One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
Phase: NA
Conditions: Mild Traumatic Brain Injury, Distress-based Psychopathology, Chronic Pain
Sponsor: VA Office of Research and Development

Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals 
  
Protocol Number:    H-37470 
Status:                        Approved 
Initial Submit Date:  6/23/2016 
Approval Period:       10/19/2018 - 10/18/2019
  
Section Aa:  Title & PI 
A1.  Main Title 
    ONE-DAY LIFE SKILLS WORKSHOP FOR VETERANS WITH MILD TBI, PAIN, AND 
PSYCHOPATHOLOGY 
A2.  Principal Investigator 
  
    Name:   
LILIAN DINDO 
Phone:   713-440-4637 
    Id:   
187894 
Fax:   
    Department:  PSYCHIATRY & BEHAVIORAL SCIENCES Email:    dindo@bcm.tmc.edu 
    Center:   
 
Mail 
Stn:   
BCM350 
A3.  Administrative Contact 
  
    Name: 
MERLYN RODRIGUES 
Phone:   713-440-4424 
    Id:   
196219  
Fax:   
    
Email:    merlynr@bcm.tmc.edu 
    
Mail 
Stn:   
BCM350 
A3a.  Financial Conflict of Interest 
Does any member of study personnel (Investigator (including investigator’s spouse and/or 
dependent children)) that are involved in the design, conduct, or reporting of the research have 
a Significant Financial Interest (SFI) that would reasonably appear to be affected by the 
research for which funding is sought and/or associated with an entity/business that would 
reasonably appear to be affected by the research? 
        No
  
Section Ab:  General Information     
A4.  Co-Investigators 
  
    Name:   
LINDSEY MARTIN  
Phone:   713-794-4947 
Id:   
179624  
Fax:   
713-748-7359 
 
Department:   MEDICINE: HEALTH SRVCS 
RESEARCH  
Email:    lindseym@bcm.tmc.edu
 
Center:    
 
Mail 
Stn:    
BCM288  
  

    Name:   
RICARDO JORGE  
Phone:   713-797-7588 
Id:   
181536  
Fax:   
Department:   PSYCHIATRY & BEHAVIORAL SCIENCES  Email:    jorge@bcm.tmc.edu 
 
Center:    
 
Mail 
Stn:    
BCM350  
  
    Name:   
REGINA MCGLINCHEY  
Phone:   857-364-2658 
Id:   
Non-Baylor  
Fax:   
857-364-4544 
Institution:  Boston VA Health Care  
Email:    Regina.McGlinchey@va.gov
Address:    857-364-2658  
A5.  Funding Source: 
    Organization:  VA CENTRAL OFFICE, RR&D 
A6a.  Institution(s) where work will be performed: 
    Michael E. DeBakey Veterans Affairs Medical Center 
A6b.  Research conducted outside of the United States: 
    
Country:   
Facility/Institution:   
Contact/Investigator:   
Phone Number:   
If documentation of assurances has not been sent to the Office of Research, please explain: 
A7.  Research Category: 
    
A8. Therapeutic Intent 
Does this trial have therapeutic intent? 
    No
  
Section B:  Exempt Request 
B.  Exempt From IRB Review 
    Not Applicable
  
Section C:  Background Information 
    
Traumatic brain injury (TBI) is the signature wound of veterans returning from Operations 
Iraqi Freedom and Enduring Freedom (OIF/OEF). Among those with a mild TBI (mTBI) 
diagnosis, the majority also suffer from stress-based psychopathology including depression, 
post-traumatic stress disorder, and other anxiety disorders, as well as persistent pain. Poor 
management of multiple conditions results in increased morbidity and mortality, increased 
risk for suicide and significantly decreased quality of life. Importantly, the association 
between seeking mental health care and stigma among veterans is frequent. Veterans are 
often unwilling to seek mental health services due to conerns that receiving such care would 

negatively impact their careers and the belief that they should be able to overcome 
psychological difficultires on their won. Furthermore, availability of speciality services is 
limited for those veterans living in rural settings. Thus the challenge for treatment providers 
is to provide a unified, efficient, accessible, and acceptable intervention for Veterans with 
these interdependent systemic comorbid concerns. 
Acceptance and Commitment Therapy is a trans-diagnostic behavioral intervention aimed at 
helping individuals develop greater psychological flexibility in facing life's challenges. Its 
unified model of behavior change has shown promise in treating depression, anxiety, and 
chronic medical conditions. Importantly, ACT has been effectively implemented in various 
treatment-delivery formats, including 1-day workshops. This flexibility in delivery format 
allows focus to be placed on how best to package and deliver the intervention to meet the 
needs of this Veteran patient population, to ensure treatment adherence, and also to increase 
chances of dissemination into clinical settings. Providing a 1-day ACT "workshop" for 
veterans with mTBI, pain, and mental health problems will allow unitary comprehensive 
care for the range of emotional, physical, and cognitive symptoms experienced by these 
veterans. Presenting the treatment as a "workshop" rather than "therapy" will also be better 
suited for the veterans who may not be explicitly seeking specialized mental health care. 
Finally, a 1 day workshop ensures treatment adherence and completion, the lack of which is 
often the greatest obstacle to effective delivery of mental health services.  
  
Section D:  Purpose and Objectives 
    
The aims of this study are to 1) develop a 1-day (6 hour) "ACT on Life" workshop tailored 
specifically for veterans with mild traumatic brain injury (mTBI), stress-based 
psychopathology, and pain; expert input from a multi-disciplinary team of a clinical 
psychologist, neuropsychiatrist, cognitive psychologist, and anthropologist will be utilized to 
produce the therapist intervention and patient manual; 2) enroll 10 veterans with mTBI, 
stress-based psychopathology, and pain in the "ACT on Life" workshop in order to obtain 
qualitative and quantitative feedback from veterans about the intervention; and utilize 
Veteran feedback to refine the treatment procedures and manuals; and 3) pilot the revised 
"ACT on Life" workshop in a new sample of 30 veterans with mTBI, stress-based 
psychopathology, and pain in order to examine the preliminary efficacy of the intervention 
on quality of life and functioning, stress-based symptoms of psychopathology, and pain. 
  
Section E:  Protocol Risks/Subjects 
E1.  Risk Category 
    Category 1: Research not involving greater than minimum risk. 
E2.  Subjects 
Gender: 
    Both 
Age: 
    Adult (18-64 yrs)

Ethnicity: 
    All Ethnicities
Primary Language: 
    English
Groups to be recruited will include: 
    Patients 
Which if any of the following vulnerable populations will be recruited as subjects? 
    Employees or lab personnel 
Vulnerable populations require special protections.  How will you obtain informed consent, 
protect subject confidentiality, and prevent undue coercion? 
    
As part of our recruitment efforts, we may include interested MEDVAMC-employed 
Veterans and/or Veterans who are students. We will obtain informed consent from each 
eligible Veteran student and/or employee and give ample time to ask questions and decide 
whether he/she wants to take part in study. Veterans will be reminded that participation in 
this study is voluntary. We will further assure employee Veterans that their employment and 
benefits will NOT be affected if they choose to participate or not.  
E3.  Pregnant woman/fetus 
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the 
research? 
    No
E4.  Neonates 
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart 
B) be enrolled in the research? 
    No
E5.  Children 
Will children be enrolled in the research? 
    No
  
Section F:  Design/Procedure 
F1.  Design 
Select one category that most adequately describes your research: 
    c) Pilot
Discuss the research design including but not limited to such issues as: probability of group 
assignment, potential for subject to be randomized to placebo group, use of control subjects, 
etc. 
    
Advertising/Recruitment: Potentially eligible Veterans will be identified through the 
following means: 1)Posters will be placed in MEDVAMC, and will contain the PI's 
telephone number for either a phone or in person screening. 2) Brochures will also be 
handed out by faculty in clinics at MEDVAMC. These brochures will also have the PI's 
telephone number for a phone or in person screening. 3) Specific recruitment will be 

targeted in the TBI clinic at MEDVAMC via posters, brochures, and faculty/staff and will 
contain information for screening. 4) Recruitment materials (flyers, brochures etc.) will be 
provided to local Veterans' community organizations and college campuses for distribution. 
5) Recruitment flyers will be posted on social media pages of different veteran organizations 
and other community social media pages. 
Screening: Once a patient has expressed interest in the study, he/she will undergo a brief in-
person or phone screening prior to the first consent. During the screening process, the 
Veteran will be asked questions related to his age, OEF/OIF/OND status, and whether he/she 
has a history of mild TBI, any chronic pain difficulties, and a current level of distress (see 
attachment for screening). The research team member may answer any questions and 
describe the study to the participant as needed. If participant meets screening eligibility, 
he/she will be told briefly about the study and will be told that he/she can review the consent 
in detail during an in-person meeting.  
Initial Assessment: At the beginning of the initial assessment, a team member will go over 
the consent and answer any questions the patient has regarding the study. If interested, the 
patient will sign the consent forms and study procedures will begin. The Veteran will 
undergo a clinical interview and complete self-report measures. This clinical interview will 
be used to confirm the presence of mTBI, significant distress, and pain. Those who are 
eligible will be invited to the treatment phase. 
Pilot 1: The first 10 Veterans will be invited to participate in a one-day workshop focused on 
teaching coping skills. These 10 Veterans will also complete 2, 6, 12 week follow-up 
assessments and will provide feedback about the workshops. 
Pilot 2. For the second pilot, all following Veterans who are eligible will be randomized at a 
2:1 ratio to either the workshop group or treatment as usual group (TAU). These Veterans 
will also complete 2, 6, 12 week follow-up assessments. Veterans who were assigned to the 
workshop will also provide feedback about the workshops. 
All participants will be given the opportunity to ask questions at any time throughout the 
study and will be reminded that participation is completely voluntary. They will also be told 
that this study will not affect their hospital care in any way.  
Inclusion Criteria: 
    
1) 18-60 years of age, 2) Clinically significant psychological distress as operationalized by a 
diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD, 3) Life time 
history of Mild TBI; 4) Presence in medical chart of chronic pain including headache, 
musculoskeletal pain or neuropathic pain; 5) Stable dose of psychiatric medications for the 
past 4 weeks. 
Exclusion Criteria: 
    
1) History of primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder); 2) a 
diagnosis of substance dependence in the year prior to enrollment in the study; 3) Active 
suicidal ideation; 4) Homicidal ideation. 
F2.  Procedure 

    
Participants who are interested in the study will complete a brief (5 minute) screening (see 
attachment) either in-person or over the phone. This takes place even prior to consent. If 
screening criteria are met, the patient will be invited to the clinic for an in-person 
assessment/interview phase. At the beginning of the in-person visit, the consent document 
will be reviewed with the patient and all questions pertaining to the study will be answered. 
If the patient is interested in the study, he/she will sign the consent and complete an 
assessment. The initial assessment will take approximately 3 hours to complete.  
The following measures will then be completed:  
Clinical Interviews. The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-
IV) will be used to assess major DSM-IV Axis I diagnoses, including mood disorders, 
anxiety disorders, and other psychiatric disorders; the Clinician Administered PTSD Scale 
(CAPS), the gold standard in PTSD assessment, will be used to make a current, post-
deployment, and/or lifetime diagnosis of PTSD.The Boston Assessment of TBI-Lifetime 
(BAT-L) will be used to determine history of blast exposure and subsequent blast-related 
TBI. 
At baseline, pattern separation task will also be completed where participants will be shown 
pictures of everyday objects and asked to indicate if the picture is old, new, or similar which 
provides an assessment of memory performance. The delay between first presentation and 
repeated presentation of a lure or repeated image will vary. Images remained on the screen 
for 2 seconds, followed by a 500 millisec inter-stimulus interval. Participants will view a 
total of 324 images. 
Self-Report Measures. Demographic questionnaire - The Depression Anxiety and Stress 
Scale (DASS-21) -The PTSD CheckList ¿ Civilian Version (PCL) - The McGill Pain 
Questionnaire - The Brief Pain Inventory (BPI) - The World Health Organization Disability 
Assessment Schedule II (WHODAS-II) - The World Health Organization-Quality of Life 
(WHO-QOL) - The Military to Civilian Questionnaire (M2C-Q) - Medication usage and 
therapy involvement - Brief Religious Coping Scale (R-COPE) - Chronic Pain Acceptance 
Questionnaire (CPAQ) - Cognitive Fusion Questionnaire (CFQ-13) - Acceptance and Action 
Questionnaire (AAQ-II) - Experiences Questionnaire (EQ) - Chronic Pain Values Inventory 
(CPVI) - Pain Intensity - Committed Action Questionnaire (CAQ) - Trauma Recovery Scale, 
Part III (TRS) - Impact of Events Scale (IES) - Social Network Index (SNI) - UCLA 
Loneliness Scale - Moral Injury Scale (MIS) 
Treatment: Pilot 1. If the assessment confirms the presence of psychopathology and mTBI, 
the patient will be invited to attend a workshop called ACT on Life based on Acceptance 
and Commitment Training (ACT). 10 Veterans will complete this ACT on Life Workshop.  
Workshop: Patients in the ACT condition will attend a 1-day group workshop. Each ACT 
group will be held at MEDVAMC, include 5-8 patients, and will last 6 hours. The ACT 
group will be conducted by the PI and a doctoral level psychologist or advanced doctoral 
student. The intervention includes: 1) Behavioral Change Training (2 hours) involving a) 
teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring 

and setting life goals and goals related to mental and physical health, and c) promoting 
effective and committed actions to achieve these goals despite the urge to do otherwise; 2) 
Mindfulness and Acceptance Training (2 hours) emphasizing new ways of managing 
troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and 
develop cognitive distance from unhelpful thoughts such as ¿I can¿t take this pain anymore¿ 
or ¿I am not good enough¿) and learning how to face willingly experiences that cannot be 
changed; and 3) Education about PTSD, TBI, and chronic pain conditions (2 hours).  
A total of 10 Veterans will complete the ACT on life Workshop in Pilot 1. These 10 
Veterans will provide feedback about the workshop at 2-weeks and 12-week follow-up 
visits. The feedback will be used to make modifications to the ACT on Life workshop so 
that it is more Veteran-centric. All following eligible Veterans will be part of Pilot 2.  
Pilot 2. If the assessment confirms the presence of psychopathology and mTBI, the patient 
will be randomized into either the ACT workshop or treatment as usual condition (TAU). 
The ACT workshop will be similar to that described above but will incorporate feedback 
from Veteran who completed Pilot 1 and any additional edits from the expert team. 
An individualized phone booster session will take place 3-4 weeks following the workshop. 
During the phone call, we will ask participants if they are using the strategies taught, 
troubleshoot difficulties, and review some of the main concepts taught in the workshop. The 
booster session interview guide is attached. 
Follow-up: At 2 weeks, 6 weeks, and 12 weeks, following the workshop, patients in both the 
ACT and Treatment as Usual (TAU) groups will complete assessments over the phone or in-
person.  
The follow-up assessments are expected to take 1 hour and are attached.  
At the 2-week follow-up, the following self- report measures will be completed: Chronic 
Pain Acceptance Questionnaire (CPAQ) - Chronic Pain Values Inventory (CPVI) - 
Acceptance and Action Questionnaire (AAQ-II) - Experiences Questionnaire (EQ) - Group 
Climate Questionnaire (GCQ) - Client Satisfaction Questionnaire (CSQ) - Feedback about 
workshop - Pain Intensity Scale - Therapy and medication usage - Committed Action 
Questionnaire (CAQ) - Cognitive Fusion Questionnaire (CFQ-13) - Brief Religious Coping 
Scale (R-COPE) - Trauma Recovery Scale, Part III (TRS) - Impact of Events Scale (IES) - 
Social Network Index (SNI) - UCLA Loneliness Scale .  
Feedback about the workshop will also be obtained from the Veterans.  
At the 6-week follow-up, the following self-report measures will be completed: Chronic 
Pain Acceptance Questionnaire (CPAQ) - Chronic Pain Values Inventory (CPVI) - 
Acceptance and Action Questionnaire (AAQ-II) - Experiences Questionnaire (EQ) - Pain 
Intensity Scale - Therapy and medication usage -Committed Action Questionnaire (CAQ) - 
Cognitive Fusion Questionnaire (CFQ-13) - Brief Religious Coping Scale (R-COPE) - 
Trauma Recovery Scale, Part III (TRS) - Impact of Events Scale (IES) - Social Network 

Index (SNI) - UCLA Loneliness Scale  
At the 12-week follow-up, the following will be completed: Clinical Interviews. The 
Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-IV) - the Clinician 
Administered PTSD Scale (CAPS). Feedback about the workshop will also be obtained from 
the Veterans.  
The pattern separation task will again be repeated at the 12 week follow-up.  
Self-Report Measures. The Depression Anxiety and Stress Scale (DASS-21) -The PTSD 
CheckList ¿ Civilian Version (PCL) - The McGill Pain Questionnaire - The Brief Pain 
Inventory (BPI) - The World Health Organization Disability Assessment Schedule II 
(WHODAS-II) - The World Health Organization-Quality of Life (WHO-QOL) - The 
Military to Civilian Questionnaire (M2C-Q) - Medication usage and therapy involvement - 
Brief Religious Coping Scale (R-COPE) - Chronic Pain Acceptance Questionnaire (CPAQ) - 
Cognitive Fusion Questionnaire (CFQ-13) - Acceptance and Action Questionnaire (AAQ-II) 
- Experiences Questionnaire (EQ) - Chronic Pain Values Inventory (CPVI) - Pain Intensity - 
Committed Action Questionnaire (CAQ) - Trauma Recovery Scale, Part III (TRS) - Impact 
of Events Scale (IES) - Social Network Index (SNI) - UCLA Loneliness Scale. 
Assessments and the treatment intervention will be audio-recorded. The audio recordings 
will be used for 1) assessment of treatment integrity (i.e., to ensure that therapists are 
following study procedures) and 2) for inter-rater reliability of the clinical interviews.  
  
Section G:  Sample Size/Data Analysis 
G1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
    Local: 80              Worldwide: 80
Please indicate why you chose the sample size proposed: 
    
80 Veterans with mTBI, stress-based psychopathology, and pain will be enrolled in this 
research study.  
Initially, ten Veterans will be enrolled in the ¿ACT on Life¿ workshop and the PI will obtain 
their feedback on the intervention so that it may be adapted and refined to meet the unique 
needs of OIF/OEF/OND Veterans with these comorbid conditions; all remaining eligible and 
interested Veterans will be randomized at a ratio of 2:1 to the refined ¿ACT on Life¿ 
workshop or TAU in order to obtain preliminary data on the efficacy of this workshop on 
quality of life, functioning, distress, and pain interference.  
Recruitment feasibility of approximately 4 subjects per month over the study period and 
budgetary restrictions were the main considerations for sample size determination. This 
study has adequate (i.e., 80%) power to detect at least Cohen¿s ds > 1 (i.e., large effect sizes) 
at a 5% significance level. Previous research has established that, when compared with 
TAU, ACT interventions have clinically relevant moderate effect sizes (i.e., smaller than the 

effects this study is powered to detect). Thus, this study is underpowered to show clinically 
meaningful efficacy of ACT when compared to TAU. However, this is not an issue given the 
pilot nature of this RCT. This pilot RCT will allow to determine feasibility of a larger well-
powered RCT. For instance, this pilot RCT will allow the PI to determine if recruitment, 
participants¿ randomization willingness and follow-up retention rates estimates are as 
anticipated and can be applied in the planning of a larger RCT in this population for which 
ACT will be developed for the first time in Aims 1 and 2 of this proposal.  
G2.  Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan 
(e.g. comparison of means, comparison of proportions, regressions, analysis of variance). 
Which is the PRIMARY comparison/analysis? How will the analyses proposed relate to the 
primary purposes of your study? 
    
Frequency data will be gathered on the number of veterans screened for participation and the 
number willing to participate in the study, the number of Veterans who are not eligible to 
participate and the reasons for lack of eligibility will also be tracked to identify the 
proportion of Veterans who may have difficulties and may be in need of an intervention.  
We hypothesize that at 3-month follow-up, Veterans randomized to ¿ACT on Life¿ will 
experience greater improvements in Quality of life (WHO-QOL), functioning (WHODAS-
II), distress (DASS-21), and pain-interference (BPI) compared to the TAU group. Data 
collected at baseline, 2-, 6- and 12-weeks follow-up for each of the aforementioned 
outcomes of interest will be compared between the groups using a generalized linear mixed 
model (GLMM) that can accommodate repeated measures over time and missing data due to 
loss to follow-up or missed interviews. Based on our previous experience with this 
population and the high retention rates for 1-day ACT trials, we anticipate a 10% loss-to-
follow-up rate at the 12-week evaluation. The GLMM model for each outcome will include 
group, week (continuous outcome) and group by week interaction as the predictors. The 
influence of key demographic variables (e.g., age, rural/urban, gender) on the outcomes of 
interest will also be explored by adding these variables as predictors to the linear models.  
Co-I Martin will train the research assistant in qualitative data analysis techniques. Dr. 
Martin and the research assistant will complete an initial reading of the transcripts and 
develop a codebook containing inductive codes (i.e. codes that emerge out of participants¿ 
experiences) and deductive (i.e. a priori) codes based on the literature and ACT domains 
(e.g. acceptance, values, and committed action). Analysts will code the data using the 
Atlas.ti (v.7) software. Using a process of negotiated consensus, analysts will meet regularly 
to compare coding results, resolve discrepancies, refine the codebook and resulting themes. 
To optimize the validity of our findings, Dr. Dindo will independently review the results and 
meet regularly with analysts to provide expert feedback on the codebook development and 
final themes. Qualitative feedback from the Veterans will enable the PI to work with Co-Is 
Jorge, McGlinchey, and Martin to refine the ACT intervention to be more Veteran-centric 
(Aim 2.b).  
  
Section H:  Potential Risks/Discomforts 

H1.  Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or 
other) and assess the likelihood and seriousness of such risks: 
    
Risks associated with assessment phase: Clinical interviews and self-report assessments 
contain questions regarding sensitive personal information. As a result, participants may be 
embarrassed or distressed when discussing current or past difficult life events. Patients may 
also experience fatigue from completing interviews/questionnaires and physical strain of 
making the movements involved in pressing the buttons or moving a mouse for the pattern 
separation task. 
Risks associated with the treatment phase: Patients may experience fatigue from a day-long 
intervention. Patients may feel uncomfortable being in a group with other patients. Patients 
may feel distress at addressing their difficulties. 
To minimize risks associated with completing questionnaires, patients will be told that they 
do not have to answer any question that they do not want to. They will also be reminded of 
their right to discontinue participation at any time during the study.  
To physical strain for the pattern separation task will be minimal and equal to or less than 
that associated with a brief period of playing an average, commercial video game. 
In order to minimize fatigue associated with a day-long group treatment intervention, several 
breaks will be given throughout the day and food/drink will be provided. In order to 
minimize discomfort with being in a group treatment, patients will be reminded of the 
importance of confidentiality. Patients will also be reminded that they can disclose as little 
or as much information as they find comfortable. All participants will be encouraged to use 
only first names in the group for confidentiality purposes. Finally, patients will be able to 
discontinue the treatment at any time. 
H2.  Data and safety monitoring plan 
     Do the study activities impart greater than minimal risk to subjects? 
        No
H3.  Coordination of information among sites for multi-site research 
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site 
research? 
        No or Not Applicable 
Is BCM the COORDINATING CENTER for this multi-site research? 
        No or Not Applicable 
  
Section I:  Potential Benefits 
Describe potential benefit(s) to be gained by the individual subject as a result of participating in 
the planned work. 

    
We do not know if subjects will benefit from being in this study. However, we hope that 
some patients will experience some relief from psychological distress symptoms or 
improved quality of life following the study protocol. 
Describe potential benefit(s) to society of the planned work. 
    
TBI is the most common injury reported among veterans of OIF/OEF. Mild TBI and its 
associated conditions hamper the well being of returned veterans. Effective treatments are 
needed to improve the quality of life and functioning of these veterans. Results from a 
number of studies shows the effects of a 1-day ACT workshop to be positive on the 
functioning and emotions of patients with a variety of mood disorders and chronic cognitive 
impairments. We hope that this intervention, which is relatively brief and thus easier to 
access than weekly treatment, will improve stress-based psychopathology and general 
functioning in patients with mTBI and pain. This study is one of the first to develop a 1-day 
ACT treatment specifically for mTBI patients. If it shows positive effects, it could be 
applied more efficiently and cost-effectively than weekly psychotherapy to a larger group of 
patients. 
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio. 
    
This protocol has a favorable risk-benefit ratio because patients will be taught new skills to 
manage distress and pain and will be given the opportunity to talk about their general 
functioning with a trained member of the study team. The potential risks of the study are 
minimal. 
  
Section J:  Consent Procedures 
J1.  Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization? 
    Yes
Please describe the portion of the research for which a waiver is required. (Example: chart 
review to determine subject eligibility)  
    
A waiver of consent is required to review the records to determine their eligibility for the 
study. The purpose of collecting information covered under 38 U.S.C. 7332 is to conduct 
scientific research and no personnel involved in this study will identify, directly or 
indirectly, any individual patient or subject in any report of such research. 
Explain why the research and the use or disclosure of protected health information involves no 
more than minimal risk (including privacy risks) to the individuals. 
    
The probability of harm does not exceed what one might expect from daily life or from 
similar situations. Only the research team will be accessing the health records and nothing 
will be printed, removed, altered, or extracted from the patient's files. 
Explain why the waiver will not adversely affect the privacy rights and the welfare of the 
research subjects. 
    
The PHI access will only be used to determine patient's eligibility for the study and will not 
be shared outside of the research team. Patient's records will not be altered in any way, 
therefore there is no change to their healthcare welfare. 

Explain why the research could not practicably be conducted without the waiver and could not 
practicably be conducted without access to and use of the protected health information. 
    
It is a necessary tool to ensure that patient's qualify for the study. Oftentimes, patient's 
approach the research team and are interested about the study but do not qualify. In order to 
encourage optimal participation, it is appropriate for the research team to access and use 
patient's protected health information to ensure the study is appropriate for the patient.  
Describe how an adequate plan exists in order to protect identifiers from improper use and 
disclosure. 
    The PHI access will only be used to determine eligibility for the study and will not be shared 
outside of the research team. 
Describe how an adequate plan exists in order to destroy identifiers at the earliest opportunity 
consistent with conduct of the research, unless there is a health or research justification for 
retaining the identifiers or such retention is otherwise required by law. 
    All data will be destroyed, including identifiers, 6 years after the conclusion of the study but 
may be retained longer if federal regulations mandate it. 
Describe how adequate written assurances exist in order to ensure that the PHI will not be 
reused or disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or disclosure 
of the PHI would be permitted under the Privacy Rule. 
    The PHI access will only be used to determine eligibility for the study and will not be shared 
outside of the research team. 
Information from health records such as diagnoses, progress notes, medications, lab or 
radiology findings, etc. 
    Yes
Specific information concerning alcohol abuse: 
    Yes
Specific information concerning drug abuse: 
    Yes
Specific information concerning sickle cell anemia: 
    No
Specific information concerning HIV: 
    No
Specific information concerning psychiatry notes: 
    Yes
Demographic information (name, D.O.B., age, gender, race, etc.): 
    Yes
Full Social Security #: 
    Yes
Partial Social Security # (Last four digits): 

    Yes
Billing or financial records: 
    No
Photographs, videotapes, and/or audiotapes of you: 
    Yes
Other: 
    No
Will additional pertinent information be provided to subjects after participation? 
    No
If No, explain why providing subjects additional pertinent information after participation is not 
appropriate. 
    Since waiver is to screen patients for eligibility into a study, there would not be information 
to disclose to subjects.  
  
J1a.  Waiver of requirement for written documentation of Consent 
Will this research require a waiver of the requirement for written documentation of informed 
consent? 
    No
J2.  Consent Procedures 
Who will recruit subjects for this study? 
    PI 
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period 
between informing the prospective participant and obtaining consent, steps taken to minimize 
the possibility of coercion or undue influence and consent procedures in detail. 
    
The research population will be identified through various methods such as advertisements, 
posters, flyers, and brochures. Physicians and staff at the VAMC can provide Veterans with 
a brochure and/or our contact information and the Veteran can contact the PI and study staff 
if interested in participating. Recruitment materials (flyers, brochures etc.) will also be 
provided to local Veterans' community organizations and college campuses for distribution. 
In order to reach veterans that don't necessarily visit the VA, we will also post recruitment 
flyers on social media pages of different veteran organizations and other community social 
media pages. 
Once a patient has expressed interest in the study, he/she may undergo an in person or phone 
screening prior to the first consent. During the screening call, the research team member 
may answer any questions and describe the study to the participant as needed. If participant 
continues to meet eligibility after screening, he/she will be told briefly about the study and 
will be told that he/she can review the consent in detail during an in-person meeting.  
Interested individuals will have an appointment scheduled during which a member of the 

research study staff (research assistant, PI and Co-Is) will obtain consent from research 
subjects which includes describing the study and review of the informed consent form, and 
explaining the risks and benefits of participation. Study staff will explain to the participants 
that participation in the study is voluntary and will in no way affect his/her treatment and 
that they can withdraw from the study at any time without explaining why. Veterans 
interested in participating in the study will sign an IRB approved consent to participate in 
this sponsored research. 
Are foreign language consent forms required for this protocol? 
    No
J3.  Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations where the subjects would 
normally have an expectation of privacy? 
    No
J4.  Children 
Will children be enrolled in the research? 
    No
J5.  Neonates 
Will non-viable neonates or neonates of uncertain viability be involved in research? 
    No
J6.  Consent Capacity - Adults who lack capacity 
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research? 
    No
J7.  Prisoners 
Will Prisoners be enrolled in the research? 
    No
  
Section K:  Research Related Health Information and Confidentiality 
Will research data include identifiable subject information? 
    Yes
Information from health records such as diagnoses, progress notes, medications, lab or 
radiology findings, etc. 
    Yes
Specific information concerning alcohol abuse: 
    Yes
Specific information concerning drug abuse: 
    Yes
Specific information concerning sickle cell anemia: 
    No

Specific information concerning HIV: 
    No
Specific information concerning psychiatry notes: 
    Yes
Demographic information (name, D.O.B., age, gender, race, etc.): 
    Yes
Full Social Security #: 
    Yes
Partial Social Security # (Last four digits): 
    Yes
Billing or financial records: 
    No
Photographs, videotapes, and/or audiotapes of you: 
    Yes
Other: 
    No
At what institution will the physical research data be kept? 
    
The research team will be working out of the Health Services Research & Development 
(HSR&D) and Michael E. DeBakey VA Medical Center (MEDVAMC). Data will be stored 
on VA servers and in locked filing cabinets in a locked room located at Health Services 
Research & Development Center of Excellence (HSR& D CoE) Nabisco building - 2450 
Holcombe Blvd., Suite, 01Y Houston, Texas 77033, room 175. 
The purpose of collecting information covered under 38 U.S.C. 7332 is to conduct scientific 
research and no personnel involved in this study will identify, directly or indirectly, any 
individual patient or subject in any report of such research. 
How will such physical research data be secured? 
    
It will be secured at HSR&D at Michael E. Debakey VA Medical Center, Building 152, 
room 175. The data will be in a locked cabinet behind a locked door - (double locked 
environment); HSR&D is a controlled access environment and only research staff has 
privilege to. Research records, including identifiers will be destroyed 6 years after cutoff (at 
the end of the fiscal year) after completion of the research project, but may be retained 
longer if required by other federal regulations or sponsor archive requirement. 
All sessions will be audio recorded by the Research Clinician using a Olympus DS-3500. 
The recorders are data encrypted and require a password to be heard. The recordings will be 
uploaded to the VA database and stored on the M drive. Once the recordings are 
downloaded to the M drive they will be deleted from the audio recorder. The database will 
be stored on a secure VA server located at the HSR&D facility which is located behind a 
firewall. These servers are password-protected and are behind a locked door with access 
limited to IT personnel. During non-business hours, the server is behind 3 locked doors. The 

Center has restricted access and is not a patient-care facility. The servers are backed up 
automatically each night. The VA server is located under the server drive (M-HSRD, L-
other). 
At what institution will the electronic research data be kept? 
    
Electronic data will be stored on the M drive (Nabisco) under the Projects folder - 
M:\Projects\Dindo . The database will be stored on a secure VA server located at the 
HSR&D facility which is located behind a firewall. These servers are password protected 
and are behind a locked door with access limited to IT personnel. During non-business 
hours, the server is behind locked doors. The Center has restricted access and is not a 
patient-care facility. The servers are backed up automatically each night. Data will not leave 
the MEDVAMC. 
Such electronic research data will be secured via BCM IT Services- provided secured network 
storage of electronic research data (Non-Portable devices only): 
    No
Such electronic research data will be secured via Other:  
    
Yes, (describe below): 
The recordings will be uploaded to the VA database and stored on the M drive. Once the 
recordings are downloaded to the M drive they will be deleted from the audio recorder. The 
database will be stored on a secure VA server located at the HSR&D facility which is 
located behind a firewall. These servers are password-protected and are behind a locked 
door with access limited to IT personnel. During non-business hours, the server is behind 3 
locked doors. The Center has restricted access and is not a patient care facility. The servers 
are backed up automatically each night. The VA server is located under the server drive (M-
HSRD, L other). 
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have 
access to identifiable research data? 
    
Yes, identify the classes of the persons: 
People who ensure quality from the institutions where the research is being done, federal and 
other regulatory agencies will have access to all of the research data. 
Please describe the methods of transmission of any research data (including PHI, sensitive, and 
non-sensitive data) to sponsors and/or collaborators. 
    Data will not be submitted to sponsors and/or collaborators. 
  
Will you obtain a Certificate of Confidentiality for this study? 
    No
Please further discuss any potential confidentiality issues related to this study. 
    
All sessions will be audio recorded (both ACT workshop and clinical interviews) by the 
Research Clinician using a Olympus DS-3500. The recorders are data encrypted and require 
a password to be heard. The recordings will be uploaded to the VA database and stored on 
the M drive. Once the recordings are downloaded to the M drive they will be deleted from 
the audio recorder. The database will be stored on a secure VA server located at the HSR&D 
facility which is located behind a firewall. These servers are password-protected and are 

behind a locked door with access limited to IT personnel. During non-business hours, the 
server is behind 3 locked doors. The Center has restricted access and is not a patient-care 
facility. The servers are backed up automatically each night. The VA server is located under 
the server drive (M-HSRD, L-other). 
Approved staff from the VA Salt Lake City (VASLC) will transcribe the non-identifiable 
audio recordings of participants' workshop feedback. The VASLC has a Professional 
Transcription Service available to VA sites and monitored by their own IRB. The study 
audio recordings to be transcribed by VASLC staff will be labeled by the subject's unique ID 
number and saved behind the VA Firewall in secure shared project folder (Dindo 
Transcriptions) on the M- Drive of the VA computer. The VASLC transcription staff will be 
given access to a sub-folder within the secure project folder. Approved study staff will place 
a copy of the audio files in this folder for an approved VASLC transcriptionist to access for 
the purposes of transcription. The VASLC transcriptionist will transcribe each interview 
verbatim and save the completed transcript in the sub-folder using the same ID number. No 
data (audio files, in process transcripts, or completed transcripts) will leave the MEDVAMC 
secure research server. As completed transcripts become available, approved study staff will 
move these files from the transcription sub-folder into another sub-folder that is only 
accessible to study staff, where they will be stored and accessed for qualitative analyses. 
  
Section L:  Cost/Payment 
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be 
responsible for research related costs? If so state for which items subject's insurance (or subject) 
will be responsible (surgery, device, drugs, etc). If appropriate, discuss the availability of 
financial counseling. 
    Subjects will not be responsible for research related costs. 
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research 
project, please note the total dollar amount (or dollar value amount) and distribution plan (one 
payment, pro-rated payment, paid upon completion, etc) of the payment. 
Dollar Amount: 
    155
Distribution Plan: 
    
Enrolled participants will be paid $100 for completing assessments over the course of the 
study ($30 for baseline, $20 for 2 week follow-up, $20 for 6 week follow-up, and $30 for 3 
month follow-up). We have also allocated $25 per participant for meals and snacks during 
the 6-hour workshop. Participants will also be reimbursed up to $30 per participant for 
mileage during in-person visits (for anyone living outside the immediate Houston area). 
($6000 or $3,000 in each year of the project) 
  
Section M:  Genetics 
How would you classify your genetic study? 
    

Discuss the potential for psychological, social, and/or physical harm subsequent to participation 
in this research. Please discuss, considering the following areas: risks to privacy, 
confidentiality, insurability, employability, immigration status, paternity status, educational 
opportunities, or social stigma. 
    
Will subjects be offered any type of genetic education or counseling, and if so, who will 
provide the education or counseling and under what conditions will it be provided? If there is 
the possibility that a family's pedigree will be presented or published, please describe how you 
will protect family member's confidentiality? 
    
  
Section N:  Sample Collection 
None 
  
Section O:  Drug Studies 
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any 
substance that is used to elicit a pharmacologic or physiologic response whether it is for 
treatment or diagnostic purposes) 
    No
Does the research involve the use of ANY gene transfer agent for human gene transfer 
research? 
    No
O1.  Current Drugs 
  
Is this study placebo-controlled? 
    No
Will the research involve a radioactive drug that is not approved by the FDA? 
    No
  
Section P:  Device Studies 
     Does this research study involve the use of ANY device? 
        No
  
Section Q.  Consent Form(s) 
None 
  
Section R:  Advertisements 
Mode of Advertising:  Other: Brochures 
Exact language of Advertisement: 

    
If the adjustment back to civilian life has been challenging, consider participating in a new 
study at the Michael E. DeBakey VA Medical Center. 
What is the goal of the study? The goal of this study is to better understand the experiences 
of returning OIF/OEF/OND Veterans and to provide strategies to help Veterans develop 
resilience and adjust to new challenges.  
What will happen during the study? If you agree to take part in this study, you may be 
invited to an 1-day group workshop with other Veterans who have had similar experiences. 
During the workshop, strategies and skills will be taught on how to develop resilience in the 
face of stress and difficulty 
How do I join? Call 713-794-7493 to discover if you are eligible.   If we are unable to 
answer your call, please leave a message and we will return your call promptly.