Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
Phase: NA
Conditions: Major Depressive Disorder, Persistent Depressive Disorder, Posttraumatic Stress Disorder, Panic Disorder, Social Phobia, Specific Phobia, Generalized Anxiety Disorder, Obsessive Compulsive Disorder
Sponsor: VA Office of Research and Development

1 
 
 
 
 
 
 
PI Name:  Daniel Gros, Ph.D. 
 
Study Title:   Transdiagnostic Psychotherapy for Veterans with Mood and Anxiety Disorders 
 
TABLE OF CONTENTS 
 
A. Specific Aims 
1 
B. Background and Significance 
2 
C. Preliminary Studies 
3 
D. Research Design and Methods 
5 
E. Protection of Human Subjects 
12 
 
1, Risk to Human Subjects 
12 
 
2. Adequacy of Protection against Risks 
15 
 
3. Potential Benefits of the Proposed Research to the Subjects 
16 
 
4. Importance of the Knowledge to be Gained 
16 
 
5. Subject Safety and Minimizing Risks 
16 
F. References 
16 
G. Consultants 
17 
H. Facilities Available 
17 
I. Investigator Brochure 
17 
J. Appendix 
17 
 
 
A. SPECIFIC AIMS 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cognitive behavioral therapy (CBT) is robustly effective in treating patients with depressive and anxiety 
(depressive/anxiety) disorders. CBT also is brief, cost-effective, and provides protection against relapse. 
However, access to CBT by patients is limited, in part, because the sheer number of different CBT protocols for 
specific disorders limits the extent to which providers can deliver all of these interventions with a high level of 
fidelity and competence (Barlow et al., 2004). In addition, most CBT protocols are not designed to treat patients 
with comorbidity. Together, this state of affairs suggests that there are unique opportunities to enhance outcomes 
and recovery in Veterans within the Department of Veterans Affairs (DVA). 
 
The primary goal of the proposed study is to improve outcomes in Veterans with depressive/anxiety disorders by 
testing a transdiagnostic CBT that distills the existing disorder-specific CBT protocols for emotional problems into 
a single, unified CBT protocol for all depressive/anxiety disorders. Currently, basic training in each of the disorder-
specific CBT protocols requires lengthy direct trainings, supervision, and case consultation. Completing these 
requirements across each of depressive/anxiety disorders would require several years. In addition, training in 
CBT designed for specific disorders would likely fall far short of adequately addressing comorbidity, which is 
highly prevalent and difficult to treat, particularly in Veteran populations. A transdiagnostic CBT approach would 
reduce the complexity of treatments and dramatically reduce training time and cost, possibly resulting in better 
prepared providers to address comorbidity as well as improved access to high-quality care and related outcomes 
in DVA patients.  
 
This study is designed to evaluate a transdiagnostic CBT specifically constructed to treat Veterans with 
depressive/anxiety disorders. The protocol includes both a primary transdiagnostic exposure component as well 
as supplementary disorder-specific modules to address ancillary symptoms. This transdiagnostic CBT has been 
investigated through focus groups with Veterans and two pilot demonstrations. This study will compare 
transdiagnostic CBT to an existing evidence-based version of CBT, behavioral activation therapy (BAT; 
psychotherapy control condition). A randomized controlled trial (RCT) of 96 DVA patients with depressive/anxiety 
disorders will be conducted to examine its efficacy, feasibility, and accessibility. Diagnostic interviews and self-
Medical University of South Carolina 
Protocol Version 2 (September 24, 2013) 

2 
 
report symptom questionnaires will be completed at pre-treatment, immediate post-treatment, and 6-month follow-
up assessment time points. 
 
Research Primary Aim 1: To examine efficacy of transdiagnostic CBT on reducing transdiagnostic and disorder-
specific mental health symptoms and improving quality of life at immediate post-treatment and 6-month follow-up.  
Hypothesis 1: The transdiagnostic CBT will result in significantly greater reductions in symptomatology (for 
principal and comorbid diagnoses) and improvements in quality of life compared to the BAT control condition at 
immediate post-treatment and 6-month follow-up. Although limited specific symptoms may ultimately be 
comparable across treatments (e.g., depression), the transdiagnostic CBT will demonstrate significantly greater 
reductions in the majority of symptoms (e.g., anxiety, panic, fear, stress). 
 
Research Primary Aim 2: To examine feasibility and acceptability of transdiagnostic CBT 
Hypothesis 2: The transdiagnostic CBT will be well tolerated by DVA patients as demonstrated by improved 
attendance and dropout rates, patient satisfaction questionnaires, and positive feedback in post-treatment 
patient interviews as compared to the BAT control condition. This hypothesis is based on the predicted greater 
symptom improvement (hypothesis 1) as well as the flexibility and individual tailoring of the treatment approach 
incorporated within transdiagnostic CBT. 
 
B. BACKGROUND AND SIGNIFICANCE 
 
 
 
 
 
 
 
 
 
 
Between 2001 and 2010, nearly 1.9 million U.S. service members were deployed in Operations Enduring/Iraqi 
Freedom (OEF/OIF), many returning home with psychiatric disorders post-deployment. As a result, the DVA has 
witnessed a large influx of new Veterans seeking mental health services. It is the responsibility of the DVA to 
provide quick, effective, recovery-oriented treatments to Veterans to ensure that they can return to their civilian 
lives with minimal impairment. However, this volume of new patients is making it difficult for the DVA to provide 
high quality psychosocial treatments for mental health concerns.11 
 
One priority area is the treatment of depressive/anxiety disorders, representing the most common psychiatric 
disorders in the United States (prevalence: 28% past year; 49% lifetime). Similar rates of depressive/anxiety 
disorders have been reported in Veterans. The category of depressive/anxiety disorders includes posttraumatic 
stress disorder (PTSD), panic disorder (PD), social phobia (SOC), specific phobia, generalized anxiety disorder 
(GAD), obsessive compulsive disorder (OCD), major depressive disorder (MDD), and dysthymic disorder (DD). 
Due to high rates of comorbidity within the depressive/anxiety disorders, the presence of one disorder typically is 
accompanied by several comorbid depressive/anxiety disorders, and the diagnostic (and hence treatment) 
distinction between disorders is not routinely reliable. In addition to severe occupational, educational, and social 
impairment, these disorders also are associated with elevated risk for cardiovascular disease, suicide, and 
substance use disorders in Veteran and civilian populations. Research also demonstrates high cost associated 
with depressive/anxiety disorders, including estimates that Veterans with depressive/anxiety disorders have 60% 
higher medical costs than their non-anxious/non-depressed Veteran counterparts. Together, these findings 
highlight the overwhelming burden associated with the these disorders and the daunting task of addressing them 
in the DVA. 
 
CBT has demonstrated reliable efficacy in treating depressive/anxiety disorders. CBT involves several different 
evidence-based treatment components that are typically delivered over the course of 10-20 weeks. Although CBT 
is a short-term intervention, the benefits of CBT typically persist following the termination of treatment, with long 
term studies demonstrating maintenance of treatment effects at least two years after treatment ends. Another 
benefit of CBT is its impact on the financial burden associated with the depressive/anxiety disorders. 
Psychosocial interventions, including CBT, significantly reduce the long-term medical costs in patients with 
depressive/anxiety disorders. Together, these findings support the effectiveness of CBT as well as its many 
additional benefits in promoting long-term recovery in patients. 
 
Despite its clear benefits, several limitations exist in the current delivery of CBT. One of the most significant 
limitations is the sheer number of different manualized CBT protocols, representing a major obstacle to providers 
through separate manuals and workbooks for each disorder, each with significant direct costs and time and 
training requirements. In addition, indirect costs also can be a significant hurdle for both providers and facilities 
(e.g., loss of revenue during training activities). Standard workshops for disorder-specific, evidence-based 
psychotherapies typically involve substantial commitment from providers. Only a small number of workshops are 
available per year and typically require out-of-town travel, representing a significant burden on providers, 

3 
 
especially if training is needed for more than one disorder (e.g., 6-12 month commitment per treatment per 
disorder), and these types of trainings are only available for specific disorders. In fact, Dr. David Barlow – one of 
the leaders in the development and dissemination of CBT – has argued that, "unless these treatments become 
more 'user-friendly' as recommended (by a recent NIMH task force), it is unlikely that most non-research clinicians 
will have a sufficient understanding of, or access to these empirically supported techniques for the 
depressive/anxiety disorders (Barlow et al., 2004)." This notion has been echoed by other CBT experts, 
suggesting less complicated treatments and related training requirements would be more easily disseminated.  
 
In contrast to the lengthy training necessary for the disorder-specific CBT protocols, a shift to a transdiagnostic 
CBT protocol for depressive/anxiety disorders would eliminate much of the unnecessary procedures, time 
commitment, and financial burden from therapists and the DVA. Transdiagnostic treatments are based on the 
notion that various disorder-specific CBT protocols contain important but overlapping treatment components that 
can be distilled into a single treatment and therefore address the symptoms and comorbidities across all of the 
disorders at once (Norton, 2009). This notion is most true of the depressive/anxiety disorders in which a large 
number of overlapping symptoms and related components of CBT exist. The transdiagnostic approach to the 
depressive/anxiety disorders represents a major shift in philosophy regarding application of evidence-based 
psychotherapy to specific symptoms after decades of developing scores of disorder-specific treatments. This 
approach aims to simplify treatment of the depressive/anxiety disorders by combining the shared/overlapping 
treatment components into a single treatment for the entire class of disorders. Transdiagnostic treatments would 
greatly reduce the training burden on providers as only one protocol would be needed for the depressive/anxiety 
disorders, rather than separate protocols for each separate disorder. In addition, because transdiagnostic 
treatments are designed to address multiple depressive/anxiety disorders at once, they are fully able to address 
the needs of patients with comorbidities without requiring providers to successfully identify and implement multiple 
treatment protocols. This transdiagnostic approach to comorbidity is in contrast to disorder-specific treatments 
that focus solely on the treatment components designed for their specific disorder. Together, these findings 
suggest that developing, evaluating, and implementing transdiagnostic treatments for multiple depressive/anxiety 
disorders and comorbidities would greatly reduce the number of protocols, costs, and trainings necessary for 
providers, thereby improving their acceptability and availability to their patients and, importantly, improving 
outcomes in DVA patients. 
 
A small number of transdiagnostic treatment approaches have been proposed for the depressive/anxiety 
disorders (Norton, 2009). Although still in development and preliminary evaluation, early outcomes suggest that 
transdiagnostic approaches can be delivered efficaciously across the depressive/anxiety disorders, with 
moderate-to-high effect sizes (Farchione et al., 2012; Norton, 2012; Schmidt et al., 2012). Because 
transdiagnostic CBT approaches have the potential to address numerous barriers to accessibility and delivery of 
evidence-based care as discussed earlier, these initial findings are very encouraging. However to date, no 
transdiagnostic CBT protocols have been developed for or studied in Veterans. 
 
The proposed investigation seeks to study a transdiagnostic CBT protocol for Veterans with depressive/anxiety 
disorders. The current status of psychosocial treatment for the eight depressive/anxiety disorders targeted in this 
study necessitates that providers receive specific comprehensive training in eight or more distinct CBTs focused 
on specific disorders, rather than the more common comorbid presentations of the disorders. The transdiagnostic 
CBT proposed for evaluation in this study has the potential to reduce the training burden tremendously, and also 
has the potential to achieve superior outcomes with regard to comorbid depressive/anxiety disorders because the 
intervention is designed specifically to address the disorders with and without comorbidity. This integrated 
treatment incorporates evidence-based practices for each of the included disorders, tailoring treatment to 
Veterans through the completion of OEF/OIF Veteran focus groups and initial piloting in VAMC patients with 
depressive/anxiety disorders. The treatment aims to improve recovery of VAMC patients with depressive/anxiety 
disorders by reducing mental health symptoms and improving quality of life. If efficacious, this treatment will have 
the potential to reduce VAMC provider-training burden and associated costs and improve the quality of care 
provided to VAMC patients with depressive/anxiety disorders by improving access to CBT. 
 
 
C. PRELIMINARY STUDIES 
 
 
 
 
 
 
 
 
 
 
 
 
Initial Demonstration of Transdiagnostic Protocol 
Fifteen VAMC patients were recruited over a 6-month period through the CBT Clinic at the Ralph H. Johnson 
(RHJ) VAMC to complete the treatment within standard clinical psychotherapeutic practices at the VAMC. All 

4 
 
participants referred to this clinic already have expressed interest in receiving psychotherapy; and, thus, none of 
the 15 invited participants refused to participate in treatment. All participants were diagnosed with multiple 
comorbid depressive/anxiety disorders and reported severe, pre-treatment symptoms of anxiety and depression. 
PTSD was the most common presenting problem (46.6% PTSD, 26.7% SOC, 26.7% PD, 7.1%) and MDD was 
the most common comorbid disorder (64.2% MDD, 14.3% SOC, 7.1% PTSD, 7.1% PD). In general, participants 
were stabilized on multiple psychotropic medications prior to beginning CBT. Twelve of the fifteen participants 
finished treatment (80.0%). Treatment completers attended an average of 11.5, 50-minute sessions. As 
presented in the table below, participants demonstrated significant improvements in symptoms of 
impairment/quality of life, depression, stress, anxiety, and PTSD across all disorders and comorbidities. These 
findings provide preliminary support for the feasibility of a structured, transdiagnostic CBT protocol for the 
depressive/anxiety disorders among VAMC patients. 
 
Efficacy of Initial Transdiagnostic CBT in VAMC Patients  
 
 
Scale (n) 
Pre 
Post  
t (p) 
Effect Size 
 
 
IIRS-Impairment (12) 
66.0 (14.9) 
41.2 (19.8) 
6.4 (< .001) 
1.42 
PTSD Checklist (7) 
56.1 (13.1) 
37.0 (14.0) 
5.6 (< .01) 
1.41 
DASS-Depression (12) 
26.2 (10.8) 
10.3 (10.3) 
5.3 (< .001) 
1.51 
DASS-Anxiety (12) 
25.2 (10.7) 
11.8 (9.1) 
5.5 (< .001) 
1.35 
DASS-Stress (12) 
26.3 (10.8) 
15.7 (9.6) 
3.6 (< .01) 
1.04 
 
Note. Sum scores reported as means (standard deviations). Cohen’s ds used for effect sizes.  
 
Focus Group with OEF/OIF Veterans 
The second step of the development of the transdiagnostic CBT protocol involved focus groups with OEF/OIF 
Veterans. These focus groups were designed to assess Veterans' opinions and interests in CBT, transdiagnostic 
CBT, and online transdiagnostic CBT. Feedback was received from four focus groups with a total of 16 Veterans 
(15 males; 1 female) who were recruited through the RHJ VAMC. Feedback could be summarized in three 
primary themes. First, participants identified symptoms of depression, anxiety, and PTSD as the most relevant to 
OEF/OIF Veterans. Participants also identified several additional symptoms (e.g., anger, sleep, hypervigilance, 
drinking to cope) that they labeled as secondary to depression, anxiety, and PTSD. Second, participants 
suggested that brief, straight-forward approaches to treatment were needed with clear objectives, assignments, 
and feedback. Participants noted that the core components should be presented early in the treatment to facilitate 
faster improvements. Third, participants suggested that treatments should include components to address and 
improve patient motivation to improve participation and assignment completion. Although several of these findings 
were predicted from the previous literature, together, these findings provided additional support for the direction of 
the transdiagnostic CBT protocol and highlighted areas of further revision/improvement. 
 
Demonstration of Revised Transdiagnostic Protocol 
The results from the initial demonstration and OEF/OIEF Veteran focus groups were used to inform the revisions 
of the transdiagnostic CBT protocol. Once the revised protocol was complete, a demonstration of the revised 
transdiagnostic CBT protocol was initiated, once again, within standard clinical psychotherapeutic practices at the 
VAMC. The methods of the second demonstration were largely identical to the first demonstration. Thirty-one 
VAMC patients were recruited to complete the treatment. All participants were diagnosed with multiple comorbid 
depressive/anxiety disorders and reported severe pre-treatment symptoms. Among the twenty-three treatment 
completers, PTSD was the most common principal diagnoses (39.1% PTSD, 26.1% MDD, 21.7% PD, 8.7% SOC, 
and 4.3% OCD) and MDD was the most common comorbidity (43.5% MDD, 26.1% PTSD, 8.7% drug/alcohol 
abuse, 4.3% PD, 4.3% SOC). Treatment completers attended an average of 11.8, 45-60 minute sessions. As 
presented in the table below, participants demonstrated significant improvements in symptoms of 
impairment/quality of life, depression, stress, anxiety, and PTSD across all disorders and comorbidities. These 
findings provide additional support for the feasibility and likely efficacy of the transdiagnostic CBT protocol for the 
depressive/anxiety disorders among VAMC patients. 
 

5 
 
Efficacy of Revised Transdiagnostic CBT in VAMC Patients  
 
 
Scale (n) 
Pre 
Post  
t (p) 
Effect Size 
 
 
IIRS-Impairment (23) 
64.3 (13.1) 
37.3 (17.6) 
7.3 (<.001) 
1.74 
PTSD Checklist (22) 
56.5 (17.8) 
33.7 (14.2) 
7.2 (< .001) 
1.42 
DASS-Depression (23) 
12.0 (6.1) 
4.8 (4.3) 
6.7 (< .001) 
1.36 
DASS-Anxiety (23) 
10.9 (5.4) 
5.0 (3.5) 
6.2 (< .001) 
1.30 
DASS-Stress (23) 
13.8 (5.1) 
7.0 (3.9) 
6.1 (< .001) 
1.50 
 
Note. Sum scores reported as means (standard deviations). Cohen’s ds used for effect sizes. 
 
 
D. RESEARCH DESIGN AND METHODS 
 
 
 
 
 
 
 
 
  
 
Project Timeline 
 
 
Project Component 
 
Year  
 
Timeframe 
 
 
Preparing for RCT 
 
Y01 
 
month 01 – 06 
 
Hiring staff 
 
Y01 
 
month 01 – 03 
 
Training on procedures/protocols 
 
Y01 
 
month 03 – 06 
 
Advertising upcoming trial for recruitment 
Y01 
 
month 03 – 06 
Randomized controlled trial 
 
Y01-Y04 
 
month 06 – 54 
 
Recruitment and active treatment 
 
 
 
month 06 – 45 
 
Ongoing data entry and integrity/fidelity reviews 
 
 
month 09 – 42 
 
Data analyses of post-treatment (follow-up) 
 
 
month 24 – 54 
 
Grant application(s) (e.g., DVA CSR&D Merit) 
Y04-Y05 
 
month 36 – 60 
Dissemination of findings 
 
Y05 
 
month 54 – 60 
Revision of manual based on findings/feedback 
Y05 
 
month 54 – 60 
 
 
RCT of Transdiagnostic CBT 
Objective  
To evaluate the transdiagnostic CBT in a RCT of VAMC patients with depressive/anxiety disorders by 
investigating its preliminary efficacy in reducing symptomatology, comorbidity, and improving quality of life 
compared to BAT (psychotherapy control condition) at immediate post-treatment and 6-month follow-up. Patient 
satisfaction and predictors of feasibility (attendance and dropout) also will be assessed.  
 
Recruitment Strategy  
VAMC patients will be recruited through the Primary Care – Mental Health Integration program and CBT Clinic at 
the RHJ VAMC. Within these programs, all VAMC patients reporting symptoms of depression and anxiety meet 
with a mental health staff member to complete a diagnostic interview and self-report measures as part of their 
standard clinical practices. If VAMC patients endorse symptoms consistent with a depressive/anxiety disorder, the 
patient's interest in participating in research will be assessed and, if agreeable to research, patients will be put in 
contact with research staff (same day meeting and/or follow-up phone to schedule research assessment). A 
research assessment will be completed with the project staff to first complete consent documentation and then 
assess inclusion/exclusion criteria (with a targeted sample of 96 VAMC patients; > 72 completers), including a 
semi-structured clinical interview and self-report questionnaires focused on the psychiatric symptoms and quality 
of life (described later). Participants who meet diagnostic criteria for the targeted disorders will be randomized into 
a study condition, and will be assigned to a project therapist. Because most VAMC patients who meet study 
criteria likely will present with multiple depressive/anxiety disorders, principal diagnosis, or the most impairing of 

6 
 
the diagnosable disorders, will be used to select patients for participation. To balance diagnoses across the two 
conditions, a stratified random assignment based on principal diagnosis will be used for the most common 
principal diagnoses (MDD, PTSD, and PD). Based on new patient consults at the RJH VAMC (i.e., nearly 1000 in 
2011 with at least one-half presenting with symptoms of an depressive/anxiety disorder), it is expected that >50% 
of the recruited VAMC patients will have served in OEF/OIF and >33% will be representative of minority groups. 
 
Eligibility Criteria  
Inclusion criteria involve: 1) participants must be clearly competent to provide informed consent for research 
participation; 2) participants must meet DSM diagnostic criteria for a principal diagnosis of a depressive/anxiety 
disorder (PD, PTSD, SOC, OCD, GAD, specific phobia, MDD, or DD); and 3) participants must be 18 – 80 years 
old. Exclusion criteria involve: 1) recent history (< 2 months) of psychiatric hospitalization or a suicide attempt 
as documented in their medical record, 2) current diagnosis of substance dependence or abuse on the structured 
clinical interview, 3) acute, severe illness or medical condition that likely will require hospitalization and/or 
otherwise interfere with study procedures as documented in their medical record (e.g., active 
chemotherapy/radiation treatment for cancer, kidney dialysis, oxygen therapy for chronic obstructive pulmonary 
disease), 4) recent start of new psychiatric medication (< 4 weeks), 5) diagnosis of traumatic brain injury (TBI) in 
their medical record and/or endorsement of screener questionnaire regarding the symptoms of TBI modified from 
the Post-Deployment Health Assessment employed by the Department of Defense, or 6) diagnosis of 
schizophrenia, psychotic symptoms, personality disorder, and/or bipolar disorder. VAMC patients excluded due to 
these factors will be reconsidered for participation once the condition related to their exclusion is resolved or 
stabilized. Together, these inclusion/exclusion criteria should allow the vast majority of interested VAMC patients 
with depressive/anxiety disorders to be eligible to participate. Ineligible VAMC patients will be referred for non-
study-related treatments within mental health at the RHJ VAMC. 
 
Procedures  
Eligible VAMC patients will be randomized into one of two treatment conditions: transdiagnostic CBT or an 
existing evidence-based version of CBT (BAT). Both treatment conditions will include 12-16 weekly 45-60-minute 
individual psychotherapy sessions. The total number of sessions will vary slightly depending on participant needs 
and progress during therapy, as is common in most CBT approaches to psychotherapy (and will serve as a 
covariate in the outcome analyses). The general format of sessions will involve: 1) brief check-in; 2) review of 
materials from previous sessions; 3) review of homework assignments; 4) overview of new materials and in-
session exercises; and 5) assignment of homework for next session. Attendance and homework completion will 
be recorded. A full battery of self-report questionnaires and a diagnostic interview will be completed pre-
treatment, post-treatment, and at the 6-month follow-up to track participants’ progression through treatment and 
maintenance. Post-treatment participant interviews will be completed at immediate post-treatment and 6-month 
follow-up to collect feedback on participants’ perspectives on the treatments. 
 

7 
 
Table of Procedures for Each Visit – Summarized Across Treatment Conditions 
 
 
Week Content 
Assessment Summary 
 
 
1 
Pre-Treatment Assessment 
Clinical interview & self-report battery (7 measures) 
 
2 
Session 1: Psychoeducation 
Brief self-report battery (3 measures) 
3 
Session 2: Treatment planning 
4 
Session 3: Introduction to behavior therapy 
Brief self-report battery (3 measures) 
5 
Session 4: Behavior therapy 
6 
Session 5: Behavior therapy 
Brief self-report battery (3 measures) 
7 
Session 6: Behavior therapy 
8 
Session 7: Behavior therapy 
Brief self-report battery (3 measures) 
9 
Session 8: Behavior therapy 
10 
Session 9: Behavior therapy 
Brief self-report battery (3 measures) 
11 
Session 10: Behavior therapy 
12 
Session 11: Behavior therapy 
Brief self-report battery (3 measures) 
13 
Session 12: Behavior therapy 
14 
Session 13: Behavior therapy (as needed) 
Brief self-report battery (3 measures) 
15 
Session 14: Behavior therapy (as needed) 
16 
Session 15: Behavior therapy (as needed) 
Brief self-report battery (3 measures) 
17 
Session 16: Relapse prevention (as needed) 
 
~18 
Post-Treatment Assessment  
Clinical interview, immediate treatment interview, &  
 
 
self-report battery (7 measures), treatment satisfaction 
 
 
~33 
6-Month Follow-Up Assessment 
Clinical interview, immediate treatment interview, &  
 
 
self-report battery (7 measures), treatment satisfaction 
 
 
Note. Behavior therapy involves the introduction, teaching, in-session and between-session practice, and mastery 
of behavioral therapeutic techniques designed to improve symptoms of depression and anxiety, including 
behavioral activation (BAT group) as well as situational, physical, thought, and emotional exposures 
(transdiagnostic CBT group). Final treatment session will take place between sessions 12-16, as determined by 
provider and participants’ collective decision. Final treatment session will involve relapse prevention content. 
Post-treatment assessment will be completed 1 week immediately after final treatment session. 6-month follow-up 
assessment will be completed 6-months after final treatment session. 
 
Randomization Procedures 
Participants will be randomly assigned (1:1) to one of the two study arms (n = 48 per arm) using a permuted block 
randomization procedure. Randomization will be stratified by principal diagnostic group and block size will be 
varied to minimize the likelihood of unmasking. After determining eligibility and completing consent and baseline 
assessment materials, enrolled participants will be assigned to treatment groups by the Project Research 
Assistant using a computer generated randomization scheme. Once a participant is randomized and attends the 
first session, they will be included in the intent-to-treat analysis. Randomization will occur at the participant level. 
As such, we will take the following steps to minimize contamination between the two arms of the study: 1) only 
one member of a household will be eligible for enrollment; and 2) other VAMC providers will be informed of their 
patients’ participation in the study, but will be blinded to the treatment condition of their patients. 
 
Transdiagnostic CBT Treatment Condition 
As noted above in the Preliminary Studies section, a transdiagnostic CBT protocol was developed and revised 
through two demonstration studies and one focus group. The resulting protocol involves several primary 
components, including psychoeducation on the symptoms of depression and anxiety (session 1), assessment of 
motivation and setup of treatment plans (session 2), exposure therapy (sessions 3-15), and relapse prevention 
(final session). In addition to these primary components, optional modules are included to supplement exposure 

8 
 
therapy later in treatment to address secondary symptoms (e.g., anger, sleep, hypervigilance, drinking to cope). 
The goal of these modules is to allow providers to tailor treatment to specific symptoms that may be present in 
any single or set of diagnoses that may be reducing the effects from the primary exposure approach. Session will 
be weekly for 45-60 minutes with homework assignments to be completed between sessions. 
 
BAT Control Condition 
To provide an evidence-based comparison for the transdiagnostic CBT condition, a second group of participants 
will receive manualized BAT. BAT is a well-established form of CBT that is based on early behavioral models that 
suggest that decreases in positively reinforcing healthy behaviors are associated with the development of 
negative affect. In general, BAT involves teaching patients to monitor their mood and daily activities with the goal 
of increasing pleasant, reinforcing activities and reducing unpleasant events. BA is a brief treatment, can be 
administered in either individual or group formats, and has demonstrated reliable effectiveness across a wide 
range of university, community, civilian and Veteran clinical samples with depression. BAT also has been shown 
to be effective in the treatment of PTSD and other related depressive/anxiety disorders in Veterans. In the present 
study, the BAT condition will be manualized, following an existing protocol in the literature. BAT will be structurally 
equivalent to the transdiagnostic CBT with the same session length (45-60 minutes), frequency of sessions 
(weekly), duration of treatment (12-16 sessions), and amount of homework.  
 
Treatment Training and Fidelity 
All therapy will be delivered by a Project Masters-Level Therapist, trained and supervised by the Principal 
Investigator (Dr. Gros). Training of treatment staff will involve mastery of the two treatment protocols, completion 
of two practice participants for each protocol, and review of all practice sessions by Principal Investigator in order 
to assess/minimize therapist drift between the two protocols. Consistent with other well-designed treatment 
outcome studies, all treatment sessions will be audio recorded with 20% of sessions randomly selected for review 
for treatment integrity and fidelity. These integrity and fidelity reviews will focus on evaluating the match between 
the treatment manuals and the material covered in session (e.g., treatment components introduced/reviewed, in 
session exercise, and homework assigned). To evaluate adherence, rating forms will be developed by the 
Principal Investigator and based upon the treatment manuals to determine if the therapist appropriately covered 
the content of each session (i.e., demonstrated the particular behavior described in each item). These rating 
forms use 7-point Likert scale response formats, and are modeled after the therapist rating forms used in other 
studies of CBTs. Staff will be recruited and trained and then asked to rate the recordings independently to allow 
for the computation of inter-rater reliability. If participants request changes to their mental health medications at 
any time during the treatment, a medication consult will be completed with their existing providers within the RHJ 
VAMC (e.g., Dr. Steve Byrd for patients recruited from Primary Care Mental Health Integration program ) with 
changes in medications recorded for inclusion in the analyses as a possible covariate. 
 
Assessment of Mental Health Symptoms, Quality of Life, and Treatment Satisfaction 
The full battery of self-report questionnaires and a diagnostic interview will be completed pre-treatment, 
immediate post-treatment, and at the 6-month follow-up to track participants’ progression through treatment and 
maintenance. These time points for the assessments are consistent with CBT research with Veterans with 
depressive/anxiety disorders. To reduce the likelihood of missing data, all assessments will be scheduled 
separately from normal treatment sessions (intake appointment, one week following the final treatment session, 
and at 6-month follow-up). Additional staff training will be required prior to administration of the diagnostic 
interview. All assessments will be completed by the Project Research Assistant. All assessment staff will be 
required to observe the Principal Investigator administer the test twice and then administer the test twice 
themselves under the direct observation of the PI. All assessment staff will be blinded to treatment condition and 
supervised by the Principal Investigator. Assessments will be recorded to investigate inter-rater reliability. In 
addition to the pre- and post-treatment and follow-up assessments with the full battery, a brief assessment 
involving a few self-report measures (e.g., Depression Anxiety Stress Scales, Illness Intrusiveness Rating Scale, 
and State-Trait Inventory for Cognitive and Somatic Anxiety) will be completed biweekly to monitor symptoms 
during the course of treatment. 
 
Albany Panic and Phobia Questionnaire (APPQ). The APPQ is a 27-item self-report measure that assesses 
agoraphobia, social anxiety, and interoceptive avoidance. Each subscale has been shown to have good internal 
consistency (αs > .85) and temporal stability (rs > .87). 
 
Anxiety Disorder Interview Schedule-5 (ADIS-5). The ADIS-5 is a well-established, semi-structured interview 
designed to assess a wide range of Axis I disorders. The ADIS-5 assesses current and past diagnoses with DSM 

9 
 
diagnostic criteria, severity scores, and lists of feared and avoided situations for the anxiety disorders. The ADIS 
has demonstrated excellent inter-rater reliability and validity of depressive/anxiety disorder diagnoses. 
 
Depression Anxiety Stress Scales 21-Item Version (DASS). The DASS is a 21-item measure with three subscales 
designed to assess dysphoric mood, fear and autonomic arousal, and tension and agitation. The factor structure, 
reliability, and validity of the subscales have been supported in the literature. The DASS scales also have 
demonstrated excellent convergence with similar measures of depression and anxiety and high internal 
consistency ( > .85).  
 
Illness Intrusiveness Ratings Scale (IIRS). The IIRS is a 13-item questionnaire that assesses the extent to which 
a disease interferes with important domains of life, including health, diet, work, and several others. Each item is 
rated on a 7-point Likert scale, ranging from 1 to 7, and summed to compute the scale score. The IIRS has been 
shown to have high internal consistency in the previous literature and present study (α = .88). 
 
Multidimensional Assessment of Social Anxiety (MASA). The MASA is a 38-item self-report measure that was 
designed to assess trait symptom dimensions consistent with the hybrid model of social anxiety. The 
psychometric properties of the MASA are supported in the literature, including its factor structure, convergent and 
discriminant validity, test-retest reliability, and internal consistency. The internal consistency was found to be 
acceptable for each of the scales in the present study (αs > .71). 
 
Mini International Neuropsychiatric Interview (MINI). The MINI is a structured diagnostic interview designed to 
provide a brief, but accurate, assessment of a wide range of Diagnostic and Statistical Manual (DSM-IV) 
psychiatric disorders, including the mood disorders, anxiety disorders, and substance use disorders. The MINI 
has demonstrated adequate inter-rater and test-retest reliability across most disorders, and specifically has shown 
good inter-rater reliability with a GAD SCID diagnosis (κ = 0.7). DSM-IV diagnostic criteria, including hierarchy 
rules, were used to establish diagnoses. 
 
PTSD Checklist (PCL). The PCL is a 17-item measure designed to assess PTSD symptom severity related to 
military/combat-related trauma. Respondents are presented with 17 specific symptoms of PTSD and asked to rate 
"how much you have been bothered by that problem in the last month" on a 5-point Likert scale, ranging from 1 
(not at all) to 5 (extremely). The PCL has been shown to have excellent internal consistency in veterans, victims 
of motor vehicle accidents, and sexual assault survivors (αs > .94) and excellent test-retest reliability in veterans 
(r = .96). In addition, the PCL has demonstrated excellent convergent validity with alternative measures of PTSD 
(rs range from .77 to .93). Due to the PCL's focus on DSM-IV diagnostic criteria, a revised PCL for DSM-5 criteria 
will be included when made available by the authors. 
 
Satisfaction with Therapy and Therapist Scale – Revised (STTS-R). The STTS-R assesses patients’ level of 
satisfaction with their therapeutic experiences. The STTS-R contains 12 items that represent two subscales: 
satisfaction with therapy and satisfaction with therapist. The measure has been investigated in a large sample of 
patients receiving group CBT for depressive/anxiety disorders. The two subscales have demonstrated excellent 
internal consistency (s > .88) and high positive correlations with indicators of successful treatment outcome. 
 
State-Trait Inventory for Cognitive and Somatic Anxiety – Trait Version (STICSA-Trait). The STICSA-Trait is a 21-
item measure that assesses trait cognitive and somatic anxiety. The cognitive and somatic subscales have been 
supported in the literature and both subscales have high internal consistency (s > .87). In addition, the STICSA-
Trait scale was found to remain stable over repeated administrations during several stress manipulations (rs > 
.65). 
 
Veterans Short-Form Health Survey (V/SF-36). The V/SF-36 is a 36-item measure designed to assess functional 
health, well being, and quality of life in Veterans, and can be scored to produce two primary subscales for 
physical health and mental health. The V/SF-36 was adapted from the original SF-36, which has received 
extensive support in the literature. 
 
Post-treatment Participant Interviews (immediate post-treatment & 6-month follow-up) 
It is essential that the transdiagnostic CBT is agreeable to VAMC patients. Thus, structured interviews will be 
completed with participants at post-treatment and 6-month follow-up to evaluate the presentation, format, and 
active components of the treatment. The two time points will assess participants immediate (post-treatment) and 

10 
 
delayed (6-month follow-up) reactions to treatment. The interview methodology allows for the acquisition of data 
through open discussion of predetermined topics as facilitated by the interviewer. Interviews will be conducted by 
the Project Research Assistant and will follow pre-determined areas of discussion. The discussion will use open-
ended questions, including follow-up probes and examples. These 30-60 minute interviews will be completed with 
all participants that completed the treatment in the transdiagnostic CBT condition. Interviews will be audio 
recorded for transcription and interviewers also will keep notes on the discussion.  
 
The following are elicitation questions that will be discussed in the interviews:  
1. What did you think about the treatment? What do you like about it? What don’t you like?  
2. What aspects of the treatment did you find to be most helpful and why? 
3. Would you recommend this treatment to other Veterans with similar problems with anxiety/depression? If 
so (or if not), why? 
4. Are there any additional things that should be included in the treatment that were not discussed?  
 
At the completion of the interviews, all audio recordings and facilitator notes will be transcribed by the project 
staff. The overarching goal of the analysis of these data is to identify a set of thematic categories and to assign 
these categories to higher-order categories to provide a clear picture of the data. Multiple steps will be involved in 
the analysis of the data: 
 
1. Narrative descriptions. Specific sections and quotes from the narratives will be carefully selected as 
exemplars of the content to characterize the general feel of the data. 
2. Content analysis. This step involves the identification of relevant examples, themes, and patterns in the 
data. The data will be organized and reviewed by the project team to first develop thematic categories for 
the relevant quotes and then eventually come to consensus about the themes. The content analysis is 
based the expectation that important insights will emerge through the evaluation from several different 
perspectives. 
3. Inductive analysis. The project team will further group the identified themes into categories that are based 
on information that was obtained from participants (indigenous typologies) and categories observed by 
the project staff, but not directly articulated by participants (analyst-constructed typologies). 
4. Logical analysis. Cross-classification process/outcomes matrices will be developed from the categories 
developed in the previous steps. 
 
Payment to Participant: 
Participants will be compensated $10 for completing the self-report questionnaire packet and $10 for completing 
the interviews for each of the 3 assessment periods (pre-treatment, immediate post-treatment, 6-month post-
treatment) for a total of $60. Payment is not contingent on completing the entire questionnaire packet and/or 
interview; rather, participants still will be compensated $10 if they begin either the questionnaire packet or the 
interviews but choose not to complete them fully. A check will be mailed to the address provided by participants 
after they complete each phase of the assessment (pre-treatment, immediate post-treatment, 6-month post-
treatment). This process will likely take appropriately 30-60 days. 
 
Data Entry and Management  
All data collected for this study will be specifically collected for research purposes and will not be used for any 
other purpose. The study database will be maintained in a password-protected system with access limited to 
authorized members of the research team. Other authorized persons, such as regulatory authorities, also may 
have access to these records. Regarding security, data will be stored on computers that are password protected, 
on a secure VAMC server, behind the VAMC firewall, and access is logged. All privacy obligations under the 
Health Insurance Portability and Accountability Act (HIPAA) will be met. During assembly of the final research 
database, all participants will be given a study identification. Participant information always will be treated as 
confidential. The study database will be maintained in a password-protected system with access limited to the 
Principal Investigator and/or authorized members of the research team. 
 
Our software (logical) security policy has three main components: 1) VAMC standard antiviral protection; 2) 
password policies; and 3) additional level of firewall protection. The National DVA maintains firewall protection. 
The backup schedule at the RHJ VAMC consists of fully-verified daily backups. The backup tapes, which are in 
current rotation, are stored locally. 
 

11 
 
All data will be entered into an SPSS database. The SPSS database will be created by the Principal Investigator 
and research assistant will be responsible for all data entry. Data quality and consistency checks (e.g., data range 
checks) will be integrated as part of the data entry procedure. Data quality will be monitored and assured in 
several ways: 1) as reported; and 2) as entered into the study database. For the former, all hardcopy data forms 
will be visually inspected by project staff prior to data entry. Furthermore, a manual comparison of randomly 
selected data hardcopy forms with data output generated from the SPSS database will be performed, and 
consistency checks will be generated as part of routine data cleaning procedures. All hardcopies of the data files 
will be stored in a locked file cabinet behind a locked door in the PI’s office at the RHJ VAMC (B530). Hardcopies 
of the data will be destroyed/shredded at five years after the completion of the study. 
 
Analysis Plan – Treatment Outcome Symptomatology and Feasibility 
 
Preliminary Descriptive Analyses  
Univariate descriptive statistics and frequency distributions will be calculated as appropriate for all relevant 
variables to identify potential departures from distributional assumptions of proposed analyses. If necessary, 
appropriate data transformations will be applied, or alternative analysis procedures (e.g., nonparametric) will be 
used. Baseline values for demographic and symptom variables will be described via frequency distributions for 
categorical variables, measures of central tendency (mean, median), and variability for the total sample and within 
race groups. The baseline variables will be compared between intervention groups using t-tests (or Wilcoxon rank 
sum tests) for continuous outcomes and chi-square (or Fisher’s Exact Test) for categorical variables. 
 
Missing Data  
The full intent to treat (ITT) analysis set will comprise all randomized participants. Missing data in the full analysis 
set will occur if participants drop out prior to the end of the study. Participants will not be discontinued from the 
study because of non-adherence and all will remain in the study unless consent is withdrawn or if there are 
concerns regarding participant safety. Missing data for the ITT analysis set will be imputed using multiple 
imputation methods. The results of analyses using study completers and protocol adherers (completer and per-
protocol analyses) will be compared with results using the ITT analysis set to test sensitivity of study conclusions 
to study drop-outs and protocol non-adherence. In addition, the information on dropout proportion will be used as 
one of the outcome measures of intervention feasibility.  
 
Efficacy (Symptomatology & Quality of Life) Measures Analyses (Primary Aim 1)  
The continuous measures of intervention efficacy and quality of life are APPQ, DASS, IIRS, MASA, PCL, 
STICSA, and V/SF-36. The primary outcome time point is at the end of the active intervention phase (immediate 
post-treatment) and the secondary time point is at the end of the naturalistic 6-month follow-up period. The 
difference in mean change from baseline to end-of-active intervention (effect sizes) for transdiagnostic CBT 
versus BAT control condition will be estimated via 95% CI. For the secondary time-point analyses, transdiagnostic 
CBT versus BAT control differences in change from immediate end-of-intervention to the 6-month follow-up will 
also be estimated using 95% CI. By assessing the magnitude of the between-intervention-group differences, as 
described by the CI, clinicians can judge whether the novel intervention provides sufficient improvement in these 
outcomes to suggest a clinically significant result that warrants further investigation. 
 
In preliminary hypothesis testing, efficacy outcome variables will be compared using the generalized linear mixed 
models (GLMM) approach. This approach provides a general framework that accommodates a wide range of data 
types (continuous, ordinal, dichotomous, categorical, count) and distributional assumptions (e.g. Gaussian, 
Binomial, Poisson) and accommodates repeated measures, covariate structure among repeated observations, 
and missing data. In the first set of primary hypothesis testing analyses, immediate post-treatment scores for each 
outcome of interest will be used (separately) as the dependent variable in the model, intervention (transdiagnostic 
CBT versus BAT control) will be included as the primary independent variable, and pre-treatment scores for the 
outcome of interest will be added as covariates. When approximate normality is assumed, GLMM reduces to a 
general linear models (GLM) approach which, in the simplest case (intervention as the primary independent 
variable with baseline level of outcome variable as covariate), is equivalent to a comparison of change from 
baseline scores for transdiagnostic CBT versus BAT control using an independent sample t-test. Additional 
covariates (e.g. age, number of psychiatric comorbidities, race, sex, combat theatre, and number of treatment 
sessions) will be added to the model to adjust for putative confounding variables. If intervention differences in 
other baseline variables are found in initial descriptive analyses, these variables will be also be added to the 
multivariable model. In secondary analyses, the modeling procedure will be repeated for the period between 
immediate post-treatment and 6-month follow-up. Given that we are seeking preliminary evidence of treatment 

12 
 
efficacy (to justify the next step in this line of research), there will be no adjustment for multiple outcomes or time 
points to avoid an overly conservative approach at this preliminary stage.  
 
Feasibility and Acceptability Analyses (Primary Aim 2) 
Measures of feasibility and acceptability are dropout proportions (dropout y/n), proportion of sessions attended, 
proportion of homework assignments completed, and patient satisfaction scores on the STTS-R. 95% CI for 
proportions will be used to estimate the proportion of participants who exit the study prematurely (drop out) within 
each intervention group and the difference in dropout proportions between the intervention groups. For the 
treatment satisfaction and adherence outcomes (STTS-R, proportion of missed sessions or homework 
assignments), the median and mean responses will be obtained within and between each intervention group. 95% 
CI for difference in means will be used to estimate the between intervention differences in treatment satisfaction 
(mean STTS-R) and adherence (e.g. average proportion of missed sessions or homework assignments) for the 
transdiagnostic CBT versus BAT control conditions. Frequency distributions describing the participants' reasons 
for noncompliance and discontinuation of participation will be developed.  
 
The GLMM modeling framework described for Primary Aim 1 will be used to compare the effect of transdiagnostic 
CBT versus BAT control on treatment satisfaction, retention (dropout), and treatment adherence (% missed 
sessions, % homework completion) . Dropout proportions (dichotomous outcome) and % of missed visits and % 
homework completion will be compared between the intervention groups using GLMM, with logistic/binomial 
regression analyses as special cases for dichotomous and percentage outcomes; STTS-R will be modeled as a 
continuous outcome using an appropriate link function. We also will model the longitudinal profile of adherence as 
a dichotomous outcome at each visit (e.g. attended/did not attend a given session). This will allow us to evaluate 
the trends in session attendance and to determine if the trends differ by intervention (e.g. whether the probability 
of missing visits is less/greater at earlier or later time points). 
 
Exploratory Analyses – Diagnostic Groups 
Exploratory analyses using GLMM modeling, as described above, will be carried out to determine if there is a 
preliminary suggestion that the effect of the intervention on efficacy and acceptability outcomes differ by principal 
diagnosis. For these analyses, a diagnosis by intervention group interaction term will be included in the model. 
Trends toward significance for the diagnosis by intervention interaction term would provide suggestive evidence of 
a possible differential diagnosis effect, suggesting that the change in the outcome variable is different for disorder 
groups (e.g., depressive disorders versus anxiety disorders) or between specific disorders (e.g., PTSD versus 
MDD). It is acknowledged that this study may not be powered to fully evaluate the statistical significance of the 
diagnostic comparisons; however, for this preliminary study, trends toward statistical significance are sought for 
future hypothesis-driven study in a larger adequately powered trial, rather than confirmation of a hypothesized 
differential diagnosis effect. Similar exploratory analyses will be completed for race and combat theatre. 
 
E. PROTECTION OF HUMAN SUBJECTS 
 
 
 
 
 
 
 
 
 
 
1.  RISKS TO THE SUBJECTS  
 
a.  Risks to the Subjects 
 
Participants will include 96 VAMC patients in the mental health service. The inclusion criteria are that participants 
must: 1) be an adult (18 – 80 years old), 2) be competent to provide informed consent for research participation, 
3) be diagnosed with an depressive/anxiety disorder as determined by a semi-structured diagnostic assessment 
(ADIS-5) at pre-treatment assessment, and 4) be able to commute to the RHJ VAMC for weekly appointments, 
immediate post-treatment assessment, and a follow-up assessment at 6-months post-treatment.  
 
Several exclusion criteria exist for the proposed investigation, including 1) recent history (< 2 months) of 
psychiatric hospitalization or a suicide attempt as documented in their medical record, 2) current diagnosis of 
substance dependence or abuse on the structured clinical interview, 3) acute, severe illness or medical condition 
that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their 
medical record (e.g., active chemotherapy/radiation treatment for cancer, kidney dialysis, oxygen therapy for 
chronic obstructive pulmonary disease), 4) recent start of new psychiatric medication (< 4 weeks), 5) diagnosis of 
traumatic brain injury in their medical record and/or endorsement of screener questionnaire regarding the 
symptoms of TBI modified from the Post-Deployment Health Assessment employed by the Department of 
Defense, or 6) diagnosis of schizophrenia, psychotic symptoms, personality disorder, and/or bipolar disorder. 

13 
 
VAMC patients excluded due to these factors will be reconsidered for participation once the condition related to 
their exclusion is resolved or stabilized. 
 
Targeted/Planned Enrollment Table 
 
Total Planned Enrollment 96 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
2 
6 
8 
Not Hispanic or Latino 
22 
66 
88 
Ethnic Category: Total of All Subjects* 
24 
72 
96 
Racial Categories 
 
American Indian/Alaska Native 
0 
0 
0 
Asian 
1 
5 
6 
Native Hawaiian or Other Pacific Islander 
0 
0 
0 
Black or African American 
9 
25 
34 
White 
14 
42 
56 
Racial Categories: Total of All Subjects* 
24 
72 
96 
 
b.  Sources of Materials  
 
All participants will randomized into either a transdiagnostic CBT psychosocial treatment for the 
depressive/anxiety disorders or the comparison evidence-based CBT, Behavioral Activation Treatment (BAT), 
control condition. The transdiagnostic CBT is a variation of pre-existing psychosocial treatments that are regularly 
administered at the VAMC and will involved 12-16 weekly 45-60-minute individual therapy appointments. The 
protocol for the BAT condition will be consistent with approaches that have been shown to be effective in the past 
literature. Throughout the course of treatment, a multi-method assessment of psychosocial factors and quality of 
life will be completed for all participants, involving 1) treatment credibility and satisfaction, 2) treatment retention 
and adherence, 3) clinical symptomatology including anxiety, depression, and impairment, and 4) general 
feedback on treatment process. Participants will be paid $10 for completing the self-report questionnaires and an 
additional $10 for the completion of the ADIS-5 for a possible combined total of $60. In addition to the pre-
treatment, immediate post-treatment, and 6-month follow-up assessments with the full battery, a brief assessment 
involving a few self-report measures (e.g., DASS, IIRS, & STICSA) will be completed biweekly to monitor 
symptoms during the course of treatment. 
 
1. Demographic Information: Age, race, sex, education, employment, and combat experience will be collected via 
a study specific demographic form. 
 
2. Albany Panic and Phobia Questionnaire. The APPQ is a 27-item self-report measure that assesses 
agoraphobia, social anxiety, and interoceptive avoidance. Each subscale has been shown to have good 
internal consistency (αs > .85) and temporal stability (rs > .87). 
 
3. Anxiety Disorder Interview Schedule-5. The ADIS-5 is a well-established, semi-structured interview designed to 
assess a wide range of Axis I disorders. The ADIS-5 assesses current and past diagnoses with DSM 
diagnostic criteria, severity scores, and lists of feared and avoided situations for the anxiety disorders. The 
ADIS has demonstrated excellent inter-rater reliability and validity of depressive/anxiety disorder diagnoses. 
The ADIS-5 is currently in press and so an editor’s copy provided in the appendix (with editor’s comments). 
The PHI (e.g., name, address, contact information, DOB) on the demographics cover page (page 1) will be 
removed in the study copy. 
 
4. Depression Anxiety Stress Scales 21-Item Version. The DASS is a 21-item measure with three subscales 
designed to assess dysphoric mood, fear and autonomic arousal, and tension and agitation. The factor 
structure, reliability, and validity of the subscales have been supported in the literature. The DASS scales also 

14 
 
have demonstrated excellent convergence with similar measures of depression and anxiety and high internal 
consistency ( > .85).  
 
5. Illness Intrusiveness Ratings Scale. The IIRS is a 13-item questionnaire that assesses the extent to which a 
disease interferes with important domains of life, including health, diet, work, and several others. Each item is 
rated on a 7-point Likert scale, ranging from 1 to 7, and summed to compute the scale score. The IIRS has 
been shown to have high internal consistency in the previous literature and present study (α = .88). 
 
6. Multidimensional Assessment of Social Anxiety. The MASA is a 38-item self-report measure that was designed 
to assess trait symptom dimensions consistent with the hybrid model of social anxiety. The psychometric 
properties of the MASA are supported in the literature, including its factor structure, convergent and 
discriminant validity, test-retest reliability, and internal consistency. The internal consistency was found to be 
acceptable for each of the scales in the present study (αs > .71). 
 
7. Mini International Neuropsychiatric Interview. The MINI is a structured diagnostic interview designed to provide 
a brief, but accurate, assessment of a wide range of Diagnostic and Statistical Manual (DSM-IV) psychiatric 
disorders, including the mood disorders, anxiety disorders, and substance use disorders. The MINI has 
demonstrated adequate inter-rater and test-retest reliability across most disorders, and specifically has shown 
good inter-rater reliability with a GAD SCID diagnosis (κ = 0.7). DSM-IV diagnostic criteria, including hierarchy 
rules, were used to establish diagnoses. The PHI (e.g., name and DOB) in the header will be removed in the 
study copy. 
 
8. PTSD Checklist. The PCL is a 17-item measure designed to assess PTSD symptom severity related to 
military/combat-related trauma. Respondents are presented with 17 specific symptoms of PTSD and asked to 
rate "how much you have been bothered by that problem in the last month" on a 5-point Likert scale, ranging 
from 1 (not at all) to 5 (extremely). The PCL has been shown to have excellent internal consistency in 
veterans, victims of motor vehicle accidents, and sexual assault survivors (αs > .94) and excellent test-retest 
reliability in veterans (r = .96). In addition, the PCL has demonstrated excellent convergent validity with 
alternative measures of PTSD (rs range from .77 to .93). Due to the PCL's focus on DSM-IV diagnostic criteria, 
a revised PCL for DSM-5 criteria will be included when made available by the authors. 
 
9. Satisfaction with Therapy and Therapist Scale – Revised. The STTS-R assesses patients’ level of satisfaction 
with their therapeutic experiences. The STTS-R contains 12 items that represent two subscales: satisfaction 
with therapy and satisfaction with therapist. The measure has been investigated in a large sample of patients 
receiving group CBT for depressive/anxiety disorders. The two subscales have demonstrated excellent internal 
consistency (s > .88) and high positive correlations with indicators of successful treatment outcome. 
 
10. State-Trait Inventory for Cognitive and Somatic Anxiety – Trait Version. The STICSA-Trait is a 21-item 
measure that assesses trait cognitive and somatic anxiety. The cognitive and somatic subscales have been 
supported in the literature and both subscales have high internal consistency (s > .87). In addition, the 
STICSA-Trait scale was found to remain stable over repeated administrations during several stress 
manipulations (rs > .65). 
 
11. Veterans Short-Form Health Survey. The V/SF-36 is a 36-item measure designed to assess functional health, 
well being, and quality of life in Veterans, and can be scored to produce two primary subscales for physical 
health and mental health. The V/SF-36 was adapted from the original SF-36, which has received extensive 
support in the literature. 
 
Participants will be asked to complete the assessment materials three times throughout the duration of treatment: 
pre-treatment, post-treatment and six-month follow-up. 
 
c.  Potential Risks  
 
There is a potential psychological risk of emotional discomfort during the assessment and treatment procedures. 
Although this reaction is not uncommon in exposure-based treatments of anxiety and depression and typically is 
brief in its duration, there are several provisions to reduce and/or avoid it in the proposed study. First, the 
proposed treatment will be designed specifically to target the reduction of emotional distress, anxiety, and 

15 
 
avoidance. Second, if a participant expresses a desire to discontinue treatment due to distress and/or a study 
clinician determines that participation is counter-indicated, all research and treatment procedures will be 
terminated. 
 
2.  ADEQUACY OF PROTECTION AGAINST RISKS  
 
a.  Recruitment and Informed Consent 
 
VAMC patients will be recruited from within the Primary Care Mental Health Integration psychotherapy program 
and CBT Clinic at the RHJ VAMC. All eligible and willing VAMC patients will be required to meet with project staff 
to review the purpose of the study and review the consent documentation. VAMC patients will be given ample 
time to discuss the study and ask questions regarding the procedures. Upon thorough review of all 
documentation, VAMC patients will sign the informed consent document prior to participation in study procedures. 
 
b.  Protection against Risk 
 
1. Participants will be made aware of the potential risks and benefits associated with participation and their right to 
withdraw from the study at any point without any negative impact on their care within the VAMC. Any 
participants expressing interest in withdrawing from the study will be referred for treatment within the VAMC.  
 
2. Participants who appear unable to tolerate the assessment process will be offered a referral to the VAMC and 
terminated from the study procedures. 
 
3. As a member of the mental health service at the VAMC, the Principal Investigator will maintain active 
collaborations and communications with other VAMC providers to ensure appropriate continuity of care and 
safeguard against any adverse events. 
 
4. All assessors and treatment providers will be trained and supervised by the Principal Investigator, who is a 
licensed psychologist. At intake, participants identified by clinical interview with both suicidal ideation and acute 
intent will be excluded from the study and immediately offered emergency psychiatric care at the VAMC. 
During the duration of the study, the Principal Investigator immediately will contact the participant and assess 
suicide risk when any instance of suicide risk is identified. If suicidal ideation is present but not intent, the 
participant will be retained in the study and reassessed for suicide risk by the investigators in one week. In 
cases of acute suicidal intent, state law requires immediate hospitalization and these guidelines will be 
followed. 
 
5. Treatment progress will be assessed throughout the active treatment phase through participant interactions 
with the project therapist as well as biweekly self-report measures of various psychiatric symptoms (e.g., 
DASS, IIRS, & STICSA). Participants who do not respond adequately to either treatment will be offered mental 
health treatment with an appropriate VAMC provider. 
 
6. All adverse events associated will be reported to CSR&D program officers and relevant IRBs. 
 
7. All participants will be informed if significant information is discovered about the treatment or if other more 
effective treatment interventions are discovered. 
 
8. Published works or presentations will be limited to aggregate findings; individuals will not be mentioned or 
identified. All participants will be linked by their social security number and then assigned a research 
identification number to de-identify the master database for data analyses. Copies of research identification 
numbers and social security numbers will be stored separately as will consent documentation and assessment 
and treatment instruments. All paper materials will be stored in locked file cabinets. Access to all research 
records will be restricted to project staff.  
 
9. All project staff will undergo training in the protection of human subjects, including the DVA’s Good Clinical 
Practice and the Miami University CITI course. 
 

16 
 
3.  POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS  
 
There are several potential benefits of the proposed research. First and foremost, a large number of VAMC 
patients with depressive/anxiety disorders will participate in an evidence-based psychosocial treatment, resulting 
in reduced symptomatology and improved quality of life. Second and more broadly, a new transdiagnostic 
psychotherapy will be evaluated in VAMC patients with depressive/anxiety disorders that likely will improve 
access to these services in the VAMC system. Thus, the risk-benefit ratio is in favor of conducting this research. 
 
4.  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED  
 
Psychosocial treatments for the depressive/anxiety disorders are greatly limited in the DVA. The limitation may be 
a result of number of factors, including both VAMC provider and VAMC patient factors. Given the high prevalence 
of depressive/anxiety disorders in the DVA, the development and evaluation of a new treatment designed to treat 
VAMC patients with transdiagnostic presentations of depressive/anxiety disorders will represent an opportunity to 
improvement services and increase access for this population and outweigh the potential risks discussed above. 
 
5.  SUBJECT SAFETY AND MINIMIZING RISKS (Data and Safety Monitoring Plan) 
 
The proposed investigation includes a clinical trial that involves the comparison of a newer evidence-based 
psychotherapy, transdiagnostic CBT, with an established evidence-based psychotherapy, BAT. Both treatment 
conditions involve active treatments have been shown to be effective in addressing symptoms in the selected 
disorders/population. Several steps were included in the proposed clinical trial for subject safety and minimizing 
risks of the research.  
 
1. Treatment progress will be assessed throughout the active treatment phase (baseline to final session of 
psychotherapy) through participant interactions with the project therapist, self-monitoring and other between 
session exercises, biweekly self-report measures of various psychiatric symptoms (e.g., DASS, IIRS, & 
STICSA), and immediate post-treatment assessment. Participants who demonstrate worsening of symptoms at 
any point in treatment (i.e., 25% increase in symptom severity for two consecutive assessment points) or do 
not demonstrated any symptoms improvement at the midway point in treatment (session 8) will be offered 
alternative mental health treatments with appropriate VAMC providers. Similarly, alternative mental health 
treatments with appropriate VAMC providers will be offered at the 6-month follow-up assessment point to all 
participants, regardless of symptomatology. 
 
2. During the active treatment phase, participants will be monitoring weekly during their psychotherapy 
appointments. Monitoring will involve interactions with the project therapist, self-monitoring and other between 
session exercises, and biweekly self-report measures of various psychiatric symptoms (e.g., DASS, IIRS, & 
STICSA). 
 
3. Monitoring will be completed by the project therapist and reviewed by the Principal Investigator during weekly 
supervision meetings. 
 
4. The study will be end at the completion of the 6-month follow-up assessment. Alternative mental health 
treatments with appropriate VAMC providers will be offered at the completion of the 6-month follow-up 
assessment point to all participants, regardless of symptomatology. 
 
F. REFERENCES/LITERATURE CITATIONS 
 
 
 
 
 
 
 
 
 
 
Barlow, D. H., Allen, L. B., & Choate, M. L. (2004). Toward a unified treatment for emotional disorders. Behavior 
Therapy, 35, 205-230. 
 
Farchione, T. J., Fairholme, C. P., Ellard, K. K., Bosseau, C. L., Thompson-Hollands, J., Carl, J.R., et al. (2012). 
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: A randomized controlled trial. Behavior 
Therapy, 43, 666-678. 
 
Norton, P. J. (2009). Integrated psychological treatment of multiple anxiety disorders. In M. M. Antony & M. B. 
Stein (Eds.), Oxford handbook of anxiety and related disorders (pp. 441-450). New York: Oxford University Press. 
 

17 
 
Norton, P. J,. (2012). A randomized clinical trial of transdiagnostic cognitive-behavioral treatments for anxiety 
disorders by comparison to relaxation training. Behavior Therapy, 43, 506-517. 
 
Schmidt, N. B., Buckner, J. D., Pusser, A.,Woolaway-Bickel, K., Preston, J. L., & Norr, A. (2011). Randomized 
controlled trial of False Safety Behavior Elimination Therapy (F-SET): A unified cognitive behavioral treatment for 
anxiety psychopathology. Behavior Therapy, 43, 518-532.  
 
 
G. CONSULTANTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
No consultants are involved in the management of the research project.     
 
H. FACILITES AVAILABLE 
 
 
 
 
 
 
 
 
 
 
 
 
The RHJ VAMC is located in downtown Charleston, SC adjacent to the MUSC campus. The RHJ VAMC is a 
primary, secondary, and tertiary referral medical center providing acute medical, surgical, and psychiatry inpatient 
care as well as primary care and specialized outpatient services. The primary service area extends from north of 
Myrtle Beach, SC to Hinesville, GA. For the most recent fiscal year, there were 875,731 total outpatient visits, with 
46,812 of unique patients, for the combined medical center and six outpatient clinics. The RHJ VAMC operates 
community-based outpatient clinics (CBOCs) for Veterans in Myrtle Beach, SC, North Charleston, SC, Beaufort, 
SC, Goose Creek, SC, Savannah, GA, and Hinesville, GA.  
 
The Mental Health Service Line (MHS) is charged with all aspects of clinical care, education, and research within 
mental health. Dr. Gros is a Staff Psychologist within the MHS with dedicated office space, support staff, and 
infrastructure. Dr. Gros also will have available the full range of resources associated with the MHS and 
associated programs. The resources of the MHS will be available to the Dr. Gros throughout the duration of the 
project. The MHS also includes the CBT Clinic and Primary Care – Mental Health Integration program, both of 
which Dr. Gros coordinates, that provide psychosocial and psychopharmacological treatments to over 300 
Veterans with depressive and anxiety disorders each year. The Research Service at the RHJ VAMC is broad-
based and has approximately 250 active research protocols being conducted by over 90 investigators. The 
Research Service is well integrated with clinical services at RHJ VAMC and coordinates research activities 
closely with MUSC. Additionally, the Charleston VA Office of Research, under ACOS, Dr. Rita Young, provides 
administrative support, including financial administration of projects, assistance with project budgets, advertising 
for and hiring new personnel, coordinating IPAs for MUSC employees, and ordering supplies. 
 
I. INVESTIGATOR BROCHURE ____________________________________________________ 
 
n/a   
 
J. APPENDIX_______________________________________________________________________________ 
 
Each of the proposed self-report measures of psychiatric symptomatology were included below. The clinician 
rated structured clinical interviews will be uploaded separated due to an alternative file format (pdf). 

18 
 
 
Demographic Intake Questionnaire 
Participant#: ____________ 
Current Age: _____ 
 
For each of the questions below, please circle the answer that applies to you. 
1. What is your racial or ethnic background? 
1 
White/Caucasian 
2 
Black/African American 
3 
Asian American 
4 
Hispanic 
5 
Native American 
6 
Other (Please list): ____________________________ 
 
2. What is your sex/gender? 
1 
Male 
2 
Female 
 
3. What is your relationship status? 
1 
Single (never married) 
2 
Single (previously married - separated, divorced, or widowed) 
3 
Married 
 
4. What is your work status? 
1 
Unemployed/looking for work 
2 
Unemployed/retired (not actively looking for work) 
3 
Unemployed/disability (not actively looking for work) 
4 
Employed (part-time) 
5 
Employed (full-time) 
 
5. What is your education history (highest level achieved)? 
1 
Did not graduate high school 
2 
High school diploma 
3 
Some college or 2-year college degree 
4 
4-year college degree 
5 
Post-graduate work or graduate degree 
 

19 
 
6. What is your disability status? 
1 
Not disabled (skipped to Question #7) 
2 
Disabled (go to Question #6b) 
 
6b. If disabled through the Department of Veteran Affairs, please list percent of service connection: ____%_  
 
6c. If disabled through the Department of Veteran Affairs, what type of disability are you connected for? 
1 
Physical health (e.g., diabetes, back injury, knee injury) 
2 
Mental health (e.g., PTSD, major depression, adjustment disorder) 
3 
Both physical and mental health 
 
7. Which of the categories best describes your total annual combined income from all sources? 
1 
0  –  < $20,000 
2 
$20,000  –  < $40,000 
3 
$40,000  –  < $60,000 
4 
$60,000  –  < $80,000 
5 
$80,000  –  < $100,000 
6 
> $100,000 
 
8. Please circle which branch of the Armed Services that you participated in? 
1 
Army 
2 
Navy 
3 
Air Force 
4 
Marine Corps 
5 
Coast Guard 
 
9. Please circle all of the combat theaters that you were deployed? 
1 
World War II 
2 
Korea 
3 
Vietnam 
4 
Desert Storm/Shield (First Gulf War) 
5 
OEF/OIF (Afghanistan/Iraq Wars) 
6 
Other (Please list): ____________________________ 
7 
None 
 
10. Have you ever participated in combat (e.g., fired your weapon or fired upon)? 
1 
Yes 
2 
No 
 
 
 

20 
 
APPQ 
 
Please rate, on the following scale, the amount of fear that you think you would experience in each of the 
situations listed below if they were to occur in the next week.  Try to imagine yourself actually doing each activity 
and how you would feel. 
 
Fear Scale: 
 
0---------1---------2---------3---------4---------5---------6---------7---------8 
No fear Slight 
 
  Moderate 
        Marked 
 
Extreme 
 
 
  Fear  
      Fear 
           Fear 
 
   Fear 
 
1. Talking to people 
 
 
 
0   1   2   3   4   5   6   7   8 
 
2. Going through a car wash 
 
 
0   1   2   3   4   5   6   7   8 
 
3. Playing a vigorous sport on a hot day 
 
0   1   2   3   4   5   6   7   8 
 
4. Blowing up an airbed quickly 
 
 
0   1   2   3   4   5   6   7   8 
 
5. Eating in front of others  
 
 
0   1   2   3   4   5   6   7   8 
 
6. Hiking on a hot day 
 
 
 
0   1   2   3   4   5   6   7   8 
 
7. Getting gas at a dentist  
 
 
0   1   2   3   4   5   6   7   8 
 
8. Interrupting a meeting  
 
 
0   1   2   3   4   5   6   7   8 
 
9. Giving a speech 
 
 
 
0   1   2   3   4   5   6   7   8 
 
10. Exercising vigorously alone 
 
 
0   1   2   3   4   5   6   7   8 
 
11. Going long distances from home alone  
0   1   2   3   4   5   6   7   8 
 
12. Introducing yourself to groups 
 
 
0   1   2   3   4   5   6   7   8 
 
13. Walking alone in isolated areas  
 
0   1   2   3   4   5   6   7   8 
 
14. Driving on highways 
 
 
 
0   1   2   3   4   5   6   7   8 
 
15. Wearing striking clothes  
 
 
0   1   2   3   4   5   6   7   8 
 
16. Possibility of getting lost  
 
 
0   1   2   3   4   5   6   7   8 
 
17. Drinking a strong cup of coffee  
 
0   1   2   3   4   5   6   7   8 
 
18. Sitting in the center of a cinema  
 
0   1   2   3   4   5   6   7   8 
 
19. Running up stairs 
 
 
 
0   1   2   3   4   5   6   7   8 
 
20. Riding on a subway 
 
 
 
0   1   2   3   4   5   6   7   8 
 
21. Speaking on the telephone 
 
 
0   1   2   3   4   5   6   7   8 
 
22. Meeting strangers 
 
 
 
0   1   2   3   4   5   6   7   8 
 
23. Writing in front of others  
 
 
0   1   2   3   4   5   6   7   8 
 
24. Entering a room full of people 
 
 
0   1   2   3   4   5   6   7   8 
 
25. Staying overnight away from home 
 
0   1   2   3   4   5   6   7   8 
 
26. Feeling the effects of alcohol 
 
 
0   1   2   3   4   5   6   7   8 
 
27. Going over a long, low bridge 
 
 
0   1   2   3   4   5   6   7   8 

21 
 
DASS 
Please read each statement and indicate the number which indicates how much 
the statement applied to you over the past week.  There are no right or wrong 
answers.  Do not spend too much time on any statement.  The rating scale is as 
follows: 
0 = Did not apply to me at all 
 
1 = Applied to me to some degree, or some of the time 
2 = Applied to me to a considerable degree, or good part of the time 
3 = Applied to me very much or most of the time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. I found it hard to wind down. 
0 
1 
2 
3 
2. I was aware of dryness of my mouth. 
0 
1 
2 
3 
3. I couldn’t seem to experience any positive feelings at all. 
0 
1 
2 
3 
4. I experienced breathing difficulty (e.g. excessive rapid breathing,  
 
breathlessness in the absence of physical exertion). 
0 
1 
2 
3 
5. I found it difficult to work up the initiative to do things. 
0 
1 
2 
3 
6. I tended to over-react to situations. 
0 
1 
2 
3 
7. I experienced trembling (e.g., in the hands). 
0 
1 
2 
3 
8. I felt that I was using a lot of nervous energy. 
0 
1 
2 
3 
9. I was worried about situations in which I might panic and make  
 
a fool of myself. 
0 
1 
2 
3 
10. I felt that I had nothing to look forward to. 
0 
1 
2 
3 
11. I found myself getting agitated. 
0 
1 
2 
3 
12. I found it difficult to relax. 
0 
1 
2 
3 
13. I felt down-hearted and blue. 
0 
1 
2 
3 
14. I was intolerant of anything that kept me from getting on with  
 
what I was doing. 
0 
1 
2 
3 
15. I felt I was close to panic. 
0 
1 
2 
3 
16. I was unable to become enthusiastic about anything. 
0 
1 
2 
3 
17. I felt I wasn’t worth much as a person. 
0 
1 
2 
3 
18. I felt that I was rather touchy. 
0 
1 
2 
3 
19. I was aware of the action of my heart in the absence of physical  
 
exertion (e.g., sense of heart rate increase, heart missing a beat). 
0 
1 
2 
3 
20. I felt scared without any good reason. 
0 
1 
2 
3 
21. I felt that life was meaningless. 
0 
1 
2 
3 
 

22 
 
IIRS 
 
The following items ask about how much your anxiety and/or depression 
interfere with different aspects of your life. 
 
Not very much  
 
→ 
 
 
 
→ 
 
 
Very Much 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Health 
1 
2 
3 
4 
5 
6 
7 
 
2. Diet 
1 
2 
3 
4 
5 
6 
7 
3. Work 
1 
2 
3 
4 
5 
6 
7 
4. Active Recreation 
1 
2 
3 
4 
5 
6 
7 
5. Passive Recreation 
1 
2 
3 
4 
5 
6 
7 
6. Financial Situation 
1 
2 
3 
4 
5 
6 
7 
7. Relationship with your Spouse  
 
(girlfriend or boyfriend if not married) 
1 
2 
3 
4 
5 
6 
7 
8. Sex Life 
1 
2 
3 
4 
5 
6 
7 
9. Family Relations 
1 
2 
3 
4 
5 
6 
7 
10. Other Social Relations 
1 
2 
3 
4 
5 
6 
7 
11. Self-Expression/Self-Improvement 
1 
2 
3 
4 
5 
6 
7 
12. Religious Expression 
1 
2 
3 
4 
5 
6 
7 
13. Community and Civic Involvement 
1 
2 
3 
4 
5 
6 
7 

23 
 
Multidimensional Assessment of Social Anxiety  
For each question, please indicate the degree to which you feel the statement is generally characteristic or true of 
you. 
1 = Not at all characteristic or true of me 
2 = Slightly characteristic or true of me 
3 = Moderately characteristic or true of me 
4 = Very characteristic or true of me 
5 = Extremely characteristic or true of me 
 
1. I feel dizzy when I am in a crowd of people.  
 
1 
2 
3 
4 
5 
2. I have used drugs and/or alcohol to forget about my worries. 
 
1 
2 
3 
4 
5 
3. My social anxiety is out of control. 
 
1 
2 
3 
4 
5 
4. There are very few things that I enjoy doing. 
 
1 
2 
3 
4 
5 
5. I distract myself when I start to think about things that bother me. 
 
1 
2 
3 
4 
5 
6. I avoid speaking with people that I do not know. 
 
1 
2 
3 
4 
5 
7. I get tension headaches before social situations. 
 
1 
2 
3 
4 
5 
8. My anxiety has gotten in the way of my relationships. 
 
1 
2 
3 
4 
5 
9. I try to avoid working on tasks when other people are around. 
 
1 
2 
3 
4 
5 
10. I avoid talking to people in authority. 
 
1 
2 
3 
4 
5 
11. I try to push upsetting thoughts away. 
 
1 
2 
3 
4 
5 
12. I have missed work or school opportunities due to my anxiety. 
 
1 
2 
3 
4 
5 
13. I have difficulty talking with people to whom I am attracted. 
 
1 
2 
3 
4 
5 
14. I am disinterested in what people have to say. 
 
1 
2 
3 
4 
5 
15. I avoid calling attention to myself in social situations. 
 
1 
2 
3 
4 
5 
16. I have trouble asking others for help. 
 
1 
2 
3 
4 
5 
17. I regularly try to block certain thoughts. 
 
1 
2 
3 
4 
5 
18. I avoid performing in public (e.g., singing or dancing).  
 
1 
2 
3 
4 
5 
19. I am rarely in a good mood. 
 
1 
2 
3 
4 
5 
20. When I start experiencing negative thoughts, I try to distract myself. 
 
1 
2 
3 
4 
5 
21. There is very little that gets me excited. 
 
1 
2 
3 
4 
5 
22. I need several drinks of alcohol in order to go to a bar or club. 
 
1 
2 
3 
4 
5 
23. I have no interest in being with others. 
 
1 
2 
3 
4 
5 
24. I avoid talking about things that I do not know much about. 
 
1 
2 
3 
4 
5 
25. I avoid speaking in front of groups of people.  
 
1 
2 
3 
4 
5 
26. I do not expect anything exciting or pleasurable will happen to me. 
 
1 
2 
3 
4 
5 
27. I would describe myself as unmotivated. 
 
1 
2 
3 
4 
5 
28. My physical health has suffered due to my anxiety. 
 
1 
2 
3 
4 
5 
29. I try to stay active to prevent my mind from wandering. 
 
1 
2 
3 
4 
5 
30. My social anxiety prevents me from doing the things I want to  
do in my life. 
 
1 
2 
3 
4 
5 
31. I frequently have to use drugs and/or alcohol to cope with my anxiety. 
 
1 
2 
3 
4 
5 

24 
 
32. I often keep my hands in my pockets so people will not notice that 
they are trembling.  
 
1 
2 
3 
4 
5 
33. When I feel anxious in social situations, I fear that I might have a  
heart attack. 
 
1 
2 
3 
4 
5 
34. I avoid making eye contact with people that I do not know very well. 
 
1 
2 
3 
4 
5 
35. I avoid situations in which I might embarrass myself. 
 
1 
2 
3 
4 
5 
36. I try to keep socially anxious thoughts out of my head. 
 
1 
2 
3 
4 
5 
37. If I am thinking about something that I do not like, I immediately try 
to think of something else. 
 
1 
2 
3 
4 
5 
38. I tend to drink alcohol in social situations to help me cope with my  
anxiety. 
 
1 
2 
3 
4 
5

25 
 
PCL-S 
Instructions: Below is a list of problems and complaints that people sometimes have in response to 
stressful life experiences.  Please read each one carefully, then circle one of the numbers to the right 
to indicate how much you have been bothered by that problem IN THE PAST MONTH.                                                       
 
 
 
  
 
Not 
at all 
A little 
bit 
 
Moderately 
Quite 
a bit 
 
Extremely 
1. Repeated, disturbing memories, thoughts, or 
images of the stressful experience? 
1 
2 
3 
4 
5 
2. Repeated, disturbing dreams of the stressful 
experience? 
1 
2 
3 
4 
5 
3. Suddenly acting or feeling as if the stressful 
experience were happening again (as if you 
were reliving it)? 
1 
2 
3 
4 
5 
4. Feeling very upset when something reminded 
you of the stressful experience? 
1 
2 
3 
4 
5 
5. Having physical reactions (e.g., heart 
pounding, trouble breathing, sweating) when 
something reminded you of the stressful 
experience? 
1 
2 
3 
4 
5 
6. Avoiding thinking about or talking about the 
stressful experience or avoiding having 
feelings related to it? 
1 
2 
3 
4 
5 
7. Avoiding activities or situations because they 
reminded you of the stressful experience? 
1 
2 
3 
4 
5 
8. Trouble remembering important parts of the 
stressful experience? 
1 
2 
3 
4 
5 
9. Loss of interest in activities that you used to 
enjoy? 
1 
2 
3 
4 
5 
10. Feeling distant or cut off from other people? 
1 
2 
3 
4 
5 
11. Feeling emotionally numb or being unable to 
have loving feelings for those close to you? 
1 
2 
3 
4 
5 
12. Feeling as if your future somehow will be cut 
short? 
1 
2 
3 
4 
5 
13. Trouble falling or staying asleep? 
1 
2 
3 
4 
5 
14. Feeling irritable or having angry outbursts? 
1 
2 
3 
4 
5 
15. Having difficulty concentrating? 
1 
2 
3 
4 
5 
16. Being “superalert” or watchful or on guard? 
1 
2 
3 
4 
5 
17. Feeling jumpy or easily startled? 
1 
2 
3 
4 
5 

26 
 
STICSA: Your General Mood State 
 
Instructions 
 
 
 
 
 
 
 
 
 
 
 
 
 Below is a list of statements which can be used to describe how people feel. 
 Beside each statement are four numbers which indicate how often each 
 statement is true of you (e.g., 1 = not at all, 4 = very much so).  Please read 
 each statement carefully and circle the number which best indicates 
 how often, in general, the statement is true of you. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. My heart beats fast 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
2. My muscles are tense 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
3. I feel agonized over my problems 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
4. I think that others won’t approve of me 
. 
. 
. 
. 
. 
1 
2 
3 
4 
5. I feel like I’m missing out on things because I can’t make up my mind 
 soon enough 
. 
. 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
6. I feel dizzy 
. 
. 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
7. My muscles feel weak 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
8. I feel trembly and shaky 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
9. I picture some future misfortune. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
10. I can’t get some thought out of my mind. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
11. I have trouble remembering things 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
12. My face feels hot 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
13. I think that the worst will happen 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
14. My arms and legs feel stiff 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
15. My throat feels dry 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
16. I keep busy to avoid uncomfortable thoughts . 
. 
. 
. 
. 
1 
2 
3 
4 
17. I cannot concentrate without irrelevant thoughts intruding 
. 
. 
. 
1 
2 
3 
4 
18. My breathing is fast and shallow. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
19. I worry that I cannot control my thoughts as well as I would like to 
. 
. 
1 
2 
3 
4 
20. I have butterflies in the stomach. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
21. My palms feel clammy 
. 
. 
. 
. 
. 
. 
. 
1 
2 
3 
4 
 
Not at all 
Moderately 
A little 
Very much so 

27 
 
The Satisfaction With Therapy and Therapist Scale—Revised (STTS–R) 
 
Please circle the number that best describes your opinion of your satisfaction with the therapy and 
therapists (                      ) you attended/completed treatment with recently. 
______________________________________________________________________________ 
Strongly 
 
Disagree 
 
Neutral 
 
Agree  
Strongly 
 Disagree  
Agree 
 
1 
2 
3 
4 
 
5 
__________________________________________________________________ 
 
1. I am satisfied with the quality of the therapy I received. 1 
2 
3 
4 
5 
 
2. The therapist listened to what I was trying to get across. 1 
2 
3 
4 
5 
 
 
3. My needs were met by the program. 
 
 
 
1 
2 
3 
4 
5 
 
4. The therapist provided an adequate explanation regarding  
 
my therapy. 
 
 
 
 
 
 
1 
2 
3 
4 
5 
 
5. I would recommend the program to a friend.  
 
 
1 
2 
3 
4 
5 
 
6. The therapist was not negative or critical towards me.   
1 
2 
3 
4 
5 
 
7. I would return to the clinic if I needed help.   
 
 
1 
2 
3 
4 
5 
 
8. The therapist was friendly and warm towards me.  
 
1 
2 
3 
4 
5 
 
9. I am now able to deal more effectively with my problems.  
1 
2 
3 
4 
5 
 
10. I felt free to express myself.  
 
 
 
 
1 
2 
3 
4 
5 
 
11. I was able to focus on what was of real concern to me.  
1 
2 
3 
4 
5 
 
12. The therapist seemed to understand what I was  
 
thinking and feeling. 
 
 
 
 
 
1 
2 
3 
4 
5 
  
_____________________________________________________________________________________________________________________ 
 
 
How much did this treatment help with the specific problem that led you to therapy?  
 
 
 
 
1 
2 
3 
4 
5 
 Made things 
Made things 
Made 
Made things 
Made things  
 a lot better 
somewhat better 
no difference 
somewhat 
a lot