Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Phase: NA
Conditions: Alcohol Use Disorder, Anxiety Disorders
Sponsor: Boston University Charles River Campus

 
 
 
Procedural Manual 
Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and 
Anxiety Disorders (StAR2) 
NIAAA Grant Number:  1R01 AA023676 
 
 
 
 
 
Last revised: 08 April 2025

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Contents 
Study Overview .............................................................................................................................. 5 
Study Personnel: Research Team ........................................................................................ 7 
General Contact Information .................................................................................. 9 
Staff Personnel Contacts and Locations ............................................................... 10 
Research Design ................................................................................................................ 10 
Subject Flow ..................................................................................................................... 11 
Subjects ................................................................................................................. 12 
Setting ............................................................................................................................... 12 
Inclusion/ Exclusion Criteria ............................................................................................ 12 
Recruitment ....................................................................................................................... 13 
Initial Evaluation Period ................................................................................................... 14 
Treatment Conditions and Specifications ......................................................................... 15 
Phone Screening .................................................................................................... 15 
Informed Consent/Screening Session ............................................................................... 16 
Unified Protocol (UP) ....................................................................................................... 18 
Take Control (TC) ............................................................................................................. 18 
Randomization .................................................................................................................. 18 
Study Sessions ...................................................................................................... 19 
Follow-up Period .............................................................................................................. 19 
Study Procedures .................................................................................................. 19 
Training & Certification ................................................................................................... 26 
Training, Certification, and Supervision of Study Therapists .............................. 26 
Protocol Certification Tracking ............................................................................ 26 
Training and Certification of IEs .......................................................................... 27 
Supervision ....................................................................................................................... 27 
Training of Phone Screeners ................................................................................. 30 
Assessment Tracking and Scheduling .............................................................................. 30 
Scheduling/Tracking Sessions .......................................................................................... 30 
Treatment Sessions ............................................................................................... 32 
Missed Treatment Sessions ................................................................................... 32 
On-going Adherence ......................................................................................................... 34 
Maintaining Inter-Rater Reliability ....................................................................... 34 
Steps for Selecting Assessments ................................................................................................... 34 

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Assessment Measures Administration .............................................................................. 34 
Description of Instruments ................................................................................................ 39 
I. Assessments of Alcohol Use (AUD Related) .................................................... 39 
II. Diagnosis & Clinical Improvement .................................................................. 40 
III. Anxiety/Mood ................................................................................................. 42 
IV. Higher-Order & Skills-Based Mechanisms .................................................... 45 
V. Potential Moderators of Treatment Outcome ................................................... 47 
VI. Other Measures ............................................................................................... 47 
VII. Biological/Medical Assessments ................................................................... 48 
VIII. Neurocognitive Assessments ....................................................................... 48 
Measures of Study Integrity .................................................................................. 50 
For participants completing the MRI component of the study: ............................ 51 
Therapist Assessments Procedures ................................................................................... 52 
Documenting Protocol Deviations .................................................................................... 52 
Handling Participant Requests for Booster Sessions or Additional Treatment ................ 52 
Managing Issues in Treatment: ......................................................................................... 53 
Alcohol Use .......................................................................................................... 53 
Noncompliance ..................................................................................................... 53 
Management of Life Crises: .................................................................................. 53 
Premature Study Termination ........................................................................................... 54 
When to Withdraw Participants from the Study ................................................... 55 
Procedures for Handling Treatment Termination ................................................. 56 
Study Protocol: Data Collection & Storage .................................................................................. 57 
Data Collection ................................................................................................................. 57 
Qualtrics ................................................................................................................ 57 
Inquisit .................................................................................................................. 58 
E-Prime ................................................................................................................. 58 
Study Databases .................................................................................................... 58 
Data Management ............................................................................................................. 60 
Data Storage ...................................................................................................................... 60 
Data Reporting .................................................................................................................. 61 
Quality Control ............................................................................................................................. 61 
Maintaining Confidentiality .............................................................................................. 61 
Certificate of Confidentiality (CoC) ................................................................................. 61 

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Limits of Confidentiality ................................................................................................... 62 
Institutional Review Board (IRB): Charles River Campus ............................................... 62 
BU/BMC IRB Policies on Human Subjects ......................................................... 63 
IRB Binder ........................................................................................................................ 64 
Initial Submission ................................................................................................. 64 
Annual Renewals .................................................................................................. 65 
Amendments ......................................................................................................... 66 
Reporting Unanticipated Problems to the IRB ..................................................... 67 
Managing IRB Content ......................................................................................... 68 
Adverse event management and report ............................................................................. 69 
Definitions ......................................................................................................................... 69 
Serious Adverse Event (SAE) ............................................................................... 69 
Unexpected Adverse Event ................................................................................... 69 
Adverse event tracking ......................................................................................... 70 
Data and Safety Monitoring Plan ...................................................................................... 70 
Data and Safety Monitoring Board (DSMB) ........................................................ 70 
Audio Recorders ............................................................................................................... 73 
Study Computer ................................................................................................................ 74 
Accounts & Server Access ............................................................................................................ 74 
BU Server (Active Directory Shared Drive) ..................................................................... 74 
How to Access the Shared Drive .......................................................................... 74 
Gmail ................................................................................................................................. 79 
How To Log a Treatment Session in Titanium ................................................................. 79 
Miscellaneous ............................................................................................................................... 80 
Documenting Participants Contacts .................................................................................. 80 
Instructions for Payment ................................................................................................... 80 
Compensation Schedule: ................................................................................................... 81 
Appendix A: Consent Form……………………………………………………………………...82 
 
 

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Study Overview 
 
Data Analysis Aims: 
1. Demonstrate that Unified Protocol (UP) treatment reduces alcohol consumption relative to 
Take Control (TC), as measured by our primary outcome measure, mean number of drinks 
consumed per week. 
 
Comparisons will be made for data obtained for the treatment period for the two conditions. 
Specifically, the hypothesis that participants in the UP condition will evidence greater reductions 
in our primary efficacy measure (mean weekly number of standard drinks) than participants 
receiving TC will be examined using conditional latent growth models (LGM), modeled using 
MPlus 7.0 (Muthén & Muthén, 1998-2012). Research personnel will examine changes in the 
weekly mean number of drinks consumed per day over the course of treatment (i.e., study 
sessions 1 to 16). They will also examine whether the proportion of subjects achieving safe 
levels of drinking (males = 2 drinks per day; females = 1 drink per day) is significantly greater in 
the UP condition than in the TC group (guidelines from USDA, 2010). This will be done by 
calculating odds ratio effect sizes (with 95% confidence interval) contrasting safe levels of 
drinking in the UP vs. TC groups. 
 
2. Demonstrate that the UP, relative to TC, reduces alcohol intake on other measures of alcohol 
consumption and evaluate the extent to which this also leads to a comparative decrease in 
measures of craving. 
 
Conditional LGM will be used to test the hypothesis that UP will both demonstrate greater 
reductions in the secondary efficacy measures of percent days heavy drinking per week (defined 
as more than 3 drinks per drinking day for biological women and more than 4 drinks per drinking 
day for biological men [NIAAA guidelines]), percent days of drinking per week, and in alcohol 
craving (as assessed by the Alcohol Urge Questionnaire and the Obsessive Compulsive drinking 
scale) than the TC condition.  
 
3. Demonstrate that the UP results in greater reductions in anxiety and depression as measured 
by the SIGH-A, SIGH-D, ODSIS, and OASIS than TC, and that there will be a correlation 
between these reductions and the decreases seen in mean weekly number of standard drinks 
consumed per day, percent days heavy drinking per week, percent days drinking per week, and 
alcohol craving.  
 
This will be examined using conditional and parallel-process LGC. Research personnel will first 
conduct separate LGM for anxiety and depression. Then they will conduct a series of parallel 
process LGM to examine how changes in anxiety and depression relate to changes in the primary 
and three secondary alcohol outcomes. Separate parallel process LGM will be conducted for 

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each alcohol outcome, and both anxiety and depression will be included in each parallel process 
LGM.  
 
4. Demonstrate that the UP results in greater changes in temperament (e.g., reductions in 
neuroticism) and emotion regulation (e.g., experiential avoidance) variables associated with 
anxiety and depression than TC, and that these changes are associated with changes in anxiety 
and depression. 
 
This will be examined using LGM models similar to those described above. These parallel 
process LGM will not provide formal tests of mechanisms of change as these models will 
examine concurrent changes. If the results from these models are promising, they will be 
followed by models that permit more fine-grained examinations of temporal dependencies of 
change. 
 
5. Demonstrate that the UP will reduce impulsive and risk-taking behaviors. Our working 
hypothesis is that the UP will decrease risk taking behavior as assessed using the Cambridge 
Gambling Task and the Balloon Analog Risk Task, and impulsivity as measured by the 
Go/NoGo and the Continuous Performance Test (CPT). 
 
Repeated measures mixed models analysis will be used to analyze data obtained for pre-
randomization and week 16 data for the Cambridge Gambling Task, the Balloon Analog Risk 
Task, the Go/NoGoTask, the CPT, and Go/No Go. Model generated group least square means 
values for week 16 will be compared using student t-tests. 
 
fMRI Aims: 
1. Demonstrate that the UP will attenuate changes resulting from performance on alcohol-word 
and negative-word Stroop tasks in the activity of frontal-parietal and midbrain regions and the 
connectivity to networks associated with these regions in AUD subjects. Our working hypothesis 
is that midbrain activity will be lower in UP participants than those in the TC condition 
following performance on alcohol and negative emotion Stroop task, which will occur in 
association with enhanced mid-brain-frontal connectivity and increased synchrony. 
 
2. Demonstrate that the UP attenuates the enhanced regional brain activity and craving- induced 
by exposure to alcohol related cues in AUD subjects. Our hypothesis is that exposure to alcohol-
related cues will increase brain activity in select limbic and prefrontal areas to a lesser degree in 
UP completers as compared to UP participants at baseline.  
 
3. Demonstrate that the UP induced changes in brain activity are predictive of reduced ethanol 
consumption. 
 

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StAR2 Grant Information 
Title: Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety 
Disorders  
Granting Agency: National Institute on Alcohol Abuse and Alcoholism 
Date of Submission: 09/01/2017  
Ending Date: 08/31/2022 
NIAAA Grant Number:  1R01 AA023676  
Study Personnel: Research Team 
Todd Farchione, Ph.D., Principal Investigator (PI) 
Dr. Farchione is a research associate professor of psychology at Boston University, and has 
worked full time at CARD for the past 13 years. Dr. Farchione oversees several research and 
clinical treatment programs provided at CARD and most recently served as the project director 
of the previous open trial aimed at evaluating the efficacy of the unified treatment protocol 
relative to existing evidence-based single diagnosis treatment protocols. Dr. Farchione will be 
responsible for day-to-day scientific and clinical management of the study. Dr. Farchione will 
assist Dr. Barlow in the certification and training of UP therapists. He will also work with Dr. 
Barlow to oversee recruitment, subject retention in the study, data collection, data management, 
and protocol adherence.  
 
Shannon Zavala, Ph.D., Co-Investigator  
Dr. Sauer-Zavala is a research associate professor of psychology at Boston University and 
director of the Unified Protocol Institute. She will provide consultation on assessment measures 
and advise the team on other study design elements and procedures. She received her Ph.D. in 
clinical psychology from the University of Kentucky. She completed her predoctoral internship 
at Duke University and her postdoctoral fellowship at Boston University. Dr. Sauer-Zavala’s 
research is focused on identifying emotional factors that are important in the development and 
maintenance of a range of mental disorders. She is also interested in using information gleaned 
from her basic psychopathology research to develop streamlined, easily disseminated 
interventions that directly target the factors that maintain disorder symptoms. In particular, Dr. 
Sauer-Zavala is interested in treatment development for borderline personality disorder. 
Marc J. Kaufman, Ph.D., Co-Investigator 
Dr. Kaufman is director of McLean’s Translational Imaging Laboratory, associate professor of 
psychiatry at Harvard Medical School, co-director of the NIDA T32 post-doctoral training 
program at McLean, and a Partners Human Research Committee member. He conducts 
translational research in addiction, psychiatric, and neurodegenerative disorders. He will be 
overseeing all study procedures conducted at BU CILSE.  
 
Amy C. Janes, Ph.D., Co-Investigator 

Page 8 of 90 
Dr. Janes is an assistant professor of psychiatry at Harvard Medical School, and the director of 
McLean’s Functional Integration of Addiction Research Laboratory. Dr. Janes uses multi-modal 
neuroimaging techniques in clinical populations to study addiction, with a specific focus on 
nicotine dependence. Dr. Janes’ research interests include: identifying individual vulnerabilities 
for developing and maintaining addictive disorders, evaluating brain changes following 
treatment, and determining how other cognitive, affective, and psychiatric disorders contribute to 
addiction. She will work with Dr. Kaufman in supervising the study procedures conducted at BU 
CILSE.  
 
Matthew W. Gallagher, Ph.D., Co-Investigator 
Dr. Gallagher is an assistant professor of clinical psychology at the University of Houston. He 
has extensive experience with the data analytic techniques that will be used in this trial. Dr. 
Gallagher will oversee data analyses related to alcohol consumption and behavioral outcomes. 
He will also advise on any statistical or other methodological issues that arise during the trial, 
will assist in the coordination, management, and verification of the dataset, and will assist in the 
preparation of reports to the DSMB.  
 
Kateri McRae, Ph.D., MRI Consultant 
Dr. Kateri McRae is a consultant on our study, who is specialized in the event-based reappraisal 
fMRI task. She will oversee our task design, provide us with standard procedures and materials, 
and give us guideline on data analysis from the event-based reappraisal task.  
 
Margaret Ross, M.D., Study MD, (0.30 calendar months in each year).  
Dr. Ross is the Medical Director at CARD, where subjects will be seen and treated in the 
proposed study. She will oversee any abnormal lab results.  
 
Pearl Hu, M.D., Study MD 
Dr. Hu is a psychiatrist at CARD. She will oversee any abnormal lab results, determine if 
participants are healthy enough to participate in the trial, and communicate with participants’ 
primary care physicians when medically necessary.  
 
Bonnie Brown, RN, Study Nurse, (0.60 calendar months in years one through four and 0.30 
calendar months in year five). 
Bonnie Brown will maintain medical records, monitor vital signs and general medical status. She 
will conduct the initial medical evaluations and will review all lab results. Ms. Brown’s effort 
reduces slightly in year 5 in view of projected reduced participants flow.  
 
Postdoctoral Research Associates 
 
Elizabeth Eustis, Ph.D., Independent Evaluator (IE) and Study Therapist 
Dr. Eustis will serve as an IE and will assist in the training of doctoral student IEs. She will also 

Page 9 of 90 
administer the ADIS-5 to participants to assess diagnostic criteria for eligibility into the project, 
and is trained to “gold standard” criterion for reliability. Dr. Eustis will also act as a study 
therapist for both the UP and Take Control conditions once trained and certified by Dr. 
Farchione. She will also oversee the RAs in all study related responsibilities, and meet weekly 
with graduate student IEs to lead a diagnostic consensus meeting to review recently completed 
baseline assessments.  
Graduate Research Assistants 
Brittany Woods, M.A., Andrew Curreri, M.A., Maya Nauphal, M.A., Nicole Cardona, 
M.A., Daniella Spencer-Laitt, M.A. 
Graduate research assistants (GRA) are doctoral students in the Clinical Psychology Program at 
Boston University. These students will serve a number of important functions, including 
assessing diagnostic criteria for eligibility into the project (both are trained to “gold standard” 
criterion for reliability). 
Research Assistants 
Stephen Allen, B.A., Emily Meyer, M.A., and Bethany Harris, B.A., Chase Johnson, M.A.,  
Lauren Woodard, B.A., Marie Torre, M.A.  
Research assistants will be responsible for scheduling participants, conducting phone screens, 
running study sessions, data management, IRB related tasks, and MRI sessions. 
General Contact Information 
Principal Investigator 
Todd J. Farchione, Ph.D., Co-Investigator, Project Director  
Research Associate Professor  
Psychology Department 
900 Commonwealth Avenue, 2nd Floor  
Boston, MA 02215 tfarchio@bu.edu 
617-353-9610 
617-851-2005 (cell) 
 
Co-Investigator 
Shannon Zavala, PhD, Co-Investigator 
Research Associate Professor 
Psychology Department 
900 Commonwealth Avenue, 2nd Floor  
Boston, MA 02215 
shannonezavala@gmail.com 
 

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Staff Personnel Contacts and Locations 
 
Name 
Title 
Office 
Work 
Phone 
E-mail 
Cell Phone 
Todd J. Farchione, 
Ph.D. 
Principal Investigator 
266 
3-6053 
tfarchio@bu.edu 
(617) 851-2005 
Shannon Zavala, Ph.D. 
Co-Investigator 
264 
8-4303 
shannonezavala@
gmail.com 
 
(859) 457-1117 
Marc J. Kaufman, Ph.D. 
Co-Investigator, Site 
Principal Investigator 
N/A 
 
kaufman@mclean.
harvard.edu 
N/A 
Amy C. Janes, Ph.D. 
Co-Investigator 
N/A 
 
ajanes@mclean.ha
rvard.edu 
 
Matthew W. Gallagher, 
Ph.D. 
Co-Investigator 
N/A 
 
mwgallagher@gm
ail.com 
 
Margaret Ross, M.D. 
Study Medical 
Director 
207 
3-5896 
mross@bus.edu 
617-699-9596 
Bonnie Brown. RN 
Study Nurse 
203 
3-5880 
bonnieb@bu.edu 
617-835-1840 
Pearl Hu, M.D. 
Study Physician  
205 
8-4306 
pearlhu@bu.edu 
 
Elizabeth Eustis, Ph.D. 
Postdoctoral 
Associate 
254 
8-0826 
eeustis@bu.edu 
 
Andrew Curreri, M.A. 
Doctoral Student 
267 
8-4305 
acurreri@bu.edu 
 
Brittany Woods, M.A. 
Doctoral Student  
267 
8-4305 
bkwoods@bu.edu 
 
Stephen Allen, B.A. 
RA 
245B 
3-5855 
strallen@bu.edu 
 
Emily Meyer, B.A. 
RA 
245B 
3-5855 
e19meyer@bu.edu 
 
Bethany Harris, B.A. 
RA 
245B 
3-6388 
beharris@bu.edu 
 
 
Research Design 
In this clinical trial, research personnel will further assess the UP’s effectiveness in 
reducing alcohol consumption in participants with comorbid AUD/AXD. Participants will be 
randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-
guided Take Control (TC; a psychoeducation-based, alcohol reduction program developed by 
NIAAA). In addition, a subset of twenty-five participants (UP condition only) will complete 
functional magnetic resonance scanning (fMRI) to examine the effects of the UP on changes in 

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brain activity in areas important to regulation of emotional and reward processes implicated in 
excessive alcohol consumption. 
The primary hypotheses are that the UP compared to TC will: 1) be superior in acute 
symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent 
days heavy drinking, percent days of drinking per week, and alcohol craving. 
 
Study Timeline 
The entire study is estimated to be completed in five years. The first six months of the 
project were dedicated to hiring staff, therapist training, and certification. Recruitment began in 
the 7th month of Year 1. Approximately 3-4 new participants will be recruited per month. 
Recruitment began in August 2017. We anticipate recruiting a total of 5 participants in Year 1, 
15 participants in Years 2 through 4, and 10 participants in the beginning of Year 5. The majority 
of Year 5 will be devoted to follow-up assessments, the completion of data entry and data 
management procedures, preliminary analyses, and the preparation of manuscripts.  
Subject Flow 
Table 1 summarizes participant flow and projected visits for each grant year. The study 
will be conducted over the course of 5 years. Based on prior study experience, we project the 
number of participants who consent and are randomized to treatment will be one-tenth the 
number of phone screens and one-half the number of diagnostic evaluations completed. 
 
Table 1. Visit Projection Table  
 
Visit Type/ 
Study Year 
01 
02 
03 
04 
05 
Total 
Phone screens  
50 
150 
150 
200 
50 
60 
Diagnostic 
evaluations  
10 
30 
30 
40 
10 
120 
Consented & 
randomized to 
treatment  
5 
15 
15 
20 
5 
60 
Study 
treatment 
visits  
48 
182 
182 
243 
72 
727 
IE initial 
assessments  
15 
25 
25 
25 
15 
20 
IE brief 
assessments  
15 
68 
71 
91 
39 
284 
IE follow-up 
assessments  
7 
28 
30 
39 
16 
120 
 

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Subjects 
A total of 60 participants will be enrolled, with a target male to female ratio of 33:27. 
This ratio reflects the higher prevalence rates of AUDs in biological men compared to biological 
women. Forty participants will be randomized to the UP condition and 20 to the Take Control 
condition. In addition, 25 participants from the UP group will receive two fMRI scans (pre- and 
post-treatment). 
Participants will be recruited via flyers, brochures, lab website and StAR Facebook page, 
MBTA advertisements, etc. Telephone screenings will determine initial eligibility, and potential 
research participants will be invited to CARD, located at Boston University, for a more extensive 
assessment of alcohol use and emotional disorders.  
Setting 
All study procedures, except for MRI procedures, will be conducted at CARD, which is 
one of the largest research clinics devoted to anxiety and related emotional disorders in the world 
and maintains a substantial research participant flow. CARD consists of approximately 15,000 sq. 
ft. of space and includes multiple individual and group treatment rooms and full-time 
administrative staff including two receptionists covering the front desk during the 12-hour clinic 
day (8 a.m. through 8 p.m.). Staff members include licensed psychologists, a psychiatrist, a nurse, 
research technicians, doctoral students from clinical psychology and counseling psychology, and 
psychiatric residents. The MRI procedures will be conducted at Boston University’s Center for 
Integrated Life Sciences & Engineering (CILSE). 
Inclusion/ Exclusion Criteria 
 
Inclusion Criteria:  
1) DSM-5 diagnosis of an alcohol use disorder (AUD) 
2) DSM-5 diagnosis of Social Anxiety Disorder (SAD), Panic Disorder/Agoraphobia (PD/A), 
Generalized Anxiety Disorder (GAD), and/or Obsessive Compulsive Disorder (OCD) as 
determined by a clinician-administered diagnostic assessment using the Anxiety Disorder 
Interview Schedule for DSM-5 (ADIS-5). Clinically significant diagnoses will be 
determined by assignment of an ADIS clinical severity rating (CSR) of 4 (definitely 
disturbing/disabling on the 0-8 CSR scale) or higher on at least the principal diagnosis 
3) Adults 21 years or older 
4) Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption 
5) Reported drinking an average of at least 15 standard drinks per week for males, or 8 for 
females occurring over a 28-consecutive day period during the 90 day-long time window 
that preceded the screening session 
6) Must be willing to discontinue any form of psychotherapy, except AA, for either anxiety 
or depression prior to screening 
 
 
Exclusion Criteria: 

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(Exclusion criteria are the specific criteria, which would disqualify an individual from participating 
in the study, not simply the opposite of the inclusion criteria):  
1) DSM-5 diagnosis of current major depressive disorder (with the exception of substance-
induced depressive disorder) that requires immediate treatment with pharmacologic agents, 
bipolar disorder, schizophrenia, current bulimia/anorexia, dementia, or other substance 
dependence, with the exception of nicotine, marijuana, and caffeine dependence 
2) Presence of suicidal ideation or history of suicide attempts (i.e. two or more 
hospitalizations related to significant suicidal ideation or following suicide attempts within 
the last five years or one such hospitalization within the last six months) 
3) Non-English speakers 
4) Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions 
within the past 5 years) 
5) Contraindications to MRI scans 
6) History of head injury with >5-minute loss of consciousness 
7) Pregnancy. Note: Women of childbearing potential (not postmenopausal for at least one 
year) will be required to provide a negative urine pregnancy test prior to each scan 
8) Implantation of anything containing magnetically sensitive material including metal plates, 
aneurysm clips, cardiac pacemakers, and stents; history of sheet metal work; 
claustrophobia 
9) Cognitive impairment (MoCA<21) 
10) Serious medical illness or instability for which hospitalization may be likely within the 
next year 
 
Exclusion from Participating in Active Treatment: 
1) Reduction in the mean number of drinks consumed per week by 50% or more between the 
phone screen and the in-person screening  
2) Report of average drinks per day falling within safe levels of alcohol consumption (i.e., 2 
drinks/day for males and 1 drink/day for females by the HHS standard) two weeks prior to 
screening 
Recruitment 
The majority of participants are expected to be self-referred and treatment seeking. 
Referrals may be recruited through a variety of methods such as: word-of-mouth referrals from 
former participants, referral from area medical and mental health professionals, advertisements 
in local newspapers, radio advertisements, MBTA advertisements, brochures/flyers, web 
advertisements (Facebook page, study website, craigslist ad, BU Quickie Jobs page), digital 
billboard advertisements, movie theatre advertisements, and through the CARD intake process.  
The StAR2 recruitment team consists of Bonnie Brown, Dr. Eustis, and Steve Allen. This 
team is responsible for recruiting participants for this study, through the following methods:  
 
1) Web Ads: Online advertisements: 

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• Facebook page: https://www.facebook.com/bostonstarstudy/ 
• Study website: https://studyforalcoholreduction.com/ 
• NIH website: https://www.nih.gov/ 
2) Radio Ads: Advertisements will be submitted to local radio stations. 
3) Newspaper Ads: Advertisements will be put in local area newspapers. 
4) Brochures/Flyers: Flyers will be posted on local bus stops, telephone poles and 
passed around the community.   
5) MBTA Ads: Advertisements will be placed on MBTA trains, buses, and 
stations. 
6) Digital Billboard Ads: Digital advertisements (e.g., the study flyer) will be 
used for recruitment. 
7) Movie Theater Ads: Advertisements will be played on screens in movie 
theaters. 
8) CARD referrals: CARD intakes that meet criteria for AUD and an anxiety 
disorder and have been assigned to the StAR waitlist.  
 
CARD Referrals  
Participants referred through the CARD intake process that have both an alcohol use 
disorder and a DSM-5 diagnosis of Social Anxiety Disorder (SAD), Panic Disorder/Agoraphobia 
(PD/A), Generalized Anxiety Disorder (GAD), and/or Obsessive Compulsive Disorder (OCD) as 
determined by a clinician-administered diagnostic assessment using the Anxiety Disorder 
Interview Schedule for DSM-5 (ADIS-5), will be placed on the StAR waitlist. CARD Clinical 
Director, Lisa Smith, will email the Research Assistants (RAs) to let them know a case has been 
added to the waitlist. The RAs should check the waitlist on a weekly basis.  
The RAs will call the eligible cases on the waitlist to conduct a 15-20 minute phone screen. The 
RA can call the participant candidate 3 times within a 2-week window to attempt to make 
contact. If the participant meets the phone screen criteria, the RAs will schedule the participant 
candidate for an in-person screening session.  
All contacts for research participants must be logged into the Titanium waitlist Referral 
Comment box along with dates. The final disposition should be clear in the notes. 
If a participant drops, or the RA is not able to contact the participant after calling 3 times in 2 
weeks, it is the study's responsibility to send a letter confirming our closure of their case. A 
template can be found here: \Dropbox\StAR2\StAR2 Letters\ Unable to Contact Letter for 
BLA.docx, Letter to Discontinue or Withdraw (StAR2).docx. Upon completion, all waitlists 
should be sent back to Dr. Smith by putting her name in the Assigned Clinician spot. The RA 
should also email Dr. Smith to let her know.  
Initial Evaluation Period 
Potential participants will be given information about the nature of the study over the 
telephone and will undergo an initial phone screening (see phone screening procedures for more 
information) to determine initial eligibility. Eligible participants will then be invited to the 

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Center for Anxiety and Related Disorders at Boston University for an in-clinic screening to 
further assess their eligibility for the study. At the screening, participants will be provided an 
informed consent form which will be verbally reviewed before signing. Participants who are 
eligible following the screening session will be randomized to one of two study conditions (UP 
or TC). A description of measures and procedures associated with the screening session can be 
found in the Assessment Measures Administration section of this manual and in the Participant 
Binder.  
As of March 18th, 2020, screening procedures were changed from in-person to remotely, 
through Zoom. Individual breathalyzers are sent via mail to the participant prior to the 
consenting appointment, as well as a Qualtrics link via email containing the digital version of the 
consent form. Using a Qualtrics survey, participants are able to digitally sign consent which 
researchers are then able to sign the same form and email the completed form to the participant. 
Treatment Conditions and Specifications 
Participants will be assigned to one of two groups: UP or TC. Participants in the UP 
group may also be asked to undergo two brain MRI scans of less than two hours of duration. The 
first MRI scan will occur after the participant has been randomized but before the first treatment 
session, and the second brain MRI scan will occur within a two week window after the last 
treatment session.  
Phone Screening 
In order to conduct a phone screen with someone that has been referred to StAR2, the RA 
will attempt to contact the participant up to 3 times within a two week period. Should more 
contact attempts be necessary, the PD should be consulted. In the event that a participant is never 
successfully contacted, the RA will document this as “Unable to contact” in the StAR2 
Recruitment Tracking Contact Log, and highlight their initials in red.  
Once the RA reaches a participant, he/she will attempt to complete the phone screen (15-20 
minutes), which includes reading the IRB approved phone screen script, and filling out the phone 
screen form to record study-specific questions and assess eligibility. The most up to date phone 
screen is saved on the Shared Drive file path: StAR2àPhone ScreensàBlank Phone Screen. 
The phone screens should be saved with the date, participants’ initials (1st initial of 1st name and 
1st three initials of last name), and the words “phone screen” (Ex. 
2018.05.02_SSBI_Phonescreen).  
Upon completion of the phone screen, the RA determines whether the participant is 
eligible based on established inclusion/exclusion criteria and interest to participate. Potential 
participants who pass the telephone screening will be identified by their initials until they are 
enrolled after the in-person screening session and assigned an ID number. If they are scheduled 
for an in-person screening session this should be recorded in the StAR2 Recruitment Tracking 
Google sheet, on the Recruitment Tracking Tab.  

Page 16 of 90 
If a phone screen has already been conducted and the RA is unable to make contact for 
scheduling the intake appointment (after 3 call attempts in 2 weeks), the RA should document 
the no contact in the log.  
All cases that are not eligible for an in-person screening session will be provided a 
referral for the type of treatment they are seeking, if requested. The list of referral options is 
saved in: Dropbox (BOSTON UNIVERSITY)\UP-AUD\Recruitment Materials\Referral 
Sources. 
Informed Consent/Screening Session 
The day before the in-person screening appointment, the RA will call the participant to 
confirm the appointment and remind him/her about the approximate length of the appointment. 
The screening session is expected to take approximately 4 hours to complete (Informed consent 
= 15 mins; Health assessment = 45 min; Self-report questionnaires = 1 hour; IE assessment = 1-2 
hours).  
On the day of the screening appointment, the RA greets the participant. Next, the 
participant’s blood alcohol concentration (BAC) will be measured using a breathalyzer to ensure 
that the participant provides written informed consent while sober (BAC=0.00%). If the BAC is 
0.00%, the RA will administer the Informed Consent Form. Discussion during the informed 
consent will include information about the treatment options, randomization procedures, and a 
brief rationale for these approaches. Participants will be invited to ask questions about the study 
procedures and expectations. Participants will also be provided information on the nature of the 
investigation, the types of assessments and treatments involved, and the potential risks involved 
in participation; they will then be asked to sign an informed consent statement prior to 
participating in the research project. The signed hard copy of the consent form will go in the 
white consent form binder, which is kept in the locked file cabinet in room 245B. A photocopy 
of the consent form will be given to the participant to keep. Participants will be informed that 
participation in the study is voluntary and that they have the right to withdraw from the study at 
any time without penalty.  
After the consent form is signed and all the participant’s questions about the study have 
been answered, the RA will accompany the participant to the medication room where the study 
nurse will complete the health screen. The health screen involves a medical history 
questionnaire, a blood and urine sample, vitals and weight, and the Montreal Cognitive 
Assessment (MoCA). If the nurse is unable to complete the MoCA at this time, the RA can 
conduct this assessment (if they have been trained to do so). The nurse will also have the 
participant complete a Release of Information Form for their primary care physician.  
Next, the RA will take the participant to a UP treatment room. The RA will then conduct 
the Alcohol Timeline Follow-Back assessment with the participant. The RA will need to collect 
drinking data for the past 90 days. Then, the RA will download the RealLife Exp application on 
the participants’ phone to activate the EMA component of the study. The survey should be 
activated on the screening session. Seven days after the screening session the RA should email 
the participant to deactivate the survey (see EMA procedures for more information). We cannot 

Page 17 of 90 
deactivate the survey pack remotely, which is why the participant needs to be instructed on when 
and how to do so. Deactivating the survey pack will only stop notifications from being sent to the 
participant during non-EMA weeks, it will not delete the account.  
The RA will give the participant the EMA instructions handout and the “What is AUD” 
handout to take home, both of which can be found in the Screening tab of the participant binder. 
The RA then loads the Screening Self-report Qualtrics survey on the study computer in room 
233D for the participant. All surveys are set up to ensure that participants answer every question, 
eliminating the possibility of blank responses. However, the RA must ensure the participant has 
reached the last page of the survey before moving on to the next portion of the session. Upon 
completion of the questionnaires, the participant notifies the RA and may take a break. The RA 
notifies the IE that the participant is ready for the assessment and emails the link to the IE 
assessment survey, which includes the ADIS, SIGH-A, and SIGH-D. Alternatively, the IE can 
access all assessment surveys through Qualtrics. When the IE finishes the assessment, he/she 
will alert the RA that the assessment is complete. The RA will thank the participant for his/her 
time, and inform the participant that he/she will receive a phone call about eligibility in the next 
1-2 weeks after the team has established consensus for study enrollment.  
 
Note: As of March 18th, 2020, screening procedures were changed from in-person to 
remotely, through Zoom. Individual breathalyzers are sent via mail to the participant prior to the 
consenting appointment, as well as a Qualtrics link via email containing the digital version of the 
consent form. Using a Qualtrics survey, participants are able to digitally sign consent which 
researchers are then able to sign the same form and email the completed form to the participant. 
 
Consensus Meeting 
Each week, the research and medical team will meet for approximately one hour to 
discuss all new participants that were evaluated for the study to come to consensus on study 
enrollment. The RA should bring the screening participant(s) binder(s) to the meeting, as well as 
the CSR sheet. The IE that conducted the ADIS will fill out the participant’s diagnoses and CSRs 
pre and post consensus meeting on the CSR sheet. The CSR sheet can be found in the screening 
tab of the Participant Binder. This meeting will allow the IEs and medical staff an opportunity to 
discuss eligibility concerns and review inclusion/exclusion criteria. Once the team has come to 
consensus, the RA will contact the participant. If the pre and post consensus meeting CSRs do 
not match, the RA will be responsible for going into the Qualtrics Data and changing the CSRs 
to match what was decided in the meeting. The old Qualtrics ADIS data for the screening 
participant should be archived so as not to be confused with the correct, updated version.  
 
Eligibility 
If the participant is not eligible, the RA will contact the participant, and will provide the 
participant with an appropriate referral if relevant, which can be found in: Boston University 
Dropbox\ StAR2\Recruitment Materials\Referral Sources. If the participant is not satisfied with 

Page 18 of 90 
the explanation for why they are not eligible, the RA will inform them the PD will contact them 
to explain further.  
If the participant is eligible, they will be randomized into either the UP or TC condition. 
They will be contacted for scheduling schedule for either session 1 or the baseline MRI (only a 
subset of UP participants will be contacted about the MRI).  
 
Treatment/Intervention 
Following the initial screening session (see description of assessment procedures for 
more information regarding the screening session), participants are randomized to one of two 
treatment conditions: 1) Unified Protocol, or 2) Take Control.   
Unified Protocol (UP) 
The UP is a 16 session, transdiagnostic, cognitive-behavioral therapy that has shown 
efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from 
alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with 
results from this study indicating a reduction from baseline in drinks consumed per day (Ciraulo 
et al, 2013). 
Take Control (TC) 
TC is a 12 session, psychotherapy platform derived from the National Institute on 
Alcohol Abuse and Alcoholism’s (NIAAA) self-help approach, Rethinking Drinking. In this 
study, TC, originally designed as a computerized treatment, has been modified by our team to be 
administered by a therapist to control for effects that may be related to patient-therapist 
interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, 
therapists will review material from TC and offer general advice on implementation of the 
alcohol reduction skills in daily life.  
Randomization 
Prior to the start of the trial, a random number generator was used to establish a 
randomization schedule that assigns participants to either the active treatment (UP) or 
comparison condition (TC). Once a new participant is enrolled in the trial, the RA will refer to 
the next assignment in the randomization schedule (shared drive: 
smb://ad/dfs/cas/StAR2/Blind/Randomization List.csv). The current trial aims to recruit 40 
participants in the UP condition and 20 participants in the TC condition. 
Once the participant is randomized, the RA will contact the participant to discuss 
scheduling and provide further information about length of the trial. TC participants will 
complete 12 sessions of therapy (in a maximum of 16 weeks), while UP participants will 
complete 16 weeks of therapy (in a maximum of 21 weeks). Additionally, follow-up assessments 
will be completed at one month and six months posttreatment.  
If the participant is randomized to TC, the next session is session 1, and the RA will 
schedule the session based on the participant’s and assigned therapist’s availability. If the 
participant is randomized to the UP condition, the RA will potentially schedule the participant 

Page 19 of 90 
for the fMRI session prior to scheduling session 1 with the therapist. The first study session will 
be scheduled within 4-weeks after the in-clinic baseline assessment. If the one-month window 
expires before the participant can complete the first session, then the assessment must be 
repeated to assess the participant’s continued eligibility for the study (a “refresher”). 
To schedule an fMRI session, the RAs will need to refer to the CILSE scheduling 
calendar (http://www.bu.edu/neuroimaging/information-for-investigators/scheduling/) to confirm 
that the scanner and the MRI technicians are available and to book the appointment. For access 
to this calendar, please email jbohland@bu.edu. The RA will need to book 30 minutes in the 
Med Lab at CARD for the urine, drug, and/or pregnancy test, and 1.5 hours at CILSE for the 
scan. Once appointments are scheduled, the RA will document the time and date for all involved 
study staff in Titanium (see How to Log a Treatment Session in Titanium). 
Study Sessions 
All participants are required to have a BAC of 0.02% or less to complete all study 
sessions. Each weekly study session will be approximately 60 to 90 minutes in duration, with the 
exception of session 1 and post treatment, which are expected to last for approximately 3 to 4 
hours.  
Follow-up Period  
One month following completion of study treatment, participants will be asked to 
complete the 1-month in-person follow-up assessment. Six months after the completion of the 
study termination, participants will complete the 6-month in-person follow-up assessment. 
During the follow-up interview, the subject will provide data for the Alcohol Timeline Follow-
Back (TLFB), ADIS, SIGH-A and SIGH-D, the self-report battery, and Treatment Involvement 
Form (TIF). The RA will administer the breathalyzer, TLFB and the TIF. The IE will conduct 
the ADIS, SIGH-A and SIGH-D, and the CGI-I and CGI-S on Qualtrics. Self-reports will be 
completed by the participant on Qualtrics. 
Study Procedures 
Participants will receive 16 treatment sessions over a period of 16 to 21 weeks for UP or 
12 treatment sessions in 12 to 16 weeks for TC. Follow-up data will be collected 1- and 6-
months post-treatment at in-clinic sessions.  
We will offer parking vouchers to participants, as needed, to help defray any costs they 
may otherwise incur while traveling to our center to complete scheduled assessment 
appointments. Research personnel will provide up to four parking vouchers (which cost 
approximately $10.00 each) to every participant for completion of study assessments. 
Note: As of March 18th, 2020, study staff adapted study procedures to operate remotely 
during the COVID-19 pandemic. These practices have continued into 2021, 2022, 2023, and the 
remainder of the study. This has included instituting procedures to conduct therapy sessions via 
telehealth (HIPAA Zoom), collecting data remotely via online services (Qualtrics, Millisecond), 
and conducting screenings remotely (HIPAA Zoom). IRB approval was obtained for all remote 
procedures. fMRI procedures were temporarily discontinued due to the COVID-19 pandemic in 
2020, but study staff re-initiated scans in 2021 in accordance with BU IRB protocols.  

Page 20 of 90 
 
Ecological Momentary Assessment (EMA) 
The EMA component is required by all participants, unless an exception is made by the 
project director, Dr. Farchione. The Ecological Momentary Assessment (EMA) component will 
collect self-reported drinking data in real time using a smartphone app, RealLife Exp. RealLife 
Exp will send timed alerts 3-times a day at 10am, 4pm and 10pm to study participants. In 
addition to the scheduled EMA assessments, participants will have the option to self-initiate the 
survey during a drinking episode if they choose to do so. We will activate the EMA component 
for 5 weeks for the UP condition (1, 4, 8, 12, 16), and 4 weeks for the control condition (1, 4, 8, 
12) over the course of treatment. Participants will be instructed to complete EMA for the full 
time period starting from the session it was activated, to when they come in for their next 
session, with the exception of the baseline EMA. The RA should activate EMA on the screening 
session, session 3, 5, 7, and 15, and deactivate EMA on session 4, 8, 12, and 16. The baseline 
EMA should be collected starting from screening session, and deactivated 7-days later regardless 
of when session 1 is scheduled. 
To “activate” the survey, the RA should search for “StAR2” in the download survey 
section in RealLife Exp, click download, and enter in the access code (“star”) when promoted. 
After the week of EMA has been completed, the RA should assist the participant in deactivating 
the survey, by swiping the downloaded StAR2 pack to the left and then pressing the trash icon. 
More detailed instructions on EMA can be found in the BU Dropbox folder: Dropbox (BOSTON 
UNIVERSITY)/UP-AUD/Life Data/StAR2 EMA Instructions.pdf. A copy of these instructions 
will also be handed out to the participant at their screening session. 
A smart phone (with limited functionality) will be provided to participants who do not 
own one themselves. The phone will be returned to study staff once participants have completed 
the study. Each participant will be assigned a dummy email address which will not include any 
identifiable information. Assigning dummy emails to the participants resolves the issue of having 
protected health information linked to identifiable information in any way. The list of dummy 
email addresses can be found at: Dropbox (BOSTON UNIVERSITY)/UP-AUD/Life Data/Life 
Data Dummy Emails.xlxs. Once an email has been assigned to a participant, the RA must update 
the list with the participants’ ID next to the email they were assigned.  
After each participant finishes their last course of EMA (on their last session), the RA 
will permanently delete access to the EMA survey based on their participant ID. This will 
prevent the participants from attempting to continue participating in EMA after treatment has 
completed. The RA will also determine if the participant completed at least 80% of the EMA 
component. If they completed 80% or more of the EMA, they should be paid $50. 
 
fMRI  
Participants that are selected for the fMRI component will also be screened for eligibility 
in undergoing brain fMRI scans after completing the assessment session at CARD. All enrolled 
participants must be willing and able to participate in the fMRI component in order to be eligible 

Page 21 of 90 
to participate in the trial, unless an exception is made by the project director, Dr. Farchione. 
About half of the eligible participants randomized to the UP condition will be asked to complete 
this component of the trial. We will ask all participants in the UP condition to complete the fMRI 
component until we have reached a sufficient number of participants (with complete scans) to 
evaluate the fMRI specific aims identified in the approved study protocol. 
One scan will occur after randomization but before the first treatment session begins and 
the second scan will occur within 2 weeks after the last treatment session. Participants will be 
screened before each scan session for alcohol use (breathalyzers), pregnancy (urine sample, 
women of childbearing potential only), and illicit substance use (urine sample). Eligible 
participants may be asked to complete 2 fMRI sessions of 2 hours total. Thirty minutes will be 
allocated for BAC, pregnancy test (urine sample; women of childbearing potential only), illicit 
substance use test (urine sample), Alcohol Use Questionnaire (AUQ), and the CILSE safety 
form. Thirty minutes will be allocated for traveling to CILSE, and prepping materials for the 
MRI, and 1-hour and a half will be used for the 3 Tesla fMRI scan involving structural imaging 
(MRI) and functional imaging (fMRI). The participant should complete the AUQ both before 
and after the fMRI scans in Qualtrics.  
The fMRI scans include a resting-state scan (no task involved), a cognitive (Stroop) task, 
an alcohol cue reactivity task and an Event Based Reappraisal Task. The Stroop, alcohol cue, and 
Event Based Reappraisal scans involve presentation of visual images to participants while they 
are in the scanner. No contrast agent or invasive procedures are used. Only personnel trained in 
working in high magnetic field environments will work on this project. Imaging data will be 
analyzed on secure networks using only encrypted files. All data obtained will be coded to 
protect participants’ privacy and confidentiality. 
If a participant is struggling with claustrophobia while in the scanner, the following 
procedures are in place: stop the task and call Dr. Farchione (cell: 617-851-2005), the project 
director, for guidance on whether to continue with the fMRI. If Dr. Farchione is unavailable, call 
the postdoctoral fellow, Dr. Eustis (CARD: 617-353-9610). If Dr. Eustis is unavailable, call Dr. 
Amy Janes (cell: 617-947-1398), the MRI consultant. All of these phone numbers are also saved 
in the study phone. Signs that the participant is struggling with claustrophobia include needing 
an RA to stay inside the scanner room during the scan, needing frequent breaks, and/or verbally 
indicating they are feeling claustrophobic or want to get out.  
 
MRI Instructions for RAs 
Two RAs will accompany participants to the Center for Integrated Life Sciences and 
Engineering (CILSE) located at 610 Commonwealth Avenue, Boston, MA 02215. All RAs 
involved in MRI visits are required to complete the Level 1 MRI safety training and quiz. 
 
Before leaving CARD the RA must: 
• 
Administer the MRI CLISE safety screening form to the participant. This form is located 
in the participant’s binder (MRI 1 and MRI 2 tabs) 

Page 22 of 90 
• 
Administer the AUQ self-report questionnaire before and after the MRI scan 
• 
Remember to bring the study laptop, charger, BU ID, and Eprime case (with license key) 
 
Instructions for Scanner Room for RAs 
Before Entering the Scanner Room:  
Note: The screening form must be reviewed by a CILSE/MRI staff member in order for the 
participant to complete the scan.   
  
• 
Make sure the linens on the scanner bed and pillow are new and clean 
• 
Have the participant change into scrubs 
• 
Ask the participant to remove ALL metal items (e.g., jewelry, belts, watches, credit 
cards). Lockers are provided for storage of clothing and personal items 
• 
Use the metal detector wand and scan the participant’s body for any metal that may have 
been missed 
• 
The RA must remove all metal items from his/her own body 
 
Familiarize the Participant with the Button Box: 
One RA will bring the participant into the scanner room, while the other RA prepares the Eprime 
tasks with the MRI technician. The RA who accompanies the participant into the scanner room 
will familiarize the subject with the button box.  
• 
Make sure the participant is using the button box that is labeled (R, G, Y B)  
• 
Explain how to use the button box, as follows:  
 
“Please hold the button box vertically, with your dominant hand on top. Use the index and 
middle fingers of your dominant hand for the top two buttons, and the index and middle finger of 
your non-dominant hand for the last two buttons.”  
 
• 
Demonstrate how the participant should hold the box and where they should place their 
fingers when explaining 
• 
Explain the order of the colors in relation to the location of the wire 
 
Example Dialogue: 
“The blue button is closest to the wire, then yellow, then green, and then red. Red is the button 
furthest from the wire.”  
 
• 
Obtain verbal confirmation that the participant understands how to hold and use the 
button box  
 
Warn Participants of Loud Noises During the Scan and Provide Ear Protection: 
• 
Warn participants again about the loud noises that will occur during the scan 

Page 23 of 90 
• 
Provide the participants ear protection and instruct them on how to use it. The RA should 
show the participant how to roll and squeeze the ear plugs in their hand and insert them 
into their ears 
• 
Confirm with the participant that the ear plugs are fully inserted and fully functional  
 
Familiarize the Participant with the Squeeze Ball:  
• Lower the scanner bed and help the participant climb on 
• Inform the participant that there is an intercom that will allow research staff to talk to 
him/her, and that staff will be checking in periodically 
•  Hand the participant the button box  
• Place the squeeze ball on the participant’s chest and explain its function 
 
Example Dialogue: 
“I am placing a squeeze ball on your chest. If at any time during the scan you feel like you have 
to stop and exit the scanner, squeeze it and a loud noise will alert us outside that we need to stop 
the scan and check on you.”  
 
• 
Receive verbal confirmation the participant understands the function and usage of the 
squeeze ball  
 
Reminders for the Participant 
• 
Inform the participant again that during the first few minutes of the scan there is a small 
possibility they will experience peripheral nerve stimulation 
• 
Remind the participant to try and stay extremely still for the duration of the scan 
• 
Remind the participant to stay awake for the duration of the scan  
 
Aligning the Head Coil  
• 
Insert foam pads in the empty space around the participant’s head in order to minimize 
movement during the scan  
• 
Place the foam leg cushion underneath the participant’s knees for comfort  
• 
Retrieve the head coil and carefully place it over the participant’s head; during this time 
please be mindful of the participant’s comfort  
• 
Raise the bed and adjust the mirror. The participants should be able to see straight back 
• 
Tell the participant to close his/her eyes and keep them closed. Turn on the aligning laser 
and line up the red laser line with the white line on the head coil  
• 
Turn off the laser and tell the participant it is now safe to open his/her eyes  
• 
Receive verbal confirmation that the participant is comfortable and believe this will be a 
comfortable position for the next hour.  
• 
Inform the participant that the bed will now be sent into the scanner 

Page 24 of 90 
• 
Once the participant is fully in the scanner inform him/her that you are now exiting the 
room and closing the door, but you will be able to communicate through the intercom  
 
Resting State Scan: 
• 
Once the RA has left the participant in the scanner room, he/she must turn on the 
intercom and inquire about the participant’s comfort. Wait for a response in order to 
continue 
• 
Inquire about the positioning of the monitor screen. Fix the mirror/screen as needed  
• 
Inform the participant that now the screen will go black for a short time. During this time, 
the resting state scan will take place. It will take approximately 10 minutes to complete. 
Remind the participant to remain awake and stay as still as possible 
 
Example Dialogue:  
“Hi X, how are you doing? Are you comfortable? Can you see the screen ok? Good. We are 
going to start in just a few minutes and you will hear those loud noises we talked about earlier. 
For right now the screen is going to go black as we collect some initial data and it will come 
back on for the tasks. Right now, we ask that you remain awake, with your eyes open and try not 
to think about anything in particular. Remember to stay as still as possible. This will take about 
10 minutes to complete.” 
 
Cue Reactivity Task:  
• 
Inform the participant that we will now run the cue reactivity task 
• 
Receive verbal confirmation that the participant understands the task and the location of 
the red button 
• 
Inform the participant that he/she will be completing this task five times with a short 
break in between each run  
• 
Check in with the participant periodically about comfort level  
 
Example Dialogue: 
“Now we will run the cue reactivity task. I want you to press the red button, which is the button 
furthest from the wire, every time you see an animal that is not a person on the screen. As with 
the last scan, please stay as still as possible.”  
 
Stroop Task: 
• 
Inform the participants that we will move on to the Stroop task  
• 
Make sure the participant remembers the order of colors on the button box. Explain the 
order of the buttons to the participants again if need be (closest to the wire is blue, then 
yellow, then green, then red) 
• 
 Explain that first there will be a practice Stroop task. After the practice task inform the 
participant that they will now begin the real Stroop Task 

Page 25 of 90 
 
Example Dialogue: 
“As a reminder, during this task you will be asked to identify the color font of the word you see 
as quickly and as accurately as you can. The words will be displayed rapidly so do the best you 
can. We will begin with a practice version and then go into the real task. Do you have any 
questions?” 
 
Event-based Reappraisal Task 
• Inform the participants that we will move on to the reappraisal task 
• The MRI technicians will go in there and switch to the 5-buttons buttonbox 
• Explain the instructions one more time 
• Ensure that you are using the correct set of images for current participant. After every 
five participants, we switch to a new set of images. Use same set for each participant’s 
pre/post/ 
 
Example Dialogue: 
“In this task, what we are really interested in is people’s ability to change how they are feeling.  
And the way we are going to ask you to change how you are feeling is by changing the way you 
think about something that we show you. You will see a series of pictures, and some of them are 
going to make you feel somewhat negative or very negative, and some pictures might not make 
you feel very negative at all.” 
 
After the Scans: 
• 
Go into the scanner room and help the participant out of the scanner bed. Ask him/her to 
sit and stand up slowly, as he/she may be dizzy or weak after lying still in the scanner for 
an extended period of time 
• 
 The participant can then change back into street clothes and is free to leave  
• 
Strip the linens off the scanner bed and put them in the hamper along with the 
participant’s used scrubs 
• 
Make a copy of the participant’s screening form, give the original to the technician, bring 
the copy back to CARD, and file in participant’s binder 
 

Page 26 of 90 
Training & Certification 
 
Training, Certification, and Supervision of Study Therapists 
UP and TC therapists will be experienced clinicians who have undergone training and 
certification in the treatment protocols utilizing procedures employed in clinical trials at CARD 
over the last 20 years (e.g., Barlow et al., 2000). Training will be done by experts from CARD 
under the direction of Drs. Barlow, Farchione. Therapists-in-training will attend group 
supervision meetings, at which both specific application and general issues of these protocols 
will be discussed. Trainees who have had previous supervised experience with the treatment 
protocols will not need to complete training cases before starting the certification process. 
The certification procedures will consist of systematic review of digital recordings. Using 
similar procedures and scales to those currently employed across treatment outcome studies at 
CARD, certification for UP therapists will be completed by expert therapists at CARD and 
overseen by Drs. Barlow and Farchione. Initially, expert raters of the protocols will certify the 
study supervisor (Drs. Farchione) who will then be able to certify junior study therapists. All on-
going adherence will be conducted by expert raters. 
The adherence rating scales are designed to assess three aspects of the therapist’s conduct 
of psychotherapy: adherence to the treatment protocol, skill in administering treatment 
components, and general therapeutic skill (e.g., attending to signs of disruption of the therapeutic 
alliance). For initial certification, expert raters listen to all treatment sessions. To be certified, all 
therapists must receive a score of 85% or higher on at least 20% of the treatment sessions 
administered. Trainees who do not meet criteria may be given additional training consisting of 
hour-for-hour supervision of another case and will try for certification again. 
Protocol Certification Tracking 
Therapist certification status on the protocols is monitored by the Research Assistant 
(RA). The RA maintains the Certification and Adherence Tracking Database to track the 
certification cases each therapist has been assigned to ensure study integrity. The database is 
organized such that each therapist has their own tab within the Excel spreadsheet that contains all 
of the certification cases for that therapist. The database is located in Google Sheets: 
https://docs.google.com/spreadsheets/d/1BCLo66umCS3H2OBiMm9BJIwks17tjh-
RYuFdhrPA4EE/edit#gid=0 
 
 
 
 
 
 

Page 27 of 90 
Training and Certification of IEs 
 
Supervision 
After initial training and certification (see Training and Certification Procedures), study 
therapists are required to meet weekly with a licensed clinician (Dr. Farchione, Project Director) 
who are trained and certified in the treatment protocols. These supervision meetings are expected 
to help maintain adherence to the treatment protocols and to help study staff resolve clinical 
issues that might arise during treatment. 
Checks on the Integrity of Assessment Procedures 
The post treatment ADIS and SIGH-A and SIGH-D will be conducted by Independent 
Evaluators (IEs) who are blind to treatment assignment. It is previously established that double 
blind procedures are often not completely effective in protecting IEs from accurate guessing of 
treatment condition (Roll et al., 2004). Based on this knowledge, research personnel will 
implement all of the steps recommended by Roll et al. (2004) to reduce the occurrence of 
providing inadvertent clues to treatment assignment and to protect against the impact of possible 
systematic bias in the responding of IEs. 
A large-scale recommendation for reducing systematic bias in the responding IEs 
includes having a PI and IEs who are affiliated with medical and non-medical professions and 
incorporating multiple sites in study. A secondary level recommendation requires training to 
criteria on primary outcome measures and periodic independent monitoring of evaluation 
implementation and scoring. The third level emphasizes using objective ratings of treatment 
effectiveness. Other suggestions include keeping the IEs separate from the research team and 
participants during their treatment sessions and making the participants aware not to reveal too 
much information to the IE about their treatment sessions and therapists. 
The IEs for the proposed study will be Ph.D. or MA-level diagnosticians who have 
previous research experience with structured interviewing and who will receive additional 
training and certification for this study under the direction of Drs. Barlow and Farchione. Dr. 
Elizabeth Eustis will supervise the individual training process of the IEs. A two-level system will 
be used to maintain the reliability of diagnoses and prevent drift in other clinical ratings in the 
study, consisting of weekly supervision and ongoing rating of selected recordings of clinical 
assessments. Each month an IE will listen to an assessment performed by another IE associated 
with the study and independently complete the assessment instruments. These duplicate ratings 
will be used both to calculate kappa coefficients and for supervision. Differences between raters 
will be discussed during supervision to identify reasons for disagreement and improve inter-rater 
reliability. These procedures will help to ensure that IEs refine their diagnostic skills and will 
also establish common guidelines for ongoing use in diagnostic decision-making. Inter-rater 
agreement will be assessed via evaluation of digital recordings of diagnostic interviews. Inter-
rater reliability (kappa) will be calculated for each of these diagnostic categories: PD/A, SAD, 
GAD and OCD. 

Page 28 of 90 
Furthermore, IEs will be asked to complete an Independent Knowledge of Treatment 
form (IEKNO) consistent with previous trials completed at the center, before and after 
conducting the post ADIS assessment, the one-month follow-up ADIS assessment, and the six-
month follow-up ADIS assessment. The IEKNO can be found in: Dropbox (BOSTON 
UNIVERSITY)\UP-AUD\Binder Materials\Study Forms. Copies of this form should also be 
stored in the Participant Binders in the proper session tabs. After the forms are completed the RA 
should scan both the pre, and post assessment IEKNO to the StAR 2 shared drive (StAR 
2\Data\Knowledge of Treatment forms). This form asks the IE to reveal whether the blind has 
been broken by asking the IE to select the condition which they think the participant has been 
assigned to and provide any relevant information as to why they believe the participant has been 
assigned to this condition. The expected rate of guessing correctly will not be greater than chance 
signifying the maintained blinds. In the event that the IE learns of the condition of the 
participants, the IE will alert the RA who will schedule future assessment time points with the 
other IEs who are still blind to the participant’s condition. This will only occur when an IE 
knows for certain which treatment a participant is receiving. If an IE learns that a participant is in 
treatment (i.e., by seeing them in the waiting area), but does not know which treatment they are 
in then the IE will not be switched.  
Minimum Requirements for IE Certification 
ADIS 
For initial certification, IEs will listen to prior ADIS training tapes and provide CSRs for all 
diagnoses. These ratings will be compared to a master file (currently monitored by Dr. Todd 
Farchione); once the IE has “matched” on three of five assessment training tapes, the IE will 
conduct a mock interview with another member of the team. The five tapes are “rolling”; for 
example, if an IE does not match on the first three tapes, but matches on the next two tapes, 
he/she/they can count the last two towards the next set of five (i.e., if a match occurs on the next 
tape, that would suffice for certification). 
 
During the next stage, the IE will observe an ADIS conducted by a trained IE and complete the 
“follow along” training ADIS in Qualtrics. After the assessment, the IE and IE-in-training will 
compare CSRs and discuss administration and case conceptualization. Next, the IE-in-training 
will administer an ADIS with a trained IE in the room for observation. The trained IE will 
complete a full evaluation of the trainee’s administration and provide feedback (using the ADIS 
checklist as an objective way to assess adherence). CSRs will also be compared. Once the IE-in-
training “matches” on all clinically significant CSRs with the trainer and passes adherence on the 
ADIS checklist, he/she/they will be certified to conduct assessments. 
Once each step is completed it can be checked off on the Blank Training Checklist in the 
Assessment Training folder, listed above.  
 
TLFB 
 
In addition to achieving ADIS certification, IEs must be certified on the additional IE 
assessment measures. This involves the administration of Timeline Follow-Back (TLFB) for 

Page 29 of 90 
assessment of past 90 day alcohol use. For initial certification in the administration of the 
Timeline Follow-back. The IEs should first read through the TLFB instructions very carefully. 
The instructions can be found in on the BU Dropbox folder (UP_AUD/Assessments/Assessment 
Training). Then the IEs should watch the training video at this link: 
https://www.youtube.com/watch?v=c5lv3gVduIc 
 
Then the IEs should successfully administer the TLFB to Dr. Sauer-Zavala. Finally they 
will need to submit a recording of their first TLFB administration for review.  
Once each step is completed it can be checked off on the Blank Training Checklist in the 
Assessment Training folder, listed above.  
 
Note: TLFB and TIF are now administered by a trained RA.  
 
SIGH-A & SIGH-D 
 
The IEs must be certified in the administration of The Structured Interview Guide for the 
Hamilton Anxiety Scale (SIGH-A), a clinician-rated measure for measuring anxiety symptoms 
and their severity, and the Structured Interview Guide for the Hamilton Depression Scale (SIGH-
D), a clinician-rated measure for measuring depression symptoms and their severity. The SIGH-
A & D training materials can be located in: Unified Protocol/Zon/Training/SIGH A SIGH-D. 
The training procedures for the SIGH-A and SIGH-D are as follows: 
• 
Read the SIGH-A Instructions and Scoring and the SIGH-D Instructions and Scoring 
document  
• 
Carefully read through the SIGH-A and SIGH-D Admin Notes 
• 
Watch the SIGH-A and SIGH-D video while scoring along on the assessment sheets 
• 
Submit ratings for the SIGH-A and SIGH-D to Dr. Farchione 
 
Certification Tracking 
All study staff should update their Certificate and Training sheet with the dates that they became 
certified in each assessment. This form can be found in (BU Dropbox/UP_AUD/Binder 
Materials/Study Binder Materials/Certificate and Training). Once filled in the form should be 
printed and added to the study binder.  
 
Consensus 
Certified IEs will then meet with the PD each week for ADIS consensus meetings and further 
supervision on intake procedures. New patients screened for the study will be presented each 
week to the full research and medical team to inform eligibility for study enrollment following 
consensus with the PD. 
 
 
IEs trained in Year 1-2: 3 (Elizabeth Eustis, Ph.D.; Brittany Woods, MA; Andrew Curreri, 
MA) 

Page 30 of 90 
Future IEs will be trained by: Principal Investigator Dr. Todd Farchione and Dr. Elizabeth 
Eustis 
Training of Phone Screeners 
Phone screens will be conducted by: RAs. New RAs will be trained by current RAs in 
conducting phone screens. 
Training process: (avg = 2 weeks) 
1. Observe 2 calls by current RAs  
2. Conduct 2 screens with current RA observation/feedback 
3. Receive approval from current RA to proceed independently
Assessment Tracking and Scheduling 
The RA is primarily responsible for tracking when assessments should occur and 
scheduling these appointments. Independent evaluators (IEs) should be notified of an upcoming 
assessment via an appointment email alert containing all of the necessary information they need 
to complete the assessment (participant’s initials, date and time of the appointment). The RA is 
responsible for signing out a room for the assessment on Titanium, unless the IE chooses to 
conduct the interview in his/her/their office.   
Scheduling/Tracking Sessions 
The RA schedules the first treatment session with the participant after the Screening 
Session appointment via phone once the full team consensus meeting has been held to determine 
participant eligibility. Once the participant is determined to be eligible, the RA determines 
randomization to treatment condition. The Randomization List can be found in the StAR2 Shared 
drive (StAR2/Blind/Randomization List). Only RAs, and the PI will have access to the 
randomization list. The RA should add participants to the list by ID number in chronological 
order. Next the RA should ask Dr. Farchione which therapist the participant has been assigned 
to. The participant should be scheduled for session 1 as soon as possible to ensure a definite start 
date within the first month after the screening session.  
Throughout the active treatment phase, the therapist is responsible for scheduling 
treatment sessions with participants, and informing the RA of the treatment schedule and time of 
upcoming appointments (via email). When discussing the date and time of the next appointment 
with the patient, the therapist should also build in time for the RA portion of the assessment (e.g., 
an additional 30 or 45 minutes before the therapy session, depending on session number).  
Therapy sessions are 50 minutes for UP participants and 30 minutes for TC participants. 
A urine sample will need to be collected by Bonnie or a trained RA on the screening session, 
MRI sessions, sessions 1, 4, 8, 12, and 16 (if applicable; for UP condition only). A blood sample 
will be collected by the study nurse on the screening and last treatment session. On session 1 and 
the last treatment session (12 for TC; 16 for UP) the RAs will need approximately 2 hours total 
to complete their portion of the session. Please see the table below for breakdown of how long to 
schedule each session for.  

Page | 31 
 
 
 
Note: As of March 18th, 2020, due to remote procedures, urine and blood sample 
collection has been reduced to the screening session and post-assessment only (after the last 
treatment session), at a Quest Diagnostics facility. A urine sample for pregnancy and drug testing 
is still collected in-person when a participant comes in for an fMRI.  
 
Scheduling time for each session: 
Session # 
Time for Medical 
Time with Therapist 
Time with RA 
Time for IE 
Baseline 
30 min 
N/A 
1.5 hours 
2 hours 
Session 1 
15 min  
50 min UP, 30 min TC 
1 hour & 45 min N/A 
Session 2 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 3 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 4 
15 min 
50 min UP, 30 min TC 
30 min 
N/A 
Session 5 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 6 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 7 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 8 
15 min 
50 min UP, 30 min TC 
30 min 
N/A 
Session 9 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 10 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 11 
N/A 
50 min UP, 30 min TC 
30 min 
N/A 
Session 12 (TC Post) 
30 min 
30 min TC 
1 hour & 15 min 30 min 
Session 12 (UP) 
15 min 
50 min UP 
30 min 
N/A 
Session 13 
N/A 
50 min UP 
30 min 
N/A 
Session 14 
N/A 
50 min UP 
30 min 
N/A 
Session 15 
N/A 
50 min UP 
30 min 
N/A 
Session 16 (UP Post) 
30 min 
50 min UP 
1 hour & 15 min  30 min 
1-mo Follow-Up 
N/A 
N/A 
1 hours  
30 min 
6-mo Follow-Up 
N/A 
N/A 
1 hours  
30 min 
 
Tracking treatment sessions will be done through Titanium. The therapist should also 
email the RA the date and time of the next scheduled session as soon as it is scheduled. The RA 
will check in at weekly lab meetings to make sure the calendar accurately reflects the status of 
each participant as this information is entered by the RA into Titanium. The RA will schedule 
time with Bonnie to complete any necessary procedures.  
Note: As of 2020, Titanium is no longer used due to remote procedures. Treatment 
sessions are now tracked through the “Retention_ActivePhase” tab of the Retention Database, 
and a Google calendar  
 
Scheduling Follow-up Assessments: 
At the post-assessment, the RA should remind participants in the active treatment 
conditions of the follow-up assessment schedule (1 month and 6 months after post). These 
participants should expect to receive a call from the RA approximately 2-4 weeks prior to the 
target date of their follow-up assessments. For the 1-month, and 6-month assessments, the RA 

Page | 32 
 
 
will also contact the patient one week, and one-day, before the assessment to confirm the 
appointment. Follow these guidelines for attempting to reach the participant.  
 
Week 1 | Begin contacting patient two weeks before the assessment target date. Send an 
email and call patient twice during that week. 
 
Week 2 | One week before the target date, call the patient twice. 
 
Week 3 | During the week of the target date, call the patient twice and send an email. 
 
Week 4 | During the second week after the target date, call the patient twice. If the patient 
does not complete the assessment by the end of this week, the assessment window has 
expired. The RA will mail an unable to contact letter to notify the patient that she/he/they 
must make contact with study personnel before the next assessment target date in order to 
avoid being withdrawn from the study for noncompliance. If the patient does not respond 
by the given date she/he/they will be withdrawn from the study. 
 
Week 5 | Await the patient’s response to the unable to contact letter. 
 
Week 6 | If study personnel do not hear from the patient after sending the letter, make one 
final call and send one final email notifying the patient of the approaching withdrawal 
response deadline. 
Treatment Sessions 
The RA is responsible for updating Titanium when a participant cancels or no-shows, and 
for emailing the team as soon as possible. If the participant fails to attend the scheduled session, 
the RA should also make a note on the front page of their Participant Binder, on the document 
titled Scheduled Sessions. This document has a list of all the sessions that need to be completed 
over the course of treatment, the date of the scheduled appointment, and the date the session was 
attended. Electronic copies of this form can be found in: Dropbox (BOSTON 
UNIVERSITY)\UP-AUD\Binder Materials\Participant Binder (Gray). The RA should also 
complete the StAR2 Retention Database, Retention_ActivePhase tab, to indicate if a session was 
attended, and when the next session is scheduled.  
Missed Treatment Sessions 
While it is expected that most participants will need to reschedule an appointment on 
occasion during the course of treatment, repeatedly missed treatment sessions are likely to 
interfere with the administration of treatment procedures and ultimately lead to poorer treatment 
outcome. The following guidelines have been set to provide some flexibility in participant and 
therapist schedules while also maintaining consistency in the administration of treatment 
protocols across study conditions: 
Allowance for Missed/Rescheduled Sessions: 
• TC: Participants will receive 12 treatment sessions in 12 to 16 weeks. 

Page | 33 
 
 
• UP: Participants will receive 16 treatment sessions in 16 to 21 weeks. 
 
Participants will have two weeks from the target date to complete each assessment. If a 
participant fails to contact study personnel for two consecutive weeks, he/she will be withdrawn 
from the study and informed of study withdrawal via letter sent to his/her home address. 
 
Calling Procedures for No-shows and Missed Sessions 
Participants will be withdrawn if there is a 2-week period of no contact and no reply after 
2 calls from study staff (e.g., RA) and 2 calls from the therapist (for a total of 4 calls), using the 
following protocol:  
On the day of a session when participant is ~15 min late for scheduled session: 1st call 
made by RA to inquire about attendance: 
o “We noticed that you are not here for your session, will you still be able to make 
it?” 
o If he/she/they answers the call, plans to attend the session, and is able to arrive at 
the Center in time to finish all session tasks and the therapy session, the 
appointment will be held as planned 
o If he/she/they answers and is unable to make the session, wait for therapist to 
provide availability for rescheduling the next session  
o If he/she/they does not answer, do not call back again until the day after the 
missed session (or Monday if their missed session was on a Friday) 
 
2nd call made by RA is made the day after the missed session if the participant has not been in 
touch. The same steps above are used for making the 2nd call. 
 
3rd call made by the therapist 1st week after missed session and 2 RA calls: 
o “You missed your session on date/time and I am calling to reschedule the 
appointment; I have an opening on (date/time) that I will schedule you for. Please 
let me know if you are unable to make it then." 
 
4th call therapist 2nd week after missed session (and 2 RA calls and 1 prior therapist call): 
o “If we are unable to schedule an appointment with you for your next session by 
(date that matches 2 week point of no contact), we will have to withdraw you 
from the study based on our attendance guidelines. Please call at your earliest 
convenience (or therapist can offer another date and time for session)." 
Participants will be withdrawn on the date that marks 2 weeks of no contact unless the 
next session is scheduled and the treatment continues. Should this pattern of no contact occur 2 
times during the course of treatment, the participant will automatically be withdrawn on the 3rd 
missed session. 

Page | 34 
 
 
On-going Adherence 
Maintaining Inter-Rater Reliability 
A two-level system will be used to maintain the reliability of diagnoses and prevent drift 
in other clinical ratings in the study, consisting of supervision with the Project Director and 
ongoing evaluations of selected recordings of clinical assessments.   
Each month an IE will listen to one assessment performed by another IE associated with 
the study and will independently complete the assessment instruments. Each IE will go through 
this process every other month creating one duplicate rating per month for all assessments. 
Further, once every 4 months, Drs. Farchione, and/or Eustis will listen to one audio 
recording of an IE assessment. These duplicate ratings will be used both to calculate kappa 
coefficients and for supervision. Differences between raters will be discussed during supervision 
to identify reasons for disagreement and improve inter-rater reliability. Additionally, Dr. Eustis 
will meet with all IEs weekly to discuss clinical ratings and diagnostic information for new 
participants. These procedures will help to ensure that IEs refine their diagnostic skills and will 
also establish common guidelines for ongoing use in diagnostic decision-making. Inter-rater 
agreement will be assessed via evaluation of digital recordings of diagnostic interviews (as 
described above) and inter-rater reliability (kappa) will be calculated.  
Steps for Selecting Assessments  
The StAR2 assessment battery was designed to:  
1. Employ different methods (RA- or clinician-rated; self-report) to provide 
converging lines of evidence 
2. Evaluate hypothesized mediators and mechanisms of change through carefully 
selected measures and time points 
Unless otherwise noted, instruments selected for this study have demonstrated clinical and 
research utility, are commonly used, and have reliability and validity data to support their use. In 
selecting assessment time-points for the present study, we attempted to strike a balance between 
adequate assessment spacing to test hypotheses about potential mediators of treatment outcome 
and participant burden.  
Assessment Measures Administration 
Schedule for assessments and interventions for the baseline period, each session, sessions 
1, 4, 8, and 12, sessions 2, 6, 10, and 14, post treatment/session 16, and 1-month and 6-month 
follow-ups. Key: BL= Baseline/Screening; 1 – Collected to determine eligibility for research 
study; 2—To be administered before or during the fMRI scan; 3 – Excluding session 1; 4 – Only 
collected at session 2; 5 – Excluding sessions 8 & 12; S1––To be administered on session 1. 
Assessment 
Schedule 
TIME OF ADMINISTRATION 
 

Page | 35 
 
 
 
BL 
Each 
Session 
Session 
1, 4, 8, 
12 
Session 
2, 6, 
10, 14 
Last Tx 
Session 
(12 or 
16) 
1 MFU & 
6 MFU 
SCREEN/MED 
Medical History & 
Chemical 
Panel/Complete 
Blood Count 
X 
 
 
 
X 
 
Urine Pregnancy Test 
X2 
 
 
 
X2 
 
Urine Drug 
X, X2 
 
 
 
X2 
 
Vitals/Weight/BMI 
X 
 
 
 
X 
 
Phophatidylethanol 
(Peth) 
X 
 
 
 
X 
 
Ethyl Glucuronide/ 
(ETG) 
X 
 
X 
 
X 
 
AUD RELATED 
Blood Alcohol 
Concentration (BAC) 
X 
X 
 
 
 
X 
Alcohol Timeline 
Follow-back (TLFB) 
X 
X 
 
 
 
X 
Alcohol Dependence 
Scale (ADS; Skinner 
& Allen, 1982) 
X 
 
 
 
 
 
Clinical Institute 
Withdrawal 
Assessment for 
Alcohol Scale, 
Revised (CIWA-AR) 
The CIWA-AR will be administered when the participant 
reports drinking 50% less than the prior assessment, as assessed 
by the TLFB. 
Obsessive 
Compulsive Drinking 
Scale (OCDS) 
 
 
X3 
 
X,  
 
Alcohol Use 
Disorders 
Identification Test 
(AUDIT) 
X 
 
 
 
 
 
Alcohol Urge 
Questionnaire (AUQ) 
X2 
 
X3 
 
X, X2 
 

Page | 36 
 
 
Comprehensive 
Effects of Alcohol 
Questionnaire 
(CEOA) 
X 
 
 
 
X 
X 
DIAGNOSIS & CLINICAL IMPROVEMENT 
Anxiety and Related 
Disorders Interview 
Schedule for DSM-5 
(ADIS-5) 
X1 
 
 
 
X 
X 
Clinical Global 
Impression Severity 
(CGI-S) and 
Improvement Scales 
(CGI-I; Guy et al. 
1976) 
X 
 
X 
 
X 
X 
Quality of Life 
Enjoyment and 
Satisfaction 
Questionnaire (Q-
LES-Q) 
X 
 
 
 
X 
X 
Adult Mental Healthy 
Continuum-Short 
Form (MHC-SF) 
X 
 
X 
 
X 
X 
ANXIETY/MOOD 
Overall Anxiety and 
Depression Severity 
and Impairment 
Scales (ODSIS & 
OASIS) 
X 
X 
 
 
X 
X 
Structured Interview 
Guide for the 
Hamilton Anxiety 
and Depression 
Rating Scale (SIGH-
A & SIGH-D) 
X 
 
 
 
X 
X 
Inventory of 
Statements about 
Self-Injury (ISAS) 
X 
 
 
 
X 
X 
MEDI 
X 
 
 
 
X 
X 
HIGHER-ORDER & SKILLS-BASED MECHANISMS 
CERQ-Short 
X 
 
 
 
X 
X 
Distress Tolerance 
Scale (DTS) 
XS1 
 
 
 
X 
 

Page | 37 
 
 
Anxiety Control 
Questionnaire 
Revised (ACQ-R; 
Brown et al., 2004) 
X 
 
X 
 
X 
X 
Beliefs about 
Emotions Scale 
(BES) 
X 
 
X 
 
X 
X 
Difficulties in 
Emotion Regulation 
Scale (DERS) 
X 
 
X3 
 
X 
X 
Eysenck Personality 
Questionnaire 
Revised – Short Form 
(EPQR-S; Eysenck & 
Eysenck, 1975, 1985) 
X 
X 
 
 
X 
X 
UP Cognitive 
Skills Questionnaire 
(UP-CSQ).  
X 
 
X 
 
X 
X 
Personality 
Assessment Inventory 
– Borderline Features 
Scale (PAI-BOR) 
X 
 
 
 
X 
 
The Personality 
Inventory for DSM-5 
– Brief Form (PID-5-
BF) 
X 
 
 
 
X 
 
Multidimensional 
Experiential 
Avoidance 
Questionnaire 
(MEAQ; Gamez et 
al., 2011) 
X 
X 
 
 
X 
X 
Anxiety Sensitivity 
Index (ASI) 
X 
 
X3 
 
X 
X 
Southampton 
Mindfulness 
Questionnaire 
(Chadwick et al., 
2008) 
X 
 
X3 
 
X 
X 
POTENTIAL MODERATORS OF TREATMENT OUTCOME 
Credibility/Expectanc
y Questionnaire 
(Devilly & Borkovec, 
2000) 
 
 
 
X4 
 
 

Page | 38 
 
 
Readiness to Change 
Questionnaire 
(RTCQ)- 
X 
 
 
 
 
 
Work and Social 
Adjustment Scale 
(WSAS) 
X 
 
 
 
X 
 
State Hope Scale 
(SHS) 
X 
 
X 
 
X 
X 
OTHER MEASURES 
Homework 
Compliance Scale 
(Primakoff et al., 
1986) 
 
X 
 
 
 
 
Treatment Skills 
Usage Questionnaire 
 
 
 
 
X 
X 
Working Alliance 
Inventory-Short 
Form-Therapist 
Version (WAI-SF) 
 
 
X3 
 
 
 
NEUROCOGNITIVE ASSESSMENTS 
 
Stroop Task (fMRI) 
X2 
 
 
 
X2 
 
Alcohol Cues Task 
(fMRI) 
X2 
 
 
 
X2 
 
Continuous 
Performance Test 
(CPT) 
XS1 
 
 
 
X 
 
Go/No Go Task 
XS1 
 
 
 
X 
 
Balloon Analogue 
Risk Task (BART) 
XS1 
 
 
 
X 
 
Rogers Risk Task 
XS1 
 
 
 
X 
 
Computerized Paced 
Auditory Serial 
Addition Test 
(PASAT-C) 
XS1 
 
 
 
X 
 
Montreal Cognitive 
Assessment (MoCA) 
X 
 
 
 
 
 
The Dot Probe Tasks 
XS1 
 
 
 
X 
 
Emotional Conflict 
Task 
XS1 
 
 
 
X 
 
Event Based 
Reappraisal Task 
X2 
 
 
 
 
X2 
 
 

Page | 39 
 
 
Description of Instruments 
Below is a brief summary of the assessment measures that will be administered in this 
study. Unless otherwise stated, instruments selected for this study have demonstrated clinical and 
research utility and have reliability and validity data to support their use.  
I. Assessments of Alcohol Use (AUD Related) 
Alcohol Timeline Follow-Back (TLFB): The TLFB will be administered at the screening session, 
and at every treatment session (not including MRI sessions) and both follow-ups. The TLFB will 
be used to estimate participants’ daily drinking. In this assessment, participants are presented 
with a calendar and asked to provide retrospective estimates of their daily alcohol consumption 
over a specified time period. It takes approximately 25-30 minutes to gather 12 months of data, 
and approximately 10 minutes to gather 90 days of data. The TLFB has high test-retest reliability 
and correlates with other established measures of alcohol use (Sobell & Sobell, 1992).  
 
Alcohol Dependence Scale (ADS): The ADS will be administered at the screening session. 
Alcohol dependence will be assessed using the ADS. This 25-item scale has an internal 
consistency reliability estimate of 0.92 (Skinner & Allen, 1982).  
 
Clinical Institute Withdrawal Assessment for Alcohol Scale, Revised (CIWA-A): The CIWA-Ar 
will be administered by study nurse Bonnie Brown, when the participant reports drinking 50% 
less than the prior assessment, as assessed by the TLFB. If Bonnie is not available, Dr. Farchione 
will conduct the assessment. The CIWA-A will be used to evaluate the severity of withdrawal 
symptoms. This 10-item scale, shortened from the 15-item CIWA-A scale, retains significant 
accuracy when compared to the original CIWA-A (r = 0.99; Sullivan, Sykora, Schneiderman, 
Naranjo & Sellers, 1989). 
 
Obsessive Compulsive Drinking Scale (OCDS): The OCDS will be administered at sessions 1, 4, 
8, 12, and 16. OCDS will be used to assess alcohol craving and the urge to drink. The OCDS is a 
14-item self-report questionnaire developed based on the Yale-Brown Obsessive-Compulsive 
Scale, an interview-based rating scale. It takes approximately 5-10 minutes to complete. The 
OCDS is significantly correlated with independent measures of alcohol craving and with the 
amount of alcohol consumed, and has a positive relationship with independent measures of the 
severity of alcoholism (Anton, Moak, & Latham, 1995).  
 
Alcohol Use Disorders Identification Test (AUDIT): The AUDIT will be administered at the 
screening session. The AUDIT will be used to screen for hazardous and harmful alcohol 
consumption. The AUDIT is a 10-item questionnaire assessing alcohol consumption and alcohol-
related problems. Each response is scored from 0-4, giving a maximum possible score of 40. In a 
study of participants in 6 countries, the overall sensitivity of the AUDIT for hazardous and 

Page | 40 
 
 
harmful alcohol use was 92% and the overall specificity was 94%, when a lower cut-off point of 
8 was used (Saunders, Aasland, Babor, De La Fuente, & Grant, 1993). 
 
Alcohol Use Questionnaire (AUQ): The AUQ will be administered before and after each MRI 
scan, sessions 4, 8, 12, and 16. AUQ will be used to assess alcohol craving and the urge to drink. 
The AUQ is an 8-item self-report questionnaire, in which participants rate their agreement or 
disagreement to statements on a Likert scale. AUQ scores are strongly correlated to the severity 
of alcohol dependence and to cognitive preoccupation with alcohol, and decline with prolonged 
abstinence from alcohol (Bohn, Krahn, & Staehler, 1995). 
 
Comprehensive Effects of Alcohol Questionnaire (CEOA): The CEOA is a 38 item self-report 
questionnaire using a 4-point Likert scale (1 disagree to 4 agree) that assesses both positive and 
negative expectancies about alcohol use and its effects. Seven factors have been identified, four 
of which are classified as assessing positive expectancies (Sociability, Tension Reduction, 
Liquid Courage, Sexuality) and three assessing negative expectancies (Cognitive and Behavioral 
Impairment, Risk and Aggression, Self-Perception). The CEOA has demonstrated good test–
retest and internal consistency reliability (Fromme, Stroot, & Kaplan, 1993). 
II. Diagnosis & Clinical Improvement  
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5): This semi-structured, 
diagnostic clinical interview focuses on DSM-5 diagnoses of anxiety disorders and their 
accompanying mood states, somatoform disorders, and substance and alcohol use. The 
information derived from the interview using the ADIS allows clinicians to determine 
differential diagnoses and gain a clear understanding of the level and severity of each diagnosis. 
Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 
(no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely 
disturbing/disabling) passing the clinical threshold for DSM diagnostic criteria. Inquiries about 
suicidal and homicidal ideation are also part of this interview. This measure has demonstrated 
excellent to acceptable interrater reliability for the anxiety and mood disorders (Brown, Di 
Nardo, et al., 2001).  
An abbreviated version of the ADIS-5 will be administered at the screening session to 
assess presence of current psychopathology. During treatment and the follow-up period, specific 
sections corresponding to those disorders identified to be clinically significant at the initial intake 
will be administered. Because the ADIS is routinely used for clinical and study evaluations at 
CARD, participants will have the option (see consent form) to consent for the use of a recent 
CARD evaluation (if applicable and at the discretion of the study team) to avoid repeating the 
diagnostic evaluation in this study (if completed within 1-month of the StAR2 screening date).  
 
Clinical Global Impressions- Improvement & Severity (CGI- I & CGI-S): The CGI provides an 
overall clinician-determined summary measure that considers all available information, including 

Page | 41 
 
 
knowledge of the participant’s history, psychosocial circumstances, symptoms, behavior, and the 
impact of the symptoms on the participant’s ability to function compared to other clinical 
participants with similar diagnoses. The CGI comprises two companion one-item measures 
evaluating the following: (a) severity of psychopathology from 1 to 7, and (b) change from the 
initiation of treatment on a similar seven-point scale. 
The CGI is administered by an experienced clinician who is familiar with the diagnoses 
under study and the likely progression of treatment. Consequently, the CGI rater can make an 
expert clinical global judgment about the severity of the illness across various time points within 
the context of that clinical experience. The clinician makes a judgment about the total picture of 
the participant at each visit: the illness severity, the participant’s level of distress and other 
aspects of impairment, and the impact of the illness on functioning. The IE also makes CGU 
ratings after the post assessment, and the 1 and 6 month follow-up assessments. 
 
Instructions: The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total 
clinical experience with this particular population, how impaired is the participant at this time?” 
The clinician is asked to rate impairment using the following seven-point scale: 1=normal, not at 
all ill; 2=borderline mentally impaired; 3=mildly impaired; 4=moderately impaired; 5=markedly 
impaired; 6=severely impaired; 7=among the most extremely impaired participants. This rating 
is based upon observed and reported symptoms, behavior, and function in the past seven days. 
Clearly, symptoms and behavior can fluctuate over a week; the score should reflect the average 
severity level across the seven days. 
The CGI-Improvement (CGI-I) is similar in its format. Each time the clinician completes 
the measure (session 4, 8, 12, 16), the clinician compares the participant’s overall clinical 
condition to the one-week period just prior to the initiation of treatment. The CGI-S score 
obtained at the baseline (initiation) visit serves as a good basis for making this assessment. 
Again, only the following query is rated on a seven-point scale: “Compared to the participant’s 
condition at admission to the project, this participant’s condition is: 1=very much improved since 
the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from 
baseline; 5=minimally worse; 6= much worse; 7=very much worse since the initiation of 
treatment.” 
The CGI-I score generally aligns with the CGI-S such that improvement in one follows 
the other. Anchors for scoring, however, are quite different, and the CGI-I is based upon changes 
from the initiation of treatment in contrast to changes on a week-to-week basis. Consequently, 
the two CGI scores can occasionally be dissociated such that a clinician may notice changes in 
the CGI-I relative to baseline despite no recent changes in the overall CGI severity score or vice 
versa. 
 
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q): The Q-LES-Q is a self-
report measure that assesses the degree of satisfaction and enjoyment experienced over the past 
week. The measure consists of 14 items and assesses satisfaction across the following domains: 

Page | 42 
 
 
physical health, mood, work, household activities, social relationships, family relationships, 
leisure activities, daily functioning, sexual drive and interest, economic status, living situation, 
physical stability, vision, and overall sense of well-being. According to Ritsner et al. (2002), the 
Q-LES-Q has demonstrated high internal consistency and good construct validity (Endicott, Nee, 
Harrison, & Blumenthal, 1993). 
 
Adult Mental Healthy Continuum-Short Form (MHC-SF): The MHC-SF is a measure of overall 
positive mental health which consists of 14 items. This assessment measures emotional well-
being, psychological well-being, and social well-being (Keyes et al., 2008). 
 
III. Anxiety/Mood 
Overall Depression Severity and Impairment Scale (ODSIS): The ODSIS is a 5-item continuous 
measure assessing depression in the following domains: frequency, intensity, functional 
impairment in pleasurable activities, work or school, and interpersonal relationships. Items are 
scored on a 5-point Likert scale of 0–4. A psychometric analysis of the ODSIS scale found good 
internal consistency (Cronbach’s alpha = .92; Bentley et al., 2014). 
 
Overall Anxiety Severity and Impairment Scale (OASIS): The OASIS is a five-item continuous 
measure of anxiety-related severity and impairment. Items are coded from 0 to 4 and are summed 
to obtain one total score. Results from three previous psychometric evaluations of the OASIS 
have indicated high internal consistency, excellent test– retest reliability, and convergent and 
discriminant validity in clinical and nonclinical samples (Norman et al., 2006). 
 
Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) 
Purpose: The purpose of this structured interview is to assist in the reliable assessment of 
anxiety severity by standardizing the method of assessment and providing clear anchor points for 
the assignment of severity ratings. The interview items and the anchor points are meant to 
supplement good clinical judgment, not replace it. 
Instructions: Begin the interview with an introduction, describing the scale and its purpose in a 
way that is relevant for the specific participant. The first question for each item should be asked 
exactly as written. Often this question will elicit enough information about the severity and 
frequency of a symptom for the clinician to rate the item with confidence. Follow-up questions 
are provided, however, for use when further exploration of additional clarification of symptoms 
is necessary. The specified questions should be asked until there is enough information to rate 
the item confidently. In some cases, additional follow-up questions may be necessary to obtain 
information. For some of the items, there may be similar questions already asked about some of 
the symptoms (for a previous item). There is no need to repeat questions about these symptoms 
unless additional information is needed to rate the severity. The final score for each item should 
reflect an assessment and balancing of the severity and frequency of the symptom. 

Page | 43 
 
 
Rating Items: All of the items have the same anchor points. The following may be useful as 
guides to rating severity: 
MILD: Occurs irregularly and for short periods of time. 
MODERATE: Occurs more constantly and of longer duration, requiring considerable effort on 
the part of the subject to cope with it. 
SEVERE: Continuous and dominates the subject’s life. 
VERY SEVERE: Incapacitation. 
For each item, several defining characteristics of each severity score are provided. These 
defining characteristics are meant as guidelines to aid in the reliable use of the severity scales 
and represent examples of the severity levels appropriate to the rating. Severity is defined most 
readily by the frequency of occurrence, and the degree of distress and interference associated 
with the symptom. The number of symptoms present is included in the severity rating only as it 
impacts distress and interference. For example, a higher rating may be achieved for a single 
severe symptom and for several mild or moderate symptoms. Alternatively, several mild 
symptoms may lead to a moderate rating of severity because of their overall impact on distress. 
In addition to the guidelines for each item, the interviewer should note the following conventions 
for boundary problems: 
None to mild boundary: Most questionable cases should be rated as one, as zero is meant to be 
an anchor point with no symptom present. 
Mild to moderate boundary: Symptoms are endorsed less than fifty percent of the time and 
cause little to no interference or distress; rate as one. Symptoms are endorsed less than fifty 
percent of the time and are rated as causing mild to moderate interference or distress; rate as two.  
Symptoms are endorsed more than fifty percent of the time and are rated as causing mild 
interference or distress; rate as two. 
Moderate to severe boundary: Symptoms are endorsed less than fifty percent of the time and 
are rated as causing severe interference or distress; rate as three. Symptoms are endorsed more 
than fifty-percent of the time and are rated as causing moderate to severe interference or distress, 
but not both; rate as three. 
Severe to very severe boundary: Questionable cases should generally be rated as a three; 
ratings of four are reserved for behavioral events clearly identified by the rating anchors. 
To elicit the information necessary for assigning severity ratings, the interviewer must assess the 
frequency of occurrence, degree of distress, and degree of interference associated with 
symptoms. The following questions are recommended for this assessment: 
 
Have you had the symptom every day? If NO, have you had the symptom more days than not? 
How much does the symptom bother you? 
How much does it interfere with your life? 
 
NOTES: Time period. The ratings should be based on the participant’s condition in the 
past week. 

Page | 44 
 
 
 
If the participant has panic attacks, this will affect the ratings of many of the symptoms. It is 
recommended to consider the total amount of time during the past week that the panic attack 
symptoms occurred, as well as their severity. For example, a participant who has few severe but 
short –lived panic attacks during the week, but who otherwise does not have many anxiety 
symptoms, would probably not have a very high total SIGH-A score. 
 
NOTE: When rating items 8-11 and 13 the interviewer should rate symptoms regardless 
of whether they did (or did not) occur during a panic attack. Simply rate the symptom as 
it occurred over the past week. 
 
Scoring: Summing each individual item leads to total scores ranging from 0 to 56.  
 
 
Structured Interview Guide for Hamilton Depression Scale (SIGH-D) 
Purpose: To measure depression symptoms and their severity. 
Instructions: The first question for each item should be asked as written. Follow-up questions 
are provided for further exploration or additional clarification of symptoms. The specified 
questions should be asked until enough information is provided to rate the item confidently. 
Follow-up questions may be added obtain necessary information. If the answer to a specified 
question is already known, it is sufficient to confirm the information with the subject (e.g., “You 
said that...”), make the rating, and continue. The final score for each item should reflect an 
assessment and balancing of the severity and frequency of the symptom. Note that participants 
with chronic symptoms may not be able to identify a period of normalcy or may report that 
“depressed” is their usual state. However, depression should not be rated as “normal” (i.e., a 
rating of “0”) in these cases. Summing each individual item leads to total scores ranging from 0 
to 53.  
Example:  
What’s your mood been like this past week (compared to when you feel OK)? 
Have you been feeling down or depressed? Sad? Hopeless? Helpless? Worthless? 
IF YES: Can you describe what this feeling has been like for you? How bad is the 
feeling? 
Have you been crying at all? 
How have you been feeling about the future? (optimistic/pessimistic) Do you feel 
better with encouragement/reassurance from others? Do you feel things will get better, 
improve, work out? 
IF DEPRESSED: In the past week, when something good, even small things have 
happened, did your mood brighten up? How long did this brighten mood last? Were 
there things that occurred that should have brightened your mood but did not? 
In the last week, how often have you felt (OWN EQUIVALENT)? Every day? All day? 
 

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Inventory of Statements about Self-Injury (ISAS): The ISAS was designed to measure the 
occurrence and frequency of 12 methods of non-suicidal self-injury (NSSI; Section I. Behaviors), 
in addition to assessing 13 functions of NSSI (Section II. Functions). In the present study, we are 
only utilizing Section I to determine presence and frequency of NSSI behaviors (current and 
past) among participants. The ISAS has shown good validity and reliability (Klonsky & Glenn, 
2008). 
 
Multidimensional Emotional Disorder Inventory (MEDI; Rosellini, 2013) is a 50-item 
self-report measure designed to assess transdiagnostic vulnerabilities consistent with a 
dimensional approach. The MEDI is representative of a transdiagnostic assessment approach that 
is well suited for treatment planning and outcome monitoring for shared mechanism treatments 
like the UP (Rosellini, Boettcher, Brown, & Barlow, in press). The MEDI assesses neurotic 
temperament, positive temperament, depression, autonomic arousal, somatic anxiety, intrusive 
cognitions, social concerns, traumatic re-experiencing, and avoidance.   
IV. Higher-Order & Skills-Based Mechanisms 
Anxiety Control Questionnaire Revised (ACQ-R): The ACQ-R is an 18-item measure designed to 
assess perceptions of control over potentially threatening internal and external events and 
situations associated with anxious responding (Brown et al., 2004; Rapee et al., 1996). 
 
Beliefs about Emotions Scale (BES): The BES consists of 12 items and is designed to assess 
negative beliefs about emotions. Responses are rated on a scale from 0 (totally disagree) to 6 
(totally agree). There is empirical support for its validity, reliability, and sensitivity to change 
(Rimes & Chadler, 2009). 
 
Difficulties in Emotions Regulation Scale (DERS): The DERS is a 36 item self-report measure 
developed to assess clinically relevant difficulties in emotion regulation. DERS items aim to 
measure participants’ difficulties with (a) awareness and understanding of emotions; (b) 
acceptance of emotions; (c) the ability to engage in goal-directed behavior, and refrain from 
impulsive behavior when experiencing negative emotions; and (d) access to emotion regulation 
strategies perceived as effective (Gratz & Roemer, 2004). 
 
Eysenck Personality Questionnaire Revised – Short Form (EPQR-S): The EPQR-S is a 
commonly used 48 item personality inventory that consists of four subscales of 12 items each: 
Extraversion, Neuroticism, Psychoticism, and a Lie scale. In this study, we will administer the 
Extraversion and Neuroticism subscales, totaling 24 items (Brown, 2007). 
 
UP Cognitive Skills Questionnaire (UP-CSQ): The UP-CSQ consists of 7 items. Participants are 
asked to rate the extent to which they used a variety of cognitive skills over the past week (e.g., 
“I looked for alternative explanations when I had distressing thoughts”) on a scale from 1 (never) 

Page | 46 
 
 
to 5 (always or when needed). Items are summed to produce a total score, with higher scores 
indicating greater skill use. The UP-CSQ has recently been developed as a measure of cognitive 
skills in our research lab at the Center for Anxiety and Related Disorders. Preliminary data 
suggests psychometric properties of this measure are promising, however, further exploration of 
the validity, reliability, and use within an AUD population are necessary and will be explored in 
this trial (Woods, Conklin, Cassiello-Robbins, Sauer-Zavala; In Press). 
 
Personality Assessment Inventory – Borderline Features Scale (PAI-BOR): The PAI-BOR is a 
24-item measure that is based off a 4-factor model of borderline personality disorder. These 
factors, identified by Jackson and Trull (2001), are affective instability, identity disturbance, 
negative relationships, and self-harm (Morey, 1991).  
 
The Personality Inventory for DSM-5 – Brief Form (PID-5-BF): The PID-5-BF is a 25-item 
personality trait assessment scale for adults age 18 or older. This measure assesses five 
personality trait domains: negative affect, detachment, antagonism, disinhibition, and 
psychoticism (Krueger et al., 2011).  
 
Multidimensional Experiential Avoidance Questionnaire (MEAQ): The MEAQ is a self-report 
questionnaire that measures experiential avoidance, which is a tendency to avoid negative 
internal experiences, and is an important concept in numerous conceptualizations of 
psychopathology. Further, the MEAQ is broadly associated with psychopathology and quality of 
life (Gamez et al., 2011). 
 
Anxiety Sensitivity Index (ASI): The ASI is a 16-item questionnaire designed to assess fear of 
anxiety-related symptoms (Reiss et al., 1986). 
 
Southampton Mindfulness Questionnaire (SMQ): The SMQ is a 16-item measure of mindful 
awareness of distressing thoughts and images (Chadwick et al., 2008). 
 
Distress Tolerance Scale (DTS; Simons & Gaher, 2005): The DTS is a self-report index of 
emotional distress tolerance with 15 items and 4 subscales. The subscales include tolerance 
(emotional distress tolerance), attraction (attraction to negative emotions), assessment (mental 
assessment of distress), and regulation (regulation of measures to sooth distress). Cronbach’s 
alpha for the scales was 0.72, 0.82, 0.78, and 0.70, respectively, with a total α of 0.82. In 
addition, criterion reliability and preliminary correlations were acceptable (Simons & Gaher, 
2005). 
 
Cognitive Emotion Regulation Questionnaire (CERQ-Short): The CERQ-short is a self-report 
measure of cognitive emotion regulation strategies used when responding to a stressful life event. 
The CERQ-short is a brief 18-item version of the original CERQ 36 item measure. The CERQ-

Page | 47 
 
 
short has nine, two-item subscales. Five of the scales assess maladaptive and adaptive regulatory 
responses. Participants rate how often statements apply to them on a five-point scale from 1 
“almost never”, to 5 “almost always”. Alpha coefficients for the short scales range from 0.68 
(Self-blame) to 0.81 (Positive appraisal and Catastrophizing; Garnefski & Kraaij, 2006; 
Garnefski et al., 2006). 
V. Potential Moderators of Treatment Outcome 
Credibility/Expectancy Questionnaire: The Credibility/Expectancy Questionnaire is a scale for 
measuring treatment expectancy and rationale credibility (Devilly & Borkovec, 2000). 
 
Readiness to Change Questionnaire (RTCQ): The RTCQ is based on Prochsaka and 
DiClemente’s (1986) stages of change model that is commonly utilized to resolve addictive 
tendencies, and is comprised of three stages: precontemplation, contemplation, and action. This 
questionnaire is therefore commonly used with excessive drinkers to measure their readiness to 
change. The RTCQ shows good validity and reliability (Rollnick et al., 1992). 
 
Work and Social Adjustment Scale (WSAS): The WSAS is a five-item measure asking 
participants to rate the degree of interference caused by their symptoms in work, home 
management, private leisure, social leisure, and family relationships. Interference is rated over 
the past week on a 0 to 8 scale (0 = not at all interfering, to 8 = severe interference). The WSAS 
is a descriptive measure of subjective interference in various domains of living (Marks, 
Connolly, & Hallam, 1973). 
 
State Hope Scale (SHS): The SHS is a 6-item measure of state and trait forms of optimism. The 
SHS provides scores for agency (i.e., “perceived capacity for initiating and maintaining the 
actions necessary to reach a goal”) and pathways (i.e., “perceived ability to generate routes to 
one’s goals”) as well as general state hope. The SHS is an internally consistent measure whose 
scores have demonstrated convergent and discriminant validity in relation to theoretically 
meaningful measures. Responses to the SHS were made on an eight-point scale ranging from 
definitely false (1) to definitely true (8) (Snyder et al., 1996). 
VI. Other Measures 
Homework Compliance Scale: At the end of each session, the therapist will evaluate the degree 
of homework compliance for each participant on a 0-6-point compliance scale. An overall 
average rating will be obtained for each participant by summing the scores for all sessions and 
dividing them by the number of sessions attended (Primakoff, Epstein & Covi, 1986). 
 
Treatment Skills Usage Questionnaire: The Treatment Skills Usage Questionnaire is a 10-item 
questionnaire that asks each participant about the coping skills he/she/they may or may not have 
learned over the course of treatment. The questionnaire is specifically concerned with 

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determining the skills that the participants has managed to consistently utilize since ending 
treatment. 
 
Working Alliance Inventory-Short Form-Therapist Version (WAI-SF): The WAI-SR is a 12-item 
questionnaire that assesses therapeutic alliance and is completed by the therapist: 1) agreement 
between participants and therapist on the goals of the treatment; 2) agreement between 
participants and the therapist about the tasks to achieve these goals; and 3) the quality of the 
bond between the participant and therapist (Tracey & Kokotovic, 1989). 
 
VII. Biological/Medical Assessments 
To assess safety-related issues, the following will be obtained from subjects: BAC (using 
an alcohol breathalyzer), urine drug screens at screening session and before each MRI test, urine 
pregnancy tests for all biological females of child bearing potential (before the fMRI scans only), 
blood chemistries and hematology at screening session and last treatment session, body weight 
and BMI, vital signs, ETG (screening and sessions 1, 4, 8, 12, 16), and Peth (pre and post). The 
Peth is a blood test that is used to detect prolonged or heavy alcohol consumptions within the 
past 2-3 weeks. The ETG test indicates the level of ethanol in urine for 1-3 days after ingestion. 
Most assessments will be obtained at the baseline assessment and following the Assessment 
Schedule. If a participant has abnormal results after analysis of the medical assessments, more 
tests will be ordered to ensure the safety of the participants.   
 
Note: As of March 18th, 2020, due to remote procedures, urine and blood sample have 
been reduced to being collected only on screening session and after last treatment session, at a 
Quest Diagnostics facility. The only exception is when a participant comes in-person for an 
fMRI, in which a urine sample is collected for pregnancy and drug testing. 
  
VIII. Neurocognitive Assessments   
Continuous Performance Test (CPT): The CPT will be administered at session 1 and the last 
treatment session. The CPT measures brain damage. The CPT includes two attention tasks, the 
second one being more difficult than the first. In the first task, participants are presented a series 
of 31 letters, one letter by one letter, and are asked to click on a button when the letter X appears. 
In the second task, participants are presented with a series of 31 letters, and are instructed to 
click on the button only when the letter X appears directly after the letter A appears. The letters 
appear at approximately 0.92s intervals, and responses are scored correctly if the button is 
clicked within 0.69s after the letter appears. In both tasks, participants receive 2 trial runs before 
being given either a 5-minute test or a 10-minute test. Participants are scored in two ways, by 
dividing the number of correct responses given by the number of correct responses possible, and 
by dividing the number of correct responses given by the total number of responses given (e.g., 
how many times she/he/they clicked the button; Rosvold et al.,1956). 

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Go/No Go Task: The Go/No Go Task will be administered at session 1 and the last treatment 
session. In this online task, participants are first presented with a go or a no-go cue, and then 
presented with a go or no-go target. Participants are instructed to respond to a go target by 
clicking on a button, and not to respond to a no-go target. The cues have a high probability of 
signaling a correct target (valid cues), and a low probability of signaling an incorrect target 
(invalid cues). Incorrect responses to the no-go target are used to assess inhibitory control, which 
reflect impulse control. A test includes 250 trials and takes approximately 15 minutes to 
complete (Fillmore 2003). 
 
Balloon Analogue Risk Task: The Balloon Analogue Risk Task will be administered at session 1 
and the last treatment session. In this online task, participants are presented with a balloon. 
Clicking a button will pump the balloon, causing it to inflate and the participant to be awarded a 
certain amount of money. This happens until a threshold is reached and a pump will cause the 
balloon to explode, leading to loss of all money earned. At any point in time, participants can 
choose between pumping the balloon further, or not pumping the balloon and collecting the 
money they have already earned. 90 trials are conducted and the average number of pumps 
delivered are used to measure levels of risk-taking (Lejuez et al., 2002). 
 
Rogers Risk Task: The Rogers Risk Task will be administered at session 1 and the last treatment 
session. In this online task, participants are assigned a certain number of points to begin with and 
are instructed to make decisions that will increase their total score. They are then presented with 
tasks that involve gambling their points. For example, they are presented with red and blue boxes 
and told that one box contains a yellow ticket. If they choose a red box that has a yellow ticket, 
they will gain 30 points, but if they choose a red box that does not have the yellow ticket, they 
will lose 30 points. If they choose a blue box that has the yellow ticket, they will gain 70 points, 
but if they choose a blue box that does not have the yellow ticket, they will lose 70 points. 
Participants’ speed of decision-making and choice are used to measure their willingness to take 
risks (Rogers, 1999). 
 
Paced Auditory Serial Addition Test (PASAT): The PASAT is a measure of cognitive function 
that assesses auditory information processing speed and flexibility, as well as calculation ability 
(Gronwell, 1977). The PASAT is presented using a computer software called Inquisit. Single 
digits are presented every 3 seconds and the participants must add each new digit to the one 
immediately prior to it. Shorter inter-stimulus intervals (e.g., 2 seconds or less) have also been 
used with the PASAT but tend to increase the difficulty of the task. Administration time is 
approximately 10-15 minutes, including practice sessions. The PASAT has demonstrated high 
split-half reliability and evidence for convergent and divergent validity (Gronwall & Sampson, 
1974). 

Page | 50 
 
 
The Dot Probe Task: Two dot-probe tasks (500ms stimulus presentations) will be used to 
measure attentional bias towards and away from negative stimuli. The Neutral-Threat (NT) 
Words is the first task, which uses general anxiety and depression-related stimuli developed by 
MacLeod, Mathews, and Tata (1986) using a protocol developed by Bar-Haim and colleagues 
(2010). The second task is Neutral-Threat-Happy (NTH) Faces, a face-based task which 
displays faces with angry, happy, and neutral expressions from the MacArthur Network Face 
Stimuli Set. This task uses the protocol devised by Bar-Haim and colleagues (TAU-NIMH 
ABMT Initiative, 2012). 
Emotion Conflict Task (Etkin et al., 2010; Etkin & Schatzberg, 2011): This task measures two 
aspects of cognitive regulation of emotional processing (conflict detection, inhibitory control) by 
requiring subjects to identify expression of an emotional face (e.g., happy, fearful) while 
ignoring an emotion word (e.g., “happy,” “fear”) superimposed on the face.  
 
Montreal Cognitive Assessment (MoCA): The MoCA was designed as a rapid screening 
instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and 
concentration, executive functions, memory, language, constructional skills, conceptual thinking, 
calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The 
total possible score is 30 points; a score of 26 or above is considered normal (Nasreddine et al., 
2005). 
 
Note: Due to sessions being conducted remotely (including the screening session) as of March 
18th, 2020, item one of the Montreal Cognitive Assessment (MoCA) is no longer administered to 
participants at the screening session. We will score the total score out of 29 instead of 30 to 
account for the change.  
Measures of Study Integrity 
Treatment Involvement Form (TIF; adapted from ACAP and LTS study forms): The TIF-TTS 
edition is a 7-item questionnaire that asks about any changes in medication, treatment, or 
lifestyle since the last assessment time point. At the beginning of each assessment, with the 
exception of the Screening Session, the RA administers the TIF to the participant and reviews it 
after every session. Any changes should be reported to the attending clinician. TIF is designed to 
assess for whether the participant has sought treatment/services outside of their study therapy 
sessions. It is used to determine start of treatment and/or change in treatment.  
 
Knowledge of Treatment Form (KNO; as used in Roll et al., 2004): The IEs complete the KNO 
form before and after the post, 1-month, and 6-month ADIS assessment. The main functionality 
of the KNO is to determine whether the blind has been broken during the post assessment, or any 
other time leading up to the assessment. Roll et al. (2004) suggest that study integrity should try 
to be maintained by having evaluators who are blind to treatment condition to prevent any biases. 
The current version of the KNO is a 3-item questionnaire that asks the evaluator to guess which 
condition they believe the participants is in and how confident they are that the participant is in 

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that condition on a 0 to 8 Likert scale (0=Not at all, 4=Somewhat, 8=Absolutely). The last item 
asks the evaluator to disclose any information that may have contributed to a potential blind 
break. 
For participants completing the MRI component of the study: 
Stroop Task: The Stroop tasks will be shown to subjects using a behavioral experiment software 
called E-Prime. During the task, neutral words and alcohol-related words will be projected on the 
screen in different color fonts. Participants will be instructed to press a color button on a button 
box that corresponds to the color of the font of the word on the screen. There are four colors on 
the button box, which are red, blue, yellow, and green. The four blocks of stimuli include 
alcohol-related words (e.g. bar, vodka), color word (e.g. blue, green), and neutral words (e.g. 
years, minute). There is a practice run of the Stroop task to get participants used to using the 
button box, which takes about 2 minutes. The Stroop task then follows, which takes about 7 
minutes to complete. 
  
Alcohol Cues Task: The Alcohol Cues Task entails the presentation of five sets of images, with 
both neutral and alcohol-related images. These cues will be shown to subjects using a behavioral 
experiment software called E-Prime. Subjects will be instructed to look at the images on the 
screen in the MRI scanner. There are five runs of the task. In the beginning of each run, 
participant will see “Get Ready” on the screen. There are 22 pictures in each run. In each run, 
participant will see a fixation cross for a varied amount of time from 6000 milliseconds to 14000 
milliseconds followed by the presentation of an alcohol image or a neutral image for 4000 
milliseconds. In each run there are 2 images with animals in it. Participants are instructed to 
press a red button on a button box each time they see an animal that is not a human on the screen. 
The entire task takes approximately 40 minutes to complete. 
 
Event-Based Reappraisal Task: The Event-Related Reappraisal task involves the presentation of 
color images selected from the International Affective Picture System (Lang, Greenwald, 
Bradley, & Hamm, 1993). These images will be shown to subjects using a behavioral experiment 
software called E-Prime. The duration of the task is 10 to 15 minutes. At the beginning of each 
trial, instructions to either “LOOK” or “DECREASE” will be presented on the screen, then an 
image will appear in the center of a black screen. Participants will be instructed to view the 
image, understand its content, and allow themselves to experience/feel any emotional response it 
might elicit. On LOOK trials, a photo will be shown and participants will be instructed to attend 
to and be aware of, without attempting to alter feelings elicited by the image. On DECREASE 
trials, participants will be instructed to reinterpret the image to alter feelings elicited by the 
image. Participants will rate the strength of current negative affect by pressing a corresponding 
button on a button box. After pressing the button corresponding to their rating, the number 
selected will be highlighted on the screen. At the end of the task, a “thank you for participating” 

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message will be presented. Participants will then be briefed upon completing the task by a study 
research assistant. The task takes about 12 minutes.  
Therapist Assessments Procedures 
The therapist is responsible for completing the Homework Compliance Scale (HCS) after 
each session. For the Take Control condition, there is never assigned HW, and for certain 
sessions of the UP there is not assigned HW. In these instances the therapist should still complete 
the HCS and select “0-Homework was not assigned”. In addition to completing the HCS every 
session the study therapist should complete the Working Alliance Inventory-Short Form-
Therapist Version (WAI-SFT) at sessions 4, 8, 12, and 16. The Clinical Global Impression-
Improvement and Severity Scales (CGI-I and CGI-S) should be completed in Qualtrics at session 
1, 4, 8, 12, and 16 (the IEs will complete the CGI and CGs at post-assessment, 1-month, and 6-
month follow-ups). To complete these assessments the therapist should go into the StAR2 
Qualtrics folder and select the session number. Within the session folder there is a Therapist 
Assessment survey battery which includes all the assessments that need to be completed for each 
session. For a detailed table indicating the assessments completed by the therapist at each session 
and the respective Qualtrics link, please see (BU Dropbox/UP_AUD/Assessments/Completed by 
Therapist/ StAR 2 Qualtrics Links of Therapist forms.xlsx). 
 
Documenting Protocol Deviations 
There are a number of protocol deviations that may occur during treatment: failing to 
administer key components of the treatment protocol, engaging in treatment procedures (or 
providing information) that may overlap with another treatment condition, and conducting 
treatment sessions that take longer than what is specified in the study protocol. A protocol 
deviation form should be completed and submitted to the IRB when a deviation occurs. The 
IRB’s response to the deviation, and the deviation submission form, should be saved in the 
StAR2 Dropbox/IRB/Protocol Deviations Submissions.  
When any protocol deviation occurs during treatment, the study staff should note this in 
the comments/protocol deviation section of the StAR2 Deviation Tracking Log in Google 
Sheets. If you do not yet have access to this, email the RA and they will grant you access. The 
RA will then document the deviation and maintain a de-identified note (Study #ID, not name) in 
the participant’s binder for records. The participant’s binders are kept in room 245B of CARD.  
Handling Participant Requests for Booster Sessions or Additional Treatment 
In general, participants will be asked not to seek additional treatment (including treatment 
from study therapists) during the follow-up period. In the event that a participant requests 
additional treatment, study staff may wish to explain the importance of refraining from additional 
treatment in the context of the research study’s aims. It may also be helpful for participants to 
think about treatment as more of an ongoing process of working on the developed and learned 
skills that occurs even after the formal program has ended, as opposed to something which has a 
definitive end-point.   

Page | 53 
 
 
If a participant is planning on seeking additional treatment, contact the Project Director 
for additional assistance. Treatment engagement during the follow-up period will be assessed at 
the 1-month and 6-month follow-up assessment and may ultimately be an additional indication 
of treatment outcome. With that being said, the study therapist should by no means encourage 
study participants to seek additional treatment during the follow-up period. 
At the final follow-up assessment, participants may request additional 
treatment.  Treatment will not be provided as part of the research study, but appropriate referrals 
should be made. These requests, and any action taken by the IE (or RA), should also be 
documented as a clinical note.  As the frequency of these requests may be used as a clinical 
outcome variable, they should be carefully documented for later review. 
 
Managing Issues in Treatment: 
Alcohol Use 
If the participant’s BAC is greater than 0.00% before signing the informed consent, 
he/she/they will have to reschedule the screening, which can be a few hours later (and BAC will 
be tested again) or another day. If asked to reschedule, the participant will be asked not to drive 
home and to make other transportation arrangements. If no one is available to take the participant 
home and he/she/they do not live in an area with public transportation access, a study staff 
member may call a taxi or car service. 
For all other study sessions, participants with BAC levels greater than 0.02% will be 
asked to remain at the center until their levels reach below 0.02, or reschedule if necessary. 
Again, if a participant is under the influence and is asked to reschedule the appointment, the 
participant will be asked not to drive home and to make other transportation arrangements.  
 
Note: Due to sessions being conducted remotely, a session is simply cancelled and/or 
rescheduled if BAC levels are above threshold.  
Noncompliance 
The following link describes IRB procedures regarding noncompliance: 
https://www.bu.edu/researchsupport/forms-policies/noncompliance-in-human-subjects-research/ 
Management of Life Crises: 
Determine Severity of Crisis 
Major Life Crises include: death of a spouse, child, or parent; major illness or accident to 
spouse or child. Minor Life Crises include: car accident with physical injury, sudden impending 
divorce, loss of job, etc. 
Major Life Crises: 
If the study staff member defines the crisis as major, one full session can be devoted to a 
discussion of this event and its impact. The study staff member should then schedule a make-up 
session within one week to cover the material missed due to the crisis (Note: This would most 

Page | 54 
 
 
likely extend the length of the study by one week and is tantamount to the participant cancelling 
a study session). If the participant continues to need help in dealing with this crisis, a second 
session may be used. However, the participant must then be withdrawn from the study and given 
alternative treatment and/or an outside referral. 
Minor Life Crises: 
If the therapist defines the crisis as minor, then it does not warrant one full session of 
discussion. The study staff may spend approximately 15 minutes discussing the event with the 
participant and then should redirect the participant back to protocol material by acknowledging 
that such an event is likely to increase feelings of anxiety and probably would occur in anyone 
experiencing such an event, asking how this event affected the participant and his/her/their 
anxiety and/or panic, and asking how his/her/their reaction to the crisis can be discussed in the 
context of treatment. 
If the event is not one in which the participant can be easily refocused, or requires more than 10-
20 minutes of session time, the therapist should end the session after a brief discussion of the 
event, and schedule another full session (within a week) to cover the missed UP or TC treatment 
material. 
 
NOTE: A life crisis and postponement of treatment can only occur once during treatment. If a 
second crisis emerges that requires postponement of treatment, it can still be addressed during 
the session. However, these participants will then be removed from study treatment and given 
alternative treatment or an outside referral. 
Removal from Protocol Due to a Life Crisis 
As noted above, this might occur if: 1) the participant needs additional support in dealing 
with the crisis, or 2) A second major crisis occurs during the course of treatment.  
 
NOTE: A question may emerge regarding the severity of a stressor not listed above, or whether 
to remove a participant from the study. In these cases, the therapist should consult first with the 
project director. If there is any disagreement between the therapist and project director, the case 
may be discussed with the PI, who will make the final decision. 
Premature Study Termination 
Every effort will be made to keep participants in the study. Participants who drop out of 
or are withdrawn from the trial will be included in the data analysis as described in the Data 
Analysis Section of the grant. Participants who choose to end treatment prematurely will be 
followed for the remainder of the trial if they can still reach the post treatment session (session 
12 for TC or 16 for UP) within 16 or 21 weeks from the session 1 date, respectively.  
The RA should attempt to collect all self-report measures and clinician administered 
assessments conducted at the major time-points (4, 8, 12, 16, 1-month, and 6-month follow-up) 
in the event of a drop-out or withdrawal (if the participant is willing and able to continue in this 

Page | 55 
 
 
manner). Self-reports can be emailed to the participants, and the clinician-administered 
assessments can be conducted over the phone in order to provide flexibility to the participant if 
unwilling to come in. All of these sessions should be scheduled on the basis of when the last 
attended treatment session occurred. The payment schedule will resume, with checks issued on 
session 8, post, and both follow-ups.  
RAs can attempt to call participants three times within two weeks after the last 
communication. If the participant does not call back after all three attempts, or answers/calls 
back but declines to continue in any capacity, study staff will make no further attempts to 
contact.  
Participants who are withdrawn from the study by the study staff will be offered 
alternative care or will be assisted to find other providers upon request. It is not necessary to 
offer alternative treatment to participants who choose to discontinue. Every effort will be made 
to record reasons for study dropout or withdrawal in the Treatment Termination Form, and the 
Attrition tab of the Retention Database. 
When to Withdraw Participants from the Study   
There are two primary reasons participants are likely to be withdrawn from StAR2: 1) 
clinical deterioration or life crises and emergencies, and/or 2) noncompliance with study 
requirements and procedures. 
Removal of participants from the research study should only occur in rare instances. In 
most cases, participants who are dropped or withdrawn from study treatment will be asked to 
complete a posttreatment assessment and will then be followed for the remainder of the follow-
up period (beginning from the date of the posttreatment assessment). In those rare instances 
when a participant is completely withdrawn from the study (upon their request or at the 
discretion of study personnel), the project director will complete a note detailing specific reasons 
the participant will not continue in the trial. 
Clinical Deterioration or Emergencies 
In some instances, participants may need to be withdrawn from the study if they suffer 
clinical deterioration that warrants referral to a higher level of care or if they experience life 
crises (as noted above), and/or medical or psychiatric emergencies that prevent adherence to 
study procedures and/or make further participation in the study ill-advised. 
Change in Diagnosis 
Diagnostic Changes that Occur Prior to the Onset of the Study: 
The diagnostic assessment (ADIS) may be administered up to one month prior to consent 
and treatment randomization. Participants who no longer meet the study's inclusion criteria at 
this pretreatment assessment will be excluded and will not be randomized to treatment. 
 
Diagnostic Changes that Occur During the Study: 

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If a participant appears to have a change in diagnostic status during the study, she/he/they will 
not be withdrawn from study treatment. These participants will remain in the study throughout 
the acute treatment phase and the follow-up phase (except in cases of severe clinical 
deterioration) or if they drop out themselves. 
Procedures for Handling Treatment Termination 
Drop-Outs  
If it becomes apparent that a participant is dropping out of the study, the therapist and/or 
RA should attempt to contact the participant by telephone to gather more information about the 
participant’s concerns/reasons for considering dropout. Sufficient information should be gathered 
to complete the Termination Form (/Dropbox/StAR2/Binder Materials/Study Forms). If the 
participant is planning on dropping out of the study, study staff can ask the participant if 
he/she/they is/are willing to come to the clinic for major assessment time point assessments 
(without completing any additional treatment sessions) at 4, 8, and 12 weeks for UP and 4 and 8 
weeks for TC, and a final assessment with the IE (post-treatment). If the participant declines 
further assessments in person, study staff may offer telephone assessments.  
 
NOTE: The Termination Form should be completed by the study staff member who contacts the 
participant. RAs please be sure to remind study therapists to document accordingly. 
Treatment Termination Due to Clinical Deterioration 
In these cases, the level of deterioration should be of a level such that the therapist and/or 
medical personnel are nearly certain that an IE will concur that withdrawal from the study is 
warranted. Inform the participant of the need to be evaluated by the IE. Inform the Project 
Director and the RA. The RA will inform the IE and schedule an appointment for the evaluation. 
The IE will administer the ADIS assessment. The results of this evaluation will be discussed with 
the Project Director and/or PI, who will then make a decision regarding removal of the 
participant from the study. The Project Director will inform the therapist of the final decision. 
The Project Director or the therapist will then inform the participant of the decision and provide 
appropriate referrals. These procedures should be conducted within 24-48 hours of knowledge of 
clinical deterioration. 
Termination Due to Psychiatric Emergency 
Examples of psychiatric emergencies include: suicidality and traumatic events (e.g., 
sexual assault, crime victimization). In these instances, the therapist has sole clinical 
responsibility for making decisions about the participants' status and should discuss concerns 
with the project director. An IE evaluation, involving the ADIS, SIGH-A, and SIGH-D, is 
always preferable before termination; however, if this clearly would not be in the participant’s 
best interest, an IE evaluation is not required. Regardless, the Project Director should be notified, 
and the Termination Form completed by either the therapist or IE (whoever has the most 
complete information). 

Page | 57 
 
 
Termination Due to Medical Emergency 
Examples of medical emergencies include: acute illness, appendicitis, hospitalization for 
a medical condition or accident. In these instances, a termination evaluation involving the ADIS, 
SIGH-A and SIGH-D, should be conducted by an IE, if possible, and can be done via telephone. 
The Project Director should be notified and a Termination Form completed. 
Study Protocol: Data Collection & Storage 
Data Collection 
Qualtrics 
The current study utilizes the Qualtrics Research Suite for online data collection, as 
developed and distributed by Qualtrics Labs Inc. (www.qualtrics.com). This data collection 
program is used by over four hundred colleges and universities around the world, and procedures 
for maintaining the security of research data are well established. The Qualtrics Research Suite is 
specifically designed to meet and exceed industry standards for Internet security as well as IRB 
standards for the protection of research participants. Their servers, database, and web presence 
employ multiple forms of enterprise-level security features to accomplish these goals. Qualtrics 
Labs Inc. has SAS 70 certification and meets the privacy standards imposed on health care 
records by the Health Insurance Portability and Accountability Act (HIPAA). 
No identifying information will be collected using the Qualtrics Research Suite online 
data collection software. Research participants will access the online questionnaires using an 
assigned ID number, which will be assigned when the participant has been approved by the PD 
for enrollment. As with traditional paper-and-pencil assessments, these online research data will 
not be directly linked to data containing individual identifiers, which are sorted in a separate 
location. Also, as IP addresses represent a form of potentially indirect identifying information 
about a participant, these will be excluded from data collection. 
Raw data will be exported from Qualtrics into SPSS databases for analyses. The data will 
be collected when the participant completes the online surveys designated by a specific link that 
will be e-mailed to the participant by the RA from the study-specific Gmail account. Once the 
participant completes the surveys, the data is automatically saved to the designated Qualtrics 
account, and ready to be exported. In order to distribute the surveys that contain the assessment 
packets, use the login information saved on the “StAR2 Login Information” in the BU Dropbox 
(UP_AUD/Procedural Manual/StAR2 Login Information). 
After each session, the RA running a given participant will go back to Qualtrics to make 
sure the data for that session were properly recorded. If the data was not properly recorded or the 
participant left the session early before completing all of the self-reports, the RA should email 
the link to the self-report battery to the participant and ask them to complete them as soon as 
possible.  

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Inquisit 
Inquisit 5 Lab is a tool for designing and administering psychological tests and 
experiments on dedicated computers, provided by Millisecond. There are four neurocognitive 
tests used in this trial: Balloon Analogue Risk Task (BART; Lejuez et al., 2002), Continuous 
Performance Test (CPT;  Rosvold et al., 1956), Go/No-Go Task (Fillmore et al., 2006), 
Millisecond Gambling Task (Rogers et al., 1999). No identifying information will be collected 
using the Inquisit lab software. The Inquisit Lab is installed on the computer in room 233D at 
CARD. There is a shortcut named “Bart_CPT_Go_Rogers.iqx” on the desktop. When 
administering the test, open the shortcut, enter participant ID (and group number), and the four 
tests will run in a row. The data manager RA should be responsible for uploading the output data 
to the shared drive StAR2\Data\Inquisit in corresponding tasks folders before 5 pm of the 
following work day, and should also ensure the data is complete. 
E-Prime 
E-Prime is a behavioral experiment software, provided by Psychology Software Tools. 
There are two emotion regulation tasks based on E-prime used in this trial: the Dot Probe Task 
(face and word version; TAU-NIMH ABMT Initiative, 2012) and the Emotion Conflict Task 
(practice and actual task; Etkin et al., 2010; Etkin & Schatzberg, 2011). No identifying 
information will be collected using the Inquisit lab software. E-prime is installed on the 
computer in the treatment room 233D at CARD. Shortcuts of the four tasks (1 Etkin practice, 2 
Etkin emotion conflict, 3 Dot probe face, 4 Dot probe words) are stored at C:\Users\CARD 
Guest\Desktop\StAR2 Emotion Regulation Tasks. When administering the test, open the 
shortcuts, enter participant ID and session number, and administer the task. The RA who is 
administering the task should sit with the participant during the emotion conflict tasks (practice 
and actual task), read the instructions to him/her/them, and make sure he/she/they understand the 
task. For the dot probe tasks, the RA can leave the room after entering the participant ID and 
session number. The data manager RA should be responsible for uploading the output data to the 
shared drive StAR2\Data\Eprime\ in corresponding task folders before 5 pm of the following 
work day, and should ensure the data is complete. 
 
Note: Due to sessions being conducted remotely as of March 18th, 2020, participants are no 
longer administered the neuropsychological battery at their session one or post-assessment.  
Study Databases 
Multiple databases have been created for data management. The purpose and location of 
each database can be found in the table below: 
 
Database 
Purpose 
Location 
StAR2 Deviation 
Tracking Log 
Used to track the protocol deviations 
https://docs.google.com/spreadsheets/d/1sM
f1jXMEyib-
DUmf5kPncWXPo_7Lbl8v5ZUHJS3cnJ4/e
dit#gid=0 

Page | 59 
 
 
StAR2 Enrolled 
Participants 
Sessions Tracking 
Uses a subset of information from the 
Retention Database to track participants’ 
session dates. There are two tabs, one for TC 
and one for UP. 
 
https://docs.google.com/spreadsheets/d/1sM
f1jXMEyib-
DUmf5kPncWXPo_7Lbl8v5ZUHJS3cnJ4/e
dit#gid=0 
StAR2 Hand-
Entered Data 
Used to enter lab results and tracks the 
progress on entering and checking TLFB and 
MoCA data 
 
https://docs.google.com/spreadsheets/d/
1fX5twUy5VGi51SxIJbc4w82EW3B-
hZ4wAPzhle7J_v8/edit#gid=0 
StAR2 Recruitment 
Tracking 
Helps with recruitment tracking and the 
eligibility outcome of potential participants as 
well as tracking every contact made with 
potential participants 
 
https://docs.google.com/spreadsheets/d/
1CfmkEyHsjWe6i5kTBZ28jEoHE5qB_
YNvhZZq0NDnDSI/edit#gid=2 
StAR2 Training 
Progress Tracking 
Tracking is a training checklist for assessors 
and therapists 
https://docs.google.com/spreadsheets/d/
1BCLo66umCS3H2OBiMm9BJIwks17t
jh-RYuFdhrPA4EE/edit#gid=0 
StAR2 Retention 
Database 
Holds the participants contact info, enrolled 
participants contact log, session number for 
each participant, attrition, and payment 
tracking. 
 
StAR2:\Data\STAR2 RETENTION 
DATABASE.xlsx 
StAR2 TLFB 
Timeline Follow-Back data and alcohol 
tracking information 
StAR2:\Data\TLFB\StAR2 TLFB.sav 
StAR2 MoCA 
Used to enter the MoCA data from the 
participants 
StAR2:\Data\MoCA\StAR2 MoCA.sav 
StAR2 Adherence 
Database 
Is used to enter the Adherence data that is 
collected 
 
StAR2:\Adherence Ratings\Adherence 
Databases\StAR2 Adherence 
Database.sav 
StAR2 TIF 
Database 
Includes all the Treatment Involvement Form 
data 
 
StAR2:\Data\TIF\TIF Database\StAR2 
TIF.sav 
StAR2 Adherence 
Randomization 
Database 
Used to randomize therapy session tapes for 
the PI to listen to in order to evaluate the 
adherence of therapists’ treatment sessions. 
StAR2:\Adherence Ratings\Adherence 
Databases\StAR2 Adherence 
Randomization Database 
StAR2 Adverse 
Events Tracking 
Log 
Used to track all expected and unexpected 
adverse study events; the outcome and action 
taken. 
StAR2\Adverse Events\StAR2 Adverse 
Events Tracking Log 
 

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Data Management 
The following data will be hand-entered in the “StAR2 Hand-Entered Data” Google sheet 
online (https://docs.google.com/spreadsheets/d/1Oxb7gQJ_LelDELWU9-
JQR_643GxKpCZEokCI4CGjn6k/edit#gid=0). For the hand-entered data, one RA will enter the 
data, a second RA will check every entry, and a third RA will randomly check 30% of the data 
entered. Research volunteers supervised by RAs may also help enter and check data. Should the 
RAs have specific concerns about data integrity, they should immediately alert Dr. Eustis for 
consultation. If necessary, the Project Director will be contacted to discuss appropriate actions. 
Should any more general abnormalities arise, the RAs are responsible for bringing such issues to 
the group in the weekly lab meeting. Any necessary changes to data will be saved in StAR2 
Hand-Entered Data Google Sheet. Upon completion of the trial, such changes will be 
incorporated into the SPSS final database.  
Data Storage  
The following guidelines will be followed:  
• Data collected using Qualtrics will be downloaded once all data collection is finished and 
saved on: \\ad\dfs\cas\STAR2\Data\Qualtrics. 
• Data collected using Inquisit will be moved from the local study computer to the shared 
drive every week and saved at: \\ad\dfs\cas\STAR2\Data\Inquisit. 
• The fMRI data will be downloaded from xnat after scan once it is available and saved at: 
\\ad\dfs\cas\STAR2\Data\Eprime\Alcohol\Downloaded from xnat and 
\\ad\dfs\cas\STAR2\Data\Eprime\Reappraisal\Downloaded from xnat.  
• The data output from Eprime will be moved from the local study computer to the shared 
drive every week and saved at: \\ad\dfs\cas\STAR2\Data\Eprime. 
• The TLFB calendar will be scanned after every session, uploaded and saved in: 
\\ad\dfs\cas\STAR2\Data\TLFB. Instructions for entering and checking the TLFB data is 
saved in the same folder. 
• The MoCA will be scanned after every screen, uploaded and saved in: 
\\ad\dfs\cas\STAR2\Data\MoCA. Instructions for entering and checking the MoCA data is 
saved in the same folder. 
• The Lab results data will be saved in: \\ad\dfs\cas\STAR2\Data\Lab results. 
• Scanned copies of Treatment Involvement Forms will be saved in: 
\\ad\dfs\cas\STAR2\Data\TIF. 
• Phone screen forms will be saved in: \\ad\dfs\cas\STAR2\Data\Phone screens. 
• Recordings for therapy sessions will be uploaded and saved in: 
\\ad\dfs\cas\STAR2\Recordings therapy sessions. Recordings for assessments will be 
uploaded and saved in \\ad\dfs\cas\STAR2\Recordings assessments. 

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Data Reporting   
The Data Manager, Stephen Allen, is responsible for updating the group once a month at 
the Monday lab meeting. These updates will be provided according to the Word template Data 
Presentation Template_Measures.docx, Data Presentation Template_Participants.docx, and 
Data Presentation Template_Measures.xlsx saved in \\ad\dfs\cas\STAR\Data\. Data reports will 
reflect all surveys completed before the prior business day. 
Quality Control 
Maintaining Confidentiality 
Maintaining confidentiality of study participants is the responsibility of all members of 
the research team and should be observed in accordance with the APA guidelines on Ethical 
Principles of Psychologists and Code of Conduct. Standards for maintaining privacy and 
confidentiality can be found here: http://www.apa.org/ethics/code/index.aspx 
 
A number of specific procedures have been developed for this study to help maintain 
confidentiality: 
1) All data entered into the data pool are strictly confidential and should not contain any 
identifying information. 
2) Computerized research data (including digital audio recordings) are stored on the 
shared drive in StAR2/Data The PI, study therapists, RAs, and volunteers working on 
data entering and checking have access to it. The data manager RA is in correspondence 
with BU CAS IT to give additional access and/or remove non-active users whenever 
changes in that nature need to be made. 
3) Data from participants who complete, drop, or withdraw from the study will be saved 
in the shared drive in: smb://ad/dfs/cas/StAR2/Retention participants/StAR2 
RETENTION DATABASE.xlsx, Attrition tab.  
4) Only key study personnel (i.e., the PIs and trained study staff) will have access to 
research data.   
5) A link between the participant’s ID number and name will be kept in a separate locked 
folder in the shared drive, and can be accessed by RAs and Dr. Farchione: 
smb://ad/dfs/cas/StAR2/Blind/randomizationlist 5.23.18.csv 
6) No identifying information will be revealed in the presentation or publication of any 
results from the project.   
7) All data will be destroyed seven years following the conclusion of the study. Audio 
recordings will be erased within one year after study completion. 
Certificate of Confidentiality (CoC) 
For this study, a Certificate of Confidentiality from the National Institutes of Health has 
been obtained. With this Certificate, the researchers cannot be forced to disclose information that 

Page | 62 
 
 
may identify the participants, even by a court subpoena, in any federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. The researchers will use the 
Certificate to resist any demands for information that would identify the participants. The 
Certificate of Confidentiality does not prevent the researchers, however, from disclosing 
voluntarily, without the individual’s consent, information that would identify them as a 
participant in the research project under the circumstances described below, in the limits of 
confidentiality section. 
A CoC does not prevent the participants or a member of their family from voluntarily 
releasing information about themselves or their involvement in the research study. If an insurer, 
employer, or other person obtains the participant’s written consent to receive research 
information, then research personnel may not use the Certificate to withhold that information. 
Additional information of CoCs can be found at: http://grants.nih.gov/grants/policy/coc/. 
Limits of Confidentiality 
Massachusetts law requires that confidentiality be broken by any of the study staff if they 
learn in the interview or during the course of treatment of likely current abuse of children, elders, 
or disabled individuals. Further, if the participant tells anyone associated with the study 
information that leads him/her/them to believe that the participant might be at risk for hurting 
themselves or others, members of the study staff are obligated to break confidentiality and take 
action to prevent harm. Also, because this research is sponsored by NIAAA, and monitored by 
the Institutional Review Board for Human Subject Research of the Boston University Charles 
River Campus, staff from these agencies may review records that identify the participants for 
audit or program evaluation. They, too, will protect the participant’s privacy. 
Institutional Review Board (IRB): Charles River Campus 
To ensure the integrity of the current study and protect all involved in participation, The 
Charles River Campus Institutional Review Board (CRC IRB) must approve all aspects of 
recruitment, assess any potential risks and benefits of undergoing treatment, and ensure that 
study procedures are carried out properly. The CRC IRB follows federal regulations that govern 
research on human subjects. 
The CRC IRB is part of a shared IRB system that also includes the BU Medical Campus 
and Boston Medical Center. Three boards serve on the Medical Campus and one serves on the 
CRC. The CRC IRB typically meets every third Tuesday of each month. The board reports to the 
“Institutional Official,” currently Mellouk, Kathryn M.; Assoc VP, Research Compliance. For 
more information, visit: http://www.bu.edu/researchsupport/.  
The Charles River Campus IRB is located on Boston University’s main campus at One 
Silber Way, 8th floor, Boston, MA, 02215. The office phone number is: 617-353-2595.  
Contact person: Please contact Shayne C. Deal with any questions at 617-358-6116 or 
sdeal101@bu.edu (This is accurate information as of July 2018 but may be subject to change 
over the duration of the study). 

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BU/BMC IRB Policies on Human Subjects  
Boston University is committed to conducting human subjects research following the 
ethical principles as outlined in the Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research. The basic ethical principles are: respect for persons, 
beneficence, and justice. All individuals (IRB, investigators, students, and staff) involved in 
conducting human subjects research must adhere to these principles. 
The CRC IRB is established in compliance with regulations of the Department of Health and 
Human Services (DHHS), Food and Drug Administration (FDA), as well as other applicable 
federal regulations, and state and local laws. This includes the following; this list is not all 
inclusive and may change depending on current funding sources: 
 
1. Office for Human Subjects Research (OHRP) 
2. Food and Drug Administration (FDA) 
3. Department of Defense (DOD) 
4. Department of Education (DOE) 
5. State and local laws 
 
Human subjects research being conducted by members (faculty, students, or employees) of 
Boston University’s Charles River Campus must be reviewed and approved by the CRC IRB. 
The CRC IRB adheres to the DHHS and FDA definitions when determining if research activities 
are human subjects research. 
The CRC IRB has the authority to approve, require modifications to secure approval, and 
to disapprove research activities being conducted by members of Boston University’s Charles 
River Campus. Officials of Boston University cannot approve research that has not been 
approved by the CRC IRB. 
The CRC IRB does not have oversight over research conducted by members when they are 
acting independently of their official BU roles and responsibilities. This research will be 
determined to be independent of their official roles and responsibilities and not subject to IRB 
review if: 
 
1. The research is conducted on their own time and not reimbursed by Boston University or 
through Boston University accounts, 
2. The research is conducted without the use of Boston University space, materials, 
supplies, or staff support, 
3. Any research publications, reports, or presentations will not list the member’s position 
and affiliation with Boston University. 
 
Investigators are responsible for determining if research projects involve human subjects and 
therefore require review by the CRC IRB. If an investigator is unsure if a project is human 
subjects research, he/she/they should contact the IRB for consultation. The IRB Director or IRB 

Page | 64 
 
 
Analysts have the authority to make the determination of whether a research project meets the 
definition of human subjects’ research. Investigators who would like a written determination 
about whether the project is human subjects research can contact the IRB office with this request. 
More information about the IRB policies can be found at: 
https://www.bu.edu/researchsupport/forms-policies/research-involving-human-subjects/ 
IRB Binder 
A binder containing IRB materials for the StAR2, including the tracking of upcoming 
deadlines and all correspondence between the StAR2 research lab and the Charles River Campus 
IRB (CRC IRB) is located in room 245B at CARD. Materials are organized chronologically by 
relevant section. The RAs are responsible for maintaining the IRB binder. The binder contains 
the following sections: 
 
IRB Correspondence List 
 
At the front of the binder is a list that tracks upcoming IRB deadlines and 
correspondences. Whenever the PI receives an IRB notice regarding any aspect of the project, 
the letter is filed by the RA in the appropriate section and the list is updated to reflect when the 
correspondence occurred, what section of the binder it is in, and who filed it. For each section of 
the binder, any IRB correspondence is placed before all other materials. For example, the IRB 
approval letter would be filed in front of the initial submission materials (i.e., the application, 
consent form, etc.) in the Initial Submissions section of the binder by the RA, who would then 
write the date of the letter and his/her/their initials in the appropriate columns on the list. On the 
StAR2 Shared Drive under the “IRB” section is the electronic copy of the correspondence list. 
This should also be updated whenever the hard copy is updated.  
If the letter includes a project deadline, then the date of the correspondence is highlighted 
on the list to indicate importance. The correspondence list is used for documenting submission of 
study renewal, amendments, deviations, and unanticipated problems and the IRB’s response to 
these submissions. It is crucial to highlight the initial and yearly submission dates and to note 
expected re-submission dates on the list, as it acts as a quick reference for important deadlines. 
For example, renewal applications should be submitted at least eight weeks prior to expiration; 
including this date on the checklist is important. Please see the following sections for further 
directions. 
Initial Submission 
Following the deadlines list is the initial submission of the UP study to the IRB. This is a 
research application that provides the IRB with the contact information of UP project 
investigators, managers, and other assistants, a background for the study, and a detailed outline 
of the project and its procedures.  
The initial submission approval was made on September 13, 2017. At the beginning of 
the initial submission section of the IRB binder is the IRB’s response to the initial submission. It 
contains approval of the study. The list at the front of the binder is updated to reflect submission 

Page | 65 
 
 
and the date of IRB approval. The date of approval must be highlighted on the list in order for 
the study renewal submission to occur on time.  
Annual Renewals 
Each year, approval of the research study must be renewed. The renewal application is 
reviewed by the IRB, which then approves the application for continuation. Requirements for 
continuing review are provided to the PI in the IRB approval letter. The PI is responsible for 
submitting a Progress Report and updated Informed Consent Form(s) (when applicable) to the 
IRB for review and approval prior to expiration of the study. Many research protocols only 
require annual review but some research projects (e.g., those with higher risks or at the request of 
the DSMB) may require more frequent review. The required frequency of review is determined 
by the IRB and is specified in the IRB approval letter.  
The Progress Report contains the following information: the complete and approved IRB 
protocol, protocol status (pending/no accrual, active, closed to accrual, completed, open for data 
analysis, open for long-term follow-up only), accrual information, accrual categories, reports of 
unanticipated problems and adverse events, subject complaints, amendment information, 
protocol exceptions, protocol deviations, protocol findings, and any presentations or publications 
of study findings. In addition, any information concerning the state of knowledge about the study 
question (particularly other information that might change the assessment of clinical equipoise or 
the risk: benefit assessment) is presented as part of the progress report. A Progress Report form 
is sent to the IRB eight weeks prior to study renewal. Failure of the PI to receive the renewal 
notice does not excuse the PI from his/her/their responsibility for submitting Progress Reports on 
time. Any protocol modifications (not included in amendments made during the study) are listed 
here to be reviewed. Copies of the submitted Progress Report and the IRB’s response are kept in 
the Annual Renewal section of the binder and on the shared drive. The correspondence list is 
updated to reflect communication between the study and the IRB.  
Based on the information provided in the Progress Report and as allowed by the 
regulatory guidance, the staff in the IRB office determines whether the progress report can be 
reviewed by a board member who is a designated expediter or whether it must be reviewed by a 
convened IRB panel. Progress Reports submitted for continuing review may be expedited when 
the research is:  
1. Approved by expedited review (as an expedited study) on initial approval and no 
changes in risks have occurred 
2. Approved by convened IRB but the research is now closed to enrollment of new 
subjects, all subjects have completed all research-related interventions, and the 
research remains active only for long-term follow-up of subjects  
3. Approved by convened IRB but no subjects have been enrolled and no additional 
risks have been identified 
4. Approved by convened IRB but now the remaining research activities are limited 
to data analysis 

Page | 66 
 
 
The continuation of research after expiration of IRB approval is a violation of the federal 
regulations. If the IRB has not received and approved continuation of a research study by the 
study’s current expiration date, all study related activities must cease (including recruitment, 
enrollment, study interventions, long-term follow-up, and data analysis) unless the IRB has 
decided that it is in the best interest of the subject(s) to continue.  
The Annual Renewal section of the binder is broken down into yearly sections. As with 
all IRB correspondences, the IRB response to the annual renewal (included requested 
modifications) is placed in front of the initial renewal application. Yearly correspondences with 
the IRB are noted on the list and dates of re-approval are highlighted as a reminder for the next 
year’s renewal. 
Amendments 
After the initial IRB application is approved by the IRB, changes to the research protocol 
require a submission of an amendment to the IRB stating the intended changes. These proposed 
changes must be approved by the IRB before they can be implemented. A copy of the 
amendment is placed under the Amendments section in the binder. The IRB’s approval of the 
changes to protocol should be kept at the front of this section. As with initial submission and 
approval, the dates of submission and approval should be noted on the list at the front of the 
binder. The Amendment Request form can be found at this link: 
https://www.bu.edu/researchsupport/formsandpolicies/form-library/.  
Once the changes have been approved, the PI must initiate the amendment(s) and update 
the consent forms to reflect a change in protocol (i.e., replace the outdated consent with the new 
IRB approved form). Until approval has been received, all procedures must be done according to 
the initial application unless subjects are at risk for harm. For subjects whose participation began 
prior to protocol modification, re-consent is not necessary unless the nature of the study has 
changed. For instance, a change in scheduling does not require that subjects who consented prior 
to this change be notified. 
The addition of new personnel to the study requires IRB notification, as it is considered 
an amendment. A letter must be sent to irb@bu.edu explaining the role of the individual and 
reasons for the addition. Also, new personnel must complete the Human Subjects Protection 
Training, which can be found at http://www.bu.edu/irb/crc-irb-forms/. Certification of 
completion is sent to irb@bu.edu. A BU Conflict of Interest form, also found at the above site, 
must be given to the individual and returned to the IRB. 
The determination as to whether expedited review or full board review is required is 
based on how the change affects the risk level of the study. Amendments to full board protocols 
are reviewed by the full board unless the amendment reflects only minor or administrative 
changes. When full board amendments are reviewed, the findings are documented in IRB 
minutes. The IRB’s decision regarding the amendment is provided to the PI. The IRB may 
conduct an audit of any research protocol if there is reason to suspect changes have been made to 
the protocol prior to or without the approval of the IRB.  

Page | 67 
 
 
 
Protocol Deviations 
Protocol deviations represent incidents, circumstances, or processes that occur during the 
research protocol that are not part of or are inconsistent with the approved IRB protocol, with the 
policies and procedures outlined in this manual, or with the Federal regulations. For example, if a 
participant does not fill out a consent form prior to participation in the study, protocol has been 
violated. Investigators are required to follow the IRB approved protocol. Once the PI or any 
member of the study team identifies an instance where the approved protocol has been seriously 
altered this must be promptly reported to the CRC IRB within 5 days. Minor changes, such as 
study visits/procedures that are either omitted, conducted outside of the visit window, or in a 
different order than specified in the protocol that do NOT affect or have the potential to affect 
subject safety or data integrity, should be submitted within 20 working days of the incident. A 
Deviation Report form must be submitted to the CRC IRB for review. The submitted form and 
the IRB’s response is kept in the Protocol Deviations Submissions folder in Dropbox 
(Dropbox/StAR2/IRB/Protocol Deviation Submissions).  
Protocol deviations are reviewed by a member of the IRB staff. PIs are required to 
provide the IRB with CAPs (corrective action plans) for all deviations which explain how the PI 
will prevent the deviation from recurring. The IRB may approve, request modifications to, or 
disapprove CAPs. Frequent or serious protocol deviations can cause the IRB to institute an audit 
of a research protocol and referral to the appropriate institutional research oversight committee.  
A listing of all protocol deviations is available to the board at the end of each annual progress 
report. The board uses the information in the protocol deviations report and the Corrective 
Action Plan (CAP) in making its determination as to whether continuation of the research is 
appropriate. 
 
Unanticipated Problems and Adverse Events.  
The CRC IRB requires that any unanticipated problem be reported using the Adverse 
Events found on the shared drive. The following information defines what unanticipated 
problems are and explains how to manage them: 
Upon submitting an Adverse Events form to the CRC IRB and receiving a response 
letter, an update to the binder list stating the date of the correspondence should be made to the 
excel sheet “StAR2 Adverse Events Tracking Log” in the Adverse Events folder on the shared 
drive by the RA. Copies of the submitted form and the response letter are also kept in the 
Adverse Events folder of the StAR2 shared drive folder.  
Reporting Unanticipated Problems to the IRB 
Effective immediately, BU/BMC investigators will no longer individually report all SAEs to the 
IRB. Instead, only those events that meet all three of the following criteria: 1) is unexpected (in 
terms of nature, severity, or frequency) given (a) the research procedures that are described in the 
protocol-related documents (such as the IRB-approved research protocol and informed consent 

Page | 68 
 
 
document), and (b) the characteristics of the subject population being studied; AND 2) is related 
or possibly related to participation in the research (in this guidance document, possibly related 
means there is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); AND 3) suggests that the research places 
subjects or others at a greater risk of harm (including physical, psychological, economic, or 
social harm) than was previously known or recognized, OR are by definition SERIOUS (Note: 
all incidents, experiences, or outcomes that are unexpected AND related or possibly related AND 
are SERIOUS are automatically unanticipated problems). Based on the above definition, many 
(if not most) AEs and SAEs that are currently reported to IRBs are NOT by definition 
unanticipated problems and, therefore, do NOT--according to the regulations--have to be 
reported to the IRB. 
The “Unanticipated Problems and Summary of Events Report” (UPSER) should be used 
to report all events that meet the definition of unanticipated problems to the IRB. The UPSER 
may be submitted by any member of the study staff at any time, even when an amendment or 
progress report is pending. These unanticipated problems, whether they are internal or external, 
must be reported to the IRB within two business days of the investigators learning of the event. 
Internal events are those experienced by subjects enrolled by BU/BMC investigators no matter 
where the “event” occurs. For single site studies, all events are internal events. Only those 
internal events that meet the definition of unanticipated problems need to be individually 
reported to the BU/BMC IRB. 
External events are those that occur to subjects enrolled at other (non-BU/BMC) sites. 
Investigators in multi-center trials receive SAE reports of all external SAEs from all sites. These 
external SAEs no longer have to be routinely reported to the BU/BMC IRB on individual SAE 
reports. Instead, external SAEs will ideally be reviewed by a monitoring entity (e.g., the research 
sponsor, a coordinating or statistical center, a DSMB/DMC, an AE monitoring committee) or the 
investigators, in accordance with a monitoring plan described in the IRB-approved protocol. 
These entities should make the determination as to whether the SAE represents an unanticipated 
problem. Instances when external SAEs are determined to be unanticipated problems should be 
rare; when they occur, they must be submitted to the IRB. The submission must include an 
explanation from the investigator or sponsor as to why the event is considered an unanticipated 
problem, and a description of the proposed protocol changes or other corrective actions to be 
taken [Note: Problems that are unexpected, related, or possibly related and represent a greater 
risk to subjects will almost always require modification to the protocol and consent]. 
Managing IRB Content 
The RAs are primarily responsible for managing content related to the IRB and for 
informing the study team of submission/revision deadlines. The RAs will construct necessary 
IRB documents and provide them to Drs. Farchione or Eustis for review before submission. 
Copies of all IRB correspondence sent or received to the PD or PI should be given to the RA so 

Page | 69 
 
 
these documents can be filed in the IRB folder of dropbox: Dropbox (BOSTON 
UNIVERSITY)\UP-AUD\IRB. 
The IRB folder in Dropbox consists of a folder for each amendment submission, an 
Adverse Events folder, Approved Documents folder, Protocol Deviation Submissions folder, and 
Continuing Review folder. Each Amendment folder is titled with the date it was submitted, the 
amendment number, and the approval status (i.e., submitted, approved, rejected, in-progress). In 
each amendment folder, is the Amendment form, the approval letter/IRB response letter, and the 
submission materials.  
Adverse event management and report 
Definitions  
OHRP guidance on unanticipated problems and adverse events: 
https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/advevntguid.pdf 
Guidelines and FAQs: http://www.bu.edu/researchsupport/compliance/human-subjects/ 
Adverse Event (AE) 
AE is defined at this institution as, “any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with the subject’s participation in the 
research, whether or not considered related to the subject’s participation in the research.”  
Serious Adverse Event (SAE) 
SAE is defined at this institution as, any adverse event that: 
1. results in death; 
2. is life-threatening (places the subject at immediate risk of death from the event as 
it occurred); 
3. results in in participant’s hospitalization or prolongation of existing 
hospitalization; 
4. results in a persistent or significant disability/incapacity; 
5. results in a congenital anomaly/birth defect; or 
6. based upon appropriate medical judgment, may jeopardize the subject's health and 
may require medical or surgical intervention to prevent one of the other outcomes 
listed in this definition (examples of such events include allergic bronchospasm 
requiring intensive treatment in the emergency room or at home, blood dyscrasias 
or convulsions that do not result in hospitalization). 
Unexpected Adverse Event 
Definition: Any adverse event occurring in one or more subjects participating in a 
research protocol, the nature, severity, or frequency of which is not consistent with either: 1) the 
known or foreseeable risk of adverse events associated with the procedures involved in the 

Page | 70 
 
 
research that are described in (a) the protocol related documents, such as the IRB approved 
protocol, any applicable investigator brochure, and the current IRB approved informed consent 
document, and (b) other relevant sources of information, such as product labeling and package 
inserts, or 2) the expected natural progression of any underling disease, disorder, or condition of 
the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for 
the adverse event. 
Adverse event tracking 
All Adverse events submissions and IRB responses to the submission should be saved in 
the BU Dropbox folder: Dropbox (BOSTON UNIVERSITY)/UP-AUD/IRB/Adverse Events. 
When adverse events come up throughout the course of the study they should be logged in The 
Adverse Event Tracking Log in Google Sheets. Here is the link: 
https://docs.google.com/spreadsheets/d/1CdxXESTvWHNcWOqDNgfScTMzdvnbhdAo6aKv72
9VK-o/edit#gid=0 
This link is shared with the bostonstar2study@gmail.com account. 
Data and Safety Monitoring Plan 
The following procedures will be followed in compliance with NIH requirements to 
ensure the safety of study participants and the validity and integrity of data. For this study a 
DSMB will be used.  
Data and Safety Monitoring Board (DSMB) 
Functions of the DSMB 
A Data Safety Monitoring Board (DSMB) will be created as an independent body 
charged with ensuring that the safety of study subjects is protected and that the scientific goals of 
the study are being met. To support these purposes, the DSMB will review any proposed 
amendments to the study protocol, perform expedited monitoring of all serious adverse events, 
perform ongoing monitoring of drop-outs and non-serious adverse events, determine whether 
study procedures should be changed or the study should be halted for reasons related to the 
safety of study subjects, and perform periodic review of the completeness and validity of data to 
be used for analysis of safety and efficacy. The DSMB will also ensure subject privacy and 
research data confidentiality and will monitor enrollment to ensure that the study conclusion is 
not delayed. 
Membership of the DSMB 
To fulfill its mission of ensuring the safety and integrity of the study, it is necessary that 
the DSMB be comprised of members who possess a high degree of competence and experience, 
as well as the ability to function independently of all other parties involved in the study. The 
DSMB members should function free of the career and financial interests of its members. The 
DSMB will consist of three members with experience in conducting clinical trials for mental 
disorders, expertise in biostatistics, and a thorough knowledge of clinical trial ethics and human 
subject protection issues.  

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Members: Drs. Todd Farchione (Project Director), Barbara Kamholz (DSMB Chair), John Otis, 
and Kristen Ellard 
 
Barbara Kamholz, PhD, ABPP, DSMB Chair 
Kamholz Clinical Psychology Services LLC 
1330 Beacon Street, Suite #349 
Brookline, MA 02446 
(617) 905-4917 
Barbara.Kamholz2@va.gov 
 
John Otis, PhD, DSMB Member 
Assistant Professor 
Department of Psychiatry  
Boston University 
National Center for PTSD  
Boston VA Medical Center 
150 South Huntington Avenue  
Boston, MA 02130 
johnotis@bu.edu 
617-232-9500 
 
Kristen Ellard, PhD, DSMB Member 
Department of Psychiatry 
Massachusetts General Hospital 
617-724-5600 
kellard@mgh.harvard.edu 
Functional Organization of the DSMB 
The Chairperson of the DSMB will communicate by e-mail and telephone conference 
with the other members. Communication pertaining to review of serious adverse events (SAEs) 
will occur within a week of receiving any new SAE report. Reporting and communication about 
other matters will occur on a yearly basis for the duration of the study. Decisions of the DSMB 
will be made based on a majority vote of the members. 
Monitoring of Safety Data by the DSMB 
1. Unblinded Reporting – Safety information for this study will be reported to the DSMB 
in an unblinded manner. A statistical penalty will not be assessed for the ongoing 
unblinded review of safety by the DSMB.  
2. Range of Safety Reporting to the DSMB – It is considered necessary for the purpose of 
monitoring the safety of the study that the DSMB review not only adverse events 
(AEs) and serious adverse events (SAEs), but also other data that may reflect 

Page | 72 
 
 
differences in safety between treatment groups. This includes treatment retention rates 
and reasons for dropout. 
3. Serious Adverse Events – Expedited review will occur for all events meeting the FDA 
definition of Serious Adverse Events (SAEs) – i.e., any fatal event, immediately life-
threatening event, permanently or substantially disabling event, an event requiring or 
prolonging hospitalization, or any congenital anomaly. Included is any event that a 
study investigator or the DSMB judges to impose a significant hazard, 
contraindication, side effect, or precaution. All relevant information will be reported to 
the DSMB for each SAE, including information about the event and its outcome, and 
the subject’s medical history and current conditions. If the SAE is considered an 
unanticipated problem (for more information see the above section on Unanticipated 
Problems) then reporting to local IRBs will be completed within 2 business days of the 
unanticipated problem. Notification by e-mail shall be made to the DSMB within 7 
days of the occurrence of any SAE.  
4. Non-Serious Adverse Events – At yearly intervals during the course of the study, as 
indicated by the grant and in accordance with the CRC IRB, and then again at its 
completion, the DSMB will be provided with unblinded summaries of the numbers 
and rates of adverse events by treatment group. These reports will include types of 
events, severity, and treatment phase. Data on individual non-serious adverse events is 
not expected to be needed for this review. 
5. Other Safety-Related Reports – At yearly intervals throughout the course of the study, 
the DSMB will also receive unblinded summary reports of treatment retention and 
reasons for dropout, by treatment arm and study phase. 
6. Study Stopping Rules – If at any time during the course of the study, the DSMB judges 
that risk to subjects outweighs the potential benefits, the DSMB shall have the 
discretion and responsibility to recommend that the study be terminated. 
 
Monitoring of Data Quality by the DSMB 
At least on an annual basis during the course of the study, the DSMB will receive a report 
on data quality and completeness. These reports are prepared by the Data Manager, in 
collaboration with other members of the research team, and at a minimum, will include an 
overview of the progress of participant intake and retention; summary reports describing 
participant compliance with treatment visits and study evaluations, as described in the protocol, 
and a summary of the completeness and quality of key data elements needed to characterize 
participants, and primary and secondary outcomes. These reports will be used by the DSMB to 
evaluate the capacity of the data capture and processing to support scientifically valid analyses. 
Data Safety Monitoring Plan 
Because all BU CILSE procedures are nonsignificant risk in nature, the co-investigator at 
BU CILSE will execute a Data Safety Monitoring Plan (DSMP) covering BU CILSE procedures. 

Page | 73 
 
 
This DSMP includes monitoring and regular reporting of accumulated study data to Drs. Barlow 
and Farchione. DSMP procedures covering subject safety will be executed if necessary to protect 
the safety of human subjects. Subject safety and adverse events will be monitored and assessed 
by study staff during each study visit. If any adverse events should occur, the subject can 
withdraw voluntarily or, if a contraindication to fMRI scans or other disqualification from study 
eligibility becomes apparent, at the discretion of the BU CILSE co-investigator. 
Adverse events related to BU CILSE study procedures will be reported to Dr. 
Barlow. Serious adverse events, non-serious unexpected adverse events that are related or 
possibly related to the study, and unanticipated problems involving subjects or others will be 
reported to Dr. Barlow as soon as possible and within 5 working days/7 calendar days. Within 10 
working days of this notification, a full written report regarding events will be submitted to Dr. 
Barlow. Events that do not fall into the above categories will be reported to Dr. Barlow in 
summary format for inclusion into the annual IRB continuing review report. 
Annual DSMB Report to NIAAA 
Annually during the course of the study, the DSMB will prepare a summary report of its 
findings regarding safety and quality based on data received. This report will include a summary 
of all safety findings, as well as an assessment of protocol compliance and data quality. Any 
recommendations to improve participant safety, protocol adherence, or data quality will be made 
in the annual DSMB report. A copy of the annual DSMB report will be sent to the local IRBs 
along with the annual renewal report. The report will be stored in the DSMB folder in the StAR2 
Dropbox folder. 
 
Study Materials 
 
Audio Recorders 
Model: Sony ICDPX370 Mono Digital Voice Recorder with Built-in USB, black 
 
For the current trial, multiple audio recorders will be obtained for certification, adherence, and 
training purposes. There are a total of 6 audio recorders currently assigned to assessors, 
therapists, and RAs; Andrew Curreri: recorder #1, Brittany Woods: #2, Stephen Allen: #3, 
UNASSIGNED: #4, Andrew Curreri: #5, and Dr. Liz Eustis: #6. Each person is responsible for 
maintaining and keeping track of the recorder at all times throughout the study. Each person 
must store the recorder in a safe, locked area when not in use (if participant recordings are still 
being stored on it). However, study staff should always attempt to upload the audio recordings to 
the recordings folder of the StAR2 shared drive directly after every session and clear the original 
audio file from the recorder. If a recorder is lost before the uploading process, the PI must be 
notified immediately.  
Recordings of the clinical interview portion of the in-clinic screening session (ADIS, 
SIGH-A, and SIGH-D) will be digitally recorded to ensure adherence to the screening protocol 

Page | 74 
 
 
and inter-rater reliability for the administration of the clinical assessments. In addition, digital 
recordings will be collected during the RA administered assessments (TLFB, MoCA) and health 
assessments with Bonnie Brown (study nurse), occurring throughout treatment.  
The digital recordings will be stored in the study shared storage, under the path: 
\\ad\dfs\cas\StAR2\Recordings assessments. The digital recordings will be destroyed along with 
the other study data, after 7 years following the end of the study.  
Study Computer 
The study computer will be used throughout the study for questionnaires on Qualtrics. 
The computer will be located in room 233D at CARD. If the computer is occupied, the RAs may 
use the study laptop or check out a room with a computer in Titanium to administer the Qualtrics 
surveys.   
Accounts & Server Access 
BU Server (Active Directory Shared Drive) 
Each study member has access to the shared drive through their own Kerberos Active 
Directory log in information. See below for instructions on how to log into the Shared Drive. The 
UP lab owns its own shared space on the BU network to maintain current documents and 
databases which are vital for the everyday functioning of the StAR2 study. This is commonly 
referred to as the “shared drive.” Since the shared drive is not considered a secure network, any 
files containing confidential or identifying information must be stored in the participants’ med 
binders in the locked medical cabinet, in the Medical Research room.  
In the StAR2 study, audio files of treatment recordings will be shared with expert raters 
for therapist certification and adherence purposes. Immediate and secure access to the audio files 
is required. The BU shared drive server is utilized to share the audio files with the experts with 
access to the folders. Each therapist will only have access to their personal recording folder. Dr. 
Farchione is the expert rater and will have access to all the recording folders. According to the 
BU shared drive security overview, everything saved to the server is encrypted upon 
transmission and storage allowing only the permitted parties involved to access to the files.  
While the audio files will not contain any identifying information, maintaining recording folders 
on the shared drive ensures that employees have access only to file names and locations, not file 
content. Given the number of files that the experts will listen to, the BU shared drive offers a safe 
and efficient means for sharing the audio files.  
How to Access the Shared Drive 
Access on CARD network computers: 
1) Log onto computer using a personalized Kerberos username and password 
2) Click on the “Start” button located on the bottom left corner of the desktop 
3) Choose “Run” in the bottom right column, and a box will appear prompting a file path. 

Page | 75 
 
 
4) Type \\ad.bu.edu\dfs\cas\star2 into the dialog box and click “OK”. This should provide 
access to the shared drive immediately 
Access by Internet: 
1) Open a web browser, such as Internet Explorer or Firefox 
2) Type \\ad.bu.edu\dfs\cas\star2 into the URL at the top, this should lead to the shared drive 
right away 
Access on Personal Computers: 
Connecting to Active Directory Resources Using Windows 7, 2000 or XP 
Note that if the person trying to access is off the BU campus, they will generally need to connect 
to the VPN first, by logging in at http://vpn.bu.edu. 
1. Before you will be able to connect, you must synchronize your Kerberos password 
with the Active Directory. To do this, complete the online form 
(https://weblogin.bu.edu/accounts/create?_hostname=ad&_conffile=kpw). It will take 
approximately 15 minutes for the changes to take effect. You only need to do this once. 
You will need to follow the rest of the steps below each time you wish to connect. Please 
note that all slash characters (“”) in the instructions below are back slashes. They are 
produced by the key above the “Enter” key on standard keyboards. It is critical that you 
use the correct character because forward slashes (“/”) will not work.  
2. Go to the Start button or Start menu and choose Run.  
3. In the resulting dialog box, type \servnameshare (replacing both with your actual server 
and share names) and click OK. You should get the values that you need to enter from 
the owner of the resource that you are accessing; this person will most likely be an 
instructor if you are a student, or a department administrator if you are faculty or staff. 
 

Page | 76 
 
 
4. In the logon box that appears, enter ad\username (substituting your BU login name for 
username) and your Kerberos password. You should then be connected. 
 
 
Connecting to Active Directory Resources Using Mac OS X 
You may connect to Active Directory resources at Boston University with Mac OS X version 
10.2 or later. Note that you will need to know the name of the server and file share that you are 
connecting to ahead of time; this information will most likely be provided by an instructor if you 
are a student or by a departmental administrator if you are faculty or staff. 
 
To connect, follow the steps below: 
Note that if you are off campus, you will generally need to connect to the VPN first, by logging 
in at http://vpn.bu.edu. 
1. Before you will be able to connect, you must synchronize your Kerberos password 
with the Active Directory. To do this, complete the online form 
(https://weblogin.bu.edu/accounts/create?_hostname=ad&_conffile=kpw). It will take 
approximately 15 minutes for the changes to take effect. You only need to do this once. 
You will need to follow the rest of the steps below each time you wish to connect.  
2. If you are running Mac OS X 10.4.5 or earlier, download and install the Microsoft UAM 
(User Authentication Module) for Mac OS X (https://products.office.com/en-
US/mac?pid=windows2000sfm). Be sure that you download the Mac OS X version. 
This step is not necessary with Mac OS X 10.4.6 or later.  
3. You are now ready to connect. To do so, go to the Go menu and choose Connect to 
Server.  
4. Enter the server name in the box in the format of smb://servername, where 
“servername” is replaced with the actual name of the server. Click Connect.  
In OS X 10.5 or later:  

Page | 77 
 
 
 
 
Earlier versions of OS X: 
 
5. This will bring up an authentication window. In the window, enter AD for the domain, 
and enter your BU login name and Kerberos password. Click Connect (or OK, on 
older versions of OS X). 

Page | 78 
 
 
OS X 10.5 or later: 
 
Earlier versions of OS X: 
 
6. You will then be prompted with a dialog to select the name of the shared drive that you 
wish to connect to. All drives to which you have access should appear in the list. Select 
the appropriate drive and click OK. The drive will mount as any other disk would. When 
you are done, you disconnect by selecting the disk and choosing Eject from the File 
Menu.  

Page | 79 
 
 
Gmail 
Scheduling Participants using Gmail 
In order to maintain an open line of communication throughout the completion of the 
StAR2 study, a Gmail account has been created for the lab. This Gmail account is mainly used 
for communicating with participants who prefer email to phone. The RA will oversee the general 
management of the Gmail account. 
Study Gmail Account Login Username and Passwords 
The login information is saved on the “StAR2 Login Information” in the BU Dropbox 
(UP_AUD/Procedural Manual/StAR2 Login Information). 
How To Log a Treatment Session in Titanium 
1. On the calendar screen, right click in the time slot/schedule where you want to add the 
appointment (Note: By default, weekend days are not displayed but this setting can be 
changed by your center administrator. To navigate to days not displayed from the 
calendar screen, click the Go To button on the menu bar and use the calendar pop-up 
window to select the desired day, or use the arrow navigation icons)  
2. Click Add > type of appointment to be added and select “Other” 
3. Enter Appointment Information: Choose an appointment code. In the description write 
StAR2, participants ID number, and session number. Also be sure to mention the RA 
and type of visit (health/med or ADIS). 
(Note: Do not put confidential information in these fields.)  
4. Click the Scheduling tab to add the room number so the appointment is added to this 
schedule 
5. Click Save (Note: Depending on the settings chosen by your center administrator, you 
may see prompts to add the appointment to your schedule, that either you or the client 
has a conflicting appointment, or assign a new client to yourself).  
6. After making the appointment for the participant, make sure to add it to the calendar of 
the person overseeing the visit: 
a. If RA portion, add the appointment to the RA’s calendar.  
b. If ADIS screening or post-assessment add appointment to the IE’s calendar.  
c. If health/med portion add appointment to Bonnie Brown’s calendar and 
schedule a medical room under the “Scheduling” tab.  
d. If therapy appointment, add to the therapist’s calendar. 
7. Click Exit. 
If a Client Cancels/No Shows to Appointment: 
If a client reschedules their treatment session, notify the rest of the study staff by e-mail 
immediately. Timely rescheduling of participants’ treatment sessions is vital because different 
assessments may need to be distributed depending on the session number.  
 

Page | 80 
 
 
How to Log a Rescheduled Treatment Session: 
1. Log into Titanium 
2. Locate the scheduled treatment session that has been cancelled and click on it 
3. Change the attendance of the appointment from “scheduled” to “canceled” and mark in 
the notes section of the event why the participant cancelled. If participant 124 canceled 
the appointment, the title would change from “124_T8” to “124_C8”. 
4. This same procedure should be followed for participants who do not notify study staff 
about their inability to complete the treatment session. The title of the appointment 
should indicate NS for “no-show”. If participant 124 did not show up to the appointment, 
the title would change from “124_T8” to “124_NS8”.  
5. If the participant has rescheduled the treatment session, please create a new treatment 
appointment as described above. In this case the rescheduled appointment should be 
marked as RTS such that if participants 124 ended up rescheduling their cancelled 
appointment, the new appointment’s title would be “124_RTS8”. 
6. Should the participant cancel a rescheduled session, the Project Director should be 
notified of the reason the participant is providing for their inability to complete the 
treatment session. If the participant misses more than 3 scheduled, consecutive treatment 
sessions, the lab should be notified as the participant may be withdrawn from the study. 
Miscellaneous 
Documenting Participants Contacts 
All contact between study staff and participants will be documented in the Retention 
Database, Enrolled Contact Log tab. Additional contact between study staff members and 
participants outside of treatment will also be documented on a specific Additional Contact form. 
This form will be completed if the participant calls, e-mails, or comes in person to CARD with 
the intent of speaking with their therapist.  
Blank “Additional Contact” forms are available in Dropbox UP_AUDàBinder 
Materialsà Study forms. A few blank forms will also be available in the RA’s office in Room 
245B. Completed forms are given to the RA to be filed in the “Study Binder” which contains 
“Additional Contact” forms for all study participants. 
Instructions for Payment 
The nurse administrator at CARD, will be responsible for issuing checks to the RA, who 
will then either provide the check to the participant directly (immediately after completing the 
study assessment) or by mail, sent within 3 business days of the payment session. Following 
completion of a paid assessment, the RA should request payment from the administrator by 
writing “StAR2”, the session number, date of session, participant’s name, and amount on a piece 
of paper (please hand the slip directly to the administrator in person). The administrator will 
write a check for the amount requested. The RA should make two copies of each check. One 

Page | 81 
 
 
copy is placed in the participant’s Med binder. The other copy is placed in the check copies 
drawer at the front desk (front desk staff can orient study staff to this drawer). 
Participants are paid at MRI 1 (UP only), session 8, last session (12 or 16), for at least 
80% completion of EMA (added to the last session check), MRI 2 (UP only), and the 1-month 
and 6-month follow-ups. The RA can give the participant the check in person on the session 
compensated for. If it is the MRI 1 session or session 8, it can be given no later than the next 
session. The RA should document when the payment has been provided to the participant (or 
was sent via mail) in the Payment Tracking Database (StAR 2 Retention Database, Payment tab).  
This database contains information on who has been paid for which assessment, when the check 
was given to the participant, and any problems that may have occurred.   
Compensation Schedule: 
The total possible amount earned by the participant if all components are completed in the study 
is $450 for UP participants and $250 for Take Control participants.  
• fMRI Scan 1 (UP only)- $100 
• Week 8- $50 
• Week 12 or Week 16 (depending on condition) $75  
• EMA Component- $50 for at least 80% completion (paid at post) 
• Scan 2 (UP only)- $100 
• 1 month FU- $100 
• 6-month FU- $100 
 
Should any questions or concerns arise, please do not hesitate to contact Drs. David Barlow or 
Todd Farchione at (617) 353-9610. 
 
Thank you for your continued cooperation! 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix A: Consent Form  
 
 
Protocol Title: Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety 
Disorders 
Principal Investigator: Todd Farchione, Ph.D 
Description of Subject Population: Adults seeking help for alcohol use disorder and an anxiety 
disorder 
Version Date: 3/16/2022 
 
Consent Statement 
 
You are being asked to participate in this research study on the treatment of anxiety and alcohol use 
disorders. About sixty subjects will take part in this study.  
 
Before agreeing to participate, please read this form carefully. The purpose of this form is to provide you 
with important information about taking part in this research study. If any of the statements or words in 
this form are unclear, please let us know. We would be happy to answer any questions to be sure that you 
understand what your participation would involve. 
 
The goal of the study is to compare a psychological treatment (the Unified Protocol) designed to be used 
for a variety of different types of psychological disorders, including anxiety disorders and alcohol use 
disorders, to a modified, therapist-directed version of Take Control, a program designed by the National 
Institute of Alcohol Abuse and Alcoholism to help individuals moderate their drinking. The Unified 
Protocol teaches skills for managing emotions like anxiety, fear, sadness, or anger while Take Control 
targets drinking behaviors more directly. In order to compare these two treatments, this study will 
compare the symptoms and functioning (e.g., how someone is doing in different areas of life) of study 
participants who receive each type of treatment. The study will include a number of different assessments 
that will be completed before, during, and after treatment. Both the treatment and assessments will be free 
of charge.  
 
The researcher in charge of this study is Todd Farchione, Ph.D. Dr. Farchione can be reached at Center 
for Anxiety and Related Disorders (CARD) at 617-353-9610 between 9 AM and 5 PM. We will refer to 
them as the “researchers” throughout this form. For emergencies after hours, please call the 24-hour 
emergency number of the study nurse Bonnie Brown, R.N. at 617-835-1840. 
 
As you are considering participating in this study, we would like to help you think through the 
participation by stating that if you are considering any change in your current drug or therapy program, 
this might not be the time to participate in a study like this. During this study, you will be asked to contact 
staff if you start any outside therapy and/or change the dose of any current medication you are taking for 
your psychological well-being. However, you may participate in self-help groups such as Alcoholics 
Anonymous. So, if you anticipate change in medications or therapy, you probably do not want to 
participate right now in this study. Of course, you are always free to visit your doctor for any 
psychological help or make any choices that you wish, but you should know that this may cause you to 
become ineligible to continue in the study. 
 

Page | 83 
 
 
If you have any questions about the research or any portion of this form, please ask us. Taking part in this 
research study is up to you. If you decide to take part in this research study, we will ask you to sign this 
form. We will give you a copy of the signed form. 
 
Sponsor 
This study is being funded by the National Institute on Alcohol Abuse and Alcoholism. 
 
What will happen if I take part in this research study? 
  
If you agree to take part in this study, we will ask you to sign the consent form before we do any study 
procedures. The study procedures are listed below. 
 
Please note that at each study visit, including the screening visit, you will be asked to complete a 
breathalyzer test. If the breathalyzer test reveals an alcohol level higher than 0.02% blood alcohol 
concentration or if you appear under the influence of another drug, you will not be able to attend the 
appointment. You will be provided with a breathalyzer, which is yours to keep following completion of 
the study. You will be asked to complete a breathalyzer test and report the result to study personnel 
during each study session.  
 
This study consists of two screening visits, 12 to 16 treatment sessions, a 1-month follow up session, and 
a 6-month follow up session. Study sessions will be conducted remotely via Zoom. We will be using 
Boston University’s secure Zoom account. Zoom requires the use of a browser but does not require any 
software download. For more information about Zoom security and privacy, please see: ZOOMcare.com. 
 
Screening visit: 
The purpose of the screening visit is to determine if you are eligible for this study. A recent diagnostic 
evaluation or recent research study screening evaluation, conducted at CARD, may be used as part of the 
screening visit in this study. This visit will take up to four hours. It will be done through Zoom and is split 
over the course of two visits. During the screening visits, we will ask you to do the following: 
 
• 
Provide information about yourself such as your birth date, race, ethnicity, and gender. 
• 
Answer questions about your medical and psychiatric history, medication and illnesses. 
• 
Fill out questionnaires about general psychological complaints such as anxiety, depression, and 
substance use.  
• 
At the time of your screening session and upon completion of the study treatment (weeks 12 or 16 
depending on which treatment you receive), we will ask you to go to a Quest Diagnostics facility 
to complete your medical testing (a urine sample for a drug screen and a blood sample via 
injection by needle). We will provide you with a testing form prior to your visits that you will 
give to a medical professional at Quest. We are also able to Uber you to a Quest Diagnostics 
testing facility near you at your convenience. 
• 
Blow into an alcohol breathalyzer. 
• 
We will ask you to report your height, weight, and the most recent blood pressure reading you 
received from a medical professional.   
• 
Answer questions about current treatments you are receiving for alcohol use disorder or anxiety 
disorders. 
• 
Be asked to participate in a neuropsychological test, administered by the research assistant 
 
If you are eligible to participate in this study, we will assign you by chance (like the flip of a coin) to one 
of two study groups. One group will receive the Unified Protocol. The other group will receive Take 
Control. Neither you nor the researchers can choose your study group.  

Page | 84 
 
 
 
 
Weekly Study Sessions 
You will receive 12 to 16 weekly study sessions following the initial screening. The weekly study session 
will be between approximately 60 and 90 minutes long except for session 1 and the last treatment session, 
which will take approximately 3 hours to complete. During these sessions, you will:  
 
• 
Be asked to complete several self-report measures asking about your mood, alcohol use, cravings, 
quality of life, and mental and emotional health.  
• 
Be interviewed by a researcher about your drinking since the last visit. 
• 
Be asked to breathe in a breathalyzer to assess your blood alcohol level at every session. 
• 
Be asked to take blood and urine tests, to assess your general health and alcohol and drug use.  
o Blood tests will occur at the screening session and on the last treatment session. 
. 
• 
Be asked to participate in some form of therapy treatment, either the Unified Protocol or Take 
Control.  
• 
Be asked to participate in some neuropsychological tests. Neuropsychological testing will happen 
at session 1 and the last treatment session. These tests will take approximately 30 additional 
minutes to complete. 
 
EMA Component 
The Ecological Momentary Assessment (EMA) component to this study will collect self-report drinking 
data in real time. The software we will be using is called Life Data. Life Data is a downloadable smart 
phone application which will send timed alerts 3-times a day (between 10am and 10pm) for up to 5, 7-day 
periods. In addition to the 3 times throughout the day you will have the option to self-initiate the survey 
during a drinking episode if you choose to do so. The drinking survey will consist of 5-6 questions To 
protect your privacy, your EMA responses will not be electronically linked to your identifiable information 
in any way.  
 
fMRI Scans 
You must be willing, and able to participate in the fMRI component in order to be eligible to participate 
in this trial. However, not all eligible participants will be asked to complete this component of the trial. If 
you are selected, we will ask you to undergo two brain magnetic resonance imagining (fMRI) scans 
during the study. These scans will take up to 1.5 hours each. One will take place during the screening 
session and the other will take place at the end of the trial. These scans will take place at Boston 
University’s Center for Integrated Life Sciences (CILSE). Results from these scans may be shared with 
research personnel at McLean Hospital who are working with us on this study.  
  
fMRI scans will be scheduled after completion of the assessment session at CARD, at which point you 
will be screened for pregnancy (women of childbearing potential), recent smoking or alcohol use, and 
illicit drug use. We will also ask you about any metal within your body. If you undergo the scans, you 
will need to remove all metal objects (such as hearing aids, dentures, jewelry, watches, and hairpins) from 
your body because these objects may be attracted to the powerful magnet used for the test. 
 
The fMRI scans include four components. The first is a resting-state scan, in which you are asked to lay 
still so we can evaluate your brain activity when you are not performing any particular tasks. The next 
task will display alcohol words on a screen and you will be asked to indicate the color of the font of the 
words you see. The following task will involve the presentation of two sets of images, those consisting of 
images of alcoholic beverages and a neutral set of cues. In the final task you will be shown a series of 

Page | 85 
 
 
images and asked to either sit with or alter the emotion the image evokes, and make ratings on the 
intensity of feeling experienced. 
 
We will ask you to lie still on a table that slides into a tunnel-shaped machine. The machine is slightly 
wider than your body. The top and sides of the tunnel will be very close to your body.  The MRI machine 
makes loud noises as it take pictures of your brain. We will give you earplugs to reduce the noise. You 
will be able to hear and speak to the research staff at all times during the MRI procedures. We can stop 
the procedure at any time.  
 
We will obtain physiological measures such as skin conductance, heart rate, pulse, and brain images. We 
will attach small sensors to the surface of your skin on your hand and/or torso to collect physiological 
data. These measures are completely safe and do not involve any physical discomfort. 
 
You will be notified if the results of your MRI examination are abnormal. If you choose to share your 
results with your primary care physician, results can be forwarded when the CARD’s Medical Records 
Release Form is signed.  
 
Post-Treatment Assessments: 
We will ask you to complete additional assessments one month and six months after the treatment 
sessions have ended. These assessments will be completed remotely via Zoom. During these interviews, 
you will be asked questions about your current alcohol use and anxiety and will be asked to complete 
some self-report questionnaires. These assessments will last approximately one hour. 
 
Reporting Sexual Misconduct, Sexual Harassment and/or Sexual Assault:  
If you are a member of the Boston University community and you report sexual misconduct to study 
personnel, including as part of study procedures, we are mandated to report the misconduct to the Boston 
University Title IX Coordinator. Members of the Boston University community include students, faculty, 
staff, affiliates, visitors, applicants for admission or employment, and independent contractors. Sexual 
misconduct includes sexual assault, sexual harassment, dating violence, domestic violence, stalking, and 
sexual exploitation. If you have questions, please review the BU Title IX policy, contact the Title IX 
coordinator, the Study Investigator, or the IRB Office. 
 
Confidentiality: 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens that 
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, 
suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have 
consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be 
disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local 
law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, 
state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other scientific 
research, as allowed by federal regulations protecting research subjects.  
The Certificate cannot be used to refuse a request for information from personnel of the United States 
federal or state government agency sponsoring the project that is needed for auditing or program 
evaluation by which is funding this project or for information that must be disclosed in order to meet the 
requirements of the federal Food and Drug Administration (FDA).  You should understand that a 
Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself 
or your involvement in this research. If you want your research information released to an insurer, 

Page | 86 
 
 
medical care provider, or any other person not connected with the research, you must provide consent to 
allow the researchers to release it. 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or 
local law of. The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
A description of this clinical trial is available on http://www.ClinicalTrials.gov. This website will not 
include any information that can identify you. At most, the website will include a summary of the results 
from this study. You can search this website at any time. 
 
In order to maintain confidentiality, data with participants’ identification information will be stored 
offline, on a password-protected external hard-drive, and locked in a drawer in CARD, which is only 
accessible to study personnel. Other study data, without any identifiable information of the participants 
will be stored online in Google sheets, under a Google account specially created for this study, which is 
only accessible to study personnel.  
 
We will make every effort to keep your records confidential. Of course, there are times when federal or 
state law requires the disclosure of your records. The instances in which your information may be shared 
are listed below: 
• 
Reporting child/elder abuse: If, during your participation in this study, we have reasonable 
cause to believe that child/elder abuse is occurring, the researcher must report this to authorities 
as required by law. The researcher will make every reasonable effort to protect the confidentiality 
of your research information. However, it might be possible that a civil or criminal court might 
demand the release of identifiable research information.  
• 
Reporting suicidal risk: If, during your participation of this study, we have reason to believe 
that you are at risk for being suicidal or otherwise harming yourself, we are required to take the 
necessary actions. This may include notifying your doctor, your therapist, or other individuals. If 
this were to occur, we would not be able to assure confidentiality.  
• 
Reporting intent to harm: If, during your participation in this study, we have reasonable cause 
to believe that you intend to threaten or harm another person, the researcher must report this to 
authorities as required by law. The researcher will make every reasonable effort to protect the 
confidentiality of your research information. However, it might be possible that a civil or criminal 
court might demand the release of identifiable research information.  
• 
Other: Records from this study could be subpoenaed by a court of law under certain conditions. 
We would also not be able to assure confidentiality if there is criminal or civil legal action related 
to sanity or competence, if you initiate legal action or ethical charge against the research, or if 
you request or allow disclosure of this information by signing a release of information form. 
Also, because this research is sponsored by the National Institute on Alcohol Abuse and 
Alcoholism, and monitored by the Institutional Review Board for Human Subject Research of the 
Boston University Charles River Campus, staff from these agencies may review records that 
identify you for audit or program evaluation. All of these agencies will protect your privacy. 
 
The following people or groups may review your study records for purposes such as quality control or 
safety: 
• 
The Researcher and any member of his research team. 
• 
The Institutional Review Board at Boston University. The Institutional Review Board is a group 
of people who review human research studies for safety and protection of people who take part in 
the studies.  
• 
The sponsor of this study, the National Institute of Alcohol Abuse and Alcoholism. 

Page | 87 
 
 
• 
Federal and state agencies that oversee or review research 
• 
Central University Offices  
 
In accordance with Boston University’s policy, we will store your data for seven years following the end 
of the study. The results of this study may be published or used for teaching. We will not put identifiable 
information on data that is used for these purposes.  
 
If you choose to sign the current consent form, you may be asked to participant in a supplemental study 
entitled “Assessment Supplement to Alcohol Use Studies.” If you choose to participate and subsequently 
sign the consent form for that study, you are also consenting to have data from this study combined with 
data from that study. Should you choose to not participant in the supplemental study, that decision will 
have no impact on your enrollment in the current study and your data will not be shared with the 
supplemental study. 
 
Alternative to Participation 
You may choose not to take part in this research study. You do not have to take part in this research study 
in order to receive treatment for alcohol use or anxiety disorders. Other treatments available for these 
symptoms include therapy that is not part of a research study and psychiatric medications. If you would 
like referrals to another type of treatment, please ask a study staff member.  
 
Compensation for Research Related Injury 
If you are injured as a result of taking part in this research study, we will assist you in getting medical 
treatment. However, your insurance company will be responsible for the cost. Boston University does not 
provide any other form of compensation for injury.  
 
Potential Risks: 
 
The primary risks involved in this study are those associated with treatment for anxiety in general and 
those associated with alcohol withdrawal. You will not be forced to do anything you do not want to do. 
You can also stop study procedures at any time. If you experience any adverse reactions, you can contact 
CARD personnel at 617-353-9610 during office hours (9AM-5PM) Monday through Friday. For 
emergencies after hours, please call the 24-hour emergency number of the study nurse Bonnie Brown at 
617-835-1840. If an emergency arises during the course of the study and you are unable to contact study 
staff, you should go to the closest emergency room immediately. However, no special provision will be 
made for compensation or for payment for treatment solely because of your participation in this 
experiment. This paragraph is a statement of Boston University’s policy and does not waive any of your 
legal rights.  
 
Alcohol Withdrawal 
You may experience symptoms associated with alcohol withdrawal during the study. These symptoms 
include shakes or tremors, chills, nausea and/or vomiting, agitation, sleeplessness, seizures, and delirium 
(disorientation, altered sensorium, and hallucinations).  
 
You may experience moderate to severe withdrawal symptoms if you stop drinking abruptly or if you 
attempt to steadily reduce your drinking. If you need treatment for withdrawal we will refer you to 
another treatment center for detoxification and you will be withdrawn from the study.  
 
Risks of fMRI 
There is a possibility of damage associated with magnetically sensitive metals being attracted to the 
magnetic field of the fMRI device. There are no known harmful effects from the strong magnetic field 
used for fMRI. But the magnet is very powerful. The magnet may affect pacemakers, artificial limbs, and 

Page | 88 
 
 
other medical devices that contain iron. The magnet will stop a watch that is close to the magnet. Any 
loose metal objects have the risk of causing damage or injury if it gets pulled toward the strong magnet. 
 
You should not have an fMRI if you have claustrophobia (fear of small spaces). The top and sides of the 
machine will be very close to your body. Because of this, you may feel anxious while inside the fMRI 
machine. If you do feel anxious during the procedure, you can ask us to stop the fMRI at any time. If you 
are pregnant or suspect you are pregnant, you should inform the study staff before the fMRI examination. 
Although there is no known risk of using fMRI in pregnant women, the safety of fMRI during pregnancy 
has not been established. Therefore, you cannot have an fMRI for this study if you are pregnant or think 
that you are pregnant.  
 
We are doing the fMRI in this study to answer research questions, not to give you medical care. This 
fMRI is not the same as one that your own doctor would order. It may or may not show problems that 
would be found on a regular fMRI. If we do see something that looks like a medical problem, we will tell 
you and forward the results to your primary care physician or help you get follow-up care. 
 
Risks of Psychological Discomfort 
You may experience discomfort and anxiety when answering questionnaires and when responding to tests 
evaluating your mood states and alcohol cravings. In addition, you may experience some discomfort or 
anxiety from discussion of personal information. You may find questions about your history distressing or 
uncomfortable. You may feel nervous when answering psychological questions. You will not be forced to 
do anything you do not want to do. You may get tired during the tasks. You can rest at any time.  
 
Loss of Confidentiality 
 
The main risk of allowing us to use and store your information for research is a potential loss of privacy. 
To protect your privacy, the storage of research data will be maintained using the suggested methods from 
the BU CAS Information Technology group. These methods involve labeling your information with a 
code and keeping the key to the code in an encrypted online storage created by the BU CAS Information 
Technology group, which is only accessible to the principal investigator.   Physical copies of data without 
identifiable information will be stored in a locked cabinet at CARD, only accessible to study personnel. 
Study data collected and maintained online including but not restricted to assessments, interviews, 
progress tracking will be de-identified, only distinguishable by study ID.  
 
Risks of Phlebotomy: 
Risks associated with having blood drawn may include: excessive bleeding, fainting or feeling 
lightheaded, hematoma (blood accumulating under the skin) and infection (a slight risk any time the skin 
is broken). The likelihood of these risks will be minimized by having blood drawn by a trained 
phlebotomist, nurse, or physician. 
 
Potential Benefits 
You may or may not benefit from this study. Study procedures may help you obtain relief from anxiety 
symptoms and associated disabilities. Study procedures may also help you reduce your drinking. 
However, benefits from these procedures cannot be guaranteed for any particular participant. As an 
indirect benefit, you will be providing information that will be helpful in expanding scientific knowledge 
about anxiety disorders and alcohol use disorders. Others may benefit in the future from information that 
is learned in this study. 
 
 
Compensation 

Page | 89 
 
 
You will earn up to $575 including $100 per fMRI assessment and an additional $50 for completing at 
least 80% of the EMA component. The remaining $325 will be distributed during the treatment and 
follow-up periods. You will receive $50 for completing all study procedures up to session 8, $75 for 
completing all study procedures associated with the post session (either 12 or 16), $100 for completing all 
study procedures associated with the 1-month follow-up, and $100 for completing all study procedures 
associated with the 6-month follow-up. To be eligible for payment, you must complete all study 
procedures associated with a compensated time point, which may include completing self-report 
questionnaires, completing labs, and/or completing neurocognitive tests.  
 
If you have any questions regarding the research or your participation in it, either now or anytime in the 
future, you are free to ask the research team. The research team can be reached at 617-353-9610 and will 
be happy to answer your questions. If any problems arise as a result of your participation in this study, 
including research related injuries, you should immediately call the Principal Investigator (Todd 
Farchione) at 617-353-9610.  
 
If you have questions about your rights as a research participant, or if you have any complaints or concerns 
and want to speak with someone independent of the research team, you may contact the Boston University 
Charles River Campus IRB at 617-358-6115. The IRB Office webpage has information where you can learn 
more about being a participant in research, and you can also complete a Participant Feedback Survey. 
 
 
 
 
Statement of Consent  
 
I have read the information in this consent form including risks and possible benefits.  I have been given the 
chance to ask questions and my questions have been answered to my satisfaction. My signature means that I 
understand the information, am 21 years old or over and agree to participate in this study.   
 
SIGNATURE 
 
 
______________________________________ 
 Name of Subject 
 
 
______________________________________ 
 
____________________ 
Signature of Subject 
 
Date 
 
 
I have explained the research to the subject and answered all his/her questions.  I will give a copy of the 
signed consent form to the subject. 
 
________________________________________ 
 
Name of Person Obtaining Consent 
 
 
________________________________________ 
 
_______________________ 
Signature of Person Obtaining Consent 
 
Date 

Page | 90 
 
 
Additional Consents: 
 
Consent to Use CARD Clinical Evaluation 
 
You consent for use of your CARD clinical evaluation to provide diagnostic and symptom severity 
information for this study. 
 
 
________________________________________ 
 
_______________________ 
Signature of Subject 
 
Date 
 
 
________________________________________ 
 
_______________________ 
Signature of Person Obtaining Consent 
 
Date 
 
 
 
 
 
 
 
 
 
Digital Audio Recording Consent 
We would like to audiotape your sessions during this study. In order to protect your confidentiality, we 
will refrain from using your name or any other identifiable information while you are being audiotaped 
and we ask that you do the same. We will store these tapes on an encrypted volume created by BU CAS 
Information Services and Technology on a sever within a secure data center and only approved study staff 
will be able to access the tapes. We will label these tapes with a code instead of your name. The key to the 
code connects your name to your audiotape. The researcher will keep the key to the code in a password-
protected computer file. All tapes and associated computer files will be stored for seven years. 
 
These audio recordings will be reviewed by members of the study staff for the purposes of supervision 
and consultation.  Sometimes study session recordings will be made temporarily available to select study 
investigators via a secure online server so that they can be reviewed for these purposes. Once the 
recordings have been evaluated, they will be removed from the server and stored on a secure hard drive, 
as described above.  
 
By signing my name below, I give permission to have any session audio recorded throughout the study.  
  
______________________________________ 
Name of Subject (please print) 
  
  
______________________________________                         ____________________         
 
Signature of Subject                                                                  Date