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Trial registered on ANZCTR


Registration number
ACTRN12613000033741
Ethics application status
Approved
Date submitted
10/01/2013
Date registered
11/01/2013
Date last updated
29/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the DEAL Project – A Web-based intervention for co-occurring depression and alcohol use in young people
Scientific title
The DEAL Project evaluation: A brief, Web-based intervention for co-occurring depression and problematic alcohol use in young people (18-25)
Secondary ID [1] 281746 0
nil
Universal Trial Number (UTN)
U1111-1138-3643
Trial acronym
DEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 288055 0
alcohol abuse/dependence 288056 0
Condition category
Condition code
Mental Health 288428 288428 0 0
Depression
Mental Health 288429 288429 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The DEAL Project program: This program is a 4-week (four hour long sessions) psychological treatment delivered entirely via the Internet. Participants access the web-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, and will provide access to the screening tools and the DEAL Project (DEpression ALcohol) intervention. Content of the sessions include CBT and motivational enhancement strategies, in the form of the previously developed intervention for depression and alcohol misuse that was effective in reducing depression and alcohol use when provided in computer-delivered format (the SHADE program). Participants are asked to complete each session of DEAL Project Web-based intervention in sequence, a week apart, from the point of randomisation. The Website tracks participants’ progress through each weekly module, with automated email reminders sent to the participant’s nominated email address.
Intervention code [1] 286283 0
Treatment: Other
Intervention code [2] 286284 0
Behaviour
Intervention code [3] 286285 0
Lifestyle
Comparator / control treatment
This is attention-control condition program first developed for the ANU WellBeing Study in which participants read information about environmental health, nutrition, stroke, physical activity, medicines in the home, temperature extremes, oral health, blood pressure and cholesterol, heart health, bacteria and food-borne illnesses, calcium and back pain. In order to replicate the interactive component of the active treatment arm, participants also complete online questionnaires that probe health factors, physical and artistic activities, education and hobbies, social, financial, and family roles, work habits and stress, medications, pain and nutrition, and alcohol use.
Control group
Active

Outcomes
Primary outcome [1] 288594 0
Depression symptoms and diagnosis
Timepoint [1] 288594 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement. Depression symptoms and diagnosis will be assessed using the Patient Health Questionnaire (PHQ-9).
Primary outcome [2] 288595 0
Drinking quantity/frequency.
Timepoint [2] 288595 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement. Drinking quantity/frequency will be assessed using the TOT-AL.
Secondary outcome [1] 300560 0
Quality of life
Timepoint [1] 300560 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement. Quality of Life will be assessed using the Assessment of Quality of Life (AQoL) scale.
Secondary outcome [2] 315386 0
DASS-21 anxiety
Timepoint [2] 315386 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement using DASS-21.
Secondary outcome [3] 315387 0
DASS-21 stress
Timepoint [3] 315387 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement using DASS-21.
Secondary outcome [4] 315388 0
hazardous alcohol use
Timepoint [4] 315388 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement using Alcohol Use Disorders Identification Test (AUDIT).
Secondary outcome [5] 315389 0
alcohol abuse/dependence symptomatology
Timepoint [5] 315389 0
Assessed at baseline and at 5, 12, and 24 weeks after intervention commencement using the WHO Composite International Diagnostic Interview (CIDI).

Eligibility
Key inclusion criteria
(1) Age of 18-25 years; (2) Current depressive symptoms (score of 7+ on DASS-21 – Depression); (3) Harmful drinking as measured by the AUDIT (score of 8+) (4) Ability to access the Internet (either in the private residence of the participant, or willingness to use the public library/other suitable venue with Internet access); (5) Australian residency.
Minimum age
18 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Psychotic symptoms lasting >2 days; (2) Non-English speakers; (3) Serious risk of suicide (thoughts of suicide or a wish to commit suicide in past two weeks); (4) Daily use of cannabis/weekly use of amphetamines.

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)
Randomisation will be automated within the program and therefore trial researchers will be blind to randomisation. Randomisation will be created using an online program, which can only be accessed after eligibility is confirmed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to one of the two study groups using the online program Research Randomizer (simple randomisation using computer software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data coding and analysis will be carried out by the authors using available software packages. Data on screening, refusals, and dropout are coded and reported as per CONSORT, and primary analyses use intention-to-treat. Preliminary analyses check for any baseline or health service utilisation differences that may confound with condition effects; later analyses control for these as necessary. Categorical and continuous measures of outcome will be examined using mixed or marginal longitudinal models (i.e., mixed model repeated measures, generalised estimating equation modelling) as appropriate. These approaches enable the inclusion of participants with missing data, without using inferior techniques such as last observation carried forward, when data is missing at random. A ‘completers’ analysis on all participants completing at least 75% of the modules will be undertaken as a secondary analysis. In addition, comparisons on selected demographic and clinical characteristics will be made between ‘completers’ and those who dropped out of treatment, to help detect any biases in outcome measures. The potential effects of a number of covariates and confounders will be modelled in the major analyses (e.g. borderline symptoms (MSI-BPD), medication status, drug use index (OTI ), gender, involvement in additional mental health treatments).

Recruitment
Recruitment status
Completed
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] 286536 0
Government body
Name [1] 286536 0
National Health and Medical Research Council
(NHMRC)
Address [1] 286536 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286536 0
Australia
Primary sponsor type
Individual
Name
Mark Deady
Address
National Drug and Alcohol Research Centre
University of New South Wales
2052 Sydney
Country
Australia
Secondary sponsor category [1] 285323 0
University
Name [1] 285323 0
University of New South Wales
Address [1] 285323 0
University of New South Wales
Sydney NSW 2052
Country [1] 285323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288606 0
UNSW HREC
Ethics committee address [1] 288606 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 288606 0
Australia
Date submitted for ethics approval [1] 288606 0
Approval date [1] 288606 0
19/12/2012
Ethics approval number [1] 288606 0
HC12546

Summary
Brief summary
The primary aim of the study is to evaluate the DEAL Project program, a brief, Internet-based intervention specifically designed for people aged 18 to 25 years with depression and co-occurring problematic alcohol use. This will be the first RCT of an Internet-delivered treatment for comorbid depression and problematic alcohol use in any age group.
Trial website
www.dealproject.org.au
Trial related presentations / publications
Deady M, Mills KL, Teesson M, Kay-Lambkin F. An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial. J Med Internet Res 2016;18(3):e71. DOI: 10.2196/jmir.5178
Public notes

Contacts
Principal investigator
Name 36902 0
Mr Mark Deady
Address 36902 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 36902 0
Australia
Phone 36902 0
+61293850320
Fax 36902 0
+61293850222
Email 36902 0
m.deady@unsw.edu.au
Contact person for public queries
Name 36903 0
Mr Mark Deady
Address 36903 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 36903 0
Australia
Phone 36903 0
+61293850320
Fax 36903 0
+61293850222
Email 36903 0
m.deady@unsw.edu.au
Contact person for scientific queries
Name 36904 0
Mr Mark Deady
Address 36904 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 36904 0
Australia
Phone 36904 0
+61293850320
Fax 36904 0
+61293850222
Email 36904 0
m.deady@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary