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Depression and alcohol misuse represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this co-occurrence is associated with increased risks and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective, however, there remains a significant gap between those in need of treatment and those receiving it, particularly in young people. The increased availability of Internet-based programs to complement health care presents a unique opportunity in the treatment of these conditions.
The objective of our study was to evaluate whether a brief, Internet-based, self-help intervention (the DEAL [DEpression-ALcohol] Project) can be effective in treating co-occurring depression and problematic alcohol use in young people (18-25 years old).
The evaluation will take the form of a randomized controlled trial (RCT), comparing the DEAL Project with an attention-control condition (HealthWatch). The RCT will consist of a four-week intervention phase and a 24-week follow-up. It will be entirely Internet-based and open Australia-wide to young people 18 to 25 years old. The primary outcomes will be change in depression symptoms and alcohol use at 5, 12, and 24 weeks post baseline. Secondary outcomes include change in general functioning and quality of life, anxiety/stress symptomatology, and a number of other depression/alcohol related outcomes. Process analysis will also measure engagement across the conditions.
This study is currently ongoing with preliminary results expected in late 2014.
This study, to our knowledge, will be the first RCT of a Internet-based treatment for comorbid depression and problematic alcohol use in any age group. If successful, the program represents a novel and innovative approach to addressing the significant harms associated with these conditions and will be an invaluable resource to those not receiving help elsewhere.
Australian New Zealand Clinical Trials Registry; ACTRN12613000033741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363461 (Archived by WebCite at http://www.webcitation.org/6Mrg9VFX4).
In the developed world, two of the top five leading global causes of years lost to disability are alcohol use disorders (AUD) and depression [
Comorbidity across the disorder classes is common. Approximately one in four (22.2%) young Australians (16-25 years old) with current major depression also meet criteria for a 12-month AUD, while 14.3% of those with a 12-month AUD meet criteria for current major depression [
These comorbid conditions are associated with increased suicidality [
Hides et al [
Internet-based interventions have been deemed to be particularly useful for those less likely to access traditional services, such as young people [
Such interventions have been shown to be effective and cost effective in treatment for depression and related disorders [
To our knowledge, there has been no youth-focused Internet-based comorbidity interventions. Furthermore, in the general population only one computerized comorbidity intervention targeting these disorders has been evaluated. These evaluations of the computerized Self Help for Alcohol/other drug use and Depression (SHADE) resource indicate electronic forms of treatment for co-occurring disorders are viable and effective [
Although unguided Internet-based interventions may not always be as effective as a face-to-face encounter with a skilled clinician, the reality is that a majority of those with depression and alcohol problems (especially young people) will never receive any face-to-face intervention. Fewer still will see a skilled clinician [
The primary aim of the study is to evaluate whether a brief, Internet-based intervention—the DEpression-ALcohol Project (DEAL)—can be effective in treating co-occurring moderate depression and problematic alcohol use in young people (18 to 25 years old). This evaluation will take the form of a RCT comparing the DEAL Project to an attention-control condition and measuring participant outcomes across time. This will be, to our knowledge, the first RCT of an Internet-based treatment for comorbid depression and problematic alcohol use in any age group.
The study will be conducted Australia-wide and entirely Internet-based with minimal participant contact. All contact made will occur via email, with the exception of follow-up contact from a clinical psychologist if participants report experiencing particular distress and are suicidal (see Safety Protocol).
The proposed RCT meets international standards for such trials.
Flow of participants through the study.
The study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000033741) and has ethical approval from the University of New South Wales Human Research Ethics Committee (HC12546). Consent will be obtained electronically from all participants and confidentially assured via rigorous data encryption.
We will aim to recruit approximately 200 participants. The trial has a purposive sample of young people reporting drinking at harmful levels with mild to moderate depressive symptoms. Young people will be informed that the study compares an Internet-based self-help program for depression and alcohol use with a healthy lifestyles program on a range of outcomes, and they will be randomly allocated to one of these groups. Recruitment will be Australia-wide, using extensive media coverage; including tertiary institutions and street press, Internet-based chat forums and blogs, government, youth-oriented services and websites, and paid Facebook and Google advertisements. The research team has been successful using similar strategies in previous studies [
Inclusion criteria include: (1) 18-25 years old, (2) current depressive symptoms (score of ≥7 on Depression Anxiety Stress Scale-21-DASS-21-Depression) [
Exclusion criteria include: (1) psychotic symptoms screener score ≥3 [
Randomization will be automated within the program and therefore trial researchers will be blind to it. This process will occur immediately after the eligibility screener and baseline assessment have been completed and consent provided.
In any trial concerned with mental health or substance use there is the potential to uncover psychological distress in participants. In this population there is an increased risk, as the participants are mild-moderately depressed and drinking at harmful levels. As recruitment (and the trial itself) is entirely Internet-based, no contact (other than email) will occur between participants and the research team during the course of the study. In order to minimize risk, study participants will be provided with a contact email of a clinician upon commencement of the trial. A trained clinical psychologist and member of the research team will monitor this email. Upon email contact, the psychologist will make contact with the participant and initiate a dialogue and negotiate local referral options where appropriate.
Upon weekly login, participants will answer a screening question regarding suicidality (thoughts of suicide or a wish to commit suicide in the past week). On the basis of their answer, they are prompted to the email contact of the psychologist.
At the beginning and end of each periodic assessment, the participant will again be presented with this referral information for crisis care.
Access to the treatment website for each of the following conditions will be for a period of 10 weeks from the point of randomization.
The DEAL Project program is a 4-week psychological treatment delivered entirely via the Internet. Participants access the Internet-based sessions from their home computer (or other preferred port for Internet access). Participant-selected pseudonym usernames/emails serve as their login code for the website. Content of the sessions is based on cognitive behavior therapy (CBT) and motivational enhancement theory and was developed from the SHADE resource [
There were 4 sessions of the HealthWatch program that were chosen for this study. This is an attention-control condition program first developed for the Australian National University WellBeing Study [
All assessment tools are frequently used in mental health and alcohol research and in Internet-based (nonface-to-face) formats.
Intended assessments and administration frequency.
Assessment instruments | Baseline |
Endpoint self-assessment |
Follow-up self-assessments |
|
Demographics | ✓ | - | - | |
Service utilization | ✓ | - | - | |
|
|
|
|
|
Patient Health Questionnaire (PHQ-9) [ |
✓ | ✓ | ✓ | |
DASS-21 [ |
✓ | ✓ | ✓ | |
|
|
|
|
|
|
AUDIT [ |
✓ | ✓a | ✓a |
|
TOT-AL [ |
✓ | ✓ | ✓ |
|
World Health Organization (WHO) Composite International Diagnostic Interview (CIDI-Alcohol) [ |
✓ | ✓ | ✓ |
|
|
|
|
|
|
Opiate Treatment Index (OTI-other drugs) [ |
✓ | ✓ | ✓ |
|
Assessment of Quality of Life (AQoL) [ |
✓ | ✓ | ✓ |
|
McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) [ |
✓ | - | - |
Program feedback | - | ✓ | - |
aAUDIT-consumption items only
bmodified to collect only general drug use data
Automatic email prompts to complete Internet-based follow-up assessments will be sent to participants at baseline, 5, 12, and 24 weeks post baseline. In line with best practice standards and our previous trial experience, the following strategies are employed to maximize retention in treatment and assessment: (1) email address required at program commencement, (2) individual email will be sent for each separate module, (3) reminder emails will be sent if participant does not complete assessment in six days, and (4) $10 iTunes voucher reimbursement provided for each scheduled assessments.
It is hypothesized that integrated treatment for depression and alcohol problems (the DEAL Project) can achieve greater reductions in: (1) depressive symptoms, and (2) alcohol use, compared to an attention-control condition at 5, 12, and 24 weeks post baseline.
Secondary aims include the examination of: (1) general functioning and quality of life, (2) depression/anxiety/stress symptomatology, (3) hazardous alcohol use, (4) AUD criteria, and (5) engagement across the conditions.
Depressed mood is measured by the PHQ-9 [
In this study, the AQoL measures general functioning and quality of life [
As mentioned prior, the DEAL Project is based on the SHADE resource. Data from the SHADE trials indicate the program is associated with a 1.53 effect size change for depression and 0.86 for alcohol between baseline and 12-month follow-up assessments. However, given the SHADE intervention is therapist-guided and longer than that of the DEAL Project, we anticipate smaller effect sizes. Therefore, in line with other brief Internet-based alcohol multi-session modularized interventions with effect sizes of 0.56 [
The authors, using available software packages, will carry out data coding and analysis. Data on screening, refusals, and dropout are coded and reported as per Consolidated Standards of Reporting Trials (CONSORT) [
Recruitment is currently underway with preliminary results expected in late 2014.
The present study will assess the effectiveness of an Internet-based comorbidity intervention for young people. It is expected that depression and alcohol use outcomes for participants who complete the DEAL Project program will be significantly better than for those allocated to the control condition.
A significant strength of the project is that it will be entirely Internet-based, without clinical guidance, thus, amplifying “real-world” applicability. This provides evidence on the feasibility of the intervention as a freely accessible program.
Previous trials of the SHADE program have used a guided approach [
A further strength of the proposed project is that the research design includes an active attention-control condition. The HealthWatch program will be used as the control, with participants being provided with a variety of health-related information. This active control [
A potential challenge for this project will be participant dropout. Dropout rates from alcohol and other substance abuse treatment interventions are often high [
In a recent systematic review, Melville et al [
A related challenge is participant follow-up. Attempts to improve follow-up rates in the current study will include using a range of reminders, flexibility around timing of follow-up assessment (as it is Internet-based), obtaining a variety of contact details of significant others to help with locating participants, reinforcing to participants the importance of conducting follow-up, and financially compensating participants for the time required to complete the assessments ($10 vouchers for full completion of each assessment battery).
A final limitation is the program length. The program is considerably shorter than other interventions of this kind. However, brief interventions have been associated with significant effects for hazardous alcohol use outcomes compared to a variety of passive and active control conditions [
Stice et al [
Finally, in both depression and alcohol use interventions, young populations tend to be less likely to commit to the full course of sessions [
Problematic alcohol use and depression are significant problems facing young people today, however, a lack of service utilization in combination with a lack of specialized treatments mean most affected young people do not receive treatment. Internet-based interventions have the potential to overcome many of the barriers to treatment in this population. This will be the first RCT, to our knowledge, of a psychological therapy in young people with co-occurring alcohol and depressive problems [
assessment of quality of life
alcohol use disorders
Alcohol Use Disorders Identification Test
cognitive behavior therapy
Composite International Diagnostic Interview
Consolidated Standards of Reporting Trials
Depression Anxiety Stress Scale-21
DEpression-ALcohol Project
McLean screening instrument for borderline personality disorder
National Drug and Alcohol Research Centre
National Health and Medical Research Council
Opiate Treatment Index
Patient Health Questionnaire-9
reliable change indices
randomized controlled trials
self help for alcohol/other drug use and depression
World Health Organization
Funding from the Australian Government supports the National Drug and Alcohol Research Centre (NDARC) at the University of New South Wales. The National Health and Medical Research Council (NHMRC), Australia funds the Centre for Research Excellence in Mental Health and Substance Use. MT is funded on an Australian NHMRC Research Fellowship. MD is supported by an NDARC PhD scholarship, which is acknowledged with gratitude.
None declared.