Computer Based Training in CBT for Spanish-Speaking Alcohol Users
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Yale University

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YALE UNIVERSITY
 HUMAN INVESTIGATION COMMITTEE
Application to Involve Human Subjects in Biomedical Research
100 FR1 (2011-2)
DATE STAMPED-RECEIVED
PROTOCOL NUMBER
SECTION I: ADMINISTRATIVE INFORMATION
Title of Research Project: 
Computer Based Training in CBT for Spanish-Speaking Alcohol Users
Principal Investigator:
Kathleen M. Carroll, PhD
Yale Academic Appointment:
Professor
Campus Address: 
40 Temple Street, Suite 6C; New Haven, CT  06511
Campus Phone: 
203-737-1544
Fax: 
203-737-1371
Pager: 
E-mail:
kathleen.carroll@yale.edu
Protocol Correspondent Name & Address (if different than PI):
 Joanne Corvino; 40 Temple Street, Suite 6C; New Haven, CT  06511
Campus Phone: 
203-785-2012
Fax: 
203-737-1371
E-mail:
Joanne.corvino@yale.edu
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable):
N/A
Campus Phone: 
Fax: 
E-mail:
Faculty Advisor:(required if PI is a student, 
resident, fellow or other trainee)           
 NA
Yale Academic Appointment:
Campus Address: 
Campus Phone: 
Fax: 
Pager: 
E-mail:
Please refer to the HIC website for application 
instructions and information required to 
complete this application.  The Instructions are 
available at http://www.yale.edu/hrpp/forms-
templates/biomedical.html 
Submit the original application and two (2) 
copies of all materials including relevant 
sections of the grant which funds this project 
(if applicable) to the HIC.  
HIC OFFICE USE ONLY
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Investigator Interests:
Does the principal investigator, co-investigator, or any other responsible research team member, or any of 
their family members (spouse, child, domestic partner) have an incentive or interest, financial or otherwise, 
that may be viewed as affecting the protection of the human subjects involved in this project, the scientific 
objectivity of the research or its integrity? See Disclosures and Management of Personal Interests in Human 
Research http://www.yale.edu/hrpp/policies/index.html#COI 
 √  Yes        No
If yes, list names of the investigator or responsible person:
Dr. Carroll holds the copyright to CBT4CBT.  Dr. Carroll has disclosed her ownership in the 
entity that distributes CBT4CBT to the Provost’s COI committee, and has an approved COI plan 
in place for her other CBT4CBT-related research.  A similar strategy will be used for the current 
project (use of Multiple PIs, quarterly DSMB reviews, a sponsor-initiated DSMP, use of an urn 
randomization program for allocation of participants to treatment, and transparency to the 
research community at large by availability of anonymized trial datasets on our website.  All 
investigators and study staff will be informed of the conflict and the strategies used to manage it.
All Yale University and Yale New Haven Hospital individuals listed as co-investigators must 
have a current financial disclosure form on file with the University’s Conflict of Interest Office.  
If this has not been done, the individual(s) should follow this link to the COI Office Website to 
complete the form:  http://www.yale.edu/coi/  
NOTE: The requirement for maintaining a current disclosure form on file with the University’s 
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital 
personnel.  Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any 
interests that are specific to this protocol.
SECTION II: GENERAL INFORMATION
1. Performing Organizations:  Identify the hospital, in-patient or outpatient facility, school or 
other agency that will serve as the location of the research.  Choose all that apply:
 
a. Internal Location[s] of the Study:
 Magnetic Resonance Research Center 
 PET Center
     (MR-TAC)   
 YCCI/Church Street Research Unit (CSRU)
 Yale Cancer Center/Clinical Trials Office (CTO)     
 YCCI/Hospital Research Unit (HRU)
 Yale Cancer Center
 YCCI/Keck Laboratories
 Yale-New Haven Hospital
 Cancer Data Repository/Tumor Registry
 Specify Other Yale Location:
b. External Location[s]:
 APT Foundation, Inc.
 Haskins Laboratories
 Connecticut Mental Health Center
 John B. Pierce Laboratory, Inc.
 Clinical Neuroscience Research Unit (CNRU) 
Veterans Affairs Hospital, West Haven
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 Other Locations, Specify:                                  
 International Research Site
Substance Abuse Treatment Unit (SATU)  and  Multi-Cultural Ambulatory Addiction
  One Long Wharf Drive                                               Services (MAAS)
  New Haven, CT                                                     426 East Street
                                                                                   New Haven, CT
c. Additional Required Documents (check all that apply):
 N/A
*YCCI-Scientific and Safety Committee (YCCI-SSC)
Approval Date: 
*Pediatric Protocol Review Committee (PPRC)
Approval Date: 
*YCC Protocol Review Committee (YRC-PRC)
Approval Date:
*Dept. of Veterans Affairs, West Haven VA HSS
Approval Date: 
*Radioactive Drug Research Committee (RDRC)
Approval Date: 
 YNHH-Radiation Safety Committee (YNHH-RSC)
Approval Date: 
 Magnetic Resonance Research Center PRC (MRRC-PRC)
Approval Date: 
 YSM/YNHH Cancer Data Repository (CaDR)
Approval Date: 
 Dept. of Lab Medicine request for services or specimens form
*Approval from these committees is required before final HIC approval is granted. See instructions 
for documents required for initial submission and approval of the protocol. Allow sufficient time for 
these requests. Check with the oversight body for their time requirements.
2. Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities. 
The duration of the project in its entirety will be 5 years and consists of two 
phases.  Phase 1 (Years 1-2) will be devoted to adapting and developing CBT4CBT for 
use with Spanish-speaking individuals with alcohol use disorders. In Phase 2 (Years 3-
5) Spanish-speaking individuals seeking treatment for alcohol use disorders will be 
invited to participate in a randomized trial evaluating the feasibility, efficacy, and 
durability of adding CBT4CBT to standard treatment.
3. Targeted Enrollment: Give the number of subjects:  
a. targeted for enrollment at Yale for this protocol 90   If this is a multi-site study, give the total 
number of subjects targeted across all sites N/A 
b expected to sign the consent form 125
c. expected to complete some or all interventions for this protocol? 90
d.  target enrollment for pilot:  __10___
4. Research Type/Phase: (Check all that apply)
a. Study Type
    
 Single Center Study
    
 Multi-Center Study
Does the Yale PI serve as the PI of the multi-site study? Yes 
No 
    
 Coordinating Center/Data Management
    
 Other: 
b. Study Phase
 N/A
    
 Pilot
 Phase I
 Phase II
 Phase III
 Phase IV
    
 Other (Specify) 
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c. Area of Research: (Check all that apply) Note that these are overlapping definitions and more 
    than one category may apply to your research protocol. Definitions for the following can be found  
    in the instructions section 4c:
    
    
 Clinical Research: Patient-Oriented
    
 Clinical Research: Outcomes and 
    
 Clinical Research: Epidemiologic and Behavioral                 Health Services
    
 Translational Research #1 (“Bench-to-Bedside”)
    
 Interdisciplinary Research
    
 Translational Research #2 (“Bedside-to-Community”) 
 Community-Based Research
5.   Is this study required to be registered in a public database? Yes 
No 
If yes, where is it registered?
Clinical Trials.gov registry 
Other (Specify) 
6. Will this study have a billable service as defined by the Billable Service Definition?
Yes 
 No
If you answered "yes", this study will need to be set up in Patient Protocol Manager (PPM)
http://medicine.yale.edu/ymg/systems/ppm/index.aspx 
7. Are there any procedures involved in this protocol that will be performed at YNHH or one of 
its affiliated entities?  Yes ___ No _X__  If Yes, please answer questions a through c and note 
instructions below.  If No, proceed to Section III.
a. Does your YNHH privilege delineation currently include the specific procedure that you will 
perform? N/A
 
b. Will you be using any new equipment or equipment that you have not used in the past for 
this procedure? N/A
 
c. Will a novel approach using existing equipment be applied? N/A
 
If you answered “no” to question 7a, or "yes" to question 7b or c, please contact the YNHH 
Department of Physician Services (688-2615) for prior approval before commencing with your 
research protocol.
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING
1. Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply.
Provide information regarding the external funding source.  This information should include 
identification of the agency/sponsor, the funding mechanism (grant or contract), and whether 
the award is pending or has been awarded. Provide the M/C# and Agency name (if grant-
funded).  If the funding source associated with a protocol is “pending” at the time of the 
protocol submission to the HIC (as is the case for most NIH submissions), the PI should note 
“Pending” in the appropriate section of the protocol application, provide the M/C# and 
Agency name (if grant-funded) and further note that University (departmental) funds support 
the research (until such time that an award is made).  
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PI 
Title of Grant
Name of Funding Source 
Funding
Funding Mechanism
Kathleen M. 
Carroll, Ph.D.
Computer Based 
Training in CBT 
for Spanish-
Speaking 
Substance Users
NIAAA
  Federal
  State
  Non Profit
  Industry
  Other For 
Profit 
  Other
Grant-M#  
R01 AA025605    
Contract# 
Contract Pending
  Investigator/Department 
Initiated
  Sponsor Initiated
  Other, Specify:
IRB Review fees are charged for projects funded by Industry or Other For-Profit Sponsors.  
Provide the Name and Address of the Sponsor Representative to whom the invoice should be 
sent.  Note: the PI’s home department will be billed if this information is not provided.
Send IRB Review Fee Invoice To:
Name:
Company:
Address:
2. Research Team:  List all members of the research team. Indicate under the affiliation column whether 
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff 
from a collaborating institution, or are not formally affiliated with any institution. ALL members of 
the research team MUST complete Human Subject Protection Training (HSPT) and Health 
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the 
protocol.  See NOTE below.
NOTE: The HIC will remove from the protocol any personnel who have not completed required training. 
A personnel protocol amendment will need to be submitted when training is completed.
Name
Affiliation: Yale/Other 
Institution (Identify)
NetID
Principal Investigator 
Kathleen M. Carroll, PhD
Yale
kmc3
Role: Co-Investigator
Manuel Paris, PsyD
Yale
mp267
Role: Co-Investigator
Luis Miguel Añez Nava, PsyD
Yale
lma27
Role: Project Director
Michelle Alejandra Silva, PsyD
Yale
ms664
Role: Research Associate
Melissa Gordon
Yale
mag85
Role:  Research Assistant
Yudilyn Jaramillo
Yale
YJ89
Role:  Data Management
Tami Frankforter
Yale
Tlf7
Role: Research Associate
Joanne Corvino
Yale
Jkc9
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SECTION IV:
 PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR 
AGREEMENT
As the principal investigator of this research project, I certify that:

The information provided in this application is complete and accurate.

I assume full responsibility for the protection of human subjects and the proper conduct of the
      research.

Subject safety will be of paramount concern, and every effort will be made to protect subjects’
      rights and welfare.

The research will be performed according to ethical principles and in compliance with all federal,
      state and local laws, as well as institutional regulations and policies regarding the protection of  
      human subjects.

All members of the research team will be kept apprised of research goals.

I will obtain approval for this research study and any subsequent revisions prior to my initiating the
      study or any change and I will obtain continuing approval of this study prior to the expiration date     
      of any approval period.

I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to
      participants.

I am in compliance with the requirements set by the University and qualify to serve as the
      principal investigator of this project or have acquired the appropriate approval from the 
      Dean’s Office or Office of the Provost, or the Human Subject Protection Administrator at
      Yale-New Haven Hospital, or have a faculty advisor.

I will identify a qualified successor should I cease my role as principal investigator and facilitate a
smooth transfer of investigator responsibilities.
_____
 
PI Name (PRINT) and Signature
Date
As the faculty advisor of this research project, I certify that:

The information provided in this application is complete and accurate.

This project has scientific value and merit and that the student or trainee investigator has the 
      necessary resources to complete the project and achieve the aims.

I will train the student investigator in matters of appropriate research compliance, protection of
      human subjects and proper conduct of research.

The research will be performed according to ethical principles and in compliance with all federal,
      state and local laws, as well as institutional regulations and policies regarding the protection of  
      human subjects.

The student investigator will obtain approval for this research study and any subsequent revisions
      Prior to initiating the study or revision and will obtain continuing approval prior to the expiration
      of any approval period.

The student investigator will report to the HIC any serious injuries and/or other unanticipated 
      problems involving risk to participants. 

I am in compliance with the requirements set forth by the University and qualify to serve as
      the faculty advisor of this project.
___________
______
_____
    Advisor Name (PRINT) and Signature
Date
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Department Chair’s Assurance Statement
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a
sponsoring company, patents, licensure) associated with this research project?
 Yes (provide a description of that interest in a separate letter addressed to the HIC.)
 No
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and
the sponsor of the research project, or its competitor or any interest in any intervention and/or method
tested in the project that might compromise this research project?
Yes (provide a description of that interest in a separate letter addressed to the HIC)
No
I assure the HIC that the principal investigator and all members of the research team are qualified by
education, training, licensure and/or experience to assume participation in the conduct of this research
trial. I also assure that the principal investigator has departmental support and sufficient resources to
conduct this trial appropriately.
    John H. Krystal, MD
   ____________________________
   Chair Name (PRINT) and Signature  
    
 Date
    
    Psychiatry
   _________________________________
   Department
YNHH Human Subjects Protection Administrator Assurance Statement
Required when the study is conducted solely at YNHH by YNHH health care providers.
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that:

I have read a copy of the protocol and approve it being conducted at YNHH.

I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest.

The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project.
  ______________________________________
    YNHH HSPA Name (PRINT) and Signature       
Date
For HIC Use Only
Date Approved
Human Investigation Committee Signature
This protocol is valid through ______________________________________________
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SECTION V: RESEARCH PLAN
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
The goal of this project is to address a major challenge in health disparities as defined 
by NIH and the Institute of Medicine, specifically, the need for accessible, effective, evidence-
based treatments for Latino/as.
     
Specific aims are as follows:

To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a 
web-based platform 

To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding 
CBT4CBT-Spanish to treatment as usual in a community based treatment program in a 
population of 90 Spanish-speaking individuals who meet current criteria for alcohol use 
disorder

To evaluate the long-term durability and/or delayed emergence of treatment effects through 
a six month follow-up after termination of the study treatments. Given previous evidence 
regarding the durability of standard clinician-delivered CBT41 and computer-assisted 
CBT4CBT25, we hypothesize that CBT4CBTSpanish will be significantly more effective than 
standard treatment alone through the follow-up.
2. Background: Describe the background information that led to the plan for this project. 
Provide references to support the expectation of obtaining useful scientific data.
A      Health disparities among Latinos, accessibility of evidence based therapies 
(EBTs).
Latinos currently represent 17% of the total U.S. population and the figure is expected to almost 
double by the year 206024 (NB: we use the term Latino to refer to individuals of Mexican, Puerto 
Rican, Cuban, Dominican, Central and South American, and Spanish descent).  Although 
recognized as the country’s largest ethnic minority group, there is ample evidence that Latinos 
experience circumstances that limit their access to culturally and linguistically appropriate 
evidence-based behavioral health treatments, compromising treatment outcomes2, 3, 25-27. This is 
highly evident in our limited ability to adequately recognize and treat substance use among 
Spanish-speaking Latinos and alcohol use disorders in particular3, 28-30.  Latinos are more likely 
to engage in heavier drinking and binge drinking than non-Latino Whites, and when they enter 
treatment, they represent the ethnic minority group at highest risk for dropout 31-33. Acculturative 
stressors and socioeconomic disadvantage, particularly unstable housing and limited financial 
resources, have been associated with poor engagement and low treatment completion rates 25, 
31, 34-37.   
Despite some attention to patterns of substance use among Latinos, most available data focus 
on prevalence and treatment outcome among Latinos as one group, with very little information 
on the differences in rates of disorders and treatment outcomes across subgroups38-41.  Limited 
data about a growing, diverse and understudied population underscores the need for research 
that will shed light on the factors associated with alcohol treatment outcomes among Latinos42, 
43. The presence and severity of risk factors such as racism, discrimination, unemployment, and 
migration-related stress will vary among Latino subgroups; therefore, patterns of use, 
vulnerability to develop an alcohol use disorder, and treatment responses can also be expected 
to differ 44-47. Understanding the influence of national origin, acculturation, patterns of 
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consumption and alcohol-related consequences among Latino subgroups is critical to advancing 
the field of health disparities research and improving treatment outcomes28, 37, 48-51.  
B. Why CBT?  
We focus on CBT because of its strong evidence base for addictions and other mental 
disorders, as well as strong evidence of effectiveness among Latinos52-54, with literature dating 
back thirty years and encompassing evidence of effectiveness and efficacy with Latinos of low 
socioeconomic status who adhere to traditional cultural values55-62. CBT has been demonstrated 
to be effective in the treatment of depression with Latinos, and CBT adaptations with limited 
English proficient immigrant Latinos are promising63-65. Organista62 notes that CBT is well suited 
for the treatment of Latinos given its: 1) focus on immediate relief of symptoms via concrete 
solutions and techniques, 2) didactic orientation, 3) present time orientation and problem 
solving, 4) active interventions, and 5) use of homework assignments and therapy manuals to 
structure the treatment, much of which may alleviate some of the stigma that some Latinos 
associate with treatment.  Benuto and O’Donohue66 reviewed the existing literature on CBT 
efficacy among Latinos in terms of strengths and weakness, and noted the vast majority of 
studies are not empirically based, and commonly theoretical and speculative in nature.  Thus, 
there is a recognized need for rigorous research to better understand CBT’s efficacy with ethnic 
minority populations67-69.  
Bernal, Miller and others have argued that competent delivery of appropriately adapted 
empirically validated therapies is of greater importance than developing completely novel 
approaches for multiple subsamples and groups70-72. For example, a meta-analysis of 76 studies 
that evaluated culturally adapted interventions, with the majority (84%) involving explicit 
integration of cultural values, suggested that interventions designed for a specific cultural group 
were likely to be four times more effective than those provided to a collective of clients from 
diverse backgrounds73 74. Among Latinos, several studies suggest that when culturally 
appropriate interventions, specifically, those delivered in Spanish and utilizing values congruent 
with the Latino culture, are integrated with elements of CBT, there is increased treatment 
effectiveness for a variety of health issues (i.e., smoking cessation, diabetes management, 
PTSD, HIV education)75-80.  Level of acculturation is another variable that requires attention as 
to its relationship with substance use issues, as this varies across Hispanic subgroups 40, 46, 66.  
C.  Why computer-assisted therapy?    
It has been recommended that the transfer of evidence-based treatment for ethnic minorities to 
real-world settings be inexpensive, accessible, and easy to apply in order to enhance successful 
adoption and sustainable integration81. Accessing health information online is a common 
practice, with one in three American adults reporting that they have consulted the worldwide 
web to better understand what medical conditions and treatment options they or someone they 
know might have82.  Among U.S. Latinos, internet use has continued to rise in the past five 
years with nearly 78% reporting at least occasional use, up from 64% in 2009. Additionally, 65% 
of Spanish-dominant Latinos access the internet through handheld devices such as a cellphone 
or tablet computer, and 72% of Latinos report owning a laptop or desktop computer, in 
comparison to 83% of non-Latinos and 70% of African-Americans83. 
 
The rising popularity and utility of technology among Latinos offers a new method for expanding 
access to health interventions. Low health literacy is associated with poor health outcomes and 
underutilization of preventive care among Latino immigrants84, 85. Regardless of educational 
level and experience using computers, tailoring technology-based health interventions to 
cultural context and language preferences has resulted in improved engagement and post-
intervention behavioral changes84. Among Latinos, internet-based health information has been 
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endorsed as an important source for understanding medical conditions and treatments, and 
accessing care86. Technology has thus become an important strategy for reducing barriers to 
care and improving health and treatment outcomes among Latinos83, 87, 88.  
D.  Addressing rigor and reproducibility in evaluations of web-based therapies11
The efficacy data from many computerized and web-based therapies for alcohol and other 
substance use disorders are promising89-96, but should be interpreted with caution due to 
multiple methodological problems that characterize much of the existing literature89, 91, 97-101. For 
example, our methodological analysis of 75 randomized clinical trials of computer-assisted 
therapies for adult psychiatric disorders indicated marked heterogeneity in study quality as no 
study met all 14 basic quality standards11. Consistent weaknesses were noted in evaluation of 
treatment exposure and adherence, rates of follow-up, inappropriate control and comparison 
conditions, and conformity to intention-to-treat principles. The uneven quality of this literature is, 
to a large extent, reminiscent of the early days of behavioral therapies research in mental health 
and addictions, where treatments were often vaguely defined, implementation was poorly 
monitored, and control conditions were absent or poorly conceived11. As described in the 
Preliminary Studies section below, we have sought to address each of these methodological 
limitations in our previous work on CBT4CBT and in the proposed study. 
Although dissemination and broadening accessibility is a primary goal of our approach to 
developing web-based versions of CBT4CBT, another important feature of web-based therapies 
is that their standardization facilitates research on their mechanisms of action102 by eliminating 
the key confound of variability of treatment across therapies.  Once built and validated, 
modularized web-based therapies lend themselves well to focused research that can refine 
treatment packages such as CBT, for example by evaluating whether individual modules exert 
intended effects on theoretical outcomes (e.g., does the coping with craving module really 
reduce craving), or contribute meaningfully to outcome103, 104).  
B.  INNOVATION

This project is innovative in that it adapts CBT4CBT, a highly promising computer-assisted 
form of CBT13, 15, 17, 102, 105-108, to address a major challenge in health disparities highlighted 
by NIH and the Institute of Medicine109; specifically, the limited research on and scarcity of 
evidence-based treatments among Latinos 28, 110. The products of the proposed study, a 
carefully adapted Spanish version of an effective computer-assisted therapy, as well as data 
on the evidence of its efficacy, is likely to have significant public health impact in improving 
access to an evidence-based treatment for alcohol use disorders among Latinos. Thus, this 
project also addresses a key NIAAA priority area; Minority Health and Health Disparities 
(MHHD).

There are no existing validated web-based therapies for Spanish-speaking individuals 
with alcohol use disorders. Thus, the proposed project is also innovative in that it will 
develop and evaluate CBT in a highly disseminable and less expensive form17, 94, 111.  If 
CBT4CBT-Spanish is demonstrated to be effective, the potential impact on reducing barriers 
to treatment and increasing access to effective interventions for Spanish-speaking 
individuals with alcohol use disorders could be of high public health significance. 

Congruence with NIAAA’s Strategic Plan to Address Health Disparities: Despite a 
visible movement towards the use of evidence-based, best practice treatments and services 
models, study results that inform the current body of research have seriously neglected the 
participation of people of color when assessing treatment outcome109. This proposal has the 
potential to broaden the knowledge base on ethnic minorities; with a specific focus on 
monolingual Spanish speakers; a group that is significantly underrepresented in research.  
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Additionally, the results of this study may provide a better understanding of how 
acculturation and psychosocial factors contribute to treatment response. 
3. Research Plan: Summarize the study design and research procedures using non-technical 
language that can be readily understood by someone outside the discipline. Be sure to 
distinguish between standard of care vs. research procedures when applicable, and include 
any flowcharts of visits specifying their individual times and lengths. 
The study will be conducted in two phases: 
Phase 1: Development and evaluation of CBT4CBT-Spanish-Alcohol (Years 1-2)
A.  Development and evaluation of CBT4CBT-Spanish-Alcohol
The first two years of the proposed project will be devoted to developing and beta-testing the 
CBT4CBT-Spanish-Alcohol program.  This will consist of, first, developing new alcohol-focused 
scenarios and translating and adapting the existing English CBT4CBT-Alcohol program for use 
with US Latinos whose principal/preferred language is Spanish, using a parallel approach to that 
described above for CBT4CBT-Spanish-Drug165 (Appendix 1). Program content, which includes 
detailed scripts and storyboards for the almost 430 unique pages projected to be needed for the 
full program, will be developed through weekly meetings of the development team (Carroll, 
Paris, Silva, Añez, Gordon) in consultation with Dr. Raul Caetano. Dr. Caetano is a world-
renown psychiatrist and epidemiologist who has worked in the public health field for nearly 35 
years and has written extensively about alcohol problems among U.S. ethnic minorities, 
especially Latinos 29, 175-179, and about cultural adaptation of empirically validated treatments180. 
Our overall strategy will be to retain key features of the existing English CBT4CBT-Alcohol 
program and critical components of cognitive-behavioral therapy, while making appropriate 
cultural adaptations4, 71, 181, 182 for use with Spanish-speaking substance users. Adaptation of the 
program will involve several steps as described below: 
1.
Generation of new content and videotaped vignettes relevant to a U.S. Latino 
sample
Although Latinos represent a large, heterogeneous group, the majority share Spanish as their 
primary language. This language, however, is also rich with complexities and variations in style 
and meaning183. As a result, language is intimately connected to both culture and the expression 
of emotional experience. Thus, in adapting interventions, it is imperative that providers be 
familiar with cultural norms such as mannerisms and verbal style, in order to make accurate 
interpretations of such expressions184. Secondary, but no less important, are cultural elements 
shared within the Latino culture. Though not necessarily unique to Latino populations, these 
cultural values are believed to play a critical role in the life of people of Latino origin185. 
Particularly important constructs include confianza (trust and intimacy in a relationship), respeto 
(respect; mutual and reciprocal deference), personalismo (personal rather than institutional 
relationship), and familismo (familial orientation). Knowledge about these values and degree of 
adherence among individuals served is essential in the development of effective treatments. 
These values carry culturally sanctioned messages that influence core elements of behavior 
change, decision-making, self-efficacy, and development of interpersonal relationships. Given 
their significance in Latino culture, researchers have emphasized the importance of 
understanding and incorporating these constructs in the treatment of Latino individuals161, 162, 186-
189.
We will develop 7 new sets of videotaped vignettes (one for each module, or episode, of the 
telenovela) for CBT4CBT-Spanish-Alcohol of a linked storyline to maximize the programs’ 
relevance to the target audience. Vignettes will take into account differing degrees of 
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acculturation, regional background, age, gender, education level, access to healthcare, and 
adherence to cultural values. In addition, we will address alcohol use within the context of 
immigration history, criminal justice involvement, domestic violence (with specific attention to 
traditional gender roles), minority status, unemployment, family intergenerational conflicts, and 
the stigma associated with seeking mental health and substance use services. 
Practice/homework assignments will be sensitive to variations in literacy level 4, 71, 181, 182. 
Shooting of the narration and vignettes will be done by the Yale Center for Academic Media and 
Technology, using bilingual/bicultural professional actors, directors, and location shooting, as 
was done for the completed CBT4CBT programs. Three related vignettes (5-10 minutes each) 
will be developed for each of the 7 modules: The first illustrates one of the main characters 
dealing with a realistic, difficult, situation that illustrates the targeted concept (e.g., refusal skills, 
thoughts about alcohol) to highlight the importance and relevance of that concept and the skills. 
The beginning of the second vignette in each module is the same as the first, but the vignette 
has a different ending as the main character utilizes the skills taught in the module. The third 
vignette illustrates the character carrying out the practice exercise for that module. 
Following shooting and editing of the narration, vignettes, and exercises, the program will be 
built and the website created through the Yale Center for Academic Media and Technology 
using HTML5.  As in our existing versions, CBT4CBT can be used on any desktop, laptop, or 
tablet independent of their operating system, as it is web-based and no software needs to be 
downloaded.   The project team works closely with the Yale Academic Media project manager to 
develop the beta version of the program.   As with the existing CBT4CBT programs, which do 
not require either reading or computer skills (users are required only to push forward/backward 
arrows or highlighted buttons), we will make every effort to make this version even more 
accessible and user-friendly with additional visuals and touch-screen options.
                    
2.
Reviewing, piloting and finalizing the program
When the beta version of the CBT4CBT-Spanish-Alcohol program is completed, it will be 
reviewed by Dr. Caetano as well as focus groups consisting of a small group of clinicians and 
clients from the Hispanic Clinic. The clinicians and clients will rate ease of use, helpfulness, 
relevance and impact of each module, as well as any possible concerns or problems 
encountered. Evaluations from the clinicians and clients will be used to make corrections as 
needed and further improve the program.  Finally, we will pilot the program with 5 clinic patients 
with alcohol use disorders who meet the proposed inclusion and exclusion criteria and obtain 
their feedback on need for clarifications and improvements.  We use the ‘thinking aloud’ 
technique190 (in which users are asked to vocalize their thoughts and reactions while using the 
program), which we have found very useful in refining previous versions of CBT4CBT. This 
feedback will be reviewed with Dr. Caetano and used to develop the final version of the program 
to be used in the randomized trial.  
B.  Randomized Clinical Trial (Years 3-5)
          1.  Overview
In years 3-5 of the proposed project, we will conduct a Stage 1 randomized clinical trial 
evaluating the program in which 90 Spanish-speaking individuals with alcohol use disorder will 
be randomized to (1) standard outpatient counseling at the Hispanic Clinic (ST; typically 
consisting of weekly individual and group supportive counseling) or (2) CBT4CBT-Spanish as 
an adjunct to ST.  Other aspects of the trial will parallel those in our completed trial of the 
English version of CBT4CBT-Alcohol16 to facilitate comparability across studies. Treatments will 
be delivered over an 8-week period with a 6-month follow-up to assess durability and/or delayed 
emergence of treatment effects. The primary outcome measure will be percent days of 
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abstinence (PDA) by week.  Secondary outcomes include percent heavy drinking days and 
number of individuals with no heavy drinking days in the last 4 weeks of treatment19.
          2.  Participants
Participants will be 90 individuals seeking treatment for alcohol use at the Hispanic Clinic of 
CMHC. The clinic treats a heterogeneous population, where 42% of those in the co-occurring 
treatment program report alcohol as their principal substance related issue and 43% are 
women. As reported above, we have demonstrated our ability to recruit, randomize, retain, and 
follow-up high numbers of closely related samples in this setting191, 192. 
         a.  Inclusion and exclusion criteria
Participants will be included who are (1) 18 years of age or older, (2) applying/referred for 
outpatient alcohol treatment, (3) meet current DSM-IV/DSM-5 criteria for alcohol use disorder 
with use in the past 30 days, (4) speak Spanish as their preferred or principal (most commonly 
spoken) language, (5) sufficiently stable for 8 weeks of outpatient treatment, and (6) willing to 
provide locator information and be contacted for follow-up for 6 months. Individuals will be 
excluded who (1) have an untreated/unstable bipolar or schizophrenic disorder, or (2) have a 
current legal case pending such that incarceration during the 8-week protocol is likely. Those 
physically dependent on alcohol can be rescreened following detoxification/stabilization (see 
Human Subjects).  
       b.  Rationale for sample choice (also see Human Subjects section).  
We are proposing broad inclusion criteria that reflect the heterogeneity of individuals seeking 
treatment for alcohol use disorders in this setting.  Literacy is not required for using the 
CBT4CBT program, and, as described below, most of the assessment instruments we use are 
clinical interviews or can be administered by reading the questions to the participants using 
procedures we have worked out in our ongoing and previous trials193-197. We are not requiring 
that participants have computer access for study inclusion, as participants can access the 
program at the clinic. 
       3. Procedures     
       a. Initial Screening 
All new admissions will be invited to participate in the protocol within two weeks of their clinic 
appointment. They will be identified by their clinicians at CMHC, the Hispanic Clinic, SATU jor 
MAAS, interest sheets, and clinic postings. Individuals who indicate they are interested in 
hearing more about the study will be offered a meeting with the research staff. An interest sheet 
providing a brief description of the study will be available for potential subjects to indicate their 
interest in learning more about the study and how to contact a member of the research team,  
should they be unable to speak with the research staff at the time of the clinic intake 
appointment. At the first interview, research staff will provide a brief overview of the protocol and 
obtain written informed consent. We use a multiple-choice test to assess participants’ 
comprehension of the protocol122, 137, with ample time to review questions to assure 
understanding of the protocol, consent, and treatments offered. After determination of eligibility, 
pretreatment assessments will be completed by the research assistant (see Table below).  
         
           b. Urn randomization
To prevent bias and increase the likelihood that treatment groups are balanced with respect to 
demographic variables (gender, education) and possible prognostic variables (severity of 
alcohol use, level of familiarity with and access to computers, level of acculturation) participants 
will be assigned to treatment conditions through urn randomization, using a Microsoft Access 
program that we have developed and implemented successfully in multiple previous trials198-202. 
In urn randomization, an algorithm modifies ongoing randomization probabilities based on prior 
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composition of treatment groups, maximizing multivariate equivalence of treatment groups203, 
while still retaining other benefits of random assignment204.
            
         c. Treatment phase
Treatment conditions are described below. Study treatments will last 8 weeks. During the 
treatment phase, all participants will complete weekly assessments, usually at the time they 
come in for treatment.  Weekly breath and urine sample collection will be supervised by the 
research assistant.  The research assistant conducting weekly and follow-up assessments will 
be blind to the participants’ treatment assignment, using procedures we have worked out in 
previous trials112.

Clinical deterioration. We will closely monitor participant treatment response and safety in all 
conditions through weekly assessment sessions. These will include breath and urine 
screens with assessment of psychiatric status. Although in our experience this is a very rare 
event in behavioral trials119, including those of computer-assisted therapy14, 100, participants 
who show significant deterioration (e.g., increased substance use or psychiatric symptoms 
that cannot be managed within the protocol) will be regarded as symptomatic failures, 
withdrawn from the treatment arm of the study, and referred appropriately, but will still be 
followed and included in the intent to treat analysis.  

Strategies to minimize attrition. In order to hold participant dropout to a minimum, we use 
multiple procedures recommended in our manual on enhancing compliance with substance 
abuse treatment205, 206.  These include rapid assignment to study treatments, thorough 
explanation of study treatments and requirements and a fully bilingual staff, close monitoring 
of participants’ clinical status, integration of the research with the clinical program, 
accessibility of study staff for questions and problems, and adequate compensation to 
participants for the time spent on completing assessment instruments.  
d. Termination and posttreatment assessment 
At the end of the 8-week treatment period, all participants will be re-interviewed by the ‘blind’ 
research assistant, who will complete posttreatment ratings (see Assessments, below). Access 
to the CBT4CBT-Spanish-Alcohol program will be terminated for participants assigned to that 
condition. Participants in all conditions will be strongly encouraged to continue in treatment at 
their primary site  (Hispanic Clinic, SATU, MAAS).
e. Follow-up
Follow-up interviews will be conducted 1, 3, and 6 months after termination of treatment. Follow-
up interviews will include the full posttreatment battery (see Assessments, below), including 
assessment of utilization of other treatments and services received. We will attempt to follow all 
participants in the intent to treat sample, regardless of their retention in treatment, using 
strategies that have been successful in multiple previous studies. These include: (a) thorough 
explanation at the initial consent interview to participants of the importance of follow-ups, (b) 
requiring that each participant provide at least 3 verified locators who are likely to have 
knowledge of their whereabouts throughout follow-up, (c) use of multiple sources and locators to 
track participants207, and (d) payment to participants of $50 for each completed follow-up 
interview, with additional monetary incentives for completing consecutive interviews on time. 
Using these procedures, our current rate of follow-up approaches 90-98% across studies16, 126. 
Thus, we have been successful in conducting true intent-to-treat analyses208, 209 in that the 
samples include post-treatment and follow-up data from all participants randomized, including 
those who have dropped out of treatment.
4.  Treatments
a.  Standard treatment as usual (ST)
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Participants randomized to this condition will receive standard treatment at the clinic at which 
they participate. This typically consists of individual and group counseling in Spanish and 
delivered by masters-level counselors.   Groups are primarily psychoeducational and individual 
sessions tend to use a motivational interviewing style with elements of CBT and DBT. 
Interventions address behavioral health, substance use, and cultural factors including migration, 
adherence to cultural values, language, and acculturation.   All participants are offered a 
number of ancillary treatments and services. Drs. Añez, Paris, and Silva hold leadership 
positions at the Hispanic Clinic, which facilitates effective integration of the trial into the ongoing 
services and procedures. As an established provider of outpatient behavioral health services for 
the Spanish-speaking community and recognized community partner in the promotion of state-
of-the-art culturally and linguistically appropriate care, the Hispanic Clinic was recently 
recognized for its efforts integrating mental health and addiction treatment with the SAMHSA 
Science to Service Award, an award designed to recognize exemplary implementation of 
evidence based treatments.  
             b.  CBT4CBT + ST
At the time of randomization, participants assigned to this condition will be given a username 
and unique password to access the CBT4CBT-Alcohol Spanish program. The RA (Ms. 
Jaramillo) will work with each participant and guide them through the use of the program on-site 
to assure they know how to use the program and answer any questions. Participants will be 
asked to spend at least one hour per week working with the CBT4CBT-Spanish-Alcohol 
program. Participants will be asked to complete all 7 modules sequentially over the course of 
the 8-week study treatment period (participants can repeat who modules or any component of 
them at their own pace). At the start of each session, the CBT4CBT program reviews the 
modules that the user has completed, and directs users to either complete a module they have 
started or move to a new one.  The program tracks, for each participant, time logged onto the 
program, modules accessed, completion of practice assignments, and learning of CBT 
principles through true/false tests at the end of each module.
     c. Rationale for design: There are multiple design options for evaluating computer-assisted 
therapies11, 12, 96, 210.  We chose to evaluate CBT4CBT-Spanish-Alcohol as an add-on to 
standard treatment for several reasons.  First, current evidence suggests web-based therapies 
have enhanced effectiveness when delivered in conjunction with clinician involvement, including 
our recent trial of CBT4CBT-Alcohol91, 92, 105. Second, evaluation of CBT4CBT-Spanish as an 
‘add-on’ is appropriate given that this will be the first Stage I evaluation of this novel treatment in 
a new language format for a new population, although it will not control for attention/ time spent.  
Third, participants may be exposed to some CBT or other EBTs in individual/group sessions as 
part of standard treatment.  Thus, the proposed randomized ‘add on’ design maximizes the 
likelihood such exposure is consistent across conditions.  Moreover, use of the skill acquisition 
measure (ARRT, see below) will allow us to evaluate change in CBT skill levels across time in 
both conditions18.  
Assessments:   
Assessments include measures used to: 1) Describe the sample, 2) Measure primary outcomes 
during treatment and follow-up, and 3) Evaluate likely mediators (e.g., skills acquisition) and 
moderators (e.g., gender, level of acculturation) in exploratory analyses. We rely on widely 
used, well-validated instruments, as well as those which have validated Spanish translations 
(e.g., AUDIT, SCID, Timeline Follow-Back)214, 215; all have been used successfully in our prior 
studies with Spanish-speaking samples160, 216-219.  Hence, only the less well-known instruments 
are described below; all assessment instruments and the schedule of their administration are 
listed on the Table.   
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Instrument name
Interview or 
self-report
Rater
Screen
Pre 
Tx
Weekly
Monthly
Post Tx
(8 wks)
Follow-up 
1, 3 6 mo
Informed Consent Quiz 122
Self-report
P
x
*PDC Screening Form
Interview
RA
x
Inclusion/Exclusion criteria
Interview
RA
x
*Follow-up contact & tracking sheet
Interview
RA
x
x
X
Marins
Self-report
P
x
Patient Characteristic Form
Interview
RA
x
Structured Clinical Interview DSM-4/5 (SCID)222
Interview
RA
x
x
Urn randomization
Interview
RA
x
Breathalyzer result
Interview
RA
x
x
x
x
x
Urine results
Interview
RA
x
x
x
x
x
CBT Website True/False Quiz
Self-report
P
x
x
x
CBT4CBT Patient Feedback Form
Self-report
P
x
Treatment Services Utilization
Interview
RA
x
x
x
x
Latino Cultural Values Scale
Interview
RA
x
Religious Beliefs Form
Self-report
P
x
WHO Quality of Life Brief
Self-report
P
x
PTSD Checklist (PCL 5)
Self-report
P
x
x
x
Perceived Stress (PSS)
Self-report
P
x
x
x
*Timeline Follow Back/ Substance Use 
Calendar 227 227-229
Interview
RA
x
x
x
X
AUDIT (Alcohol Use Dis. Ident Test) 214, 230-232
Interview
RA
x
x
X
Drinking Consequences (SIP) 217
*Brief Symptom Inventory (BSI) 46, 233-235
Self-report
P
x
x
x
x
Addiction Severity Index (ASI)215, 236, 237
Interview
RA
x
x
x
ARRT (Alcohol Risk Response Test) 22
Taped role-play
RA
x
x
x
X
*Change Strategies Inventory (CSI) 240, 241
Self-report
P
x
x
x
X
*Evaluation of treatment, endpoint174
Self-report
P
x
Serious Adverse Events Reporting Form
Interview
RA
*indicates translated and validated form available through our CTN MET-Spanish study194 197

The Psychotherapy Development Center (PDC) Screening Form has been used in all of 
our previous studies and provides general information, including demographic data, country 
of origin, substance use history, previous substance use and psychiatric treatment history, 
medical history, recent life events, family history and social support, treatment attitudes and 
expectations, and has been expanded to include level of experience with computers and the 
internet.  

The extent to which the participants can demonstrate effective coping skills will be 
assessed by the Alcohol Risk Response Test (ARRT)22, which we adapted from the 
Situational Competency Test248. The ARRT is a role-play task that asks participants to 
articulate what they would do when faced with 7 problems specifically geared to the 
CBT4CBT modules. Hence we can evaluate the extent to which CBT4CBT is successful in 
imparting the specific strategies intended in comparison to ST alone. Participants’ 
responses are audiotaped and then scored independently by ‘blind’ raters for number of 
and quality of coping plans. The ARRT has good psychometric qualities, including high 
interrater reliability, concurrent and predictive validity22.  We also have used it to 
demonstrate treatment-specific acquisition of coping skills in CBT4CBT108. It will be 
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administered at multiple points to evaluate temporal relationships between change in this 
putative mediator and outcome 249, 250.
4. Genetic Testing   N/A 
 
5. Statistical Considerations: Describe the statistical analyses that support the study design. 
Outlined below is the general strategy for data analyses for the randomized clinical trial 
in Phase 2 (years 3-5) of the study which will address each specific aim: (1) determination of the 
efficacy of treatments, and (2) analysis of the follow-up data, as well as our exploratory, 
secondary aims (analysis of mediators).
Outlined below is the general analytic strategy for addressing the specific aims for this Stage 1 
trial:
1.  Determination of Treatment Outcomes
a.  Data reduction: Primary outcome variables have been defined a priori to reduce the 
risk of Type I error.   Preparatory analyses include evaluation of baseline equivalence of 
treatment groups on demographic and prognostic variables and comparability of rates of data 
availability across conditions.
b. Strategies for management of differential attrition: Data analyses will be conducted on 
the intent-to- treat sample and we will attempt to follow all participants regardless of their 
retention in treatment. We have established our ability to contact and follow participants who 
drop out of treatment and to conduct true intent-to-treat analyses 16, 208, 209, including 
supplemental analyses that account for whether data was collected before or after 
dropout/withdrawal208. While we anticipate that assertive efforts to locate and interview 
participants who drop out of treatment will result in low numbers of missing participants and 
minimal missing data in the final dataset, we will minimize the impact of missing data through 
the use of random effects regression modelling251-253.  
c.  Evaluation of treatment effects at posttreatment and follow-up: The principal strategy 
for assessing the efficacy of the study treatments on outcome over time will be random effects 
regression models for continuously measured primary (e.g. percent days of abstinence by 
week) and secondary (e.g., acquisition of coping skills) outcome variables. The focus of the 
repeated measures analyses will be the ‘contrast by time effects’, which essentially evaluates 
whether the slopes, or rates of change, of one group differ from the slopes of another group. We 
have used these methods to evaluate main and interaction effects, with appropriate covariates 
(e.g., retention, compliance with treatment, time spent working with the CBT4CBT program) in 
multiple previous trials14, 151, 160, 200, 201, 254. Follow-up data will be analyzed using random-effects 
regression modeling 255 for our primary outcome measures across time, using the contrasts 
described above, with appropriate covariates (e.g., length of time in treatment, exposure to 
other treatment during follow-up). Random effects regression models have several advantages 
in follow-up data from clinical trials of substance users where participants are unlikely to attend 
follow-up evaluations precisely at the desired fixed points, and are less vulnerable than 
traditional MANOVA approaches to missing data208, 209, 251, 252.  As in our previous trials 16, 126, we 
estimate that our extensive efforts to track participants will yield a 90% follow-up rate.
        d.  Adequacy of sample size: This Stage 1 trial is intended to provide initial pilot testing and 
feasibility testing of the web-based CBT4CBT program in a Spanish-speaking sample of 
individuals with alcohol use disorder.  Based on SSize software, the proposed sample sizes will 
enable us to detect effect sizes of .35 or higher for either hypothesis, which will be the criterion 
for determining whether CBT4CBT-Spanish-Alcohol has adequate promise to justify a fully 
powered randomized trial256.  This sample size was sufficient for the English-language trials of 
the drug and alcohol versions of CBT4CBT, which yielded effect sizes of .46-.5913, 15, 16.
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Power calculations for random effects regression 
Power
Estimated 
effect size
Estimated 
ICC
# of 
datapoints
Sample 
size per 
cell
H1:  (CBt4CBT-S + ST) v ST, main effect for active treatment 
        phase (assessed weekly, baseline-8weeks)
.80
.35
.40
9 
45
H2:  (CBT4CBT-S  + ST) vs ST, main effect for follow-up 
         (assessed monthly, end of treatment-6 months)
.80
.50
.80
7 
40
      
  
                2.   Treatment specificity and mediators
We will explore the extent to which participants improve coping skills over time using the ARRT 
as described above and the extent to which acquisition of coping skills may mediate outcome 
for CBT4CBT-Spanish-Alcohol in this sample.  We have described our use of these models and 
strategies to evaluate treatment mediators in Preliminary Studies, above, and in several 
papers13, 105, 108, 151. Following the general analytic framework outlined by Kraemer257, we will use 
the product of the coefficients method to evaluate the relationship between the mediator (e.g., 
acquisition of CBT-specific coping skills as measured by the ARRT), or indirect effect, and 
outcome155, 156, 258. After running a regression equation to determine (1) the effect of treatment 
on the mediator (provides beta weight for a), we will evaluate (2) the strength of the relationship 
between the mediator, treatment, and outcome (provides beta b). Using MacKinnon’s software 
PRODCLIN259, we will evaluate the asymmetric confidence intervals for the product of the 
regression estimates (a*b).
SECTION VI: RESEARCH INVOLVING DRUGS, BIOLOGICS, PLACEBOS AND DEVICES
If this section (or one of its parts, A or B) is not applicable, state N/A and delete the rest of the 
section.
N/A
SECTION VII: HUMAN SUBJECTS 
1.
Subject Population: Provide a detailed description of the types of human subjects who will   
be recruited into this study.
Participants will be individuals seeking outpatient treatment for alcohol use at the 
Connecticut Mental Health Center (CMHC), where the majority of clients are male (73%), middle 
aged (62%), unemployed (71%), unmarried (56%), and have not completed high school (64%).  
Spanish-speaking participants will be recruited from two CMHC outpatient programs (The 
Hispanic Clinic at 34 Park Street and the Substance Abuse Treatment Unit at One Long Wharf) 
or Connecticut Mental Health Center clinicians. Additionally, MAAS (The Multi- Cultural 
Ambulatory Addiction Service at 426 East Street) has been appointed a recruitment site
2.
Subject classification: Check off all classifications of subjects that will be targeted for 
enrollment in the research project. Will subjects who may require additional safeguards or other 
considerations be enrolled in the study? If so, identify the population of subjects requiring special 
safeguards and provide a justification for their involvement.
 Children
 Healthy 
Fetal material, placenta, or dead fetus
 Non-English Speaking
 Prisoners
 Economically disadvantaged persons
 Decisionally Impaired
 Employees
 Pregnant women and/or fetuses
 Yale Students 
Females of childbearing potential
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NOTE: Is this research proposal designed to enroll children who are wards of the state as 
potential subjects? 
 Yes  
 No (If yes, see Instructions section VII #4 for further 
requirements)
3.
Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or    
exclusion?
             Participants will be included who:
1. Are 18 years of age or older.
2.
Are applying for outpatient alcohol treatment, with some alcohol use in the past 30 days 
3. Speak Spanish as their preferred or principal (most commonly spoken) language.
4.
Are sufficiently stable for 8 weeks of outpatient treatment
5.
Can commit to 8 weeks of treatment and are willing to be randomized to treatment
6.
Are willing to provide locator information for follow-up.
Individuals will be excluded who:
1.
Have an untreated bipolar or schizophrenic disorder
2.
Have a current legal case pending such that incarceration during the 8 week protocol is 
likely.
4.
How will eligibility be determined, and by whom? 
Individuals who indicate they are interested in hearing more about the study will be 
offered a meeting with research staff will provide a brief overview of the protocol and continue 
the informed consent process.  After written informed consent has been obtained, screening 
assessments will be completed to determine eligibility. 
5.
Indicate recruitment methods below.  Attach copies of any recruitment materials that will
                  be used.
 Flyers
 Internet/Web Postings
 Radio
 Posters
 Mass E-mail Solicitation
 Telephone
 Letter
 
 Departmental/Center Website
 Television
 Medical Record Review
 Departmental/Center Research Boards
 Newspaper
 Departmental/Center Newsletters
 Web-Based Clinical Trial Registries
 Other (describe):
 Clinicaltrials.gov Registry (do not send materials to HIC)
Direct referral from intake clinicians; Interest Sheets, billboards
6.
 Recruitment Procedures:
a.
Describe how potential subjects will be identified. 
All new admissions will be invited to participate in the protocol within two weeks of their 
initial clinic appointment.  They will be identified by their clinicians at CMHC, the Hispanic Clinic, 
SATU or MAAS using interest sheets, and clinic postings. Individuals who indicate they are 
interested in hearing more about the study will be offered a meeting with the research staff.  An 
interest sheet providing a brief description of the study will be available for potential subjects to 
indicate their interest in learning more about the study, and how to contact a member of the 
research team, should they be unable to speak with the research staff at the time of the clinic 
intake appointment. 
b. Describe how potential subjects are contacted. 
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Subjects will be introduced or referred to research staff who will have offices in the clinic. 
Eligibility screening may occur at this time or scheduled at a more convenient time.  
c.
Who is recruiting potential subjects? 
Project Director and RAs 
 
7.
a. Will email or telephone correspondence be used to screen potential subjects for eligibility 
prior to the potential subject coming to the research office? 
 Yes  
 No
b. If yes, identify any health information and check off any of the following HIPAA 
identifiers to be collected and retained by the research team during this screening process. 
HEALTH INFORMATION:
_____________________________________________________________________________
HIPAA identifiers: 
 Names 
 All geographic subdivisions smaller than a State, including: street address, city, county, precinct, zip codes and their 
equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly-available data from 
the Bureau of the Census: (1) the geographic unit formed by combining all zip codes with the same three initial digits 
contains more than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units containing 
20,000 or fewer people is changed to 000. 
  Telephone numbers
 Fax numbers 
 E-mail addresses
 Social Security numbers 
 Medical record numbers
 Health plan beneficiary numbers 
 Account numbers 
  All elements of dates (except year) for dates related to an individual, including: birth date, admission date, discharge 
date, date of death, all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages 
and elements may be aggregated into a single category of age 90 or older 
 Certificate/license numbers 
 Vehicle identifiers and serial numbers, including license plate numbers 
 Device identifiers and serial numbers 
 Web Universal Resource Locators (URLs) 
 Internet Protocol (IP) address numbers 
 Biometric identifiers, including finger and voice prints 
 Full face photographic images and any comparable images 
 Any other unique identifying numbers, characteristics, or codes 
8.
Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical 
relationship with any potential subject? 
 Yes, all subjects
 Yes, some of the subjects
 No
If yes, describe the nature of this relationship.
Drs.  Paris, Añez Nava, and Silva are licensed psychologists who provide 
services within the Hispanic Clinic of the Connecticut Mental Health Center.
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9.
Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA 
Authorization for either the entire study, or for recruitment purposes only.  Note: if you are collecting 
PHI as part of a phone or email screen, you must request a HIPAA waiver for recruitment purposes.)
N/A
Choose one: For entire study: ______ For recruitment purposes only: ______
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data;
ii. If requesting a waiver of signed authorization, describe why it would be 
impracticable to obtain the subject’s signed authorization for use/disclosure of this 
data;
By signing this protocol application, the investigator assures that the protected 
health information for which a Waiver of Authorization has been requested will not 
be reused or disclosed to any person or entity other than those listed in this 
application, except as required by law, for authorized oversight of this research 
study, or as specifically approved for use in another study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale 
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject 
name, purpose, date, recipients, and a description of information provided.  Logs are to be 
forwarded to the Deputy HIPAA Privacy Officer.
SECTION VIII: CONSENT/ ASSENT PROCEDURES
1. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent. 
Michelle Alejandra Silva, PsyD; Yudilyn Jaramillo, (Research Assistant), 
2. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will 
be obtained, including parental permission or surrogate permission and the steps taken to ensure 
subjects’ independent decision-making. 
Five Spanish-speaking clinicians and clients from the clinic will be invited to review and 
evaluate the preliminary version of the CBT4CBT-Spanish website.  The Project Director/ 
Research Assistant and potential subjects will discuss the basic components described in the 
HIC-approved translated Information Sheet in a quiet, private setting.  Potential participants of 
Phase 1 will be provided an opportunity to ask questions and time to consider his/her decision 
to participate in the review and evaluation of the program.  Verbal consent will be obtained by 
the Project Director/RA prior to engaging a client or clinician in the pilot activities.  A copy of the 
Information Sheet will be given to the participant.
The Project Director or Research Assistant will obtain written informed consent prior to 
any study related procedures of Phase 2. All study related documents will be translated into 
Spanish and subjects will be consented in Spanish. The informed consent process will be 
conducted in a private, quiet setting. The Project Director/RA and the participant will discuss the 
basic components described in the HIC-approved translated consent form. These include: 
participation is voluntary and participants may withdraw without consequences to clinic services 
received, purpose, procedures, randomization, visit schedule, risks and benefits, potential 
compensation, alternatives to study participation, and confidentiality.  Potential participants will 
be provided an opportunity to ask questions and time to consider his/her decision to participate. 
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A translated comprehension quiz will be given to ensure the participant has an adequate 
understanding of study. A copy of the consent form will be given to the participant.
3. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the 
research being proposed. 
Study personnel will use a multiple-choice consent quiz to assess participants’ 
comprehension of the protocol.
4. Documentation of Consent/Assent: Specify the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects. 
Phase 1: Information Sheet (same for patients and clinicians)
Phase 2: Compound Authorization and Consent Form 
5. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for 
research involving non-English speaking subjects. Translated copies of all consent materials must 
be submitted for approval prior to use. 
Dr. Silva will oversee the translation of consent documents which entails initial 
translation and back-translation by an independent translator (Dr. Paris).  A Spanish-speaking 
Research Assistant, Yudilyn Jaramillo will be dedicated to this project. The Research Assistant 
will assist with subject recruitment and the informed consent process.
6. Waiver of Consent: Will you request either a waiver of consent, or a waiver of signed consent, for 
this study? If so, please address the following:
 This section is not applicable to this research project
Waiver of consent: (No consent form from subjects will be obtained.)
a.
Does the research pose greater than minimal risk to subjects? 
 Yes  
 No
b.
Will the waiver adversely affect subjects’ rights and welfare? 
 Yes  
 No
c.
Why would the research be impracticable to conduct without the waiver? 
d.
Where appropriate, how will pertinent information be returned to, or shared with subjects
at a later date? 
Waiver of signed consent: (Verbal consent from subjects will be obtained.) Phase 1 only
 This section is not applicable to this research project
a.
Would the signed consent form be the only record linking the subject and the research? 
 Yes  
 No
b.
Does a breach of confidentiality constitute the principal risk to subjects? 
 Yes  
 No
OR
c.
Does the research pose greater than minimal risk? 
 Yes  
 No AND
d.
Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No
7.  Required HIPAA Authorization: If the research involves the creation, use or disclosure of 
protected health information (PHI), separate subject authorization is required under the HIPAA 
Privacy Rule. Indicate which of the following forms are being provided:
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 Compound Consent and Authorization form
 HIPAA Research Authorization Form
SECTION IX: PROTECTION OF RESEARCH SUBJECTS
1. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, 
or inconveniences associated with subjects participating in the research. 
Psychological risks are minimal and not different from those of equivalent non-study
psychotherapeutic interventions. 
Computer-based interventions have been used safely in multiple investigations with a range of 
populations, and we are unaware of any reported risks associated with these interventions.
The data collected from interviews and self-report forms, as well as urine and breath collection, 
carry no risk other than those normally associated with these procedures.
2. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
The Project Coordinator will supervise the participants’ use and understanding of the program 
closely, and research and clinic staff will be available to monitor participants’ reactions to the 
program and to answer any clinical issues.  Careful training and supervision of therapists will 
further minimize these risks.
The web-based intervention is highly secure (annual Security Design Review by Yale 
Information Technology Services is required). The program does not collect any PHI or specific 
information regarding recent drug use or illegal activities.
3. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan 
(DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make the 
final determination of the risk to subjects.) For more information, see the Instructions, page 24.
a. 
What is the investigator’s assessment of the overall risk level for subjects 
participating in this study? 
b.
If children are involved, what is the investigator’s assessment of the overall risk 
level for the children participating in this study? 
c.
Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan 
from  http://www.yale.edu/hrpp/forms-templates/biomedical.html  for
i. Minimal risk
ii. Greater than minimal/moderate risk
iii. High risk
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i. How will adverse events and unanticipated problems involving risks to subjects or 
others be reported, reviewed and managed?
ii. What provisions are in place for management of interim results?
iii. What will the multi-site process be for protocol modifications?
Overall level of risk for participants is minimal given the nature of this project and 
procedures in place for careful identification of potential subjects, informed consent process, 
and protection of confidentiality.  
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For the randomized trial phase of this study (years 3-5), a Data and Safety Monitoring 
Board (DSMB) will monitor this project because this population might be considered vulnerable 
due to their alcohol use. This board is already in place for the Yale Psychotherapy Development 
Center (Carroll, PI). The DSMB is composed of Yale investigators who are independent of the 
proposed trial and experienced in various aspects of the conduct of clinical trials for the 
treatment of addictive disorders. We have developed a standard DSMB report form that is used 
in all Center related trials that summarizes, on a quarterly basis:
1. Recruitment, retention, and follow-up rates for the study and compares them to target rates.
2. Rates of data completeness and availability of primary outcome data.
3. Occurrence of AEs and SAEs.
4. Report of study progress since the last report.
5. Rates of recruitment of women, minorities, and children with respect to targets.
These reports are generated by the Data Manager each quarter and signed by each 
study PI prior to their submission to the DSMB. DSMB comments are documented and 
forwarded to the Yale IRB at the time of the annual review and re-approval.  
Because the projected effect sizes may not be large enough for detection during interim 
analyses, we are not proposing a preliminary analysis of accumulating efficacy and safety data 
by treatment assignment. Instead, we propose to submit a quarterly report of aggregate data to 
the DSMB members that contains screening data, baseline demographics, retention data, 
serious adverse events data, as well as accrual status including projections, times to 
milestones, and any other data that will help in the assessment of the clinical trial. Based on this 
report, each DSMB member will complete a form making one of two recommendations: 1) 
continue recruitment as planned; or 2) schedule formal DSMB meeting immediately. If any 
DSMB member recommends a meeting, this will be scheduled within one week, minutes will be 
kept, the report will be reviewed with the PI, and the committee will vote on whether the study 
should: 1) continue recruitment unchanged; 2) continue with a protocol amendment; 3) stop 
recruiting pending further investigation. If, after this meeting, any DSMB member votes to stop 
recruitment or requests a protocol modification, the Yale IRB will be informed.  
Participants who experience a significant psychiatric or medical problem requiring an 
overnight hospitalization at an acute care facility will be considered to have experienced an 
SAE. In general, most SAEs will result in inpatient care and thus in transfer to the inpatient 
division of CMHC. All SAEs will result in the completion of an SAE Form and a verbal report 
within one hour to the Principal Investigator (Dr. Carroll) and the clinic directors (Drs. Añez, 
Paris). Within 24 hours, the following additional individuals will be informed: 1) all co-
investigators; and 2) the DSMB. Adverse events that are serious and unanticipated and 
probably, possibly, or definitely related or adverse events occurring with greater frequency than 
anticipated will be reported to the Yale Human Investigation Committee within 48 hours of 
discovery.  The procedures for SAE reporting include written documentation using the clinical 
notes related to the adverse event and specific forms detailing the event with a sign-off by all 
appropriate supervisory personnel.  Communication of recommendations and decisions from all 
parties (DSMB, Yale Human Investigations Committee, and CMHC Administration) are made 
back to the investigator in a timely manner. We will report all protocol amendments or changes 
in the informed consent form to NIDA as well as any temporary or permanent suspension of 
patient accrual.
4.    Confidentiality & Security of Data:
a.    What protected health information (medical information along with the HIPAA identifiers) 
about subjects will be collected and used for the research?   
In Phase 1, no PHI will be collected.  In Phase 2, PHI that will be collected includes 
names, addresses, phone numbers, and email addresses for locator purposes. 
Our study assessments/forms have been designed to avoid collecting identifiable 
information (e.g., no PHI identifiers are collected on CRFs). The only dates collected are 
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protocol session dates. These are changed to ‘number of sessions completed’ when data sets 
are anonymized and released to other investigators.
b.    How will the research data be collected, recorded and stored?
Research data are collected on CRFs, and sent to data managers in our research offices 
on a closed secure network.  All computers used by research staff are password protected.  No 
identifying information is on CRFs.  Only authorized individuals will have access to CRFs.
c.    How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard   
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
 Other
d.    What methods and procedures will be used to safeguard the confidentiality and security of    
the identifiable study data and the storage media indicated above during and after the 
subject’s participation in the study?
Do all portable devices contain encryption software? 
 Yes   
 No
         If no, see http://hipaa.yale.edu/guidance/policy.html
 
Confidentiality in regards to collected materials will be maintained via a numbered 
reference system maintained by the Project Director.  Participants’ names will appear only on 
the consent form, HIPAA authorization form, and “key” form kept by the Project Director. The 
key form linking subject names to ID codes will be stored in a separate, locked file cabinet.    
Data are stored at our secure data management center; data sets do not include identifying 
information.
In addition, we have designed all of our CBT4CBT websites such that no sensitive 
information (i.e., information on illegal behavior) or PHI is collected or stored by the website 
(including IP address).  Moreover, to avoid participants inadvertently revealing sensitive 
information, the website does not use any ‘blank fills’, and the program shuts down after 10 
minutes of inactivity.
e.
What will be done with the data when the research is completed? Are there plans to destroy     
the identifiable data? If yes, describe how, by whom and when identifiers will be destroyed. 
If no, describe how the data and/or identifiers will be secured.
Paper copies of participant records containing ID numbers will be moved to a secure 
archive in Temple Medical Building; 40 Temple Street, New Haven, CT.  Source files with 
subject names will be stored in the regulatory coordinator's office separately under triple lock 
(building entry, office entry, separate locked file cabinet designated for name files only).  The 
paper log linking subject names to ID codes will be stored in a separate, locked file in the 
regulatory coordinator's office.  At the end of the required record retention period, data will be 
destroyed in accordance with Yale ITS policies 1609 and 1609PR.01. Source data are 
generally destroyed 3 years after completion of the study at a secure location by Shred-It.
f.   Who will have access to the protected health information (such as the research sponsor, the  
investigator, the research staff, all research monitors, FDA, QUACS, SSC, etc.)? (please 
distinguish between PHI and de-identified data) 
The Yale PI and the research staff will have access to PHI and coded data.  The funding 
agency, NIAAA, may access the data for routine audits.
g.   If appropriate, has a Certificate of Confidentiality been obtained?
Applied for.
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h.   Are any of the study procedures likely to yield information subject to mandatory reporting   
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -
incidents of child abuse, elderly abuse, etc.). Please verify to whom such instances will need to 
be reported. 
Limits to confidentiality include only disclosure of acute suicidality, homicidality, or abuse 
of a minor/elder, as is standard in clinical practice and indicated in the consent form.  When 
there is reasonable cause to suspect or believe there is a case of child abuse or elder abuse, a 
report will be made to the CT Department of Children and Families (DCF) or CT Department of 
Social Services (DSS), Protective Services for the Elderly (PSE).  Designated clinic personnel 
will be notified as per clinic policies.
         6/29/2011SECTION X: POTENTIAL BENEFITS
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the subject(s) or to society at large. (Payment of subjects is not considered a 
benefit in this context of the risk benefit assessment.) 
The major potential benefit in this study is in reduction of alcohol use via the study 
treatments, which may, in turn, foster improvement in participants’ legal, medical, interpersonal, 
psychological and occupational functioning.
         SECTION XI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.     Alternatives: What other alternatives are available to the study subjects outside of the research?
Individuals who do not wish to participate or who are ineligible for the trial will be referred 
back to their clinician.
2. 
Payments for Participation (Economic Considerations): Describe any payments that will be 
made to subjects, the amount and schedule of payments, and the conditions for receiving this 
compensation. 
Phase 1 (Development of the CBT modules, Years-1-2):
A sample of 5 clinicians will be asked to review the CBT4CBT program in Year 2; They 
will be paid $200 for completing all 7 modules of the program and providing evaluation and 
feedback.  If a reviewer does not complete all of the modules they will be compensated for the 
modules they do complete at a rate of $28.50 per module.  Their feedback will be incorporated in 
final modifications to the program. 
Phase 2 (Randomized trial, Years 3-5):
Subjects will be compensated for time required to complete baseline assessment at $40, study 
assessments at $25 at each weekly assessment time point; $50 at post-treatment, $50 at 1-
month follow-up; $75 at 3-month follow-up; and $100 at 6-month follow-up.  The pilot subjects 
will not be participating in the follow up phase, therefore, there will be not follow up 
compensation.
3.
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs 
associated with participation in the research, and the interventions or procedures of the study that 
will be provided at no cost to subjects.      
There will be no costs to subjects associated with participation in this study.   Subjects 
will not be charged for study treatments or evaluations they receive at the clinic.  Subjects may 
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be charged for treatment as usual at the clinic; but most patients receive treatment with no-out 
of pocket expenses or on a sliding scale.   
4.
In Case of Injury: This section is required for any research involving more than minimal risk.
a.     Will medical treatment be available if research-related injury occurs? 
b.     Where and from whom may treatment be obtained? 
c.     Are there any limits to the treatment being provided? 
d.     Who will pay for this treatment? 
e.     How will the medical treatment be accessed by subjects? 
Because we are evaluating standard behavioral approaches with strong empirical 
support and no known adverse consequences, study related injuries are expected to be 
extremely rare.  There will be no compensation and/or medical treatment available if injury 
occurs. Participants or their insurance carrier will be expected to cover costs of any medical 
treatment.
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