Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety
Phase: PHASE2
Conditions: Anxiety Disorders
Sponsor: VA Office of Research and Development

Institutional Review Board for Baylor College of Medicine and Affiliated 
Hospitals 
  
Protocol Number:    H-42354 
Status:                        Approved 
Initial Submit Date:  10/30/2017 
Approval Period:       1/18/2018 - 11/14/2018
  
Section Aa:  Title & PI 
A1.  Main Title 
    IMPROVING VETERAN FUNCTIONING WITH INTENSIVE TRANSDIAGNOSTIC CBT FOR ANXIETY 
A2.  Principal Investigator 
  
    Name:   
ELLEN TENG 
Phone:   
713-578-5513 
    Id:   
138684 
Fax:   
    Department:   PSYCHIATRY & BEHAVIORAL SCIENCES  
Email:    
eteng@bcm.edu  
    Center:   
Mail Stn:   BCM350 
A3.  Administrative Contact 
    None 
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:   
TERRI BARRERA  
Phone:   
713-440-4490 
Id:   
168362  
Fax:   
Department:    PSYCHIATRY & BEHAVIORAL SCIENCES  
Email:    
terrib@bcm.tmc.edu 
Center:    
Mail Stn:    BCM350  
  
    Name:   
NANCY PETERSEN  
Phone:   
713-794-8615 
Id:   
970104  
Fax:   
713-748-7359 
Department:    MEDICINE: HEALTH SRVCS RESEARCH  
Email:    
petersen@bcm.tmc.edu
Center:    
Mail Stn:    BCM288  
  
    Name:   
KAREN DRUMMOND  
Phone:   
Id:   
Non-Baylor  
Fax:   
Institution:    
University of Arkansas Medical School  
Email:    
kldrummond@uams.edu
Address:    
 

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? 
    Yes 
  
Section B:  Exempt Request 
B.  Exempt From IRB Review 
    Not Applicable 
  
Section C:  Background Information 
    
The process of recovery and community reintegration across the lifespan for Veterans with posttraumatic stress 
disorder (PTSD) and anxiety disorders (henceforth referred to as anxiety-based disorders) is a significant 
problem. Resuming and participating in major social life roles within the community is challenging due to the 
debilitating nature of anxiety, which often results in avoidance of everyday activities and social withdrawal. 
Consequences of untreated anxiety-based disorders range from substantial impairment in social, vocational, 
emotional and physical functioning to high rates of suicide. 
Despite the effectiveness of evidence-based CBT for anxiety based disorders, a significant proportion of 
Veterans do not initiate treatment. Nationwide data indicate that less than 10% of recently deployed Veterans 
receive an adequate course of psychotherapy within the first year of being diagnosed with a mental health 
disorder. Avoidance associated with anxiety and fear-based disorders (e.g., PTSD) lead to low rates of 
treatment engagement and high rates of treatment dropout. For instance, attrition rates in PTSD treatment (20-
40%) are similar to attrition rates (25%) for treatment of other disorders such as panic disorder and social 
anxiety disorder. Furthermore, length of time required to deliver evidence-based psychotherapies interferes with 
daily (family, work, school) activities and necessitate arranging time off work, scheduling around school 
schedules, and traveling to multiple appointments.  
Novel and innovative approaches capable of improving community reintegration, quality of life, and clinical 
outcomes, while also keeping Veterans engaged in treatment are much needed. Given the impact PTSD and 
related anxiety disorders can have on family members, it is also important to learn about their perspectives 
regarding the advantages and disadvantages of new treatment approaches.  
  
Section D:  Purpose and Objectives 

    
The overall objective of the proposed study is to improve reintegration across the lifespan and quality of life in 
Veterans with anxiety-based disorders including co-occurring depression. A randomized controlled trial will test 
the effectiveness of transdiagnostic group CBT delivered in an intensive weekend format. This transdiagnostic 
protocol addresses multiple anxiety-based disorders in a single protocol by incorporating general core 
components of CBT with additional skills-based modules that can be flexibly tailored to any anxiety disorder. 
Intensive CBT (iCBT) is an innovative and promising method of treatment delivery with the potential to produce 
rapid improvement in functional and clinical outcomes. The compressed format (e.g., weekend) of iCBT 
increases the likelihood that Veterans will engage in and complete treatment. During the course of the study, we 
will also gather qualitative data from Veterans who participated in the weekend treatment (and their family 
members) to obtain a deeper understanding of how iCBT and environmental barriers and facilitators have 
impacted their overall functioning and quality of life.  
  
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), Geriatric (65+ 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? 
    Mentally ill 
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject 
confidentiality, and prevent undue coercion? 
    
Project staff will review the consent form with the patient, including the study procedure, patient’s rights, risks 
and benefits of participation, and the methods that will be taken to protect the patient’s confidentiality. The 
patient will have the opportunity to ask questions throughout the process. Each patient will be given his/her own 
copy of the informed consent form to follow along by during the consent process and to keep for future 
reference. Patients will be asked to reiterate their understanding of the important points of the consent form to 
ensure that full informed consent is obtained. Study staff will clarify any necessary points and answer questions. 
Participants will not require a Legally Authorized Representative for this study.  
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. 
    
The clinical trial will compare the effectiveness of iCBT to standard CBT (sCBT) and treatment as usual (TAU). 
A total of 252 Veterans from all war eras will be recruited who have at least one of the following disorders: 
PTSD, panic disorder (PD), social anxiety disorder (SAD) and generalized anxiety disorder (GAD). Veterans 
with or without co-occurring depression will be included. Participants will be randomized to iCBT, sCBT, or TAU. 
The study design uses unequal randomization to the active intervention arms and to treatment as usual to 
reduce unnecessary recruitment. Thus, the percent chance that participants will be randomized to one of the 
three conditions are: 37% iCBT, 37% sCBT, and 24%TAU. Participants in iCBT will receive treatment over one 
weekend (16 total session hours); those in sCBT will receive the same treatment weekly, over 12 weeks (16 
total session hours); and those assigned to TAU will receive routine clinical care. Assessments will be 
completed at four time points: baseline, 1-month, 3-months, and 6-months.  
This protocol should be considered minimal risk because the likelihood and degree of discomfort anticipated in 
this intervention are lower than what people would encounter in daily life. This is a non-invasive behavioral 
intervention that is designed as a two-day workshop to teach participants about anxiety and provide them with 
opportunities to practice examining and adjusting their thoughts based on evidence. Participants have the 
benefit of having trained therapists available to guide and help them engage in these exercises. The workshop 
is similar to other classes and seminars people may attend in daily life. The room is set up as a classroom with 
individual desks and chairs for participants. Breaks are scheduled throughout the day, and participants are 
informed that they may take a break whenever they need.  
It is important to note that the content of the treatment protocol is not new; cognitive behavioral therapy (CBT) is 
a well-established, empirically supported treatment for anxiety and mood disorders. In fact, it is the gold-
standard treatment and recommended by NIMH as a first line intervention for anxiety and mood disorders. The 
PI of this study has been offering weekend CBT for anxiety disorders at the MEDVAMC for the past 10 years. 
The compressed weekend format for delivering this treatment has been established across several clinical trials 
to be a safe and feasible method of providing treatment. Veterans report high satisfaction with this treatment 
format and prefer it over standard weekly sessions (Teng et al, 2015, Journal of Anxiety Disorders, 33, 1-7). All 
of these factors support the rationale that the protocol should be considered minimal risk.  
Inclusion Criteria: 
    
(1) Veteran at least 18 years old; (2) current diagnosis of at least one anxiety-based disorder: PTSD, PD, SAD, 
or GAD (based on ADIS-5); (3) moderate-to-poor life enjoyment and satisfaction as indicated by a score of 42 or 
lower on the Q-LES-Q-SF (4) stable on psychotropic medication for 4 weeks before study participation; and (5) 
willing to be randomized to treatment condition. Inclusion criteria for family members of Veterans randomized to 
the weekend intervention who wish to participate in the qualitative interview: (1) at least 18 years old and (2) has 
regular contact with the Veteran (e.g., sees or talks with Veteran several days/week).  
Exclusion Criteria: 
    
(1) Active symptoms of mania or psychosis at baseline (based on ADIS-5); (2) depression with active suicidal 
ideation/intent that would preclude treatment (based on ADIS-5 & BDI-II); (3) moderate-to-severe cognitive 
impairment as indicated by a score below 20 on the SLUMS; (4) active drug/alcohol abuse during the initial 3-
months of study enrollment (otherwise Veterans with comorbid substance/alcohol dependence are study 
eligible); and (5) undergoing concurrent transdiagnostic CBT for anxiety. 
 
F2.  Procedure 

    
Recruitment  
Several methods of recruitment will be used in the study. Letters will be sent to Veterans enrolled for care at the 
MEDVAMC, including those scheduled for appointments in outpatient clinics (e.g., General Mental Health, 
Primary Care, Post Deployment, PTSD). In addition, flyers advertising the study will be posted throughout 
MEDVAMC, community based outpatient clinics affiliated with MEDVAMC, and Vet centers located in Houston. 
We will also recruit from non-profit organizations serving Veterans in the Houston community (e.g., U.S. Vets). 
The study will also be advertised through electronic messaging boards throughout the hospital, Veterans 
newsletters such as the “VA Star,” and via free list-serves that Veterans subscribe to such as the “Houston 
Military Affairs” mail group.  
Assessments  
Participants will undergo a total of four in-person assessments. A pre-screening will be conducted using the Q-
LES-Q-SF to determine a moderate level of impairment in general functioning. Veterans obtaining an 
impairment score of 42 or lower will be study eligible and complete a full baseline evaluation. Data obtained 
from the Q-LES-Q-SF at the pre-screen will not be used for research purposes. If the Veteran meets inclusion 
criteria and agrees to participate, s/he will be consented and re-administered this measure, which takes 
approximately 5-10 minutes to complete. The baseline evaluation will occur approximately 1-2 weeks before 
treatment. The baseline evaluation will include a structured diagnostic interview (ADIS-5) and psychological 
screening measures to determine general emotional functioning and the presence of specific psychiatric 
disorders. During the pre-treatment appointment, it will be explained to the patient that that all assessment and 
treatment sessions will be supervised by a licensed psychologist (PI). Patients will also be informed that study 
staff will need to access their medical records periodically to track relevant psychiatric and medical information. 
Protected health information that will be collected from Veterans in this study include: name, address, telephone 
numbers, dates of appointments related to the study, last four digits of social security number, and voice 
recordings. Demographic information, medications prescribed, and dates of mental health treatment 
appointments will also be collected. VA Quality Assurance and BCM IRB personnel responsible for providing 
general oversight of this study (e.g., patient enrollment and consent forms) may also have access to research 
data. Specific data that may be accessed include symptom measures collected during the course of the study. 
Study data regarding individual information that is not in the patient's medical record will remain confidential and 
inaccessible to other agencies. Health records of participants in this study will be flagged since they are 
participating in an intervention for a psychiatric disorder.  
Assessments at four time points (baseline, 1-month, 3-month, and 6-month follow-up) will be conducted for all 
three conditions. Diagnostic assessments will be conducted by study staff being directly supervised by the PI or 
another licensed psychologist. All assessments will be conducted in individual sessions that will occur either at 
the MEDVAMC or over the telephone (no social security numbers will be requested from subjects or potential 
subjects via phone). Veterans will be provided opportunities for breaks during in-person assessments and two 
phone appointments will be scheduled to reduce fatigue effects. Should a participant need immediate attention 
(e.g., expresses active suicidal intent or psychosis) during the assessment, the PI will ensure that the patient is 
seen by a provider through the walk-in clinic at the MEDVAMC that same day. Follow-up assessments will be 
conducted by an evaluator masked to treatment assignment.  
Participants will receive a modest amount of monetary compensation for study participation, as detailed in 
Section L.  
Assessment Battery 
The assessment battery will consist of the following: (1) Community Reintegration of Injured Service members – 
Computer-Adaptive Test (CRIS-CAT), a commonly used measure of community reintegration following 
deployment; (2) Short-Form 12 Health Survey (SF-12), measures eight domains related to physical and mental 
health, health perceptions, and the impact of physical or emotional problems on general functioning via self-
report; (3) Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms, minimizing those that 
overlap with depression; (4) Beck Depression Inventory - Second Edition (BDI–II) assesses severity of 
depressive symptoms; (5) Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF) 
is a brief, 16-item measure of subjective functioning and satisfaction across a range of life domains including 
work, leisure activities, social relationships, and physical health; (6) Saint Louis University Mental Status Exam 
(SLUMS) is an 11-item clinician-administered screening measure of cognitive impairment; (7) Anxiety Disorders 
Interview Schedule DSM-5 (ADIS–5) is a gold-standard semi-structured clinician interview used to assess for 
the presence of all anxiety disorders including PTSD. Modules examining the presence of psychosis, mood and 

substance abuse disorders are also included; (8) Demographic and Military Survey is a brief questionnaire we 
have used in previous studies that inquires about general demographic and military information. Veterans are 
asked about their periods of service, deployment dates, whether they seek healthcare outside of VA, and other 
information pertaining to their education and employment history; (9) Perceived Barriers to Seeking Mental 
Health Services (PB-SMHS) assesses concerns specific to Veterans that are related to seeking mental health 
counseling and related services; and (10) Client Satisfaction Questionnaire-8 (CSQ-8) is a brief 8-item measure 
used to assess overall treatment satisfaction. All measures will be administered at each assessment period, 
except the ADIS-5, Q-LES-Q-SF, SLUMS, Demographic Questionnaire, and PB-SMHS, which will only be 
administered at baseline. The CSQ will only be administered at 1-month and 3-month follow-up periods. The 
complete battery of assessments can be administered in 2-3 hours.  
Treatments 
Participants will be randomly assigned to one of three treatment arms (iCBT, sCBT, TAU), described in detail 
below. Both iCBT and sCBT treatments are identical except for delivery format. Persons delivering the treatment 
will include a masters-level and doctoral-level interventionist who will be trained to deliver treatments in both 
intervention conditions under the supervision of Dr. Terri Barrera, a licensed psychologist and co-investigator on 
this project. Dr. Barrera is experienced in transdiagnostic treatment for anxiety and in the delivery of exposure-
based treatments for anxiety disorders with Veterans. She will work closely with the interventionists to ensure 
that all patients are closely monitored, with their safety taking priority above the needs of the study. Our pilot 
work with Veterans at the MEDVAMC and community based outpatient clinics demonstrates the intensive 
weekend format to be a safe mode of treatment delivery. However, as an added level of precaution, the 
MEDVAMC has an emergency department with an on-call psychiatrist available 24 hours a day in the unlikely 
event that a patient needs immediate medical intervention. 
Standard Cognitive Behavioral Treatment: The sCBT condition consists of 12 treatment sessions delivered once 
weekly over a 12-week period. Duration of sessions will be approximately 90 minutes, depending on the session 
module. For example, psychoeducation sessions typically last 60 minutes, whereas cognitive restructuring and 
exposure sessions typically last up to 90 minutes. Thus, the entire treatment requires approximately 16 hours of 
direct patient contact. A maximum of 6 Veterans may be enrolled per group cycle. The transdiagnostic treatment 
protocol consists of (1) psychoeducation about the general treatment structure, the nature of anxiety disorders 
and co-occurring symptoms such as depression, and physiology underlying the fight/flight response; (2) 
cognitive restructuring, a method of challenging maladaptive thoughts that maintain negative affect and fears by 
examining evidence that replaces catastrophizing and overestimations in thinking; and (3) exposure to feared 
stimuli through imaginal, interoceptive, or in-vivo exercises. Treatment concludes with relapse prevention 
planning. Homework is completed regularly over the course of treatment. Patients will be asked to monitor and 
record their anxiety and mood symptoms, complete thought records, and engage in exposure exercises.  
Intensive Cognitive Behavioral Treatment: The iCBT condition will contain the same treatment components as 
sCBT, but the intervention will be delivered over one weekend, lasting 8 hours each day (see weekend itinerary 
in Section S: file named "H42354 Study Measures). A maximum of 6 Veterans may be enrolled per group cycle. 
Veterans will be asked to complete practice assignments using thought records during the treatment. They will 
also be asked to monitor and record their anxiety and mood outside of treatment. 
Treatment As Usual: The TAU condition consists of routine clinical care patients would typically receive at the 
MEDVAMC. This may include medication management alone (visits once every 4 months, on average) or in 
conjunction with other forms of individual or group therapies that involve supportive counseling or educational 
and skills-based classes (e.g., anger management, PTSD Recovery 101, etc.). These time-limited classes 
typically occur once per week for a total of 8 – 12 weeks. The TAU condition may also include Veterans who 
participate in disorder-specific evidence-based interventions such as cognitive-processing therapy or prolonged 
exposure therapy, as these treatments reflect the current standard of routine care in VA. Information on 
participants’ engagement in these and all other forms of mental health treatment during the study will be 
collected via self-report and chart review. This information will be examined and if needed, will be controlled for 
in subsequent analyses. Upon completing the 6-month follow-up, patients in this condition will be offered iCBT 
or sCBT. 
Interviews 
A maximum of 40 Veterans who completed iCBT and their family members will be invited to participate in a 

qualitative interview. The purpose of the interview is to obtain Veteran perspectives on the iCBT format. Using 
an interview guide (see Section S file named "H42354 Study Measures," the PI or another study staff member 
will conduct in-person interviews at the MEDVAMC approximately 1-month after completing treatment. The 
inclusion of up to 40 Veterans will be ample to achieve theoretical saturation concerning the impact of iCBT on 
the recovery process. Veterans will provide written informed consent (and sign a release of information form for 
family members present) before interviews begin and be compensated $25 upon completion. All interviews will 
be digitally audio-recorded using a microphone linked directly to a VA networked computer. De-identified audio 
recordings of the interviews will be saved to the MEDVAMC Research folder on the S Drive: Research-
Data/Teng Lab/H42354 Transdiagnostic.  
  
Section G:  Sample Size/Data Analysis 
G1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
    Local: 335              Worldwide: 335 
Please indicate why you chose the sample size proposed: 
    
A total of 335 participants will be recruited for this study: 252 Veterans will be recruited to participate in the RCT; 
40 Veterans who participated in iCBT and their family members (up to 40) will be invited to participate in the 
qualitative interview.  
For the RCT, a total of 252 patients will be randomized across the 3 arms (95 to iCBT, 95 to sCBT, and 62 to 
TAU) to have 80% power to detect differences among groups in the primary outcomes. A recent meta-analysis 
of transdiagnostic treatment for anxiety demonstrated a medium effect size (g=.69) on quality of life outcomes. 
Based on these findings, we are using a more conservative effect size of 0.50 to calculate the sample size that 
will need to be recruited and randomized to draw conclusions. We will use unequal randomization to the active 
intervention arms and to treatment as usual to reduce unnecessary recruitment. We also inflated the sample 
size to account for intraclass correlations among patients and for attrition and loss to follow-up in order to obtain 
the number that must be recruited for the study. The recruited sample size of 95 for iCBT and 95 for sCBT, 
assuming 20% attrition at 1 month and accounting for clustering of patients within therapists, will result in 49 
patients per group for analysis. For our primary analyses, this sample size will have 80% power to detect a 
medium effect size of .57 using a two-group t-test with á=.05 two-sided significance level.  
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? 
    
For our primary analyses, we will compare changes between the iCBT, sCBT, and TAU groups at all time 
periods in a single regression using a hierarchical mixed-model analysis. Because the number of patients 
randomized to the 3 groups is not equal, we will test for unequal variances and if necessary, will account for this 
in our regression models. For outcomes with unequal variances, in the mixed model, we will estimate the 
variances separately and adjust the degrees of freedom for the unequal variances. A priori covariates will also 
be included in the model. A significant time-by-treatment interaction will be followed by pairwise contrasts to 
determine whether the active interventions differed from TAU and whether the active treatments differed from 
each other. We will report the p-values and adjust p-values post-hoc using multiple comparisons procedures 
(e.g., Bonferroni) as recommended in the literature. For secondary analyses, we will run hierarchical linear 
regression models for each outcome using the baseline and 1 month data and with the a priori covariates. 
Hierarchical logistic regression models will be used to test differences in treatment engagement across 
conditions.  
  
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: 

    
The anticipated risks of participating in this study are minimal. However, as with any type of treatment for 
anxiety-based disorders, there is a chance that patients will not experience noticeable improvement in their 
anxiety symptoms; and some may find their symptoms worsen during treatment. At times, some patients may 
experience discomfort or embarrassment in disclosing personal information or in discussing issues typically 
addressed in therapy. While engaging in various cognitive and behavioral exercises, patients may experience 
momentary discomfort (e.g., talking about traumatic event, tensing parts of the body). Patients will be monitored 
closely by a trained clinician and will not be asked to engage in potentially anxiety-provoking exercises for 
prolonged periods of time or do more than they are willing. In the event that a patient remains distressed or 
upset after a therapy or evaluation session, that individual will be encouraged to speak to the 
therapist/interviewer or another mental healthcare professional. All patients will have access to study personnel 
during regular business hours and access to emergency services 24 hours a day, 7 days a week through the 
emergency department at their local hospital. The PI and co-I, Dr. Barrera, are experienced in the delivery of 
exposure-based treatments for anxiety disorders and will ensure that all patients are closely monitored, with 
their safety taking priority above the needs of the study. 
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. 
    Patients who participate in the study may experience functional and symptom improvement related to their 
anxiety.  
Describe potential benefit(s) to society of the planned work. 
    
Information obtained from this study will be used to make the treatment more available to other Veterans 
experiencing similar problems. Based on findings from this study, the next project will evaluate broader 
dissemination of the treatment. Thus, potentially many more Veterans may benefit from this study.  
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio. 
    
This protocol has a favorable risk-benefit ratio because CBT is an empirically validated procedure for treating 
anxiety-based disorders. Patients in this study have the added benefit of receiving close monitoring through 
regular assessment periods. Finally, the potential risks of the intervention are minimal and typically transient. 
  
Section J:  Consent Procedures 
J1.  Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization? 
    No
  
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. 
    
Any member of the study staff may obtain consent from study participants. This study will include Veterans from 
all war eras recruited from Houston and surrounding areas. Veterans may be referred from their healthcare 
providers at the MEDVAMC, community-based outpatient clinics, or Veterans Centers. Participants may also 
self-refer to the study through posted advertisements in Veteran newsletters or Veteran list-serves. People who 
self-refer to the study will be asked to confirm Veteran status and if they are enrolled as a patient at the 
MEDVAMC. If they are, a study appointment will be scheduled; if they are not currently enrolled at the hospital, 
they will be provided with the phone number for patient enrollment and invited to contact study personnel once 
they have completed this process. During the study appointment, a member of the study staff will describe the 
study and review the informed consent form, explaining the risks and benefits of participation. Patients 
interested in participating in the study will sign VA Form 10-1086, Consent to Participate in VA Sponsored 
Research (see Section Q: Consent Form).  
Veterans who participate in the weekend intervention (iCBT) will be invited to participate in an interview with 
study staff members to obtain their perspectives of this treatment format. From each weekend cohort, 1- 2 
Veterans will be randomly selected to participate in the interview. At the time of setting up an appointment for 
the interview, Veterans will be informed that they may bring along a family member to the interview to share 
their perspectives with the study team. When participants arrive for the interview, a member of the study staff 
will describe the purpose of the interview and review the informed consent form, explaining the risks and 
benefits of participation. Veterans and family members who participate in the study will each sign a separate 
consent form (VA Form 10-1086, Consent to Participate in VA 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: 
    No
Specific information concerning drug abuse: 
    No
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 #: 
    No
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? 
    
All paper forms of original data collected from this study will be stored in a locked cabinet in a secured office at 
the Michael E. DeBakey VA Medical Center, Houston, Texas. (MEDVAMC) (Room 6C-119) Paper data (aside 
from the consent and HIPAA forms) will not contain any HIPAA identifiers or other sensitive information. Each 
participant will be assigned a participant study number, which will be used on paper data. Paper data will not 
leave the MEDVAMC. 
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. 
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.  
How will such physical research data be secured? 
    Data will be stored at the MEDVAMC in building 100. Data will be kept in a locked file cabinet in room 6C-119.
At what institution will the electronic research data be kept? 
    
All research data in electronic form will be kept on a secure server of the MEDVAMC (2002 Holcombe Blvd, 
Houston, TX), which meets VA and BCM security requirements. The server is password-protected and access 
is limited to IT personal. During business and non-business hours, access to the server is behind locked doors. 

The server is backed up automatically each night. Data will be stored in folders on the S drive (S:Reseach-
Data/Teng lab) and only the research staff will be given permission (requiring a logon and password) to access 
these folders. All paper forms of data collected from this study will be stored at the MEDVAMC in Building 100 in 
a locked cabinet in a secured office (Room 6C-119). Paper data (aside from the consent and HIPAA forms) will 
not contain any HIPAA identifiers or other sensitive information. Each participant will be assigned a participant 
study number, which will be used on paper data. Paper data will not leave the MEDVAMC. Results that are 
presented for publication will be reported in aggregate form, and therefore will not contain individual identifying 
information. 
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): 
Yes, (describe below): Electronic data will be stored on a VA secure server under the main "Research-Data" 
folder on the S drive. The pathway is: S Drive: Research-Data/Teng Lab/H42354 Transdiagnostic. 
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. 
    No PHI will be transmitted to sponsors or collaborators. De-identified transcripts of interviews will be sent via 
overnight mail to co-investigator, Dr. Karen Drummond. 
  
Will you obtain a Certificate of Confidentiality for this study? 
    No
Please further discuss any potential confidentiality issues related to this study. 
    
Participants in the study will authorize digital audio recording of clinician administered interviews, treatment 
sessions, and qualitative interviews conducted during the study by signing the consent form. Audio recordings 
will be recorded using a microphone directly connected to a VA networked computer and the recording will be 
saved in a password-protected, encrypted file on the secure VA server, the S drive (S: Research-Data/Teng 
Lab/H42354 Transdiagnostic), that is accessible only by study staff and people who ensure quality from the 
institutions where the research is being done. The only individually identifiable information contained on the 
audio recording is the voice print. All recordings will be labeled with participant numbers. 
Transcriptions of the qualitative interviews will be sent via overnight mail to Dr. Karen Drummond at 4300 W 7th 
St. Little Rock, AR 72205 with a tracking number. Transcriptions will not contain sensitive information or any of 
the 18 HIPAA identifiers 
  
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. 
    Patients who participate in this study will be engaging in research and will not be billed for services provided 
within this protocol. 

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: 
    225 
Distribution Plan: 
    
Patients will receive a payment voucher in the amount of $50 for completion of each assessment period 
(baseline, 1-month, 3-month, & 6 month follow ups). The total amount they may receive is $200. 
A subset of participants who complete treatment and participate in the qualitative interview will receive an 
additional $25. The total amount they may receive is $225.  
  
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) 
Transdiagnostic Treatment for Anxiety 
Transdiagnostic Treatment for Anxiety Interviews 
  
Section R:  Advertisements 
Mode of Advertising:  Other: Flyers, Electronic Messaging Boards, Newsletters 
Exact language of Advertisement: 
    
VETERANS: ARE YOU STRUGGLING WITH ANXIETY?  
Symptoms of anxiety may include: constant nervousness, uncontrollable worry, panic attacks, fear or avoidance 
of situations, people, places, to name a few.  
The MEDVAMC is conducting research on a new brief treatment for Veterans with anxiety and related 
symptoms. The treatment is offered over one weekend or in weekly sessions and includes three follow-up visits. 
If you are eligible, you may receive this treatment for free and receive compensation for completing 
assessments over the course of the study.  
If you have some of the symptoms listed above and would like more information, please contact the study 
coordinator at (713) 791-1414 ext. 26419.