Testing the Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adult Canadians: A Randomized Controlled Trial (RCT)
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: University of Manitoba

 
 
 
 
 
 
 
 
 
Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and 
Emotional Problems 
 
Ethics Amendment Approved February 28th, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
Summary of Project 
Background: It is currently estimated that between 50-60% of individuals with an alcohol use 
disorder also suffer from comorbid anxiety and/or depression (Swendsen & Marikangas, 2000). 
This statistic makes alcohol dependence and emotional disorders the highest co-occurring 
disorders among general populations (Conway, Compton, Stinson, & Grant, 2006). Individuals 
who suffer from both disorders often experience poor overall health, physical injury, marital 
dysfunction, increased suicidality, early mortality (Beidel, Frueh, & Hersen, 2014). Given the 
increased consequences for adults suffering from both disorders, there is a critical need for 
research aimed at designing effective treatments for alcohol misuse and co-occurring emotional 
problems.    
 
 
Individuals with alcohol problems who also suffer from an emotional disorder (compared to 
those who do not) experience high rates of relapse, have greater functional impairment, and have 
poorer responses to treatment among individuals with significant alcohol problems. Existing 
treatments for alcohol misuse and co-occurring anxiety/depression typically include parallel or 
sequential interventions, meaning that individuals are treated for one disorder followed by the 
other, or separate treatments are conducting at similar times by two different professionals 
(DeVido & Weiss, 2012; Mueser, Noordsy, Drake, & Fox, 2003). However, neither approach 
takes into consideration the interconnectedness of these highly comorbid disorders, and often 
times there is little communication between professionals when the disorders are treated 
separately. For example, a person who suffers from depression would find it difficult to quit 
drinking if their depressive symptoms (i.e., triggers for drinking) were not addressed in 
treatment. In turn, this same person’s depressive symptoms would likely be made worse by 
repeated unsuccessful attempts to control their drinking. In this case, it would be challenging for 
the individual to make progress for either disorder/in either treatment. Therefore, treatments that 
do not target the symptoms of both alcohol use and anxiety/depression simultaneously may not 
be sufficient. There are limited integrated treatments designed to target alcohol use and 
emotional problems simultaneously.  
 
Goal: Considering the limitations of current interventions for comorbid alcohol misuse and 
anxiety and/or depression, and the staggering rates of these co-occurring disorders, there is a 
need for integrated treatments designed to target both disorders simultaneously. Furthermore, it 
is important that said integrated treatment options are both cost-effective and feasible, thus 
reducing the burden on the health care system. Therefore, an online integrated treatment stands 
to provide both an effective and economical option. There is a growing body of literature 
suggesting the potential effectiveness of combining Cognitive Behavioural Therapy (CBT) and 
Motivational Interviewing (MI) to treat alcohol misuse and comorbid emotional problems (Riper 
et al., 2014). These treatments teach people coping skills for both disorders (e.g., challenging 
negative thoughts), while simultaneously improving their motivations to change problem 
behaviours (Hofman, 2012; Lundahl & Burke, 2009). To date, the only intervention of this 
nature has been developed at the Swiss Research Institute for Public Health and Addiction in 
German (Schaub et al., 2016). This study will adapt this intervention for use in English speaking 
young adults in Canada. By developing an online integrated treatment for alcohol use and 
emotional problems, we will be able to reach rural and Northern communities where the 
prevalence rates of these disorders are particularly high. Furthermore, online treatments are 

associated with less stigma and shame, which may provide additional opportunities for early 
intervention through participation in the intervention. Overall, this accessible and cost-effective 
treatment stands to reduce the symptoms of both alcohol misuse and anxiety/depression, thus 
potentially improving the overall health and well-being of hundreds of Canadians.  
 
Method 
The study design will be a two-arm randomized controlled trial (RCT). This method is 
considered the “gold standard” in conducting clinical research in order to determine the 
effectiveness of an intervention. Prior to initiating the full study, a pilot-testing phase will be 
used to ensure that the intervention components are translated, created, and presented in ways 
that are most helpful and engaging for young adults. This will also be done in order to receive 
feedback on the modules prior to opening them up to the public. In order to obtain this pilot 
feedback, the full intervention will be provided to both knowledge users and professionals. Once 
we have received feedback, we will meet as a team (i.e., primary investigators, graduate students, 
research assistants), to discuss changes and apply feedback as necessary.  
 
After completion of the pilot phase, we will begin the active study phase. First, interested 
participants will be encouraged to contact the lab via e-mail. Once they have expressed an 
interest in the study, they will be given access to information about the study and the consent 
form. After reading the informed consent form, they will be able to provide informed consent on 
the study website and then register for an account. Once they have consented to participate and 
registered, they will visit their e-mail inbox to verify their e-mail address and create a password. 
Once they have confirmed their login information, they will immediately be directed to the 
baseline assessment measures. These measures will also be used to determine whether 
participants are eligible to participate. If at any point a participant is deemed ineligible on a 
measure, they will automatically be redirected to a “Thank You” page so as not to make them fill 
out questionnaires unnecessarily. In order to determine eligibility, participants will first be 
assessed for suicidality. Individuals who are deemed “Minimal” or “Lower” risk on the screener 
will be able to proceed to the remainder of the questionnaires in order to determine eligibility. 
Those that are identified as “Higher” risk will immediately be deemed ineligible. At this time, 
they will be directed to a screen with urgent information on how to proceed next. This page will 
provide them a list of resources in their area that we will urge them to contact as soon as 
possible. We will make it clear that their safety and well-being is our utmost concern by stating 
that we are concerned about their safety and strongly encourage them to access supports as soon 
as they can.  
 
If individuals meet the eligibility criteria in terms of suicidality (i.e., minimal or low risk), they 
will then be provided with the remainder of the baseline measures. If participants do not meet 
our eligibility criteria, we will still provide them with access to the intervention, but will not 
track their data, and their responses to the baseline measures will not be retained. After eligible 
participants complete the baseline measures, they will be randomly assigned to one of the two 
treatment conditions using a 1:1 ratio. The first condition will be the integrated treatment (i.e., 
active experimental condition) where participants will have access to the 12 treatment modules, 
developed using combined elements of CBT and MI. Throughout the modules, participants will 
identify goals related to alcohol use and mood, learn strategies to cope with alcohol cravings, 
triggers, and social pressures, and learn how to prevent relapse. Modules will also include 

content designed to target anxiety and depression, focusing on strategies designed to help reduce 
negative thinking and worry, increase behavioural activation, and increase self-care (e.g., 
relaxation techniques, sleep hygiene).  
 
Participants will have 8-weeks to complete the modules and will immediately be given access to 
all modules. While it is technically possible to work through the modules in any order, they will 
be encouraged to work through the modules sequentially. In order to bring a small social 
presence to the treatment, each module will begin with a brief introduction video. Previous 
research suggests that adding this social factor will personalize the online program and may 
influence accountability (Mohr, Cuijpers, & Lehman, 2011), especially considering that it is self-
guided. The purpose of these videos will be to summarize the content of the upcoming module, 
as well as provide motivation to continue with the program. Participants will also be supported 
by an e-coach during active treatment. This coaching content will all be automated, with the 
exception of specific questions participants may have for their e-coach. They will be able to ask 
these questions over e-mail. The purpose of the e-coach will be to answer any questions the 
participant may have as they work their way through the modules. Coaches will provide ongoing 
feedback about module progress and provide reminders about completing each section of the 
intervention. They will also provide support to participants should have they additional questions 
or concerns throughout the program. Therefore, the use of e-coaches will help to reduce the risk 
of attrition. Research shows that both automatic and personal feedback are central to improving 
adherence during self-guided behaviour change interventions (Mohr et al., 2011). At the outset of 
treatment, participants will also be asked to select an animated personal companion whom they 
identify with in terms of sex, age, occupation, and family background. The purpose of this 
companion is to provide advice and examples pertaining to the content throughout the 
intervention. The personal companion will appear in each module at least once.  
 
The second condition will be psychoeducational (i.e., the control condition). Participants 
randomly assigned to the control condition will receive links to websites that provide general 
psychoeducation about alcohol (e.g., https://www.niaaa.nih.gov/publications/brochures-and-fact-
sheets), and mental illness (e.g., https://www.jack.org/resources). Therefore, the control group 
will have access to available online psychoeducational material. A psychoeducation control 
group is common in clinical research in order to determine the efficacy and effectiveness of 
online interventions (Schaub et al., 2016). It is also important as we do not want to harm patients 
in any way or prevent them from getting something that is already established are effective. For 
ethical reasons, participants in the psychoeducation control group will be given access to the 
active integrated treatment at the end of the study, regardless of whether they have completed all 
of the assessments.  
 
Research Instruments: Participants will be assessed at three time points throughout the study: at 
baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at 
follow-up (i.e., 24 weeks, T2). The primary outcome of interest will be the number of standard 
drinks consumed during the seven days prior to the assessment. This will be assessed using the 
Timeline Follow-Back (TLFB; Sobell & Sobell, 1992) procedure at all assessment points (T0-
T2). The TLFB has been widely used in studies, including treatment studies (Keough, O’Connor, 
& Colder, 2016; Schaub et al., 2016). As a secondary outcome, depressive symptoms will also be 
assessed at all time points using the CES-D, a 20-item self-report questionnaire used to indicate 

depression severity (Radloff, 1977). Anxiety symptoms will also be assessed at all three 
assessment points using the GAD-7, a 7-item self-report questionnaire used to measure the 
severity of anxiety symptoms (Spitzer, Kroenke, Williams, & Löwe, 2006). In order to determine 
clinically significant and combined reduction in alcohol use and comorbid emotional problems, 
we will use a combined outcome of alcohol use on the AUDIT, and cut-offs from the GAD-7 and 
CES-D. We will also measure participants’ quality of life using the World Health Organization 
Quality of Life assessment (WHOQOL-BREF). This is a 26-item self-report measure that 
assesses functionality in various life domains (The WHOQOL Group, 1998). A sum score will be 
used to assess overall quality of life at all assessments points (i.e., T0-T2). We will also collect 
information on participants’ use of other substances using the National Institute on Drug Use 
(NIDA ASSIST; National Institute on Drug Abuse, 2009), and their executive functioning using 
the WebEx (Buchanan et al., 2010). This information will be collected to examine transfer 
effects to other substances, as well as to examine the potentially moderating effects of executive 
functioning. Finally, we will obtain a measure of participants’ level of motivation in terms of 
importance, confidence, and readiness. Participants will complete all measures at each of the 
three time points, with the exception of the Demographics questionnaire and the AUDIT, which 
will only be completed at baseline.  
 
Participants  
A target sample of 400 participants will be recruited for the study. Participants will include 
Canadian young adults struggling with moderate alcohol misuse and emotional problems. 
Inclusion criteria will include: 1) individuals between 18 and 35 years old, 2) reporting 
difficulties with alcohol indicated by a score >3 for women and >4 for men on a brief version of 
the Alcohol Use Disorders Identification Test [AUDIT; Saunders et al., 1993] known as the 
AUDIT-C, 3) reporting depression and/or anxiety symptoms indicated by a score >16 on the 
Center for Epidemiological Studies Depression Scale [CES-D] and/or a score of  >5 on the 
Generalized Anxiety Disorder Scale-7 [GAD-7], 4) fluency in English, and 5) have weekly 
Internet access. Exclusion criteria will include the following: 1) self-reported engagement in 
other psychological or pharmacological treatments for alcohol misuse and/or depression/anxiety; 
2) elevated suicidality (defined as scoring greater than “minimal risk” on a screener); and 3) 
current psychosis or mania. Interested participants will be invited to contact the primary 
investigators for a link to the study website. Participants will be sent a link with information 
about the study and be able to provide informed consent electronically directly on the treatment 
website. They will also be provided with detailed instructions on how to create a user account for 
the self-help program, and be encouraged to contact the researchers should they have any trouble 
at this stage. After they have provided informed consent, they will be able to register on the 
study website. They will need to create a username as well as verify their account via e-mail 
before they can access the website. After informed consent has been obtained and their account 
has been verified, they will immediately be asked to complete the baseline assessment measures. 
If they are eligible, they will be able to access the 12 treatment modules and continue with the 
study procedure. Interested adults with clinically-elevated symptoms (i.e., those who score above 
the cut-offs on our screening tools) will be still given access to the integrated intervention, and 
will be given the contact information for a mental health professional in their area. However, 
they will be excluded from the study and their data will not be tracked. 
 

Participants will be recruited both in-person (e.g., presentations, posters) and online through 
university clinics, community agencies, online advertisements (e.g., Google Ads, Kijiji), social 
media, and word of mouth. All participants who request it will receive a summary of the study 
results once the study is complete. These summaries will debrief participants about the main goal 
of the study. Furthermore, all participants will be offered the option of receiving an electronic 
summary of the study results after it is complete. This summary will be sent to participants by 
email. 
 
Informed Consent 
Participants will first read about the study rationale and procedure, and then will be told the 
following during informed consent: 1) the potential risks and benefits of the interventions, 2) 
safety arrangements that have been put in place for them during and after the study, 3) the 
circumstances under which they should contact a professional from an emergency list that will be 
accessible at all times via the menu item “Help Me” on the intervention website, and 4) that 
participation is voluntary and they are free to withdraw from the study at any time without 
penalty. As previously mentioned, participants endorsing significant suicide ideation and/or 
plans will be told to visit a hospital or other resources for support immediately. Following 
informed consent, participants will be able to register on the intervention website where they will 
have access to the treatment modules.  
 
Participants will not able to participate until they have provided informed consent. Participants 
will provide electronically recorded informed consent through the treatment website. They will 
be taken to this page by receiving a link from the researchers. The website will first show a brief 
version of the consent form with the main components highlighted. However, participants will be 
provided with a downloadable version of the consent form on this same page as well. They will 
be told to download and read the entire version in full before signing it. They will also be 
encouraged to save this copy of the form. The goal of this procedure is to reduce space on the 
website page as well as increase the likelihood of the participant retaining a copy for their 
records. This procedure is being utilized by our colleagues in Switzerland, as well as in similar 
online self-help programs around the world.  
 
After they have provided informed consent, they will be invited to create login information on 
the treatment website, and from there will complete the baseline assessment measures to 
determine eligibility. Therefore, we will not obtain information from individuals who do not 
consent to participate. After the completion of baseline measures, participants that are deemed 
eligible will be given access to the intervention. In other words, consent will be obtained from 
the participant prior to the baseline assessment. Should participants have any questions about the 
study before and/or after completing it, the name and contact information of the Principal 
Investigator, Dr. Matthew Keough, will be included on the consent form. Participants are 
encouraged to delay their participation until their research related questions have been asked and 
answered. 
 
Risks and Benefits  
Possible Risks: There are increased risks associated with recruiting young adults with alcohol 
misuse and emotional symptoms. We would expect higher base rates of suicidal ideation and 
self-harming behaviours in these individuals relative to those without these mental health 

concerns. Therefore, we will have safeguards in place in order to minimize the risk of harm. 
Young adults who report significant suicide ideation and/or plans during screening will be given 
a recommendation to visit their local medical professional (GP or hospital) for support as soon as 
possible. We will also be monitoring changes in suicidality at three time points, and will direct 
participants to emergency services if needed. Supports will also be accessible to participants at 
all times via the menu item “Help Me” on the intervention website. This will include a list of 
mental health services, including community resources, public and private psychologists, 
hospitals, and helplines. Participants in the control condition (psychoeducational) will be given 
access to the active treatment after the final assessment (6-months). They will receive all 
elements of the integrated intervention. While there is a risk that the content may be potentially 
distressing to some participants, resources will be provided as safeguards in order to mitigate 
these feelings of distress.  
 
Possible Benefits: There are also potential benefits to participating in the current research. By 
working through the 12 modules, participants will be provided with the skills to cope with 
emotional challenges that are often triggers for alcohol use. The development of protocols is 
empirically informed, and there is a strong evidence base suggesting their success. Thus, 
completing each module throughout treatment stands to elicit a reduction in symptoms of both 
alcohol misuse and emotional problems. Furthermore, the proposed intervention stands to benefit 
Canadians as a whole by offering a potentially successful and cost-effective treatment option by 
which to improve their mental health. By offering the program online, we will be able to reach 
Northern and rural communities who otherwise may not have had access to treatment. By 
offering this widespread treatment in a user-friendly manner (i.e., online), participants also stand 
to benefit from access to treatment without any stigma, which is a known barrier to accessing 
treatment among substance users (Livingston, Milne, Fang, & Amari, 2012). Additionally, the 
program is being offered free of charge, when standard rates of therapy are as high as $180/hour. 
Finally, the proposed treatment may provide an opportunity for early intervention to a population 
that is already struggling.  
 
Anonymity and Confidentiality  
In order to determine who is eligible to participate in the study, potential participants will need to 
create a unique username to access the program. Outside of this username, no identifying 
information will be collected on the study website. Therefore, the only potentially identifying 
information collected would be if participants create a username using their first and last name. 
Eligible participants will also be given a unique participant ID. Participant ID numbers will be 
automatically generated by the study website immediately after registration using an incremental 
number system. The data collection file will contain these participants ID’s and scores on each 
measure, but will not contain identifiable information (i.e., usernames). The data file used for 
statistical purposes will remain completely anonymous at all times. The de-identified raw data 
will be retained indefinitely for dissemination purposes/meta-analyses in order to inform future 
research. While we will be using e-mail addresses to contact interested participants this 
information will never be recorded nor linked to their data. All study data will be automatically 
collected on the website without identifying information.  
 
Since we will not be collecting identifying information, no formal records of client data will be 
retained. The only data retained will be the scores to questionnaires obtained through the study 

website itself. Furthermore, while the program was designed using in-person treatment methods, 
it is ultimately a self-help program. Therefore, it is not necessary nor feasible to make a client 
record for each participant given the nature of the self-guided program as well as the lack of 
identifying information being obtained.  
 
Only primary researchers and coaches will have access to the e-mails received by participants 
who decide to contact their e-coach. These e-mails will come to the e-mail address affiliated with 
the treatment website, and for which only coaches and primary researchers will have access. 
Although limited identifying information will be collected from participants, Dr. Keough, his 
graduate students, and all other research assistants involved in the project will complete PHIA 
training and sign a pledge prior to becoming involved in the research. Dr. Keough and the two 
primary graduate students involved in the project (i.e., the Research Assistants who will also be 
acting as e-coaches) have already signed this pledge. The only potential breach of confidentiality 
will be if clients accidentally leave their computer screen open in a public space with the clinical 
trial open on the desktop. In order to mitigate this, the treatment website will automatically log 
the participant out after they have been inactive for 20 minutes. Limits to confidentiality will be: 
if the participant poses an imminent risk to themselves or another individual, if issues 
surrounding child welfare are disclosed, or if the researchers are legally subpoenaed. All 
participants will be made aware of issues surrounding confidentiality in the consent form.  
 
Results of the study will only be presented at the aggregate level - individual data will not be 
reported or presented. Data will be collected on the treatment website. Further, data will be kept 
and analyzed on a password-protected computer in Dr. Keough's locked laboratory. Only Dr. 
Keough and members of his laboratory will have access to the data for projects and theses.  
 
Compensation 
Participants will be compensated with a $30 Amazon gift card for completing all three 
assessments ($10 per assessment).  
 
Dissemination  
The results of this study will be presented at academic conferences and published in peer-
reviewed journals on addictive behaviours. Results will only be presented at the aggregate level, 
and individual data will not be presented. This will inform both research and practice by making 
the findings accessible to academics, practitioners, and the general public. Results of this study 
may have implications for the clinical treatment of alcohol misuse and emotional problems 
among adults. Specifically, if effective, this study will demonstrate the effectiveness of a novel 
integrated treatment for individuals suffering from alcohol misuse and comorbid emotional 
disorders, and thus offer a feasible treatment options for said individuals. 
 
 
 
 
 
 
 
 

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