Many young adult Canadians struggle with comorbid alcohol misuse and emotional problems (ie, depression and anxiety). According to national statistics, 3.1 million Canadians consume enough alcohol to place themselves at risk of harm or injury [1]. Existing reports show that 50%-60% of adults with an alcohol use disorder also meet clinical criteria for a depressive or anxiety disorder [2-5]. Prevalence rates of these mental health concerns vary based on the geographic location, with the highest rates of alcohol abuse and emotional problems being reported by people living in rural and Northern communities [1]. In addition, data show that the combinations of alcohol misuse and depression or anxiety are the most frequent mental health comorbidities in general populations [6,7]. We know that this comorbidity results in high disease burden—much more than each disorder separately [6,7]. At the individual level, comorbid alcohol misuse and depression or anxiety are linked to chronic poor health, increased suicidality, marital dysfunction, physical injury, and early mortality [2,8,9]. At a societal level, this comorbidity contributes to overburden on the health care system, high rates of absenteeism and unemployment, and increased legal problems [10]. There is currently a need for effective integrated treatments designed to treat alcohol misuse and co-occurring emotional problems.

This study will design and deliver an online self-help intervention for comorbid alcohol misuse and emotional problems in young adults (aged 18-35 years). This intervention will contain strategies drawn from cognitive behavioral therapy (CBT) and motivational interviewing (MI)—both evidence-based psychotherapies for alcohol misuse and depression or anxiety [11,12]. The main strength is that this intervention will be integrated—meaning that it will target symptoms of both alcohol misuse and depression or anxiety within the same treatment. In addition, the Web-based platform is advantageous relative to face-to-face approaches. We will be able to better reach individuals in rural and Northern communities—where we know that some of the highest rates of alcohol misuse and emotional issues exist. These individuals often have difficulty accessing in-person treatments because of community remoteness. Thus, they may be left to struggle with major mental health concerns and associated harms. Furthermore, young adults may feel less stigma associated with accessing support online. Thus, the proposed treatment has the potential to improve the health and well-being of young adult Canadians and their families.

Research on integrated treatment is relatively new. This is surprising, given that it has been long understood that alcohol misuse and comorbid emotional problems are associated with a complex clinical presentation [5,8]. Specifically, the presence of an emotional disorder (relative to its absence) contributes to high rates of relapse, greater functional impairment, and poorer responses to treatment among individuals with substantial alcohol problems [5]. Traditional approaches to treating comorbid alcohol misuse and depression or anxiety include sequential or parallel intervention [13,14]. During a sequential approach, clinicians treat the disorder viewed as “primary” first, followed by the treatment of the comorbid condition. Often times, this means that symptoms of emotional problems are not addressed in treatment until an individual achieves some notable period of abstinence from drinking. Thus, in the sequential model, treatment is provided for one disorder at a time—with the more acute disorder (ie, alcohol misuse) taking first priority. The sequential model of intervention remains the most widely used approach to treating alcohol misuse-depression or anxiety comorbidities [14]. In contrast, the parallel model involves treating alcohol misuse and emotional problems separately by two distinct professionals or clinical teams [13,14]. A notable example of this approach would be a person seeing a family doctor for management of antidepressant medications while working with a psychologist to reduce drinking. Therefore, in the parallel model, an individual receives support for alcohol misuse and depression or anxiety simultaneously, but from distinct professionals.

Although still widely used, sequential and parallel approaches are limited as intervention models for comorbid disorders [14]. A sequential approach may be necessary for crisis situations, such as when a person needs hospitalization for alcohol-related seizures or acute suicidality. However, in the absence of an emergency warranting the immediate stabilization of one disorder over the other, sequential treatment may impede the treatment of both disorders [13]. Specifically, sequential treatment does not consider the interconnectedness of alcohol misuse and emotional problems. Moreover, in a parallel treatment model, there is often little communication between professionals independently treating each disorder [14]; this is problematic because professionals often have different case conceptualizations and treatment recommendations. Hence, it is very common for a person to receive conflicting advice and feedback in a parallel treatment approach [14]. Furthermore, it is up to patients to integrate distinct treatment approaches, which is likely difficult because of high rates of cognitive impairment among those with alcohol problems [14]. The limitations of a parallel approach may lead to adverse patient outcomes, such as frustration, continued mental health challenges, and, in the most extreme case, discontinuation of treatment of both disorders. Overall, attesting to the above limitations, the literature shows that sequential and parallel approaches result in poor treatment outcomes in those struggling with alcohol misuse and comorbid emotional problems [15-17].

Integrated psychological treatments are designed to target symptoms of comorbid disorders within the same intervention [14]. There is a growing interest in combining CBT and MI to treat alcohol misuse and comorbid emotional problems [6,18]. CBT is an evidence-based therapy where the goal is for patients to develop better coping skills for alcohol and mood or anxiety issues [11]. These skills become important when patients have to navigate challenging internal (eg, negative thoughts) and external (eg, stressors) triggers in their daily lives. Meta-analyses show that CBT leads to marked reductions in depression and anxiety symptoms, with effect sizes being moderate-to-large relative to other treatments [11,19]. In addition, relapse rates for depression after CBT tend to be half those of medication treatments [20]. Besides, CBT has been shown to be effective in reducing substance and alcohol use, though effect sizes tend to be smaller relative to the effects found for depression and anxiety [21]. Moreover, MI is an evidence-based psychological intervention, often described as a patient-centered, collaborative approach to help elicit and strengthen motivation for change [22]. The emphasis in MI is to help patients resolve ambivalence about change and, hence, move in a positive direction that is consistent with personal values. Several meta-analyses support the use of MI as a front-line intervention for alcohol misuse, with typical effect sizes being in the moderate-to-large range relative to no treatment [23]. Furthermore, MI has been used to treat depression and anxiety, though the evidence base is comparably smaller than for alcohol misuse [24,25].

Emerging work suggests that combined CBT and MI have synergistic, beneficial effects on both alcohol misuse and comorbid emotional problems within an integrated framework [6]. MI aims to improve patients’ motivation for changing problem behaviors. Motivational deficits are common in both alcohol misuse and emotional disorders, and the data show that low motivation for change predicts poor treatment engagement and poor outcomes [22]. By increasing motivation for change using MI, clients may be more willing to engage in the effortful activities of CBT (eg, homework and behavioral activation)—which are essential for building better coping skills. In addition, concurrent MI may help to clarify patients’ core values in CBT by developing a discrepancy between current and desired behavior. Thus, from a theoretical perspective, MI and CBT naturally complement each other in the treatment of comorbid alcohol and emotional problems. While this is a relatively new treatment approach, emerging data are promising. Much of the work has focused on testing the usefulness of CBT or MI for alcohol misuse and comorbid depression [6]. Comparatively, there has been much less focus on targeting co-occurring anxiety symptoms in this literature. A recent meta-analysis of 12 RCTs showed that combined integrated CBT or MI (relative to control conditions) reduces alcohol misuse and depressive symptoms [6]. Effect sizes were comparable for subclinical (relative to clinically elevated) symptoms, suggesting that integrated CBT or MI may be beneficial in earlier stages of risk as well. Furthermore, combined CBT or MI has the potential to alleviate co-occurring anxiety symptoms in those with alcohol misuse. However, the usefulness of integrated treatments for the alcohol misuse-anxiety comorbidity remains unexamined.

Current integrated psychological treatments use a traditional face-to-face modality [6]. However, there are distinct advantages of online delivery of integrated treatment among Canadian young adults. First, online interventions would be able to reach young adults from rural and Northern communities. We know from most recent health statistics that the highest rates of alcohol misuse and emotional issues exist in these communities [1]. Second, young adults may be more willing to engage in an online self-help intervention (relative to in-person); this is because an online modality may be associated with reduced shame and stigma—which are known, persistent barriers to seeking treatment among substance abusers [26]. Third, online treatments offer the potential for early intervention [27,28]. Self-guided online interventions may be helpful during a period earlier in the risk pathway when young adults are experiencing moderate (but still subclinical) problems. This may serve to prevent an escalation of clinical disorders later in adulthood. Finally, online interventions could markedly reduce the burden on the mental health care system in Canada. More young people with alcohol misuse and co-occurring emotional problems would be helped for much less cost relative to inpatient treatments. Data show that cost-effective, online interventions reduce alcohol misuse [29], depression [30], and anxiety [31] separately, with effect sizes being comparable to those of in-person treatments.

The goal of the proposed study will be to adapt, implement, and test an integrated, online treatment for alcohol misuse and comorbid emotional problems in young adult Canadians. The intervention will be adapted from a new online integrated treatment developed by collaborators Schaub et al at the Swiss Research Institute for Public Health and Addiction [27] called Take Care of You; this intervention is in German and Dutch, and it is the first online integrated treatment for alcohol misuse and depression in young adults. Take Care of Me (ie, the current intervention) is an internet-based, self-help program designed to reduce symptoms of alcohol use and emotional problems (ie, depression and anxiety). The treatment combines elements of CBT and MI and is designed to target young adults at risk for developing more severe alcohol misuse, depression, and anxiety should they not receive care. This intervention will be translated into English, and new treatment modules will be added to target anxiety symptoms as well. This is an important and novel expansion of the German-Dutch intervention, given the high co-occurrence of alcohol misuse and anxiety symptoms in clinical and general populations [7,8]. In addition, depression and anxiety symptoms tend to co-occur at high rates in young adults [6]. Accordingly, the proposed study will be a randomized controlled trial (RCT) examining the efficacy of an online, self-help intervention for alcohol misuse and comorbid emotional problems relative to a psychoeducational control group. We have proposed the following hypotheses:

A two-arm RCT will be used. Eligible participants will be randomized to either the online integrated treatment condition or the psychoeducational control condition. Assessments will occur before randomization (T0; baseline), at 8 weeks (T1; treatment end), and at 24 weeks (T2; follow-up). The study will not be blinded. Participants will be made aware of which condition they have been assigned to as soon as they complete baseline measures and are deemed eligible. Blinding of researchers is not necessary as they will not be providing treatment to participants.

Recruitment of study participants began in June 2018 and will continue until January 2020. Participants will be recruited through a number of means across the country (Textbox 1). Our main recruitment objective is to recruit across Canada using Web-based advertisements (eg, Google Ads, Kijiji, and Craigslist), contacting student services at major Canadian universities, and through social media (eg, Facebook). The goal is that utilizing Web-based means will ensure that a large sample of Canadian young adults receives the link to the study website. In addition, prominent addiction community services in the province of Manitoba have agreed to assist with recruitment, which will provide access to many individuals struggling with alcohol use problems. Study posters will also be put up at community organizations, hospitals, local university campuses, and popular drinking locations (eg, bars and restaurants). Recruitment rates will be monitored on an ongoing basis (eg, % completing screening relative to % meeting criteria to participate). With regard to our recruitment strategies, one potential drawback is that participants may come primarily from the same place (eg, the same university), creating a homogenous sample. However, our plan is to utilize many different avenues, with the goal of creating as heterogenous a sample as possible. Similarly, it is possible that those recruited through social media may share characteristics that interact with their experience in the program. Utilizing multiple recruitment strategies simultaneously, as well as examining potential moderators upon data analysis, will help mitigate this potential challenge.

There has been a shift to include heterogeneous samples in RCTs to improve the generalizability of findings to other samples [32]. Therefore, inclusion or exclusion criteria will be kept to a minimum. Our main participant demographic will be young adult Canadians with, at least, moderate alcohol misuse and emotional symptoms. Young adults will be targeted as the highest national rates of drinking are observed among individuals in this age group [33]. Furthermore, we know young adults are at an increased risk of both alcohol-related problems and emotional challenges [6]. Inclusion criteria for participation will be as follows: (1) individuals aged 18-35 years; (2) scores >3 for women and >4 for men on a brief version of the Alcohol Use Disorders Identification Test (AUDIT-C) [33]; (3) self-reporting, at least, moderate depression or anxiety symptoms, or both, indicated by a score >16 on the Center for Epidemiological Studies Depression Scale (CES-D) [34], and a score of >10 on the Generalized Anxiety Disorder Scale (GAD-7) [35]; (4) fluency in English; and (5) having weekly internet access. Individuals will be ineligible to participate if they (1) self-report engaging in other psychological or pharmacological treatments for alcohol misuse or depression or anxiety; (2) report elevated suicidality, defined as scoring greater than “minimal risk” on the P4 Suicidality Screener [36], a widely used measure in RCTs, as well as in primary care settings worldwide; and (3) report current psychosis or mania.

Interested participants will be invited to contact the primary investigators for a link to the study website (Figure 1). They will have seen this contact information from any of the recruitment materials that informed them about the study. The website link will include all pertinent information about the study; it will also direct them to the page where they will be able to provide informed consent on the treatment website. Prior to consenting, participants will be informed about the following: the inclusion or exclusion criteria of the study, the potential risks or benefits of completing the intervention, safety arrangements during and after the study, and that participation is voluntary. In addition, they will be told the circumstances under which they should contact their family doctor or another professional from an emergency list that will be accessible at all times via the menu item “Help Me” on the intervention website. They will first 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. Informed consent will be demonstrated by checking several boxes, stating that they have read and understood the terms of the research. After participants 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 email before they can access the website. All data will be encrypted and stored on a Canadian host server. No other personal information will be required to register. After informed consent has been obtained and their account has been verified, they will immediately be asked to complete the baseline assessment measures to determine the eligibility.

Eligible participants will be randomly assigned to either the treatment or control condition using a 1:1 ratio (Figure 1); this will happen automatically on the study website.

Participants will immediately be provided with instructions on the study website once they have been assigned to either group. Participants assigned to the treatment condition will be told that they have been selected to participate in the program and will be provided with instructions on how to proceed. Individuals assigned to the control condition will be provided links to general psychoeducation websites about alcohol and mental illness but told that they would be given full access to the program in 6 months. Assessments will then take place at the end of treatment (ie, T1, 8 weeks) and at follow-up (ie, T2, 24 weeks or 16 weeks after the end of treatment). In addition, participants will be asked to provide brief feedback (eg, helpfulness and enjoyment) about their experience in the program at the follow-up assessment. Participants will be reminded of the assessments at each time-point via email. They will receive automatic reminders about the assessment every 2 days for 1 week until they have completed the assessment. Participants will be compensated with a Can $10 Amazon gift card for each assessment that they complete, for a total potential compensation of Can $30. Participants will be told about the compensation process during informed consent.

Table 2 provides a schedule of assessments. Demographic information will include age, biological sex, gender, ethnicity, history, and treatment for any physical or mental conditions, and family history of alcohol use. All self-report questionnaires will be administered through Web.

A recent meta-analysis showed that combined CBT and MI resulted in statistically significant reductions in alcohol use and depressive symptoms, with effect sizes being in the small range for both clinical and subclinical groups (g=0.17-0.27). Data show relatively comparable effect sizes for online and in-person interventions for alcohol misuse and emotional symptoms [29,30]. Therefore, a small effect size (g=0.25) is expected for group differences in alcohol use and emotional symptoms at the end of treatment. Using G*Power, the sample size required to detect a small effect with 80% power, alpha=.05, and a correlation of .50 between repeated measures was N=164. Based on the previous literature using online interventions to target alcohol use and depression [28], approximately 30% of participants are expected to be lost at follow-up. Therefore, to consider attrition, the sample size will be increased to N=214; this will allow for a buffer, should recruitment and attrition pose more of a challenge than anticipated.

Before hypothesis testing, we will run preliminary analyses (eg, baseline differences and missing data analyses). In addition, we will examine overall group differences in clinically meaningful variables (ie, % below moderate cutoffs on the AUDIT, CES-D, and GAD-7 after treatment and at follow-up). Next, generalized linear mixed models will be used under the framework of intent-to-treat to evaluate the main hypotheses that integrated treatment will result in the largest reductions in alcohol use, depression, and anxiety. The use of generalized linear mixed models is a multilevel modeling technique that is preferable to repeated-measures analysis of variance for pre- and postanalyses, as it will allow us to include all randomized participants in analyses [41]. This results in less bias due to missing follow-up data [41]. However, owing to potential attrition problems, we also plan to conduct a sensitivity analysis to ensure that data are missing at random. Furthermore, primary and secondary outcomes will be tested sequentially in a mixed within- (repeated assessments) and between-subjects (treatment condition) design.

We are aware of the increased risks associated with recruiting young adults with moderate (and distressing) alcohol misuse and emotional symptoms. We would expect higher base rates of suicidality and self-harming behaviors in these individuals relative to those without these mental health concerns. Accordingly, we will have safeguards to minimize the risk of harm. Young adults who report suicidal ideation and plans during screening will be recommended to visit their local medical professional or hospital for support. In addition, they will be given access to the integrated intervention, but their data will neither be analyzed nor included in the RCT. We will also be monitoring changes in suicidality at each assessment and will direct participants to emergency services if needed. Moreover, participants will have full-time access to a list of mental health services, including community resources, hospitals, and helplines. Supports will also be accessible to participants at all times via the menu item “Help Me” on the intervention website. Finally, participants in the control condition will be given access to the active treatment after the final assessment (6 months). They will receive all elements of the integrated intervention. To maintain transparency, updates will be made on ClinicalTrials.gov at each stage of the research process. Finally, the project has been funded by Research Manitoba, meaning that it has undergone a substantial peer-review process also considering safety aspects right from the beginning (Multimedia Appendices 1 and 2).

High rates of substance use and emotional issues in Canada demonstrate a clear need for additional and more accessible mental health services in the country. In addition, many provinces have considerable rural spread, meaning that several communities are dispersed throughout the province with little access to major city centers; this poses a substantial challenge for providing equal access to mental health care services. Furthermore, young people living in remote communities are at a marked disadvantage, as they seem to be struggling most with substance use and related problems but have limited access to treatment facilities. Thus, the proposed study has the potential to substantially improve the health and well-being of young adults living across the country. Given that we will be targeting young adults (ie, those who are early in the risk pathway), our intervention may help individuals change their mental health trajectories. That is, an early evidence-based intervention may provide “at-risk” young adults effective coping strategies and, therefore, prevent the escalation of problems in the future, thus, resulting in fewer adults with alcohol use and emotional disorders. Furthermore, the intervention stands to provide a cost-effective method (relative to traditional in-person treatments) of improving mental health care delivery to Canadians. Online interventions have the potential to save the government millions of dollars via the reduced burden on the health care system.

Intervention studies show substantial variability in attrition rates, depending on the treatment orientation and clinical severity [43,44]. Generally, dropout rates are high in populations with alcohol and substance use disorders—ranging from 21% to 80% [45]. We are aware of this possible influence on attrition. However, regular contact with the intervention support person will likely provide personalized support that is not typical of online interventions; this may reduce dropout. In addition, we will offer participants the possibility to receive a summary report at the end of the study of overall findings. This report will contain information about the effects of the treatment, significant or not, based on aggregate-level data. The combined use of the strategies above will help reduce attrition. An additional limitation of this study is the use of self-report measures in a Web-based format, of which not all have been tested online. However, assessments of this nature remain widely used in clinical research and increasing reliability and validity evidence for these Web-based tools is accumulating in the clinical literature.

The proposed intervention is a potentially effective, cost-friendly means to enhance mental health care delivery to young adults in Canada. Currently, no such treatments exist for young adults in the country who struggle with addiction and comorbid emotional problems. Research wise, the proposed intervention is a novel expansion of the Swiss study. One major new feature will be the inclusion of content that specifically targets anxiety symptoms—which are currently missing from existing online integrated treatments. It is essential to provide young adults with the skills to cope with these emotional problems because both are known triggers for alcohol misuse and both often occur within the same individual. Therefore, by including new skills to target anxiety, we will enhance the therapeutic benefits of our intervention. Overall, the proposed intervention stands to have a substantial positive impact on the lives of young Canadians and on government expenditures related to mental health care.