Increasing the Effectiveness of CBT for Anxiety in Veterans by Involving Family Members.
Phase: NA
Conditions: Anxiety Disorder
Sponsor: VA Office of Research and Development

Increasing the Effectiveness of CBT for 
Anxiety in Veterans by Involving Family 
Members
NCT05340478
July 7, 2022

 
 
  
Institutional Review Board for Baylor College of Medicine and Affiliated 
Hospitals 
  
Protocol Number:    H-51655 
Status:                        Approved 
Initial Submit Date:  4/14/2022 
Approval Period:       7/7/2022 - 6/14/2027 
  
Section Aa:  Title & PI 
A1.  Main Title 
     INCREASING THE EFFECTIVENESS OF CBT FOR ANXIETY IN VETERANS BY INVOLVING FAMILY 
MEMBERS 
A2.  Principal Investigator 
  
     Name:   
ELLEN TENG 
Phone:   
7137911414 
     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:   
CAITLIN CLARK 
Phone:   
7137911414 
Id:   
206021 
Fax:   
Department:   PSYCHIATRY & BEHAVIORAL SCIENCES 
Email:    
caitlinc@bcm.edu 
Center:   
Mail Stn:   BCM350 
  
     Name:   
KAREN DRUMMOND 
Phone:   
Id:   
Non-Baylor 
Fax:   
Institution:   
CENTRAL ARKANSAS VETERANS HEALTHCARE 
SYSTEM 
Email:    
KAREN.DRUMMOND@VA.GOV
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 
  
A9. ClinicalTrials.gov Registration 
Does this protocol/trial require registration on ClinicalTrials.gov due to it: meeting the definition of an Applicable 
Clinical Trial, being required under the terms and conditions of an award, or being proposed to be published in 
ICMJE journals? 
     Yes 
  
Who will be responsible for registering and maintaining the registration of this Applicable Clinical Trial? 
     The BCM PI will register the trial because either:
     -   the trial is BCM PI-initiated,
     -   BCM is the lead site of this multicenter trial, or,
     -   the industry sponsor has instructed the BCM PI to register the trial, or, 
     -   registration of this trail is required as a term and condition of the reward by the funding agency.
  
ClinicalTrials.gov Identifier: 
     NCT05340478 
  
Section B:  Exempt Request 
B.  Exempt From IRB Review 
     Not Applicable
  
Section C:  Background Information 
     
Anxiety disorders and posttraumatic stress disorder (PTSD) are highly prevalent among Veterans; estimates 
indicate that 30-40% of military service members experience at least one anxiety-based disorder, with PTSD 
being the most prominent. Prevalence estimates for posttraumatic stress disorder (PTSD) in Veterans range 
from 21-29%. Panic disorder (PD), generalized anxiety disorder (GAD), and social anxiety disorder (SAD) are 
common in Veterans, with prevalence estimates 6%, 8%, and 15%, respectively. Comorbidity among the anxiety 
disorders is also high and poses unique challenges to treatment. The process of recovery and community 
reintegration across the lifespan for Veterans with anxiety-based disorders is a significant problem.9 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. Consequently, PTSD and 
anxiety are associated with substantial impairment in social, vocational, emotional, and physical functioning and 
high rates of suicide. 
Cognitive behavioral therapy (CBT) is the front-line treatment for PTSD and anxiety disorders. Through the 
combination of psychoeducation, cognitive restructuring, and behavioral exposure to feared stimuli, patients are 
taught skills to overcome their fears. Although CBT for anxiety is effective, a significant proportion of patients 
(approximately 50%) do not achieve remission after completing treatment. For example, outcomes obtained from 

military and Veteran populations indicate that up to 75% retained a PTSD diagnosis following CBT. Although 
different explanations exist for poor treatment response, treatment engagement is a common problem for those 
undergoing exposure-based treatments. LeBeau and colleagues reported that the degree to which adults 
engaged in CBT exposure exercises outside of session predicted treatment outcomes. Unfortunately, the very 
nature of anxiety motivates people to engage in avoidance behaviors related to their fears, which can undermine 
the effectiveness of treatment. 
Recent research shows that interpersonal factors between a patient with anxiety and a family member may also 
function to maintain anxiety symptoms through a process known as accommodation. This occurs when family 
members adjust their own behaviors to help reduce the distress experienced by their loved one. This may take 
the form of the family member providing constant reassurance to the patient, using distraction, serving as a 
safety object by accompanying the patient outside of their comfort zones, warning others how to behave around 
the patient, and assuming more responsibilities typically handled by the patient. Although well-intentioned, 
accommodation behaviors by family members are detrimental and directly undermine the effectiveness of CBT 
approaches by facilitating further avoidance for the patient. Accommodation behaviors are associated with 
increased symptom severity and functional impairment. Over time, this pattern of responding becomes strenuous 
and exhausting to the family member and can deteriorate the relationship with the loved one. Thus, when a 
member of the family has mental illness, it impacts the family as a system by disrupting the equilibrium within 
that unit. In these instances, family members adjust patterns of how they respond and interact with the individual 
to restore balance to the family unit. 
Despite this knowledge, the primary focus of most current evidence-based CBT approaches for anxiety continue 
to focus exclusively on treating the symptomatic individual. Only recently have researchers begun investigating 
brief interventions to target decreasing accommodation behaviors in family members of adult patients. Such 
interventions provide psychoeducation on how anxiety is maintained and teach family members new skills that 
will facilitate the patient¿s recovery from anxiety. These studies, along with results obtained from pediatric 
samples show that addressing accommodation behaviors in treatment is associated with reduced symptom 
severity, increased treatment response, satisfaction, and engagement by family, and improved remission rates. 
Anxiety disorders and PTSD are highly prevalent among Veterans and service members but there has been 
limited focus on the development of CBT interventions that incorporate family members in the treatment provided 
to Veterans. Except for Cognitive-Behavioral Conjoint Therapy for PTSD, which provides treatment to couples in 
which one or both persons have PTSD, the majority of VA evidence-based psychotherapy (EBP) rollouts focus 
on treating the individual. Thus, novel and innovative approaches that involve family members and caregivers in 
treatments provided to Veterans are needed. 
  
Section D:  Purpose and Objectives 
     
This study will examine the feasibility/acceptability of, and satisfaction with, a new intervention for family 
members of Veterans undergoing CBT for anxiety-based disorders. Adjunctive Family-CBT (AF-CBT) is framed 
within a family-systems approach, which addresses recovery of the Veteran within the context of the family unit 
rather than the patient as an individual. AF-CBT provides family members psychoeducation on anxiety and 
teaches skills that can be used to facilitate the recovery of Veterans who are in the process of completing 
treatment for anxiety. 
A total of 47 Veterans and family member dyads (V/F dyad) will be recruited for this study. Phase 1 will recruit 12 
V/F dyads for family members to receive AF-CBT while the Veteran undergoes CBT for anxiety. Each V/F dyad 
will participate in a post-treatment assessment that includes a semi-structured qualitative interview to gain a 
deeper understanding of their experience with the intervention and feedback on ways to refine the intervention. 
In this phase, AF-CBT will be delivered in three separate cohorts (approximately 4 V/F dyad in each cohort). The 
intervention will be refined using two adaptation frameworks (IM and FRAME) to guide the process, following 
completion of each cohort. Phase 2 of this study will recruit 35 additional V/F dyads to participate in the finalized 
version of AF-CBT. 
Treatment feasibility, acceptability, and satisfaction will be evaluated via self-report assessment and qualitative 
interviews. The Family Accommodation Scale for Anxiety (FAS-A) will also be adapted for use with Veterans and 
administered at baseline and 1-month follow-up. The goal of this study is to further adapt and refine an 
adjunctive intervention for family members of Veterans who undergo CBT for anxiety. The long-term goal is to 
examine the effectiveness of AF-CBT as a therapeutic strategy to enhance the effectiveness of exposure-based 
treatments for anxiety for Veterans. 
  

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 information about the study 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. Patients will be 
asked to reiterate their understanding of the purpose and procedures related to the study. 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. 
     
This study examines the feasibility and acceptability of, and satisfaction with, a new intervention for family 
members of Veterans undergoing CBT for anxiety disorders/PTSD. A total of 47 V/F dyads will be recruited. 
Phase I will focus on refining the AF-CBT intervention, and Phase II will deliver the finalized AF-CBT protocol to 
V/F dyads. 
In phase 1, 12 V/F dyads will be recruited to refine the adapted AF-CBT intervention. Family members will 
receive AF-CBT while the Veteran undergoes iCBT for anxiety. The AF-CBT intervention will be delivered in 

separate cohorts (approximately 4 V/F dyads in each cohort). During the 1-month assessment, information 
obtained from qualitative interviews with each cohort will subsequently be used to refine the intervention in an 
iterative process. In phase 2, 35 V/F dyads will be recruited and administered the finalized version of AF-CBT 
following the same treatment and assessment format. Qualitative interviews will focus on each V/F dyad's 
experience with the AF-CBT intervention and whether specific components of the intervention facilitated the 
Veteran's recovery process. 
Inclusion Criteria: 
     
(1) Veteran at least 18 years old; (2) current diagnosis of at least one anxiety-based disorder: PTSD, PD, SAD, 
GAD, or Other Specified Anxiety Disorder (based on ADIS-5); (3) moderate-to-poor life enjoyment and 
satisfaction as indicated by a score of 47 or lower on the Q-LES-Q-SF (4) BAI score of 16 (moderate anxiety) or 
higher; (5) stable on psychotropic medication for 4 weeks before study participation; and (6) has a family 
member willing to participate in the study. The identified family member must be an adult over the age of 18 
years who either lives with the Veteran or has frequent contact (>3 days/week) and can commit the time to 
attend the AF-CBT intervention. 
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; and (4) active drug/alcohol abuse during the initial 
3-months of study enrollment (otherwise Veterans with comorbid substance/alcohol dependence are study 
eligible) 
F2.  Procedure 
     
Recruitment: Veterans will be recruited through the Center for Innovative Treatment of Anxiety & Stress 
(CITRAS) at the Michael E. DeBakey VA Medical Center. CITRAS is an anxiety specialty clinic and receives 
direct referrals from clinics throughout the main hospital (e.g., General Mental Health Clinic, Post-Deployment 
Center, Primary Care Mental Health, PTSD Outpatient Clinic) and 11 community-based outpatient clinics 
(CBOCs). Flyers advertising the study will be posted throughout MEDVAMC and CBOCs, and the study will be 
advertised through electronic messaging boards throughout the hospital, posters, and VA approved social media 
outlets. 
Procedure: Veterans expressing interest in the study will speak with a member of the study team who will 
provide information about the study. Veterans expressing interest in the study will be pre-screened with the Q-
LES-Q-SF and BAI to determine if a moderate level of impairment in general functioning and anxiety are present 
(this data will not be included in research data set). If so, an appointment will be scheduled for interested 
Veterans and identified family members to complete a brief joint assessment, which will take about 2 hours. The 
Veteran will be scheduled for a separate appointment to complete a full baseline evaluation (where the Q-LES-
Q-SF and BAI will be re-administered) approximately 2 weeks before receiving treatment. This appointment will 
last about 2.5 hours. The family member will start AF-CBT within 1-2 weeks of when the Veteran participates in 
anxiety treatment (delivered over 1 weekend). Approximately 2 weeks after the family member completes AF-
CBT, the V/F dyad will meet with a study clinician for a conjoint (1.5 hour) booster session. The V/F dyad will be 
asked to complete a 1-month follow-up assessment, which will include a qualitative interview regarding their 
experience with the treatment (approximately 2.5 hours). It is anticipated that most participants will complete the 
study in approximately 4 months. 
Assessments: Veterans will undergo two assessments (baseline & 1-month follow-up). 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. All assessments will be 
supervised by a licensed psychologist. Veterans will 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 may also have 
access to research data. Study data regarding individual information that is not in the patient's medical record 
will remain confidential and inaccessible to other agencies. Family members will also be asked to complete a few 
brief measures at baseline and 1-month follow-up time points. 
Qualitative Interviews: All V/F dyads who complete AF-CBT will be invited to participate in a qualitative interview 
following completion of AF-CBT. The purpose of the interview is to obtain V/F dyads' feedback about AF-CBT. 

Collection and analysis of qualitative data will be overseen by Co-I, Dr. Drummond, and interviews will be 
conducted using a semi-structured interview guide (attachment in Section S) by Dr. Hinojosa-Lindsey 
(consultant). 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. Lighthouse for the Blind will transcribe the audio recordings by accessing 
the research folder on the S Drive through their contractor PIV card or through receiving files via encrypted e-
mail. Transcriptions will be saved to the research folder. 
Measures: (1) Community Reintegration of Injured Service Members (CRIS), a commonly used measure of 
community reintegration following deployment; (2) Beck Anxiety Inventory (BAI) assesses the severity of anxiety 
symptoms, minimizing those that overlap with depression; (3) DASS; (4) 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; (5) Saint Louis University Mental Status Exam (SLUMS) is an 11-item clinician-administered screening 
measure of cognitive impairment; (6) 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; (7) 
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; (8) Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item measure that assesses overall 
treatment satisfaction; (9) Family Accommodation Scale is a 16-item self-report measure of anxiety symptom 
accommodation during the past month; (10) Couples Satisfaction Index (CSI) assesses satisfaction in the 
relationship; (11) Revised Dyadic Adjustment Scale (RDAS) assesses several domains of relationship quality; 
(12) Modified Treatment Evaluation Inventory (MTEI) is a brief 9-item measure that uses a 5-point Likert scale to 
assess acceptability of treatment components; and (13) Inventory of Psychosocial Functioning (IPS) a measure 
that assesses functioning across different domains of life. The ADIS-5, SLUMS, Demographics Form will be 
given at baseline only and the CSQ and MTEI will given at 1-month follow-up only. The remaining measures will 
be administered at both time points. 
Treatments: Veterans will receive iTCBT, which is a transdiagnostic cognitive-behavioral group treatment for 
anxiety disorders. iTCBT is delivered over two consecutive days (1 weekend), lasting 8 hours each day. A 
maximum of 6 Veterans may be enrolled per group cycle. iTCBT includes psychoeducation about the nature of 
anxiety and skills training for changing maladaptive thoughts and behaviors. Family members of Veterans will 
receive AF-CBT, which is adapted from existing protocols that have been used with non-Veteran adult 
patients.AF-CBT is a brief intervention and consists of two 2-hour long sessions delivered in small groups of 
family members (maximum of 6). Two weeks after completion of AF-CBT, a conjoint booster session will be 
provided to V/F dyads to check in on progress and provide guidance in tailoring intervention components to the 
V/F dyad. In addition to psychoeducation on anxiety, how CBT works, the role of accommodation behaviors in 
maintaining anxiety and teaching alternative strategies for accommodation, AF-CBT includes modules that focus 
on improving communication and behavioral interactions between the V/F dyad. 
Persons delivering AF-CBT and iTCBT will include trained masters-level and doctoral-level clinicians working 
under the direct supervision of the PI. Co-I's Dr. Clark and Ms. Myers will lead all AF-CBT sessions. Participants 
will be closely monitored by Drs. Teng and Clark, 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. 
Due to COVID-19 pandemic, participants will have the option to receive AF-CBT and iTCBT virtually via clinical 
video telehealth (CVT). At this time, the majority of outpatient mental health care at the MEDVAMC is being 
provided via CVT modalities and all clinicians are working remotely. Clinicians will provide treatments to 
participants in this study using approved platforms (e.g., VA Video Connect, BCM Zoom for Healthcare). 
  
Section G:  Sample Size/Data Analysis 
G1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
     Local: 94              Worldwide: 94

Please indicate why you chose the sample size proposed: 
     
The sample size proposed in this study is appropriate for a feasibility trial. A total of 12 V/F dyads (24 
participants) will be recruited for Phase 1 to refine the adapted AF-CBT intervention. In Phase 2 a total of 35 V/F 
dyads (70 participants) will be recruited to determine the feasibility/acceptability of, and satisfaction with, the 
intervention. This sample size was determined based on the number of referrals CITRAS received in the past 
year and the rate of monthly Veteran enrollment (9-11 per month) in our current trial. Because this study requires 
involvement of a family member, we conservatively estimated that about half of the Veterans enrolled each 
month would be eligible for this study. Although we do not expect a high rate of attrition, the sample of 35 
accounts for 20% attrition. This ensures enough participants to provide robust feedback and will allow us to draw 
meaningful conclusions about the feasibility, acceptability, and satisfaction associated with this treatment. 
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? 
     
Specific Aim 1 involves the adaptation and refinement of AF-CBT through an iterative process, guided by two 
adaptation frameworks. Qualitative interviews involves a data-coding process will use conventional and directed 
content analysis/coding techniques. The data coding process will be divided into three steps: (1) Open Coding, in 
which Dr. Drummond and the PI independently review the recordings to identify key emerging themes; (2) Top-
Level Coding will be applied to the remaining interviews and differences will be resolved through consensus. 
New themes that emerge will be added to existing codes. (3) Sub Coding will be applied to further refine broad 
constructs represented by top-level codes into sub-categories. 
Specific Aim 2 will examine the feasibility/acceptability of, and satisfaction with, AF-CBT. Feasibility will be the 
percentage of V/F dyads who agree to participate out of the number invited to participate (benchmark of 50%). 
Retention rate will be the percentage of family members who attend both sessions of AF-CBT including the 
booster session (benchmark of 70%). Acceptability will be measured using the MTEI, in which a score > 27 
indicates the treatment was found to be acceptable. Satisfaction will be assessed through the CSQ-8, where a 
score > 25 indicates satisfaction. 
Specific Aim 3 will assess the internal validity and test-retest reliability of the FAS-A adapted for Veterans and 
their family members. Cronbach's alpha will be used to test the internal consistency of the measure and 
Pearson's r will be used to calculate test-retest correlation of the measure administered at different time points. 
An exploratory aim will use Pearson's r to examine the association between changes on the Family 
Accommodation Scale-Anxiety with changes on the CRIS45 and BAI measures. 
  
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. Clark, 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. 
As with any study, there is always a small risk for loss of confidentiality. However, study personnel will make 
every effort to minimize these risks by assigning participant numbers and storing documents with identifying 
information in password-protected files on a secured network. There are also certain situations in which study 

staff may need to break confidentiality in order to protect you or others from direct harm. These situations include 
reports of abuse or neglect of a minor or vulnerable adult and plans to harm yourself or others. Participants in 
group treatments will be informed and reminded at the beginning of sessions to maintain confidentiality of 
session content by not sharing sensitive information with other people outside of group, including family 
members. 
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. 
     
Veterans and their family members who participate in the study may experience functional and symptom 
improvement related to the Veteran's anxiety. Participants may also experience improvements in the quality of 
their relationships. 
Describe potential benefit(s) to society of the planned work. 
     
Information obtained from this pilot study will inform a larger clinical trial to evaluate the effectiveness of AF-CBT. 
Ultimately, if shown to be effective, this intervention will be among the first to incorporate family members of 
Veterans directly into the recovery process. 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? 
     Yes 
Please describe the portion of the research for which a waiver is required. (Example: chart review to determine 
subject eligibility) 
     
A waiver of HIPAA authorization is requested for the entire study AND a waiver of consent is requested to 
access medical records for eligibility screening. No written HIPAA authorization forms will be collected from 
participants. This applies to all enrolled participants because this study is being conducted remotely through 
telehealth and obtaining verbal consent for HIPAA is not permitted. 
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. 
     
This research provides a behavioral intervention to help participants better understand anxiety and learn skills to 
reduce their anxiety. Behavioral interventions are a form of psychotherapy or talk therapy, in which participants 
learn about the causes of their anxiety and practice skills (e.g., changing their thoughts) to overcome their fears. 
Thus, this research presents no more than minimal risk of harm to participants and involves no procedures for 
which written consent is normally required outside of the research context. 
Explain why the waiver will not adversely affect the privacy rights and the welfare of the research subjects. 
     
The waiver will not adversely affect the privacy rights and welfare of the research subjects because our study 
team will continue to uphold and maintain the privacy rights of participants and place their welfare above the 
needs of the study. All members of the study staff must complete privacy and HIPAA training, and we have 
standard operating procedures in place to protect our participants welfare and privacy. 

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. 
     
Since the study is being offered virtually, obtaining HIPAA consent is not possible, as HIPAA consent cannot be 
obtained remotely. The study offers a behavioral intervention to Veterans and their family members, which 
requires access to protected health information. 
Describe how the research could not practicably be carried out without using the collected identifiable biospecimens 
in an identifiable format. 
     N/A 
Describe how an adequate plan exists in order to protect identifiers from improper use and disclosure. 
     
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 VA-secured folders: (S:Reseach-
Data/Teng Lab and M:\Research-data\Teng Lab Audio\H-51655 AF-CBT Audio & Media). Only the research staff 
will be given permission (requiring a logon and password) to access these folders. 
Aside from the demographics form, data will not contain any HIPPA identifiers or other sensitive information. 
Each participant (V/F dyad) will be assigned a participant study number, which will be used to label all electronic 
data collected. A separate electronic document linking the subject number to participants' identifying information 
will be stored in a password-protected file in the PI's folder on the S drive, which is a secured server. Audio 
recordings of qualitative interviews will be reviewed by a member of the study team before transcription, and any 
identifying information will be scrubbed from the recordings. Results that are presented for publication will be 
reported in aggregate form, and therefore will not contain individual identifying information. 
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. 
     
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. 
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 consent form that will be reviewed with all participants prior to study initiation describes the procedures in 
place to ensure that PHI will not be reused or disclosed to other persons or entities unless required by law or for 
oversight of the research. All participants, including non-Veterans, will receive a copy of the VHA Notice of 
Privacy Practices via DocuSign for their review, and VA Form 10-0483, Acknowledgement of the Notice of 
Privacy Practices, for their signature. 
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 #: 

     No
Partial Social Security # (Last four digits): 
     Yes 
Billing or financial records: 
     No
Photographs, videotapes, and/or audiotapes of you: 
     No
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. 
     
The purpose of this study is to refine a behavioral intervention (in preparation for a larger study) for family 
members that can help Veterans who experience problems with anxiety. Thus, it is not anticipated that any new 
pertinent information will emerge from the study that will need to be conveyed to participants. 
  
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 Center for Innovative Treatment of Anxiety and Stress (CITRAS) is a program in the Mental Health Care 
Line that provides specialty treatment of anxiety and stress-related disorders. Providers throughout the hospital 
including MEDVAMC community based outpatient clinics refer patients directly to CITRAS through an electronic 
consult for evaluation and specialty treatment. Veterans who are referred to CITRAS for treatment by their 
healthcare providers will be contacted by a CITRAS staff member and informed of treatment options including 
the opportunity to participate in this research study. If a patient expresses interest in participating in this study, 
we will discuss the protocol with them and schedule an appointment with them and their family members to meet 
with a member of the study team to discuss the study and conduct a baseline evaluation. If a patient is not 
interested in participating in this study but would nonetheless like treatment, they will be scheduled for treatment 
as routine clinical care. 
Any member of the study staff may obtain consent from study participants. This study will include Veterans and 
family members recruited from Houston and surrounding areas. 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 all 
information in the informed consent form (see attachment in Section S), explaining the risks and benefits of 
participation. The consent form will be sent to participants via DocuSign, which has been approved for use in this 
study by VA ORD (see attachment in Section S). Standard operating procedures for how DocuSign will be used 
to obtain consent and where the electronic documents will be stored is outlined in the attachment in Section S. 
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: 
     No
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 
Identifiable biospecimens 
     No
Other: 
     No

At what institution will the physical research data be kept? 
     
This research involves electronic administration of questionnaires and will not result in any physical research 
data. All research data will be in electronic form and will be stored 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 VA-secured 
folders: (S:Reseach-Data/Teng Lab and M:\Research-data\Teng Lab Audio\H-51655 AF-CBT Audio & Media) 
and only the research staff will be given permission (requiring a logon and password) to access these folders. 
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? 
     We do not anticipate having hard copy documents containing sensitive information. However, if we do obtain 
hard copy data, we will secure them in a locked filing cabinet in a locked office (Building 108-A, Room 206). 
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 VA-secured folders: (S:Reseach-
Data/Teng Lab and M:\Research-data\Teng Lab Audio\H-51655 AF-CBT Audio & Media), and only the research 
staff will be given permission (requiring a logon and password) to access these folders. 
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): 
Electronic data will be stored on a VA secured server in the following folders: (S:Reseach-Data/Teng Lab and 
M:\Research-data\Teng Lab Audio\H-51655 AF-CBT Audio & Media) 
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 collaborators. Audio recordings will be made of qualitative interviews and 
deidentified recordings will be saved to the MEDVAMC Research folder on the M:\Research-data\Teng Lab 
Audio\H-51655 AF-CBT Audio & Media drive. Lighthouse for the Blind will transcribe the saved audio recordings 
by accessing the folder through their contractor PIV card or through receiving files via encrypted e-mail. 
Transcriptions will be saved to the VA-secured folder on the S drive. 
  
Will you obtain a Certificate of Confidentiality for this study? 
     No
Please further discuss any potential confidentiality issues related to this study. 
     N/A 
  
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. 
     Veterans and family members 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: 
     100 
Distribution Plan: 
     
Veterans will receive a payment voucher in the amount of $50 for completion of each assessment period 
(baseline and 1-month follow-up). The total amount they may receive is $100. Family members of Veterans who 
participate in the study will not receive payment for their participation as this is a VA-funded study, and payments 
are directed to Veterans. However, family members will receive a psychoeducational intervention that would 
otherwise not be available to them, free of charge. 
  
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? 
     No
  
Section P:  Device Studies 
     Does this research study involve the use of ANY device? 
         No 

  
Section Q:  Consent Form(s) 
Anxiety Treatment for Veterans with Participation from Family Members (Veteran Version) 
Anxiety Treatment for Veterans with Participation from Family Members (Family Member Version) 
  
Section R:  Advertisements 
Mode of Advertising:  Internet 
Exact language of Advertisement: 
     
(The information below will be posted on VA approved social media outlets such as Facebook and Twitter) 
Struggling with anxiety? MEDVAMC is offering a research study for Veterans and family members. Participation 
involves assessment and weekend workshops. Compensation provided for participation. If interested, send an e-
mail to CITRAS@va.gov or call (713) 791-1414 x26419. 
Mode of Advertising:  Other: Flyers, Posters, Newsletters, Electronic Message Boards 
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, and places. 
The MEDVAMC is conducting research on a new program for Veterans with anxiety that involves their family 
members. The program provides Veterans with a brief weekend treatment for anxiety and family members with a 
brief class that provides information about anxiety and teaches skills to support their loved ones. The study 
includes one follow-up visit. You may receive compensation for participating in the study. 
If you have some of the symptoms listed above and would like more information, please contact us at 
CITRAS@va.gov or (713) 791-1414 ext. 26419.