Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence
Phase: NA
Conditions: Alcohol Abuse
Sponsor: University of Pennsylvania

 
 
 
Protocol title: 
 
 
 
NCT number: 
 
  
Impact of enhancements to smartphone-based 
continuing care for alcohol dependence 
Short title: Smartphone Based Continuing Care of 
Alcohol 
 
NCT02681406 
 
Document 
date:  
 02/14/2019 
 
  
 
  
Principal 
investigator:   James R. McKay and David Gustafson 
 
  
 
  
Protocol 
description: 
  
We will recruit 280 patients with moderate to severe 
AUD in a treatment program to test the efficacy and 
cost efficiency of a smartphone based application for 
treating alcohol addiction (ACHESS) with telephone 
monitoring and counseling (TMC). Participants will be 
randomized to: treatment as usual; ACHESS; TMC; or 
TMC plus ACHESS. Participation in the study lasts for 
18 months with research visits at baseline, 3, 6, 9, 12, 
and 18 months. The intervention lasts 12 months. 

 
Brief description 
We will recruit 280 patients with moderate to severe AUD in a treatment program to test the 
efficacy and cost efficiency of a smartphone based application for treating alcohol addiction 
(ACHESS) with telephone monitoring and counseling (TMC). Participants will be randomized 
to: treatment as usual; ACHESS; TMC; or TMC plus ACHESS. Participation in the study lasts 
for 18 months with research visits at baseline, 3, 6, 9, 12, and 18 months. The intervention lasts 
12 months. 
Key Personnel 
Study Investigator: James McKay, PhD 
Study Contact: Megan Ivey 
Other key personnel: Katherine Crockett, Kristin Jones, Ali Keenan, April Howard, Tyrone 
Thomas 
Study Instruments 
We will use the battery of widely used, well-validated instruments that we have used in prior 
studies.  These include the SCID (First, et al 2002) and MINI done at baseline only. We will 
collect blood samples for CDT testing at both baseline and 18 months. The following will be 
completed at baseline, 3, 6, 9, 12, and 18 months:  urine toxicology, Time-Line Follow-Back 
(TLFB; Sobel et al, 1996), Addiction Severity Index (ASI; Mclellan et al 1992), negative 
consequence of alcohol use (SIP; Miller & Tonigan, 1995, Feinn et al, 2003), abstinence-specific 
social support (IPA; Zywiak et al, 2009); and measures of coping (Litt et al, 2003), self-efficacy 
(alcohol version of the DTCQ; Annis & Martin, 1985), readiness to change (URICA; Prochaska 
& DiClemente, 1985), self-help involvement (McKay, et al, 1994), quality of life (SF-12; Ware 
et al, 1996, and EQ-5D; EuroQol Group, 1990), non-study medical services (Polsky, et al, 2010), 
and the modified DATCAP (French, et al, 1997). 
 
Randomization 
Urn randomization will be used to balance the groups on gender and co-occurring drug use 
disorder (yes/no), to ensure that the treatment conditions do not differ on these factors. 
 
Administration of Surveys and/or Process 
At baseline, the interviewer will administer the drug and alcohol sections of the SCID, MINI, 
Time Line Follow-Back, Addiction Severity Index, a Drug urine toxicology test, a breathalyzer, 
as well as instruments for Process of Change, Commitment to Abstinence, Self-Efficacy, and 
Self-Help. This baseline assessment will take approximately 2 hours to complete. In addition, the 
participant will have blood drawn to test for %cdt. 

Follow up assessments will occur at 3, 6, 9, 12, and 18 months post baseline. Each follow up will 
include a urine drug screen, as well as completion of the ASI, Time Line Follow Back, Self-
efficacy, Coping, Alcohol specific Social Support, Readiness to Change, Self-Help, and quality 
of life questionnaires. At the 18 month (final) research appointment, participants will again have 
their blood drawn. Each follow up will take approximately 1.5 hours to complete. 
Data Management 
All research information obtained will be kept strictly confidential. Interview and questionnaire 
data will be kept in locked cabinets. Subjects will be identified only by number on the 
computerized database. Access to identifying data will be limited to research staff engaged in the 
project. Our Center Data Management Unit features web-based data entry. Windows 2008 
Enterprise is used to create a network structure whereby workstation and remote clients can 
electronically enter data through a user interface application developed in JAVA. This web 
interface only allows for data entry, not for querying of the full database. Databases are created 
in SQL Server. The restrictions are that the site requires double authentication and SSL prior to 
access being granted. There are no restrictions on computer location. Mr. Petro, DMU Director 
and primary developer of the web-based system, will be responsible for working with the project 
staff to ensure the integrity of the data entry process. The data will then be exported into a 
spreadsheet to be analyzed by the data analysts. The exported spreadsheet will not contain any 
PHI, as data will be coded using study identification numbers, the key list of identifiers and 
participant names is kept separately in a secured database with limited access and double 
password protected entry. Data is intended to be collected directly into this computerized system. 
However, due to connectivity or other computer access issues, data may need to be collected on 
paper and then entered into the web-based system by a research assistant. In either case, the 
research assistant performs the first quality assurance check for completeness and consistency 
(QA 1). Telephone calls that are recorded (upon consent) will require special authentication from 
select users to access. These recordings, therefore, will not be encrypted. Then the coordinator 
performs the next quality assurance review (Final QA) to maintain accuracy, completeness, and 
consistency. Once Final QA is complete, the record is then locked. If any further alterations need 
to be made, they must be done in writing through Mr. Petro. 
Other sites 
Site   University of Wisconsin - Madison  
  
Contact   Molly Lumley 
PI   David Gustafson 
Mail   1513 University Ave., Rm 4120 
Madison, WI 53706 
Phone   608-235-2304 
Email   mah@medicine.wisc.edu 
Management of Information for Multi-Center Research 

All participant recruitment and research will occur at and by the University of Pennsylvania. The 
University of Wisconsin - Madison has developed and will maintain and work with us regarding 
the smart phone application. 
Abstract 
The goal of this R01 is to determine whether adding TMC (Telephone Monitoring and 
Counseling) to ACHESS (Addiction version Comprehensive Health Enhancement Support 
System, a smart phone communication system) produces superior outcomes to those obtained 
with ACHESS alone.  Specifically, 280 patients with moderate to severe alcohol use disorder in 
an intensive outpatient program (IOP) will be randomized to receive ACHESS only, TMC only, 
ACHESS plus TMC, or TAU (treatment as usual), in a 2 x 2 design, for 12 months. All 
participants will be seen for research assessments for a total of 18 months, at baseline, 3, 6, 9, 12, 
and 18 months post baseline.  Additional analyses will examine four secondary outcome 
measures, including a biological measure of alcohol use, and hypothesized moderation and 
mediation effects. The results of the study will yield important information on improving patient 
alcohol use outcomes by integrating mobile automated recovery support and counselor contact. 
Objectives and Hypotheses. 
 
a.  Primary Objective: To use a 2 x 2 design to test for main effects for TMC and 
ACHESS and the combination of TMC+ACHESS on the primary alcohol use outcome in 280 
IOP participants with moderate to severe alcohol use disorder:  
 
Hypothesis 1:  Both TMC and ACHESS will generate significant main effects on % days 
heavy drinking across the 18-month follow-up.   
 
Hypothesis 2: The TMC+ACHESS condition will generate lower % days heavy drinking 
than the TMC Only and ACHESS Only conditions across the 18-month follow-up. 
 
b.  Secondary objectives:  Test three secondary hypotheses and one secondary research 
question: 
 
Hypothesis 1:  Treatment effects described above will also be obtained on negative 
consequences of drinking, a dichotomous measure of abstinence from all substances, a biological 
measures of alcohol use (%CDT), and on a quality of life measure.   
 
Hypothesis 2:  TMC and ACHESS effects and advantage of TMC+ACHESS over TMC 
Only and ACHESS Only will be greater in those with: (a) prior alcohol treatments; (b) greater 
alcohol use prior to IOP; and (c) alcohol use, poor social support, and low motivation in the first 
3 weeks of IOP.   
 
Hypothesis 3: Beneficial effects of ACHESS and TMC will be mediated by increases in 
self-efficacy, coping, social support for recovery, and readiness to change. 
 
Compare TMC Only and ACHESS Only on primary and secondary outcomes 
c.  Economic objectives. Economic analyses will demonstrate that: 

 
Hypothesis 1: TMC+ACHESS will be cost-effective relative to TMC Only and ACHESS 
Only 
 
Hypothesis 2: ACHESS Only will be cost-effective relative to TMC Only 
Primary outcome variable(s)* 
The primary outcome measure will be percent days of heavy alcohol use (i.e.,  5 drinks/day for 
men,  4 drinks/day for women) within each follow-up period. Studies have consistently 
supported the reliability and validity of the TLFB with alcohol dependent individuals.  
Frequency of heavy alcohol use was selected because alcohol-related problems are correlated 
with the frequency of heavy drinking days.  This outcome is also sensitive to reductions in 
problematic or high-risk use, which are particularly important in a disease management model. 
Secondary outcome variable(s)* 
Five secondary outcomes will also be examined: alcohol use related negative consequence (SIP), 
any substance use within a follow-up period (yes/no, as determined by TLFB, ASI, and urine 
drug screens), carbohydrate deficient transferrin (%dCDT), and quality of life (as assessed with 
the SF-12), treatment attendance.  The first two measures were selected to provide a fuller 
picture of overall substance use and severity of drinking consequences.  Although the study 
interventions are primarily focused on reducing alcohol use, reductions in other drug use and 
negative consequences are clearly desirable and clinically important.  CDT was included to 
provide a biological measure of heavy drinking, to corroborate results obtained with the self-
report TLFB.  The quality of life measure was included to obtain a more global, overall health 
outcome. Data will also be obtained on the frequency, timing, and total time in each ACHESS 
service, including when and what service each participant starts with, and where they go from 
there.  It will also include the timing, content, and completeness of weekly and daily 
assessments. Finally, data will be obtained regarding treatment attendance as the number of days 
the participant attended treatment at the site from which we recruited them. This data will be 
used for economic reasons. 
Background* 
Role for New Communication Technology in Continuing Care.   
a.  Background.  New Information and Communication Technologies (ICTs) may add to the 
efficacy of continuing care by addressing the limitations of these models, and may yield cost 
savings. Efficacy studies of ICTs in chronic disease self-management are promising. People with 
addictions tend to view ICTs favorably and they acknowledge more drug use and psychiatric 
symptoms online than in interviews.  Further, computerized screening and brief interventions 
have been shown to reduce problem drinking. Interactive Voice Response, which provides 
prompts and collects data from people dealing with substance misuse, has been associated with 
reductions in alcohol use.  ICTs boost motivation in health domains where social support is key 
to positive outcomes. A recent review found positive outcomes in 29 of 32 randomized trials of 
personal computer and single service (e.g. texting) cell phones for managing many different 
chronic diseases (e.g. addiction, pain, depression, cancer, diabetes, heart disease).   

 
New mobile phone communication technology provides a way to bridge periods between 
continuing care sessions.  It provides a personalized recovery support system during the evenings 
and on weekends when live professional counselor are unavailable. A recent review summarized 
findings from seven studies in which mobile phones were used to enhance psychotherapy for a 
range of behavioral disorders. Most of these were small pilot studies designed to determine 
feasibility, rather than efficacy.  However, in the four studies that did calculate effects, the 
magnitude of effects favoring the mobile phone interventions was in the moderate-to-large range 
(d= .40 to 1.15).  The authors concluded that more effective phone-based adjunctive 
interventions featured (a) better integration of the telephone technology with psychotherapy, (b) 
mobile telephone protocols that clearly adhered to and supported the goals of the psychotherapy, 
and (c) face-to-face introductions to the program.  Recent studies not included in this review 
provide further evidence for the feasibility of using mobile phones as a component in therapy for 
adolescents and in borderline personality disorder.  An important challenge for the alcohol 
treatment field is to determine how best to integrate new automated mobile recovery support 
technology and counselor- or therapist-delivered continuing care.   
  
b.  Work of University of Wisconsin Team on Internet Health Supports.  For 25 years, 
Wisconsins NCI-designated Center of Excellence in Cancer Communication Research and 
AHRQ designated Center of Excellence in Aging Research has developed and tested ICTs to 
improve health behaviors, quality of life, and access to care using an evolving needs-based 
platform called the Comprehensive Health Enhancement Sup-port System (CHESS) for patients 
and family caregivers (chess.wisc.edu).  In randomized efficacy trials CHESS significantly 
improved: (a) quality of life and self-efficacy for women with breast cancer vs. control and 
Internet groups, (b) quality of life and costs of care in people with HIV, (c) asthma control for 
young children, (d) quality of dying and survival length for lung cancer patients, and symptoms 
of distress in adult children of alcoholics.  Clinical trials of personal computer CHESS systems 
are now underway for prostate cancer and families of children with bone marrow transplants. 
   
Addiction CHESS (ACHESS) is a smart phone-based adaptation of CHESS that provides 
adjunctive recovery support to individuals receiving continuing care for substance use disorders.  
ACHESS offers easy access anytime and anywhere to 10 services tailored to meet patient needs 
(also see Specific Aims).  Services come in text and audio-video formats, and include the 
following:  
 
Social Relatedness services: one-touch links to family, others in recovery, discussion 
groups, and treatment staff if desired, via phone, email, and text messaging; GPS driven alerts to 
social supports  
 
Coping Competence services: regular assessment of risk and protective factors to aid 
patient in self monitoring and inform counselors or monitors on status, tailored information on 

coping, relaxation training and games to divert attention from craving, and Healthy Events 
Calendar.  
The ACHESS system is ideally suited to address the four primary limitations in continuing care 
outlined earlier.  Daily assessments of patients abstinence confidence, ongoing GPS monitoring, 
panic button functions, and weekly assessments of risks and protective factors provide clinicians 
and patients with access to near real-time data that are not available from weekly or bimonthly 
therapeutic contacts, which directly addresses heterogeneity of response and lack of between 
session information on patient status.  The other features, including links to supporters and peers 
and tailored tools and information, provide more rapid access to social support and other 
recovery supports during periods when counselors are not immediately available.  Please view a 
3-min video at http://chess.wisc.edu/chess/projects/addictioncessvideo.aspx. 
Although clinician to patient contact can be part of ACHESS, the majority of its functions do not 
require such contact.  Patients choose whom they want assessment data to go to, and in many 
cases they select friends or family rather than counselors.  When patients choose to forward 
information to a clinician, assessments generate alerts to clinicians only if the patient reports 
recent substance use, or another problem (i.e., craving) that is over a predetermined severity 
level.  These procedures have led to relatively little contact be-tween counselors and patients in 
ACHESS studies (see below).   
c.  Alcohol Research Findings.  In a completed NIAAA-funded controlled trial, alcohol 
dependent patients (N=349) beginning a continuing care intervention following residential 
treatment were randomized to receive adjunctive ACHESS for 8 months or standard continuing 
care only.  Participants primarily were male (61%), unemployed (78%), and users of other drugs 
(63%); 76% had been in addiction treatment before (22% with 5+ treatments), 58% had a high 
school diploma or less, and 47% had co-occurring mental health diagnoses.  The participants 
continued to use the ACHESS system at a high rate through the 8 month period over which it 
was provided. At the 8 month point, 70% of subjects were using ACHESS at least weekly; 
compared to 92% in month one.  This drop off is less than any other CHESS application we have 
studied.  Alcohol use out-comes were markedly better in the group randomized to ACHESS. 
Across 4, 8 and 12 month follow-ups, those who responded to all surveys (70%) reported 57% 
fewer heavy drinking days (p=.003; d=.39) and 30% higher rates of complete abstinence 
(P=.007; OR 1.74) in the ACHESS condition compared to TAU.  Similar significance levels 
were found in an intent-to-treat analysis with the full sample. 
 
Of the participants randomized to ACHESS, 28% reported a lapse or relapse at some point via 
ACHESS prompts in the 8 months and another 11% were designated as at risk for relapse at 
some point in the 8 months based on ACHESS data. In addition, most participants at some point 
had a score on one of the 10 assessment items that was over a predetermined threshold.  
Participants in this study chose whom they wanted their ACHESS data to be forwarded to:  
family/friends, a person who monitored ACHESS utilization, or to their counselor.  When 
participants selected the counselor, the counselor in most cases responded to these prompts by 

texting the participant, with an average of less than 2 such texts per patient per month.  Slightly 
more than half of the participants (58%) pressed the panic button on one or more occasions, 
although data on how many of these incidents resulted in connection with a source of recovery 
support are not available.  
 
Although one might expect that older participants would not use ACHESS as much as younger 
participants, in fact participants 30 years old used ACHESS slightly more than younger 
participants (mean of 65 vs. 59 out of 123 possible days).  Moreover, only 14% of the 
participants in this trial reported lost or stolen phones. Results from a pilot study by Galloway et 
al. in which cellular telephones were given to six methamphetamine dependent outpatients for 
ecological momentary assessment also indicated good compliance with the protocol. Participants 
were called three times per day for seven weeks and they completed 65% of all possible calls, 
and all phones were returned at the end of the study.  The findings from these studies provide 
strong support for the feasibility and impact of ACHESS in treatment seeking,  patients with 
moderate to severe alcohol use disorder. 
 
Other pilot tests of ACHESS have been conducted with participants who had alcohol use 
disorders. One pilot study with veterans being treated within the VA for alcohol dependence 
identified 30 people with 3 or more admissions to detox over an 18-month period and offered 
ACHESS to them. These people had 217 admissions prior and 20 subsequent to receiving 
ACHESS. A cost savings study is currently underway with discussions of expanding delivery of 
ACHESS to five other VA medical centers. 
 
d.  Limitations of ACHESS.  ACHESS does not provide regular, ongoing contact with a 
continuing care counselor.  This reduces the cost of the intervention, but could also limit its 
effectiveness.  For example, the lack of a sustained relationship with a caregiver may reduce the 
positive effects that are accounted for by so-called general factors such as the therapeutic 
alliance.  It is also not clear whether patients who have initial success and therefore limited or no 
contact with a counselor will use the ACHESS features to con-tact a counselor for help if they 
begin to struggle, or will respond to counselor outreach efforts via text messages or telephone 
calls.  The lack of regular contact with a counselor may also lead to less utilization of ACHESS 
features such as monitoring and panic button messages indicating a need for help.  Prior research 
has indicated that innovative mobile phone interventions are more effective when better 
integrated with psychotherapy.  We hypothesize that a continuing care intervention that 
integrates ACHESS with regular, albeit brief, telephone contact with continuing care counselors 
will provide general supportive factors, facilitate more consistent and extended use of ACHESS 
functions, help patients plan more effectively and proactively for high risk situations, and shorten 
the duration and intensity of relapses should they occur. 
 
e.  Optimal ACHESS duration.  It is also not clear at this point how long ACHESS needs 
to be provided to generate strong long-term drinking outcomes.  In the recent study by Gustafson 
and colleagues, ACHESS was provided for 8 months to alcohol dependent patients leaving a 

residential program.  However, there is no strong theoretical or empirical basis for that particular 
duration.  Therefore, we propose to test the efficacy of 6 vs. 12 months of ACHESS availability.  
There is evidence from reviews of continuing care studies that interventions of 12 months or 
more are more likely to generate positive effects than interventions of a shorter duration.  
Therefore, we are hypothesizing that 12 months of ACHESS will produce better outcomes than 6 
months.  However, the range of functions provided by ACHESS on a 24/7 basis may facilitate 
faster learning of new coping skills and more rapid consolidation of social support for recovery.  
Moreover, the combination of ACHESS with TMC for the first six months may also generate 
stable recovery more rapidly, thereby reducing the need for more extended recovery support and 
containing the cost of the intervention.    
5.  Telephone-Based Continuing Care.  McKay and colleagues have developed a flexible, 
patient-centered approach to the long-term management of substance use disorders, Telephone 
Monitoring and Counseling (TMC). The theoretical basis of TMC comes from Stress and Coping 
Theory, which emphasizes the identification of high risk situations, increasing self-efficacy, and 
improving coping strategies; and Social Control Theory, which stresses monitoring, structure, 
and goal direction. These goals are also consistent with the primary goals of the Chronic Care 
Model, as described by Wagner et al., which include support for patient self-management, links 
to community resources, interventions to increase self-confidence and skill levels, a focus on 
goal setting, and identification of barriers to achieving goals and methods to overcome such 
barriers.  The studies in our research program are described briefly here. 
 
a.  12-Week Telephone Continuing Care Study.  We developed an initial telephone-based 
intervention (TEL), which we compared to treatment as usual group counseling (GC) and relapse 
prevention (RP) continuing care in a randomized study with 359 IOP completers who all had 
current dependence on alcohol and/or cocaine.  TEL produced higher abstinence rates across the 
24 month follow-up than GC (p .05).  Abstinence rates were somewhat higher in TEL than in 
RP, although not significantly so. Biological measures of heavy alcohol use (concentrations of 
liver enzymes) also confirmed that TEL was superior to GC and RP at 12 and 24 months.  In 
cocaine dependent participants, there were significant group by time interactions with cocaine 
urine toxicology in which the advantage for TEL over GC and RP increased over the follow-up.  
Longitudinal mediation analyses indicated that changes in self-help involvement, self-efficacy, 
and commitment to abstinence accounted for the treatment effect favoring TEL over GC on 
abstinence outcomes.  
 
b.  Telephone-Based Adaptive Alcohol Disease Management Study.  We developed an 
18-month telephone-based intervention, which was compared to standard care in 252 IOP 
patients with current alcohol dependence who completed 3-4 weeks of IOP.  Telephone 
Monitoring and Counseling (TMC), which was a more structured, adaptive version of the TEL 
intervention in the prior study, consisted of 20-30 minute telephone calls that were provided 
weekly for 8 weeks, twice monthly for 10 months, and monthly for the final 6 months.  Each call 
began with a 5 minute structured assessment of risks and protective factors, followed by CBT 
focused on developing coping responses to the most pressing problem identified in the 
assessment.   

 
During the 18 month treatment period, rates of any alcohol use (OR= 1.88) and any 
heavy alcohol use (OR=1.74) were significantly higher in standard care (TAU) than in TMC.  
Significant group x time interactions were obtained on % days alcohol and heavy alcohol use, in 
which the advantage for TMC over TAU increased over time.  Subgroup analyses over the full 
24 month follow-up showed effects favoring TMC over TAU on % days drinking were greater in 
women (OR=0.47, p=.04) and those with prior treatments for alcoholism (OR= 0.59, p= .02); 
and in those with social networks that supported continued drinking (OR=0.44, p=.02) and low 
readiness to change (OR=0.53, p=.05) after 3 weeks of IOP.  
 
c.  Telephone-Based Adaptive Cocaine Disease Management Study.  In a similar 
continuing care study with cocaine dependent patients (N=321), there was significant 
interactions between cocaine and alcohol use at baseline and the treatment conditions (p= .03) on 
the primary outcome, a measure of abstinence from cocaine, other drugs, and heavy alcohol use 
(confirmed by urine toxicology tests).  In patients with any days of cocaine or alcohol use in the 
30 days prior to baseline (which included the week prior to intake and the first 3 weeks of IOP), 
abstinence rates were higher in TMC than in TAU, with the treatment effect larger in those who 
had been drinking at baseline (OR=2.47, p= .007) than in those who had been using cocaine 
(OR=1.95, p= .04). Conversely, in patients with no days of cocaine or alcohol use in the 30 days 
prior to baseline, there were no treatment effects.      
d.  Summary of Findings from Our Research Program.  Across three major randomized 
controlled outcome studies, our telephone-based continuing care interventions have produced 
better alcohol and/or cocaine use outcomes than standard care for patients with current substance 
dependence (or, in the third study, substance use in the first few weeks of treatment). These 
projects also demonstrate our ability to collaborate successfully with publicly funded treatment 
programs, recruit large samples in a timely fashion, deliver novel continuing care interventions, 
and maintain high follow-up rates.  
e.  Limitations of TMC.  The primary limitation of TMC is that there are periods of a week or 
longer between sessions when there is no contact between counselors and patients (as is the case 
with most behavioral interventions).  The sessions help patients to process substance use 
episodes in the prior week, and to prepare for anticipated relapse risks in the coming week, but 
changes in risk factors and other live events between sessions are not monitored in near real time 
fashion.  Therefore, the intervention has limited ability to help patients during times of crisis, or 
when circumstances change between sessions.  In addition, TMC is not able to quickly link 
patients to other sources of recovery support (i.e., peers, family, community/on line resources). 
 
Study Design: Phase II 
The proposed 2x2 randomized trial employs an experimental, prospective design, in which 280 
subjects with current, moderate to severe alcohol use disorder will be randomly assigned into 
four conditions and followed for 18 months.  The follow-ups will be at 3, 6, 9, 12, and 18 months 
post baseline.  The research assistants will be blind to the randomization to the extent possible, 

though over the 18 months of participation, it is likely that the study participant will reveal their 
intervention. 
Study duration* 
In the first six months of Y1, staff from the U Penn and UWisc groups will collaborate to 
produce an alcohol smart phone version of ACHESS that is integrated with the TMC protocol, 
and counselors will be trained to use data produced by the ACHESS system as part of delivering 
TMC. Starting in month 7 of Y1, participants will be recruited for the clinical trial.  Recruitment 
of participants will be completed before the end of Year 3 and follow-ups will be completed by 
month 52.  The bulk of the data analysis and report writing will be take place during Year 5. 
Resources necessary for human research protection 
Sufficient office space is available at the CSA and IOPs to conduct the clinical interventions and 
research assessments. Laboratory facilities and personnel are available to collect and process the 
urine samples. Research staff will go through rigorous training and periodic retraining. The 
recruitment will occur at an intensive outpatient program with whom the research group has 
worked on many studies. The enrollment is high and in every past study the research group has 
reached the recruitment goal. 
Target population* 
The subjects will be 280 patients with current, moderate to severe alcohol use disorder, ages 18-
75, who are in treatment in Philadelphia area intensive outpatient programs (IOP).  Based on our 
previous research, we anticipate the population to look like this: The average age of this group of 
subjects will be about 40 years. About 75% of the subjects will be African-American, 21% will 
be White, and 4% will be other minorities.  Approximately 10% will be Hispanic, and 40% will 
be female.  About one-third will be employed and all will have a relatively stable residence.  The 
population can be characterized as lower socioeconomic class. 
Accrual* 
Participants will be recruited from Philadelphia area IOPs. The City of Philadelphia's 
Department of Behavioral Health has been supportive of our research for many years and has put 
the PI in touch with willing IOPs. Typical Philadelphia area IOPs provide traditional, 12-step 
oriented treatment, delivered through 9 hours of (primarily) group counseling per week.  Patients 
typically are retained for approximately 2 months in the program.  IOP graduates are usually 
referred to standard outpatient care, although relatively few follow through with this. 
Key inclusion criteria* 
To be eligible for participation, patients must: (a) have a DSM-V diagnosis of current, moderate 
to severe alcohol use disorder; (b) have completed 3 weeks of IOP; (c) be 18 to 75 years of age; 
(d) have no current psychotic disorder or dementia severe enough to prevent participation in 
treatment; (e) have no acute medical problem requiring immediate inpatient treatment; (f) not be 
on methadone or in other forms of substance abuse treatment, other than IOP; and (g) be willing 

to participate in a randomized clinical trial.  Finally, subjects will (h) be able to provide the 
name, verified telephone number, and address of at least two contacts willing to provide locator 
information on the patient during follow-up, and (i) be functionally literate and have sufficient 
visual ability to read the smart phone. Other substance use disorders will not exclude IOP 
patients from participation, provided they have current alcohol moderate to severe alcohol 
disorder. 
Key exclusion criteria* 
Participants will be excluded if they (a) do not have a DSM-V diagnosis of current, moderate to 
severe alcohol use disorder; (b) have not completed 3 weeks of IOP; (c) are not 18 to 75 years of 
age; (d) have a current psychotic disorder or dementia severe enough to prevent participation in 
treatment; (e) have an acute medical problem requiring immediate inpatient treatment; (f) are in 
other forms of substance abuse treatment, other than IOP; and (g) are not willing to participate in 
a randomized clinical trial; (h) are not able to provide the name, verified telephone number, and 
address of at least two contacts willing to provide locator information on the patient during 
follow-up, and (i) are not functionally literate or have sufficient visual ability to read the smart 
phone. 
Populations vulnerable to undue influence or coercion* 
The population with which we work tend to be economically disadvantaged. We attempt to safe-
guard them from coercion by downplaying compensation during recruitment, and by using the 
previously accepted pay rates of approximately $10 per hour, with a higher payment at follow-up 
($50). People who have missed research visits may receive more than $50 at their next visit due 
to the increased information we will be asking them. Our participants are compensated for their 
time, and are also given $4 to compensate for their transportation to come to our offices. The 
rates of pay are not believed to be coercive. 
Subject recruitment* 
When patients enter IOP, they will be told about the study by IOP staff.  Patients who express 
interest in participating will be referred to a study technician on site.  The research technician 
will explain the study, obtain an initial informed consent for screening, and administer a brief 
instrument that collects demographic data and eligibility screening information.  Patients then 
will be given an appointment for the baseline assessment to be conducted three weeks later. If 
the baseline is not scheduled at the time of screening, the research technician will schedule the 
appointment at a later date via telephone, or with permission from the eligible participant, via 
SMS text message.  Patients who choose not to participate in the study will continue to receive 
treatment as usual.  We will also display study recruitment flyers and leaflets at the recruitment 
sites with the site director's approval. Patients who become interested in the study from seeing 
our flyer or leaflet will call a study technician to complete a phone screening interview.  The 
patient will provide verbal consent to complete the phone screen. If the patient is determined to 
be eligible, they will be scheduled for a baseline appointment.  If the patient chooses not to 
participate they will continue to receive treatment as usual. At the initial baseline assessment, 
patients who agree to participate will sign a second informed consent, after they have 

successfully passed an informed consent quiz.  Patients who meet criteria for participation will 
then complete the remainder of the baseline assessments and be randomly assigned to one of the 
four treatment conditions. However, we will place eight early participants into the TMC + 
ACHESS treatment condition in order to ensure smooth delivery of this combined intervention 
prior to randomizing other participants. 
Participants will be compensated $40 for completing the baseline assessments and will receive 
$50 for completing each follow-up assessment. Participants will be paid at the end of the 
research visit. Payments will be made using GreenPhire ClinCards. Clincards are reloadable 
prepaid cards that may be used for in-store purchases (by selecting either the "credit" or debit" 
option), online purchases, ATM to get cash, and cash advances at a bank. If the participant 
completes all assessments, their total compensation will be $290.  Additionally, participants will 
be reimbursed $4 per visit for travel. This takes the place of SEPTA  tokens that we had been 
providing. For those participants who we see for the 18 month follow up but have missed the 
preceeding follow ups, we will pay them an additional $10 for each Time Line Follow Back they 
provide us for the visits they missed. If they missed the 12 month research visit then the will 
receive $60. If they missed all the research visits between baseline and 18 months they will be 
paid a total of $90 ($50 for the 18 month visit, plus $10 for 3 months, $10 for 6 months, $10 for 
9 months, and $10 for 12 months). 
Procedures* 
Baseline assessments will be conducted after the third week of IOP. The baseline visit will 
include consenting and gathering contact information, assessments (ASI, SCID, MINI, TLFB, 
and self-assessments), a urine specimen, and a blood draw. All procedures are for research 
purposes only and will not be part of their clinical chart at their IOP.  At the completion of the 
baseline visit after final determination of eligibility has been completed, the participant will be 
randomized and will be compensated $40.00.  
 
Participants will be randomized to either 1) ACHESS only for 12 months 2) TMC only for 12 
months; 3) ACHESS with TMC for 12 months; or 4)TAU. 
 
1. b. ACHESS Only.   
Setup.  During an initial face-to-face meeting with the participant, which will occur at the IOP, 
the counselor enters the following information into the ACHESS system:  participant 
demographics, self-efficacy, healthy events of interest to participant, therapeutic goals and care 
plan, high risk locations, key relapse triggers, and attitudes toward drug use.  Protocols for 
contact are discussed and programmed into the smart phone (i.e., high risk locations for GPS 
monitoring, protocols for what happens when panic button is pushed, etc.).  A password will also 
be selected by the participant and used to protect the phone. Participants will also be trained to 
use the ACHESS system during this session.  Follow-up training is available through brief video 
tutorials for each ACHESS service. 

Non-emergency contacts.  Participants can use the recovery support functions of ACHESS 
whenever they wish (see below). Following 7 days of inactivity, the system sends a message to 
the participant and to a member of Dr. Gustafsons staff monitoring ACHESS utilization, who 
will encourage ACHESS use via text messages.  Technical support for ACHESS operation will 
be available via phone.   
Assessments.  Each day, ACHESS contacts participants to obtain information on confidence for 
maintaining abstinence.  Once per week, participants are also prompted to complete a brief 10-
item assessment of risk and protective factors, which is very similar to the Progress Assessment 
used at the start of each call in TMC. Risk factors include sleep difficulties, emotional distress, 
urges to drink/craving, tempting situations, and interpersonal problems.  Protective factors 
include abstinence self-efficacy, involvement in AA or other mutual support groups, spirituality, 
social support, and engagement in productive activities.  These items make up the Brief 
Addiction Monitor (BAM), which is now widely used within the VA to monitor patient progress.  
The areas assessed by these items have predicted relapse across many studies.  ACHESS 
combines that information with data from prior assessments to predict relapse in the coming 
week.  If a participant exceeds a threshold, an alert is sent to ACHESS staff and the participant is 
encouraged via text messages to seek additional support (see below). 
Automated provision of services.  ACHESS provides links to relevant resources.  For 
participants with low abstinence confidence or worrisome scores on the risk or protective items 
of the progress assessment, ACHESS automatically provides suggestions of relevant coping 
skills.  It also offers relaxation exercises, games for distraction, connections to online peer 
support, links to a healthy events newsletter, suggestions for diversionary activities, and contact 
with the participants support system.  
Social support.  Participants have access to discussion groups populated by other participants in 
the study, via online bulletin board, text messaging, or live chats.  Guidelines for appropriate use 
of these formats are stressed while patients use ACHESS. Any mention of use of a phone for 
illegal purposes in ACHESS online chat rooms will result in the phone being turned off.  Mobile 
software allows participants to text their location to pre-approved friends, family, and peers so 
that they can respond to requests for help.   
 
Additional features.  These include access to audio and written information on addiction, 
web links, GPS driven information on local self-help meetings and treatment services, 
inspirational messages, and reminders via texting to take medication and attend appointments.  
Participants may also use the smartphone to access the web and make telephone calls, so that 
they do not have to carry two phones.  
 
Limitations on counselor involvement.  As in Dr. Gustafsons prior ACHESS study, 
participants receiving ACHESS Only will not have regular contact with a continuing care 
counselor.  Rather, when participants report low confidence or other concerning data in the 
weekly assessment, the system will send a message to the patient and to a member of Dr. 
Gustafsons staff monitoring ACHESS utilization, who will encourage more active use of 

recovery supports via text messages. Participants who want to re-engage with treatment will be 
sent text messages urging them to contact NET and request an evaluation session. 
 
Replacement of lost or stolen smartphones.   We will provide up to one replacement 
smartphone to participants.  For those who also lose the second phone, we will offer to load the 
ACHESS program onto a smartphone that they obtain on their own.  The cost of replacement 
phones are in the budget.  
 
2. Telephone Monitoring and Counseling Only (TMC). Participants will have one face-to-face 
session with the counselor who will provide TMC, to enable the counselor to develop initial 
rapport, explain the intervention, establish goals for the treatment, and provide a copy of a 
workbook to the participant.  Telephone calls occur weekly for the first month, twice monthly for 
the next three months, monthly for months 4-7, and every other month for months 8-12 (i.e., 16 
possible calls). Each call is initiated either by the counselor or the participant, depending on 
which method will yield the greatest likelihood of a successful connection in that case.  
 
Each telephone call will be 15-30 minutes in duration.  At the beginning of the call, the 
participant completes the brief Progress Assessment.  These data are analyzed in real time with a 
computer program developed in our prior studies, which yields summary scores for risk factors, 
protective factors, and the ratio of risk to protective factors. Participant and counselor go over the 
1-2 goals that the participant is working on, and objectives that need to be accomplished to reach 
each goal.  Problems that were identified in the Progress Assessment are addressed, and coping 
behaviors for any anticipated upcoming high risk situations are identified and rehearsed. In 
addition, reinforcement of participant strengths and positive behaviors, and further 
encouragement for involvement in pro-recovery lifestyle activities are provided.   
For participants randomized to this condition that do not have reliable access to a telephone, a 
cell phone with unlimited talk and text will be offered to allow the participant to engage in 
telephone counseling intervention and contact study personnel. Participants have the option to 
refuse the phone. At the end of the intervention, participants will be given the phone and will 
have to pay for phone services after that time. 
 
3.  .  TMC and ACHESS (TMC+ACHESS).   
 
General protocol.  Each participant will have one face-to-face session (60-75 minutes) 
with the counselor who will provide the telephone intervention to him/her, to enable the 
counselor to develop an initial rapport with the participant, explain the protocol, and establish 
initial goals for the treatment.  Programming of the participants smart phone, protecting it with a 
password, and orientation to ACHESS will also occur in this meeting.  Subsequent telephone 
calls will occur on the same schedule as in the TMC Only condition (see above).   
 
Obtaining and processing data on risk level.  As described above, participants will be 
contacted daily by ACHESS and queried about their confidence in remaining abstinent for the 

day and weekly to administer the brief progress assessment (noteto avoid redundancy, we will 
use the ACHESS BAM assessment, which is very similar to the TMC progress assessment).  
When participants report worrisome information in the prompts (see ACHESS description 
above), alerts will be sent directly to counselors as long as the participant approves. A graph with 
current scores and scores from the past few assessments will be sent to the counselor each week 
(and also forwarded to the participant, if he/she would like to receive this information).  In 
addition, participants will be able to activate their smart phones at any time and complete 
additional BAM assessments if they wish to do so.  These procedures will provide counselors 
with timely information on relapse risk.  
 
4. Treatment as Usual (TAU).  Participants in this condition will get standard care in the NET 
IOP, plus access to weekly step-down standard outpatient care if they complete IOP and wish to 
continue.  They will not receive ACHESS or TMC.  As is the case in virtually all public 
treatment programs, all treatments at NET are based on 12-step principals and are delivered 
almost entirely through group counseling sessions.   
 
Regardless of the intervention and whether participants are active in the intervention, all 
participants will be followed for research visits at 3, 6, 9, 12, and 18 months after baseline. The 
schedule of assessments is described elsewhere. All assessments and procedures are for research 
and are not part of clinical care and will take place at our offices at 3535 Market Street, Suite 
500, Philadelphia, PA.  
 
To achieve high follow up rates, we focus on patient education and motivation, collection of 
extensive and verified locator information, between assessments contacts via the mail and 
telephone, confirmation of follow-up appointments prior to follow-up date, and standardized 
tracking procedures. 
 
At the completion of each follow up, participants will be paid $50 in the form of a Greenphire 
ClinCard. They may receive more if they missed a preceding follow up, see compensation. 
Analysis Plan* 
More detailed information can be found in the grant. 
Data analytic approach. The responses for the primary hypotheses comprise continuous 
measurements over the 3, 6, 9, 12, and 18 month follow-up points. Secondary outcomes are a 
mix of binary and continuous measures.  Our main analyses will compare the interventions using 
mixed effects linear regression models for frequency (percent days) of heavy alcohol use and 
other continuous outcomes, and mixed effects logistic regression models for dichotomous 
outcomes. Given the small number of time points, we will regard time as a categorical variable, 

although we may simplify the model if smoother (polynomial or spline, for example) time trends 
appear adequate for model fit. 
Data confidentiality 
How will confidentiality of data be maintained? Check all that apply 
Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study.  
Computer-based files will only be made available to personnel involved in the study through 
the use of access privileges and passwords.  
Prior to access to any study-related information, personnel will be required to sign 
statements agreeing to protect the security and confidentiality of identifiable information.  
Wherever feasible, identifiers will be removed from study-related information. 
A Certificate of Confidentiality will be obtained, because the research could place the 
subject at risk of criminal or civil liability or cause damage to the subject's financial 
standing, employability, or liability.  
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
confidentiality. (This is not an option for FDA-regulated research.)  
Precautions are in place to ensure the data is secure by using passwords and encryption, 
because the research involves web-based surveys.  
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects.  
 
Subject Confidentiality* 
All staff have been properly trained for HIPAA awareness and human research. All staff will 
sign a confidentiality agreement prior to beginning work on the project, to further raise 
awareness of the importance of confidentiality and privacy. We will do our best to make sure 
that the personal information obtained during the course of this research study will be kept 
private. However, we cannot guarantee total privacy. If information from this study is published 
or presented at scientific meetings, the subject's name and other personal information will not be 
used. The subject will be given a subject number for the study. All the information that is 
provided on questionnaires and interviews will be coded with this number rather than the 
subject's name. Information related to the smart phone will not be related to a name - each patient 
will be identified by a 
subject ID number. ACHESS programmers will not program identifiable information into the 
ACHESS program. While we can not guarantee that subjects will no program identifiable 
information into the phone themselves, such as contact information and meetings, we will make 
every attempt to review security measures with the subjects (passwords, pattern locks, refraining 
from using names, etc.). All study data forms will be kept in locked cabinets. The results of 
testing for drug or alcohol use as part of the research assessments will be provided to the subject, 
but will not be provided to treatment personnel in the subject's treatment program unless it is 

request in writing by the subject. The questionnaires that are filled out on paper and the 
interviews that are completed will be kept in locked cabinets until the 
information has been entered into computer files. After that, the questionnaires and forms will be 
kept in locked and secured storage areas at the University of Pennsylvania for 7 years. After that, 
they will be destroyed. The data stored in computer files will not have your name or any other 
identifying information attached to it. In all disclosures outside of the University of Pennsylvania 
Health System and School of Medicine, the subject will not be identified by name, social 
security number, address, telephone number, or any other direct personal identifier. 
Subject Privacy* 
Subjects can expect research staff to do everything possible to honor their privacy. In attempts to 
limit access to personal and identifiable information, potential participants will be referred to 
research staff by IOP staff. Prior to collecting prescreening data, a consent will be signed by the 
potential participant so that it is clear why they are being asked questions and what the research 
is about. Participants may be called on the telephone about appointments. When participants are 
called, researchers will identify themselves as being from the University of Pennsylvania, calling 
about an appointment. If the person on the other end of the line is not the potential participant, 
but asks about the appointment, we are not at liberty to discuss particulars and will refer the 
individual to the participant. Staff is instructed not to identify themselves as addictions research, 
or make any statements that may breech confidentiality by referring to addiction or treatment. 
Participants will be seen at their IOP and at our offices at 3535 Market Street. In both settings, 
research staff will meet with the participants in private areas and keep conversation at a low level 
to keep others from being able to hear what is discussed. 
Data Disclosure* 
The following individuals and organizations may use or disclose the subject's personal health 
information for this research project: The University of Pennsylvania Institutional Review 
Boards (the committees charged with overseeing research on human subjects) and University of 
Pennsylvania Office of Regulatory Affairs, The University of Pennsylvania Office of Human 
Research (the office which monitors research studies), and authorized members of the University 
of Pennsylvania and the University of Pennsylvania Health System and School of Medicine 
workforce who may need to access your information in the performance of their duties (for 
example: to provide treatment, to ensure integrity of the research, accounting or billing matters, 
etc.). As part of the study the Principal Investigator, study team and others listed above, may 
disclose the subject's personal health information, including the results of the research study tests 
and procedures to the following: University of Wisconsin: Dr. Gustafson and his staff will assist 
us in incorporating your information into the ACHESS program. This includes feedback in new 
text and programming. Blood samples will be tested by Dr. Ray Anton's lab at the Medical 
University of South Carolina.  Government agency and/or their representative: National Institute 
on Drug Abuse, The Philadelphia Department of Public Health Institutional Review Board, and 
representatives of the Behavioral Health Department of the City of Philadelphia. 

1. Consent Process  
Overview* 
Patients who express interest in participating will be referred to a study technician on site.  The 
research technician will explain the study in a private location and allow for ample time for 
discussion and questions, obtain an initial informed consent for screening, and administer a brief 
instrument that collects demographic data and eligibility screening information.  Patients then 
will be given an appointment for the baseline assessment to be conducted three weeks later.  
Patients who choose not to participate in the study will continue to receive treatment as usual.  
Patients who call a research technician from information provided on our recruitment forms and 
express interest in the study will have the study explained by the research technician, and ample 
time will be given for discussion and questions.  The research technician will obtain verbal 
consent from the patient to administer a telephone screening that will collect demographic 
information and eligibility screening information.  Eligible patients will then be scheduled for an 
appointment to complete the baseline assessment.  Patients who choose not to participate after 
the telephone screening will continue to receive treatment as usual. At the initial baseline 
assessment three weeks later, patients who agree to participate will sign a second informed 
consent, after they have successfully passed an informed consent quiz.  The consent document 
will be reviewed with the participant at research follow ups. 
Potential Study Risks* 
The risks of the research are conceived to be minimal (e.g., possible embarrassment) and consist 
of those incurred in providing self-report data on alcohol and drug-related history and problems, 
and social and psychiatric problems, for example embarrassment. If a potential employer were to 
discover you were participating in this study it may have negative consequences on your 
employability.  As with any phone, if you lose the provided cell phone there is a risk that 
someone can access your contact list, therefore having not only their contact information but also 
be able to identify you. There is also a slight risk of bruising from the blood draws.  There are 
minimal medical risks associated with research participation.  All subjects will receive at a 
minimum treatment as usual in the programs from which they will be recruited. 
Potential Study Benefits* 
The project will yield information on the efficacy of two telephone-based continuing care models 
and whether the combination of a smart phone-based recovery support system and regular 
contact with a counselor produces better alcohol use outcomes than either intervention alone.  
Information will also be obtained regarding moderators and mediators of treatment effects that 
are obtained. This information will be of direct value to treatment providers and should help to 
guide future treatment efforts with this patient population. 
Data and Safety Monitoring* 
Dr. McKay, one of the two Principal Investigators, will be responsible for monitoring the safety 
and effectiveness of this trial, executing the Data and Safety Monitoring (DSM) plan, and 
complying with the reporting requirements. Dr. McKay will provide a summary of the DSM 

report to NIAAA on an annual basis as part of the progress report. The DSM report will include 
the participants socio-demographic characteristics, expected versus actual recruitment rates, 
treatment retention rates, any quality assurance or regulatory issues that occurred during the past 
year, summary of SAEs, and any actions or changes with respect to the protocol. The DSM 
report to NIAAA will also include, when available, the results of any efficacy data analysis 
conducted. 
 
Data will be collected using standardized forms and will only be identified with the studys ID of 
the participant. The codes that link the name of the participant and the study ID will be kept 
confidential by the project coordinator in a secured cabinet. Most of the study data will be 
entered directly into databases as it is collected, via the Penn Centers web-based data entry 
system.  These databases are password and firewall protected, and do not contain the participants 
name or any other identifying information.  Data forms that are not amenable to web-based data 
entry will be transported to the PIs data entry center, and will be entered in the computer 
independently by two teams of trained data entry staff, and discrepancies will be corrected by a 
supervisor, based on source documents. The quality of the data will be monitored once per 
month. The studys statistician will analyze the data, using SAS and SPSS software.   
 
CHESS websites and mobile applications implement secure and up-to-date instances of 
Microsoft IIS and Microsoft SQL solutions.  The hosting of CHESS IS infrastructure is 
comprised of a range of server class virtual machines operating on a multi-node deployment 
spanning throughout the University of Wisconsin  Madisons engineering campus.  On the client-
side, users accessing secure CHESS websites and mobile application do so using pre-established 
log-in credentials over a 128-bit Encryption with Extended Validation (EV) HTTPS connection 
verified by COMODO.  In order to ensure the integrity and functionality of the CHESS IS 
infrastructure fault tolerant methods such as layered logical and physical redundancy, 
environmental and access controls, as well as comprehensive backup systems are employed.   
Operational administration and maintenance of these systems is carried out by members of the 
CHESS technical team and staff from the Computer Aided Engineering Center.  The policy 
framework with which CHESS systems adhere by include the CHESS Data and Security 
Monitoring Plan, the College of Engineering-Network Security Policy, and the various 
University of Wisconsin  Madisons IT Policies. 
  
Penn staff will have access to the use data through the A-CHESS administrative tool, a password 
protected site, which provides tools for an agency/provider to sign up new clients, add agency 
specific content as well as look at a-CHESS use data (which you can download into an excel 
spreadsheet).  So there is really no need for UW to transmit data to Penn since you are able to 
access the use data on your own.  If there was a need at some point for us to transmit use data we 
would make specific arrangements to send an encrypted file. 

 
 
The primary study outcomes will be frequency of heavy drinking days (5 drinks for men, 4 
drinks for women) in each period of the follow-up (e.g., months 1-3, 4-6, 7-9, 10-12, 13-18).  
Secondary outcome measures include alcohol related consequences, abstinence from alcohol and 
drugs, quality of life, and a biological measure of alcohol use (%CDT).  Outcome data will be 
analyzed using mixed effect regressions for continuous and categorical data and various 
packages to examine mediation effects (i.e., MPlus).  The alpha level will be set at 5%.  
 
Data quality will be monitored by random inspection of the completed forms by the research 
coordinator and any problems detected will be discussed with the PI.  Therapists will receive 
standardized training on each of the therapies, which are all manualized.  Adherence to therapy 
techniques will be monitored using audiotapes and individual supervision provided by the 
clinical coordinator and the PI.  If therapy drift is observed the therapists will be re-trained.  
 
Blind interim analyses of the data will be conducted at two points when 50 and 75% of the 
sample has been accrued. If the results show statistically overwhelming significant differences 
between groups, the study will be stopped (or one of the conditions stopped). 
 
Safety monitoring plan  
During screening, study applicants will undergo a psychiatric diagnostic evaluation using a 
standardized interview instrument.  Patients with psychiatric conditions who deteriorate 
significantly during the course of the study will be referred to their psychiatrists for further 
evaluation, and dropped from the study if warranted for safety reasons. 
 
In this study we will use the FDA definition of serious adverse events (SAEs).  SAEs will be 
systematically assessed at each clinic visit. Any SAE, whether or not related to study 
intervention, will be reported to the IRB and NIAAA. The initial SAE report will be followed by 
submission of a completed SAE report to both institutions.  In the event that a patient either 
withdraws from the study or the investigator decides to discontinue a patient due to SAE, the 
patient will be monitored by the investigator via ongoing status assessment until either a 
resolution is reached (i.e., the problem requiring hospitalization has resolved or stabilized with 
no further changes expected), the SAE is determined to be clearly unrelated to the study 
intervention, or the SAE results in death.  Outcome of SAEs will be periodically reported to 
NIAAA.  A summary of the SAEs that occurred during the previous year will be included in the 
annual progress report to NIAAA. 
Risk / Benefit Assessment* : Minimal Risk