recapped and all tubes frozen in temporary storage at the VA lab, Dr. Young’s lab or Waco Building 93 
(rooms 2A 116, 2A 117). Whole blood in the green-top EDTA tubes will be spun and supernatant 
separated into three test tubes (coded). Blood products will be temporarily stored in a freezer at -20 and 
will be periodically (depending on patient flow) transported by automobile by team members with data 
transport waivers, or by VA clinical lab transport to be stored at the Temple VA clinical lab until transfer 
to Dr. Young’s lab (Building 205, 3R05 and 3R08 or to Waco Building 93, 2A 113, 2A 116, 2A 117). Blood 
from redtop and purple top tubes will be processed for cell protein and other constituents in Waco building 
93 (2A 113, 2A 116, 2A 117). All blood preparation will take place at the VA by trained personnel. 
DNA/RNA extraction from the DNA/RNA tubes will be performed by team members using DNA/RNA 
extraction kits (Amplicon: Building 205, 3R05 and 3R08). Coded DNA/RNA samples will be stored at -
20/-80 and in liquid nitrogen until testing (Building 205, 3R05 and 3R08). Blood product samples will be 
stored at -20/-80 and in liquid nitrogen for future use, with appropriate IRB approval (Building 205, 3R05 
and 3R08). Initial genotyping (Stage 1 and 2) and lab work will be performed in Dr. Young’s lab (Temple 
Building 205, 3R05 and 3R08). The results of the genotyping will be saved in a coded, de-identified 
dataset and stored on VA computers on the secure CTVHCS Research Service-approved drive  and 
S:\CoE Data\FX drive that will only be accessible to study staff. Below is a 3-phase description of the 
genetics research. 
If research staff do not have access to phlebotomy service (or if, for example, participants have a fear of 
needles), no blood will be drawn in Phase II. Instead, participants can volunteer to donate a second saliva 
sample in Phase II, using OragenTM DNA tubes as in Phase I. OragenTM test tubes do not need to be 
frozen, and will be stored at room temperature (Building 93, 1A-137, 2A 113) until transport by team 
members to Dr. Young’s lab in Temple for long-term storage at RT (Building 205: 3R05 and 3R08). 
Stage 1:  
SERT (SLC6A4). We will perform SERT genotyping with a triplex/double digestion PCR protocol as 
adapted from Young et al., 2006 and Wendland et al., 2006 to genotype for the 5HTTLPR + rs25531 
variants, the inton 2 VNTR 9, 10 and 12 repeats (IN2) and the Ile425Val a-g mutation (Ile/Val425). The 
digestion protocol using HpaII and BccI yields Sa, Sg, La, Lg, IN2-9, IN2-10, IN2-12, Ile425, Val425. All 
possible haplotypes will constructed from the variants and used in the analysis. Although the Sg and Val 
425 are quite rare (0.25%), we expect to genotype a few subjects with these variants subjects (0.5%). 
We will carefully monitor information on the additional Leu425 (and other) functional polymorphism(s) to 
ascertain whether resequencing will be required. Genotyping will be performed at CTVHCS Temple 
Building 205. 
Stage 2:  
5HT-2A, 5HT1A, 5HT6, CRHR1, CRHR1, MAOA, P11, FKBP5, GR, GNB3, CRH, TPH1, TPH2, BDNF, 
TrkB, microRNA panel (exigon mirnome panel or equivalent). Phase 2 SNP genotyping and 
Plasma/lymphocyte RNA/methylation/hormone assays will be performed serially on ABI TaqMan SNP 
Genotyping Assays (Applied Biosystems, Inc., Foster City, CA) and bead-based saliva hormone assays 

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in duplicate with negative controls. TaqMan fluorogenic 5’nuclease assay (Applied Biosystems) using a 
final volume of 5ul (2 ng genomic DNA and 2.5ul TaqMan Universal PCR Master Mix) will be used. 
Thermal cycle conditions (508C for 2 min, 958C for 10 min, 40 cycles of 928C for 15 sec and 608C for 1 
min) in 384-well plates processed in a Dual 384-Well GeneAmp PCR System 9700 (Applied Biosystems) 
with endpoint fluorescent readings performed on an ABI PRISM 7900 HT Sequence Detection System 
(Applied Biosystems). For assessment of haplotype coverage, we will use International HapMap project 
(release 19 October 2005 2006-01-24 or later), which remaps release 19 based on NCBI Build 35 
coordinates.  
Stage 3:  
SNP, gene expression, copy number analysis, gene epigenetic modifications, protein analysis, and deep 
resequencing. We will use commercially available SNP chips, microarray panels or commercial 
resequencing to assay for additional for polymorphisms in all genes and for microRNA and gene 
expression changes. Pooled samples may be used initially to investigate clinical subsets. Data from 
SNPs will be used to generate haplotype data which will be assayed for linkage and association as above. 
Aims and Hypotheses  
Specific Aim 1: Identify clinically-relevant, modifiable psychosocial factors that predict improved 
functioning over time. 
Hypothesis 1a: Higher levels of acceptance, self-compassion, and positive attributions, and better 
emotion regulation will predict improved functioning over time after accounting for the covariates 
(number of TBI exposures, combat exposure, time since deployment, physical health symptoms).  
Specific Aim 2: Identify clinically-relevant, modifiable psychosocial factors that predict membership in 
latent class trajectories of functioning. 
Hypothesis 2a: Higher levels of acceptance, self-compassion, and positive attributions, and better 
emotion regulation will predict membership in the least impaired trajectory after accounting for the 
covariates.  
Hypothesis 2b: Lower levels of acceptance and self-compassion, and greater negative attributions 
and emotion dysregulation will predict membership in the most impaired trajectory after 
accounting for the covariates.  
Specific Aim 3: Identify clinically-relevant, modifiable psychosocial predictors of transitions between 
trajectories of functioning. 
Hypothesis 3a: Higher levels of acceptance, positive attributions, self-compassion, and emotion 
regulation will predict recovery (i.e., moving to a less impaired trajectory) after accounting for the 
covariates.  
Hypothesis 3b: Lower acceptance and self-compassion and higher levels of negative attributions 
and emotion dysregulation will predict chronicity (i.e., staying on an impaired trajectory) after accounting 
for the covariates. 
Planned Analyses 
We will use both traditional (e.g., maximum-likelihood regression) and advanced approaches (e.g., latent 
growth models, parallel process models, growth mixture models, latent transition models) to analyze the 
data. For example, to test Aim 1 in a traditional manner, principal component analysis (PCA) will be used 
to create a composite functional impairment factor (see Preliminary Studies section for data in support of 
this approach). This approach will greatly reduce the overall number of tests conducted and provide us 
with a broad index of functional impairment. Variables used to create the functional impairment factor will 
include measures of functional disability (WHODAS 2.0, IPF), community reintegration (CIQ), quality of 
life (QLS), and mental health problems (e.g., CAPS, SCID, PCL-M, BDI-II). Either a clinical interview (i.e., 
CAPS, SCID) or self-report measure (PCL-M, BDI-II) will be used to assess mental health problems 
depending upon the time point (interviews for the post-deployment, baseline, and 24-month time points, 
self-reports for the 8- and 16-month time points). Change scores will then be calculated and regressed 
onto the hypothesized predictors and covariates (including prior level of functional impairment) to test 
Hypothesis 1a.  
Advanced approaches for longitudinal data analysis will be employed in the current proposal that 
generally fall under the latent growth modeling (LGM) framework (Bollen & Curran, 2006; Preacher et al., 
2008), which allows modeling of the change/growth trajectory of different variables assessed on multiple 

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occasions across time. Generally, scores on the repeated measures will be correlated due to the fact that 
they are measures of the same participants over time. The growth models take this dependency into 
account by treating the repeated measures as separate variables, and fitting a proposed trajectory shape 
to the scores across time. The initial status and growth rate of the growth trajectory are modeled as latent 
variables (i.e., growth factors). The means of the latent variables represent the overall starting point and 
the overall growth rate of the population, respectively. The variances of the growth factors capture the 
variability of individual growth trajectories. The advantages of using LGM over other approaches include 
the flexibility of placing constraints on the model while allowing growth parameters describing participants’ 
trajectories to serve as predictors of other variables as well as growth models (Bollen & Curran, 2006; 
Preacher et al., 2008).
LGM assumes that individuals come from a homogeneous population while latent class growth analysis 
(LCGA; Nagin, 1999; 2005) allows multiple subpopulations to be inferred from the data. However, LCGA 
imposes an unrealistic restriction that the random variations of the latent growth factors within classes 
are not modeled (Muthén, 2004; Palardy & Vermunt, 2010). Combining LCGM and LCGA, Growth 
Mixture Modeling (GMM) is a more general modeling framework that has the capacity of modeling both 
random variation of the latent growth factors and the unknown heterogeneous subpopulations 
simultaneously. Latent transition models (LTMs) are related to growth mixture models but study changes 
in class membership rather than growth of observed variables (Collins & Lanza, 2010). For reasons of 
compactness and ease of understanding, we present path diagrams of the main analyses below rather 
than their multi equation algebraic equivalents.
Power Analysis. Research questions are translated into testable hypothesized models and are presented 
below in path diagrams. The corresponding statistical power of the hypothesized models was estimated 
using the Monte Carlo procedure available in Mplus (Muthén & Muthén, 1998-2012). For each power 
analysis, 1000 datasets were simulated following a hypothesized model. This model included a particular 
effect size of interest for each test. The model(s) of interest were then estimated for each dataset, and 
the proportion of datasets in which the null hypothesis was rejected was taken as the (empirical) power 
of the test (L. K. Muthén & Muthén, 2002).
Hypotheses 1a. The regression models used to test hypothesis 1a (H1a) will be well-powered (>.99) to 
detect effect sizes of the magnitude we expect to 
find (i.e., medium to large) based on our 
preliminary analyses. To examine the effect of 
the change in the malleable/modifiable factors on 
the change/improvement in the long term 
functional recovery, we propose using a parallel 
growth model (Cheong, MacKinnon, & Khoo, 
2003) as presented in Figure H1ab in which 
linear growth models are specified for individual 
modifiable factors functional recovery. The 
statistical power of the target effect, the direct 
effect from the slope of the modifiable factor to 
the slope of the long term functioning (i.e., the 
bolded arrow in Figure H2ab), is evaluated. 
Given 
the 
proposed 
sample 
size
(500 
participants with 5 repeated measures), the 
empirical power for detecting a medium direct 
effect from the slope of modifiable factor to the 
slope of long term functioning is larger than .90.  
Hypotheses 2a & 2b. These two hypotheses can 
be examined by using GMM as presented in Figure H2ab. Based on the results from the preliminary 
studies, the statistical power for detecting a three-class solution is larger than .90 given the proposed 
sample size (500 participants). We also calculated statistical power for the effects of the modifiable factors 
on latent class membership. Assuming a small to medium effect size (odds-ratio = 1.82, which roughly 

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corresponds to a Cohen’s d of 0.34), the empirical power of the modifiable factors on predicting class 
membership ranged from .72 to .91.
Hypotheses 3a & 3b. These two hypotheses can 
be examined by using the sequential process 
GMM (L. K. Muthén & Muthén, 2012) as 
presented in Figure H3ab. These power analyses 
used similar growth factor parameters from 
hypotheses 2a and 2b, and assumed a small 
transition 
probability 
of 
.20. 
Measurement 
invariance of the latent class formed by the first 
three time points and that formed by the last two 
time points was assumed. The statistical power 
for detecting transitions from latent trajectory 
class 1 to latent trajectory class 2 was larger than 
.79 given the proposed sample size (500 
participants). We also calculated statistical power 
for the effects of the modifiable factors on 
predicting transitions. Statistical power for one 
modifiable 
factor predicting 
one 
or more 
transitions was larger than .72, assuming small to 
medium effect sizes (odds-ratios ranging from 1.6 
to 2.7).
Missing 
Data 
Management.
Longitudinal 
designs, by their very nature (i.e., the length of 
data collection,
the presence of multiple 
assessment points), pose challenges regarding 
missing observations, with partial participation 
and participant attrition being of particular 
concern. Based on past research by this study 
team with other populations who showed high
levels 
of 
responsibility 
in 
meeting 
study 
obligations, we anticipate that retention rates will 
be good and that missing data will be minimal. 
Nonetheless, a limited amount of missed data are 
anticipated to occur. Based on our pilot data, we 
expect the amount of missing data to be 20% or less. In addition, we will implement multiple methods to 
reduce participant attrition (e.g., reminder and follow-up calls, thank you notes, incentives; cf. Kleschinsky 
et al., 2009; Scott et al., 2006). We will also implement data screens using Mplus (Muthen & Muthen, 
2009) to characterize and elucidate patterns of missing data. When missing data do occur, full information 
maximum likelihood (FIML) estimation will be used to estimate parameters and standard errors. FIML is 
a principled approach to missing data management that is considered “state of the art” by leaders in the 
field of missing data management (e.g., Schafer & Graham, 2002). FIML is a maximum-likelihood based 
estimation procedure that directly estimates parameters and their standard errors for the full sample from 
the existing and limited data. Thus, there is no attempt to replace missing data values (e.g., Arbuckle, 
1996; Hedeker & Gibbons, 1994, 1997; Horn & McArdle, 1980; McArdle & Bell, 2000; Neale et al., 1999). 
Instead, as the term “maximum likelihood” suggests, the parameter estimates are derived in a manner 
that maximizes the likelihood that the data were drawn from the population of interest (Kline, 2005). FIML 
is the optimal procedure for handling missing data within both SEM and LGM frameworks, and, in fact, 
using estimation methods other than maximum likelihood in SEM requires explicit justification (Kline, 
2005; Hoyle, 2000). The primary advantage of using FIML over other procedures is that it produces 
relatively unbiased parameter estimates and standard errors (Schafer & Graham, 2002).

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IMPACT 
Due to a change in PI, on December 18, 2019, the treatment arm of Phase III of this study (aka: IMPACT) was 
put on hold, and ultimately closed prior to the RCT stage. Sixteen veterans were enrolled into the adaptation 
and refinement stages of IMPACT. All data collection for this arm was completed by February 2020. Primary 
activities for this arm of the study are no longer active. Data from IMPACT will be moved to the SERVE Data 
Repository with the rest of the Phase III data at the completion of the study. 
Specific Aims 
A sub-study is integrated into the scientific aims in which we will translate knowledge gained in prior 
Phases regarding modifiable factors that predict functional impairment as well as in Dr. Meyer’s broader 
treatment outcome research program to adapt an intervention specifically designed to promote functional 
recovery among the most severely functionally impaired war veterans. This study component is referred 
to as: Intervening on Modifiable Predictors using Acceptance and Commitment Therapy (IMPACT). 
IMPACT involves use of a Successive Cohort Design (SCD) to refine Acceptance and Commitment 
Therapy for promoting functional recovery (ACT-FX). ACT is an empirically-supported, acceptance and 
mindfulness-based form of behavior therapy that has been used with a range of mental and physical 
health conditions commonly experienced by war veterans. We will first pilot ACT-FX with two cohorts of 
5 participants each and refine it based on veteran and clinician feedback. We will then select 90 
participants from the longitudinal study and randomly assign them into either ACT-FX or mental health 
treatment as usual (TAU) while continuing the longitudinal assessments for long-term follow-ups. The 
over-arching goal of this research is to provide data to inform evidence-based prevention and treatment 
programs designed to assist returning Veterans with achieving optimal functioning upon reintegrating into 
civilian life. The specific aims of IMPACT are: 1) develop, refine, and evaluate the feasibility and 
acceptability of Acceptance and Commitment Therapy specifically designed to improve functioning in 
Veterans (ACT-FX); 2) evaluate if participation in ACT-FX leads to the emergence of a new trajectory 
class that is characterized by long-term functional recovery. 
Description of ACT-FX 
ACT-FX will be an adaptation of the ACT treatment model aimed at reducing functional impairment 
associated with any combination of the most common mental and physical wounds of war. ACT is a 
mindfulness-based behavioral treatment in which the primary goal is improved functioning. In ACT, clients 
are guided through a series of behavioral and experiential exercises focused on six core processes: 
mindful awareness, emotional acceptance, defusion from maladaptive thoughts, self-as-context, 
clarification of personal values, and committed action. The theory underlying ACT posits that low levels 
of psychological flexibility, which arises from lack of connection with the present moment, experiential 
avoidance, and disengagement from values-based behavior, leads to functional impairment across a 
range of mental and physical health problems. Such a transdiagnostic approach appears essential given 
high comorbidity in severely impaired Veterans. ACT is currently being disseminated across VA as an 
evidence-based treatment for depression. Moreover, several studies support the efficacy of ACT for 
several of the other most common mental and physical health conditions experienced by war veterans 
that are, in turn, associated with functional impairment and disability. As part of Aim 1, our expert 
treatment adaptation team (Drs. Meyer, Vowles, Walser, Morissette, DeBeer, and Elliott) will integrate PI 
Meyer’s ACT manual that focuses on promoting recovery in Veterans with co-occurring PTSD-AUD with 
content drawn from Co-Is Vowles’ and Walser’s ACT manuals focusing on reducing functional impairment 
associated with chronic pain and depression, each of which has empirical support. An integrated session 
overview and treatment blueprint (i.e., the values and goals worksheet) have also been developed (see 
appendices). ACT-FX will be an individual, outpatient psychotherapy, with sessions occurring 
approximately weekly for approximately 12 sessions. Each session includes: 1) mindfulness training; 2) 
review of between-session mindfulness practice and behavioral assignments; 3) new content and 
experiential exercises; and 4) development of values-consistent behavioral assignments to improve 
functioning. Daily mindfulness practice will be facilitated by audio recording in-session exercises and 
using free mindfulness websites, apps, and CDs. Veterans will document their between-session practice 
using paper-and-pencil logs. Veterans will be given the option to invite a support person (e.g. spouse or 
significant other) to sit in on a session Thus, the number of sessions will typically be 12 or 13, though it 
is possible that some veterans may require an additional session or two if, for example, a session needs 

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to be completed over the course of two weeks due to time constraints or other logistical factors. Based 
on feedback that we receive from veterans during stages 1 and 2, we may decide to modify the ACT-FX 
treatment protocol to include additional sessions (e.g., up to 16 sessions).  
Study Methods and Procedures 
Veterans enrolled in the Phase III longitudinal study who meet a few additional eligibility criteria will be 
recruited into the successive cohort treatment component of the Phase III study (Aims 2 and 3; total n = 
100). Participants who are eligible and who elect to enroll in the treatment portion of the study will 
participate in outpatient psychotherapy. This treatment is currently designed as 12 one-hour-long 
treatment sessions with ACT-FX over 3 to 4 months, though treatment length may be modified based on 
veterans’ feedback, followed by a post-treatment assessment that will be virtually identical to the 8- and 
16-month follow-up assessments in the observational study, and for those in the treatment adaptation 
phase only, a 30 minute Veterans’ Experiences Qualitative Interview conducted post-treatment. The 
Successive Cohort Design (SCD) method involves several steps:1) identifying a promising, theory-driven 
treatment approach; 2) developing or adapting initial treatment manuals, supporting materials (e.g., 
handouts), and measures; and 3) iterative revisions based on qualitative and quantitative data collected 
through providing the treatment to successive cohorts of patients. We already identified the general 
treatment approach (ACT) and reported on its utility in promoting recovery in people living with 
depression, chronic pain, and co-occurring PTSD-AUD.  
Stage 1: Adaptation. Our treatment adaptation team will continue the process of forming ACT-FX by 
integrating our existing ACT manuals focusing on promoting recovery in Veterans living with PTSD, AUD, 
depression, and chronic pain, and by integrating principles of TBI rehabilitation, resulting in a 
personalized intervention to promote broad functional recovery. Clinician and Veteran qualitative 
feedback provided from the first Veteran cohort (n = 15) will provide the treatment adaptation team with 
recommendations for improvements. We will consider changes to the sequencing of treatment sessions 
and whether to add a session(s). Also, where therapist feedback suggests, additional or refined questions 
for the semi-structured interview guide (see Appendix) will be used for subsequent Veteran interviews. 
For Veteran feedback, individual qualitative interviews will be conducted immediately following 
completion of ACT-FX. The current interview guide is a modified version of the interview guide used 
during our ACT for PTSD-AUD study. A Co-I experienced in qualitative interviewing will conduct all 
recorded phone interviews, and lead coding and analysis of the interviews. Project staff will provide live 
transcription as close to verbatim as possible as a safeguard in the event of a recording failure. Following 
each interview, staff will review and edit transcriptions using recordings to ensure completeness. Guiding 
our analytic approach, we will use an integration of matrix and grounded theory techniques. Immediately 
following interviews for each treatment cohort, the coders will independently use a summary template to 
capture key information relevant to key domains from the interview guide relevant to guiding treatment 
adaptation (e.g., Treatment Initiation, Engagement, Experiences). Summaries will then be compared in 
a matrix, and discrepancies resolved by consensus. These matrices will be reviewed and compared 
across participants in each cohort. In the second round of coding, grounded theory analysis will be used 
to identify new or emergent themes. The coders will review transcripts and repeatedly meet to discuss 
an identify novel themes emerging in the data. This will result in a secondary set of inductively derived 
codes. Once this coding schema is finalized, the coders will code transcripts independently using 
qualitative software. Discrepancies during this round of coding will be reviewed to allow for discussion 
toward consensus. The final content of thematic codes will then be reviewed with constant comparison 
among participants to identify Veteran attitudes and perspectives to inform potential revisions for further 
adapting ACT-FX. Qualitative findings be presented to the treatment adaptation team to aid in 
modifications to the ACT-FX manual.  
Stage 2: Treatment refinement. We will treat a second cohort (n = 15), followed by using the same 
methods described above in Stage 1 to guide additional modifications. Data regarding retention, client 
satisfaction, qualitative content, therapist adherence, therapist competence, and treatment outcomes will 
also be reviewed and compared with Stage 1 to verify that prior modifications had the intended benefits.  
Stage 3: Pilot RCT. We will conduct a pilot RCT of the refined ACT-FX protocol compared to mental 
health TAU with 90 Veterans (45 per group). The goals of the pilot trial are to evaluate feasibility 

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(enrollment with randomization, treatment completion) and acceptability (treatment satisfaction). We will 
also examine whether changes in the treatment targets are correlated with changes in outcomes. 
Description of TAU and randomization. Our preliminary data indicate that most SERVE participants who 
will be eligible for the pilot RCT already receive mental health TAU through VA. Among Veterans 
randomized to TAU, those already receiving TAU will continue in TAU. Those who are not already 
receiving TAU will be offered a clinical referral to address the Veterans’ most pressing mental or 
behavioral health concern (e.g., to the PTSD clinic or to primary care-behavioral health for pain 
management). Offering such referrals has been our procedure throughout SERVE. Because of the 
complexity of our target population, TAU will involve a variety of interventions. In accordance with 
recommendations for tracking TAU in RCTs, a brief (5 minute) weekly phone call will be conducted with 
TAU participants to closely track their use of VA and non-VA mental health services using our treatment 
involvement form. Our statistician Dr. Kwok will use permuted-block randomization with varying block 
sizes to determine treatment assignment. 
 
 
Treatment Discontinuation 
Treatment will be discontinued for participants who: (1) become actively suicidal or homicidal; engage in 
an uncontrolled episode of alcohol or drug use that requires immediate treatment, (2) require inpatient 
psychiatric treatment and further study treatment is determined to be clinically inappropriate, (3) resume 
or initiate a relationship in which they are being physically or sexually abused, or (4) fail to attend 3 
consecutive therapy sessions without a reason judged by their therapist to be acceptable. For intent-to-
treat purposes, all participants, including those who terminate early, are followed at mid-treatment, post-
treatment, and 3-month follow-up. 
Assessment schedule for the IMPACT SCD study 
For participants treated in Stages 1 and 2, measures collected during their baseline assessment from the 
longitudinal assessment study will also serve as their pre-treatment assessment. For participants treated 
during the Stage 3 pilot RCT, measures collected during their 8-month follow-up will form the majority of 
their pre-treatment assessment. Supplementary pre-treatment measures will also be administered during 
the initial IMPACT appointment. Waiting until participants complete their 8-month follow-up to enroll in 
the pilot RCT standardizes the follow-up duration for Veterans in the pilot RCT, and allows us to confirm 
that newly enrolled Veterans’ level of functional impairment has remained high across two time-points 
before treating them. Participants in the pilot RCT will complete a post-treatment assessment upon 
completion of treatment approximately 4 months following randomization lasting 1 hour, which will closely 
mirror the 8- and 16-month follow-ups from the Aim 1 study. These participants will complete the 16- and 
24-month follow-up assessments (i.e., 4- and 12-months post-treatment) as part of the Aim 1 study, which 
will allow us to assess the durability of treatment effects, including whether booster sessions may be 
warranted. Assessors blind to treatment condition will complete the final assessment that includes 
interviews. 
 
IMPACT Assessment Instruments. [DATA COLLECTION COMPLETED] 
Measures/ Proposed 
Indicators 
Purpose 
 
Description/Rationale 
Interpersonal Needs 
Questionnaire (INQ) a,b 
PV 
Self-report measure that assess thwarted belongingness and perceived 
burdensomeness (Van Orden et al., 2012). The INQ has demonstrated good 
convergent validity, internal consistency and concurrent validity (Van Orden et al., 
2012). 
Beck Scale for Suicide 
Ideation (BSSI) a,b 
DV, Med 
Widely-used self-report measure of intensity of thoughts and behaviors associated with 
suicide. Includes 2 additional items that ask about past suicide attempts as well as the 
level of suicidal intent during the most recent attempt. Prior research shows that 
endorsement of suicidal thoughts and behaviors can be greater on self-report 
questionnaires compared to interviews. Thus, this measure complements the suicide 
focused interviews. 
Suicide Cognitions Scale-
Brief a,b  
DV, Med 
Self-report measure of suicide-related thoughts that load onto the following subscales: 
unsolvability, unlovability, and unbearability. Brief version was recently validated across 
3 chronic pain samples (Bryan et al., 2016). 
PTSD Checklist-5 (PCL-5) a 
Med  
Self-report of symptoms of PTSD during the previous month. Demonstrates high 
sensitivity and specificity in relation to a lengthy diagnostic interview for PTSD (CAPS), 

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with which it was co-developed. Strong psychometric properties, including in numerous 
Project SERVE papers. 
Patient Health Questionnaire-
9 a 
Med, DV 
Self-report measure used for screening, diagnosing, and monitoring depression. It 
incorporates DSM-IV diagnostic criteria (Question 9 screens for suicidal ideation; 
Kroenke, Spitzer & Williams, 2001). 
Alcohol Use Disorders 
Identification Test (AUDIT) a 
Med 
Self-report measure to screen for alcohol-use disorders (Saunders, Aasland, Babor, 
Fuente, & Grant, 1993). 10-item measures adopted by VA as the gold-standard 
screening for alcohol use disorders in mental health and primary care clinics. Good 
internal consistency (α=.80 - .94) and test-retest reliability (r=.86), and strong concurrent 
validity with the MAST and CAGE screening measures (Babor et al., 2001). 
Drug Abuse Screening Test 
(DAST) a 
Med 
Self-report measure to quantify drug misuse and related psychosocial impairment. Good 
internal consistency and concurrent validity with frequency of drug use over 12-months 
(Skinner, 1982). Moderately correlated with denial and social desirability. The 
instructions will be updated to more explicitly assess for misuse of opiates that may 
have been prescribed. 
Acceptance and Action 
Questionnaire 
(AAQ-II) a,b,c 
PV 
Self-report measure assessing acceptance, experiential avoidance (attempting to alter 
the form or frequency of unwanted internal experiences), and taking action despite 
experiencing unwanted private events (Bond, et al, 2011). Strong psychometrics in 
multiple SERVE publications (Meyer et al., 2013; 2018; in press, DeBeer, Meyer, et al., 
2017).  
Brief Experiential Avoidance 
Quest. (BEAQ) a,b,c 
PV 
The BEAQ is a single-factor item that assesses the modifiable construct of experiential 
avoidance (Gamez et al., 2013). 
Self-Compassion Scale – 
Short Form (SCS-SF) a 
PV 
Self-report measure of self-compassion, consisting of a total scale score and six 
subscale scores: self-kindness, self-judgment, common humanity, isolation, 
mindfulness, and over-identified (Neff, 2003; Raes, Pommier, Neff, & Van Gucht, 2011). 
The SCS-SF is strongly correlated with the original long form (r=.97) and has the same 
6-factor structure with one higher-order factor. Internal consistency was .86 for the 
whole measure, with subscale alphas ranging from .54 to .75 (Raes et al., 2011). 
Difficulties in Emotion 
Regulation Scale (DERS-
Brief) a 
PV 
Self-report measure (Bjureber et al., 2016) of 6 domains of emotion dysregulation: 
nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, 
difficulty with impulse control, lack of emotional awareness, poor emotion coping 
strategies, and lack of emotional clarity.  
Five Facet Mindfulness 
Questionnaire a 
PV 
Self-report measure assessing multiple facets of the modifiable factor of mindfulness. 
The FFMQ has demonstrated good construct validity and internal consistency. Good 
predictive validity in research with veterans. 
World Health Organization 
Disability Assessment 
Schedule II (WHODAS 2.0) a 
 
DV 
Self-report assessment of functional disability with total score and 6 domains of 
functioning: understanding and communicating, mobility, getting along with others, life 
activities (i.e., work, education, household responsibilities), participation in society, and 
self-care (Üstün et al., 2010). Both global and specific areas of functioning are crucial in 
thoroughly understanding functional recovery, as Veterans may function well in one 
area and have difficulty in another. Moreover, some domains may be affected by 
contextual factors instead of representing functional capacity (e.g., work functioning in a 
struggling economy independent of impairment). 
Inventory of Psychosocial 
Functioning (IPF) – Brief a 
DV 
Self-report measure (Co-I Marx et al., 2009; Bovin et al., 2018) of Romantic 
Relationships with a Spouse/Partner, Family, Work, Friendships and Socializing, 
Parenting, Education, and Self-Care. The short version has a .90 correlation with the full 
80-item instrument (Co-I Marx, personal communication). Higher scores indicate greater 
functional impairment.   
Quality of Life Scale (QLS) a 
DV 
Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in areas distinct 
from health status (mate, physical well-being, relationships with others, social, 
community, and civic activities, personal development and fulfillment, recreation, and 
independence). Good internal consistency and high test-retest reliability (Burckhardt et 
al. 2003).   
Values Tracker a 
DV 
Brief self-report measure of value engagement. Good predictive validity in research with 
chronic pain samples. 
Meaning in Life Questionnaire 
a,b 
PV 
Brief self-report assesses presence and search for meaning in life (Steger et al., 2006). 
Social Connection Index a,b 
DV, Med 
Self-report measure of frequency of contact with others, number of close friends and 
relatives, level of secure attachment in relationships, frequency of problems getting 
along with friends and family members. 
Brief Loneliness Measure a,b 
DV, Med 
Brief self-report measure of loneliness for use in large survey studies. Highly correlated 
with lengthier measures such as the UCLA Loneliness Scale. 
Interpersonal Reactivity 
Index-Brief (B-IRI) a,b 
DV, Med 
Brief self-report measure of disposition to empathic responding; 2 subscales assess 
perspective taking and empathic concern. Good reliability and validity (Ingoglia et al., 
2016).  

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Multidimensional 
Psychological Flexibility 
Inventory (MPFI) a,b 
PV 
60-item self-report (Rolffs, Rogge, & Wilson, 2018) used to assess the dimensions of 
the psychological flexibility model that underlies Acceptance and Commitment Therapy 
 
Expressions of Moral Injury 
Scale (EMIS) a,b 
DV 
17-item self- report (Currier et al., 2018) to assess for problems associated with 
exposure to morally injurious events 
Credibility & Expectancy 
Questionnaire b 
PV 
Widely-used 6-item self-report measure of the credibility of the treatment approach and 
expectations for positive response to the treatment (Borkovec & Nau, 1972). Used in Dr. 
Meyer’s prior ACT studies (Hermann, Meyer et al., 2016; Meyer et al., in press). 
Client Satisfaction 
Questionnaire a 
DV 
Widely-used 8-item self-report measure of treatment satisfaction (Larsen et al., 1979). 
Used in Dr. Meyer’s prior ACT studies (Hermann, Meyer et al., 2016; Meyer et al., in 
press). 
Working Alliance Inventory d 
PV 
Widely-used, brief self-report measure of clients’ perceptions of working alliance with 
therapist on 3 dimensions: goal, task, and bond (Horvath, 1981).  
Note: a = Included in post-treatment assessment for those participating in the IMPACT treatment component; b = pre-treatment 
assessment, c administered weekly during IMPACT; d administered after session 2 and again at post-treatment only for those 
receiving ACT-FX 
 
Participants 
Veterans will be recruited (total n = 100 across 3 stages) from the ongoing longitudinal assessment study. 
Additional inclusion criteria are: 1) Veterans will have a global disability (mean item) score on the 
WHODAS 2.0 of 0.89, which is 1 SD above the mean of our large non-psychiatric sample of Veterans 
from SERVE and VA Boston during both of their last 2 assessments; and 2) Those enrolling in the pilot 
RCT must be willing to be randomized. Additional exclusion criteria are: 1) recent (1 month) or anticipated 
change in psycho-pharmacological treatment. Veterans may stay on current medications but will be 
asked to refrain from changes to the extent possible based on safety; 2) for those randomized to ACT-
FX, current participation in another form of individual or group psychotherapy; 3) logistical circumstances 
that would interfere with study completion; 4) Presence of a non-alcohol substance use disorder (SUD) 
deemed to be the primary focus of treatment. Those with a principal AUD will be eligible. Additional 
diagnoses of non-alcohol SUD are allowed, unless they are deemed the principal focus of treatment. 
Potentially eligible Veterans who score above the clinical cutoff on the DAST will be asked additional 
questions during the eligibility screening to determine whether they meet criteria for a principal non-
alcohol SUD (see phone screen); and 5) AUD/SUD of sufficient severity that residential, rather than 
outpatient, treatment is indicated based on potential safety concerns associated with withdrawal. This 
determination will be made by the PI, with consultation from the Veteran’s existing treatment providers, 
as appropriate. We will begin the treatment adaptation (Stage 1) and refinement (Stage 2) by recruiting 
transfer participants who have already been assessed over time immediately following their baseline 
assessment. The pilot RCT will include both transfer and newly enrolled Veterans. 
Recruitment and Retention 
We expect that our total sample of 500 eligible Veterans will include 360 experiencing sufficient functional 
impairment to be eligible to participate in IMPACT (210 transfers and 150 new Veterans), of whom we 
will attempt to enroll 100. This plan is highly feasible based on PI Meyer’s prior ACT for PTSD-AUD study 
completed at CTVHCS. In addition to being compensated for their time completing the assessments for 
the longitudinal assessment study as described above, IMPACT participants will be compensated as 
follows: Those in the adaptation phase will be paid $40 for completing the post-treatment assessment 
$10 for completing weekly assessments at each study visit, and $40 for completing the post-treatment 
qualitative interview ($200 total). Those in the pilot RCT will be paid $25 for completing supplemental 
pre-treatment measures, $40 for completing the post-treatment assessment, and $10 for completing 
weekly assessments at each study visit ($175 total). During the treatment adaptation and refinement 
stages, the weekly assessment will involve completing the AAQ-II and BEAQ and documenting 
completion of between-session assignments as part of ACT-FX. During the pilot RCT, those assigned to 
the ACT-FX group will be compensated $10 weekly for completing the AAQ-II and BEAQ and 
documenting between-session assignments; those assigned to TAU will be compensated for completing 
the AAQ-II and BEAQ and documenting ongoing treatment involvement (by phone).  
Training of study therapists 
Doctoral-level therapists will provide the treatment under Dr. Meyer’s supervision. Dr. Meyer has served 
as both a national training consultant and as a regional trainer in VA’s national training program in ACT 

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as an evidence-based treatment for depression. He will train and supervise the study therapists following 
the process used in this national roll-out training program. This process includes an in-person training 
workshop, weekly case consultation, and ratings on ACT core competencies on all sessions for the first 
case. Treatment sessions will be video or audio-recorded. Following the initial training case, 20% of 
subsequent sessions will be rated for competency and adherence. Weekly case consultation will continue 
throughout the study. 
Aims and Hypotheses 
Specific Aim 1: Develop, refine, and evaluate the feasibility and acceptability of a transdiagnostic, 
personalized ACT-based behavioral therapy (ACT-FX) specifically designed to improve functioning in 
Veterans. 
Hypothesis 1: ACT-FX will be feasible and acceptable to Veterans with complex mental and 
physical wounds of war. 
Specific Aim 2: Evaluate if participation in ACT-FX leads to the emergence of a new trajectory class 
among Veterans in Project SERVE that is characterized by long-term functional recovery. 
Hypothesis 2: ACT-FX treatment will predict membership in a new trajectory class characterized 
by functional recovery compared to Veterans receiving TAU who will continue to exhibit flat or 
worsening trajectories. 
Planned Analyses 
Aim 1: All randomized participants will be included in these analyses. ACT-FX will be considered 
feasible and acceptable if: 1) we are able to recruit, enroll, [and randomize] the target sample within the 
specified timeframe; 2) given our complex sample, we have treatment completion rates > 60% based 
on completing > 9 treatment sessions. Our treatment completion rate was 67% in our ACT for PTSD-
AUD pilot trial, which is high for this population, despite our stringent completion criterion; and 3) client 
satisfaction ratings are equivalent or better (maximum of d = .2 lower) than those for Veterans 
randomized to TAU. 
Aim 2: We will test whether ACT-FX is associated with the emergence of a functional recovery 
trajectory by re-running the GMM analyses described above (H1b), focusing on treatment involvement 
as a predictor. Our preliminary analyses indicate that we have previously detected latent class 
memberships comprised of similar numbers of participants even without an intervention. Thus, we 
should be able to detect emergence of a recovery class should ACT-FX yield effects similar to our pilot 
work.