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Trial registered on ANZCTR


Trial ID
ACTRN12614000310662
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
24/03/2014
Date last updated
24/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical trial of internet-based treatment for binge drinking and depression in young Australians
Scientific title
The impact of an internet-based treatment and social networking support for binge drinking and depression on mood and alcohol use outcomes in young Australians
Secondary ID [1] 283387 0
Nil known
Universal Trial Number (UTN)
U1111-1148-9814
Trial acronym
iTreAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290325 0
Alcohol Misuse 290326 0
Condition category
Condition code
Mental Health 290726 290726 0 0
Depression
Mental Health 290728 290728 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will compare 3 intervention conditions:
(1) 12 * Online monthly self-assessments of mood (Depression Anxiety Stress Scale 21) and alcohol use (Timeline Follow-back for past month). It is anticipated that this will take approximately 10 minutes, and participants will complete these assessments once per month for 12 months post-baseline (active control);
(2) Online monthly self-assessment + DEAL (4 online sessions of cognitive behaviour therapy treatment for depression and alcohol misuse, to be completed once weekly for 4 weeks. Each session takes approximately 30 minutes to complete, with access to the DEAL program provided from the point of randomisation. Access to the DEAL program will be provided for a 12 month period, allowing people to revisit the material over this time); and
(3) Online monthly self-assessment + DEAL + Breathing Space Social Networking site (12 months of access to Breathing Space, with moderation provided by clinical psychologists with expertise in treating depression and alcohol misuse).

All participants will undergo baseline assessment, and follow-up assessment at twenty-six, thirty-nine, fifty-two and sixty-four weeks post-baseline.

Participants will receive $20AUD for each of the baseline and follow-up assessments they complete. Participants will receive monthly reminder emails to prompt completion of the online monthly self assessments. For weeks 1-12 following baseline, participants allocated to the conditions involving the DEAL program and/or Breathing Space social networking will receive a reminder email to access the corresponding program if more than one week has lapsed from their last login. Between weeks 13-53 post-baseline, participants allocated to conditions involving DEAL will receive monthly reminder emails to remind participants to utilise the skills used in the DEAL program and to revise the DEAL content if/when required. Reminder emails to participants allocated to the Breathing Space condition will be sent between weeks 13-52 if a participant has not accessed the social networking program in the previous month.
Intervention code [1] 288239 0
Treatment: Other
Intervention code [2] 288240 0
Behaviour
Intervention code [3] 288241 0
Lifestyle
Comparator / control treatment
Participants in the monthly online self assessment group complete monthly online assessments of their mood (using the Depression Anxiety Stress Scale) and their alcohol consumption (Timeline Follow Back for Alcohol Use) for a 12-month period. No other treatment is provided by the study, however participants are free to access other treatments as usual.
Control group
Active

Outcomes
Primary outcome [1] 290905 0
Depressive symptoms (as measured by the Depression, Anxiety Stress Scale - 21 item; and the Structured Clinical Interview for DSM - Depression).
Timepoint [1] 290905 0
Baseline and 26, 39, 52 and 64-weeks post-baseline (DASS-21). Baseline, 26 and 52-weeks post-baseline for the SCID - Depression).
Primary outcome [2] 290906 0
Alcohol use (as measured by the Alcohol Use Disorders Identification Test; the Alcohol Time Line Follow Back and the Structured Clinical Interview for DSM - Alcohol).
Timepoint [2] 290906 0
Baseline and 26, 39, 52 and 64-weeks post-baseline (AUDIT and TLFB). Baseline, 26 and 52-weeks post-baseline for the SCID - Alcohol).
Secondary outcome [1] 305579 0
Other drug use (tobacco, cannabis and caffeine) as measured by the Opiate Treatment Index and the Drug Use History.
Timepoint [1] 305579 0
At baseline and 26, 39, 52 and 64-weeks post-baseline.
Secondary outcome [2] 305580 0
Quality of Life as measured by the AQoL-6D
Timepoint [2] 305580 0
At baseline and 26, 39, 52 and 64-weeks post-baseline.

Eligibility
Key inclusion criteria
Participants will be between the ages of 18-30 and living in Australia, with low mood (score at least 12 on the Depression Anxiety and Stress Scale - 21) and binge drinking (binge drinking at least 2 times in the previous month, where a binge is 5 or more standard drinks in one sitting, as measured by the Time Line Follow Back).
Minimum age
18 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who cannot understand English sufficiently to complete the various assessments and DEAL program. People who do not have access to the internet (either in their private residence, or do not have a willingness to use the public library/other suitable venues with internet access).

In NSW it is illegal to buy alcohol for or sell alcohol to people under 18 years of age, so they have been excluded from this research. This study does not include those aged over 30 as it is focusing on treatment of young people who are notoriously more difficult to engage and retain in traditional treatment services than are adults.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants for will be identified via advertising of the project online. An advertisement shall be placed to appear on the 'Facebook profiles' of people between 18 and 30 years of age, living in Australia.

Potential participants will be asked to respond to an online advertisement for the study by clicking on a link which will direct them to a Consent to be screened page and Screening assessment. The screening instruments will be the DASS, a number of questions about drinking in the last month, and perceptions of the credibility of internet-delivered treatment. Potential participants will be offered the chance to go in the draw to win a prize of approximately $400 value (an iPad) by completing the screening assessment and leaving their contact details. It will be made clear in the advertising that only one prize is available. When participants complete the screener, they will be given the option to share a link to the website through Facebook, Twitter or email in order to reach more potential participants. For every referred person who completes the screener, the referring participant will get an extra entry in the draw to win an iPad. Referring links will contain an identifying number unique to each completed screener to enable tracking of where the referred participants came from. Additionally, the screener will contain a question of where the participant heard about the project (e.g., Facebook, GoogleAds, friend).

After respondents to the online facebook advertisement complete the Screening assessment and once consent to be contacted is obtained, a member of the iTreAD team will telephone eligible potential participants. A brief screening interview will be conducted with the person to determine their understanding of the study procedures as outlined in the Participant information statement and to gain informed consent.

After informed consent is obtained, eligible participants will be enrolled in the study, and complete the baseline assessment with the iTreAD via the telephone. At the conclusion of the baseline assessment, participants will receive their random allocation to either:
(a) Monthly online self-assessment for 12 months (OSA);
(b) OSA + 12-months of access to a 4-week program of web-based intervention for binge drinking and depressed mood (DEpression ALcohol), DEAL);
(c) OSA + DEAL + 12-months access to a purpose-built social networking site (BreathingSpace).

Participants and assessors will be blind to treatment allocation until the conclusion of the baseline assessment, at the point at which the random allocation is revealed. Allocation will be concealed from both participant and assessor, and will be conducted centrally by computer. Assessors will access this computer program at the point of randomisation to reveal the allocation to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the three groups is by random permutations (using random block sizes), separately for men and women. Randomisation will be created using an online program, which can only be accessed after eligibility is confirmed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data coding and analysis will be carried out by the research team using available software packages (eg. SPSS). Variables hypothesised to change over time according to treatment allocation will be examined using repeated measures analysis of covariance (e.g. alcohol use). Chi-square analyses or logistic regression will be performed on categorical outcome variables (abstinence vs. not). Outcome measures will be analysed in two ways (1) intention to treat (with study dropouts regarded as continuing users and/or with unchanged scores relative to baseline); (2) performed with the sub-sample of participants who actually took part in treatment and completed all follow-up phases. The sample size was determined based on feasibility of recruitment within the funding-body specified time frame.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288291 0
Government body
Name [1] 288291 0
NHMRC
Address [1] 288291 0
National Health and Medical Research Council GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601
Country [1] 288291 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
National Drug and Alcohol Research Centre
UNSW
22-32 King Street
Randwick
NSW 2031

Country
Australia
Secondary sponsor category [1] 287012 0
University
Name [1] 287012 0
University of Newcastle
Address [1] 287012 0
Priority Research Centre for Translational Neuroscience and Mental Health
PO Box 833
Newcastle NSW 2300
Country [1] 287012 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290188 0
University of New South Wales
Ethics committee address [1] 290188 0
Human Research Ethics Committee
University of New South Wales
NSW 2052
Australia
Ethics committee country [1] 290188 0
Australia
Date submitted for ethics approval [1] 290188 0
Approval date [1] 290188 0
05/11/2013
Ethics approval number [1] 290188 0
HREC Ref: # HC13299

Summary
Brief summary
We will directly target young people with comorbid depression and binge drinking behaviours and, for the first time, evaluate an internet-based psychological treatment program, augmented with peer-driven social networking. This program can easily be translated into primary care, clinical and real world settings for use by young people experiencing these conditions. Via this study, we aim to:
(1) Demonstrate that young people, aged 18-30 years, who are experiencing low mood and are binge drinking will engage with web-based treatments that target their multiple problems simultaneously;
(2) Demonstrate that young people with these problems will benefit from web-based treatment targeting low mood and binge drinking simultaneously; and
(3) Demonstrate the additional benefit of peer-led social influence on engagement and mood and binge drinking outcomes for young people, when offered in conjunction with a web-based treatment for these conditions.
We will examine the relative impact of:
(a) Monthly online self-assessment (OSA) for 12 months; OSA
(b) OSA + 12-months of access to a 4-week. program of web-based intervention for binge drinking and depressed mood (DEpression ALcohol - DEAL); OSA + DEAL
(c) OSA + DEAL + 12-months of access to Breathing Space.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43606 0
Dr Frances Kay-Lambkin
Address 43606 0
National Drug and Alcohol Research Centre University of New South Wales 22-32 King Street Randwick, NSW 2031
Country 43606 0
Australia
Phone 43606 0
+61293850333
Fax 43606 0
Email 43606 0
f.kaylambkin@unsw.edu.au
Contact person for public queries
Name 43607 0
Dr Frances Kay-Lambkin
Address 43607 0
National Drug and Alcohol Research Centre University of New South Wales 22-32 King Street Randwick, NSW 2031
Country 43607 0
Australia
Phone 43607 0
+61293850333
Fax 43607 0
Email 43607 0
f.kaylambkin@unsw.edu.au
Contact person for scientific queries
Name 43608 0
Dr Frances Kay-Lambkin
Address 43608 0
National Drug and Alcohol Research Centre University of New South Wales 22-32 King Street Randwick, NSW 2031
Country 43608 0
Australia
Phone 43608 0
+61293850333
Fax 43608 0
Email 43608 0
f.kaylambkin@unsw.edu.au