Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000061033
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
19/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an internet-based treatment for comorbidity of alcohol disorders and depressive mood.
Scientific title
Evaluate the efficacy of an internet-based psychological program for people who are concurrently depressed and drinking alcohol at harmful levels.
Secondary ID [1] 1269 0
nil
Universal Trial Number (UTN)
U1111-1113-1485
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 256477 0
alcohol misuse 256478 0
Condition category
Condition code
Mental Health 256647 256647 0 0
Depression
Mental Health 256648 256648 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
brief intervention and therapist support - 1 module motivation enhancement plus an additional 5 modules of integrated treatment with email support from therapist.
a) all modules are internet based
b) each module can be done at the client's own pace. they could be completed in one sitting (approximately an hour each) but it is recommended that the client pace themselves and complete the modules on a weekly basis.
c) the overall length of the intervention is 3 months because we ask people to check in weekly for 3 months to complete alcohol use charts and mood monitoring while they continue to implement changes instigated by the programs
d) general topics in the 5 modules are 1) motivation for change and making plans to change 2) mindfullness and activity planning 3) cravings and dealing with risky situations 4) problem-solving and cognitive-behavioural therapy (CBT) 5) building relationships and conflict resolution
Intervention code [1] 255762 0
Treatment: Other
Comparator / control treatment
There are a total of 3 comparison treatment arms in this study: 1) brief intervention only (1 module motivation enhancement)
2) brief intervention + self guided modules (1 module motivation enhancement + 5 modules of self-guided integrated treatment)
3) brief intervention + therapist support.
group 1 (brief intervention) is an online module that could be completed in one sitting of approximately one hour, but it can be done at whatever pace the client feels comfortable with.
group 2 (BI + 5 modules) again could be completed in one sitting taking approximately one hour per module, but it is recommended that the modules are attempted on a weekly basis. both groups are given up to 3 months to complete the intervention while also completing weekly mood monitoring and alcohol use questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 257540 0
alcohol use - measured by Alcohol Use Disorders Identification Test (AUDIT) + patient report on past month of alcohol use
Timepoint [1] 257540 0
3, 6, 9 and 12 months following randomisation
Primary outcome [2] 257541 0
depressed mood - measured by Depression Anxiety Stress Scale (DASS) and Hamiliton Depression Rating Scale (HAM-D)
Timepoint [2] 257541 0
3, 6, 9 and 12 months following randomisation
Secondary outcome [1] 262778 0
to predict therapeutic alliance, satisfaction, number of treatment modules accessed and number of tools completed from self-guided versus therapist-support, treatment response in the first month and baseline demographic and disorder-related variables. Satisfaction and treatment response will be assessed via the Working Alliance Inventory (Short Form) and self-report from 1-100 "How useful did you find this program?"
Timepoint [1] 262778 0
12 months following randomisation
Secondary outcome [2] 262779 0
to test whether alcohol and depression outcomes from internet treatment are moderated by therapeutic alliance, treatment expectancy, disorder independence, number of modules accessed or tools completed or gender. Treatment expectancy will be measured on a scale of 1-100 in response to questions such as "How likely do you think it is that this treatment will help you reduce your drinking?" Disorder independence will look at which of the disorders became apparent first, e.g., did the depression lead to substance abuse or vice versa?
Timepoint [2] 262779 0
12 months following randomisation
Secondary outcome [3] 262780 0
to examine the relative unit cost of the treatments by comparing outgoing costs for each of the treatment arms (e.g., therapist time etc)
Timepoint [3] 262780 0
12 months following randomisation

Eligibility
Key inclusion criteria
1) reported weekly alcohol consumption of more than 14 units/week over the last month
2) score more than 8 on the Alcohol Use Disorders Identification Test
3) score at least 14 on the Depression scale of the Depression Anxiety Stress Scale (e.g., 'moderate' depression)
4) sufficient english to complete treatments and assessments without translation
5) able and willing to access internet/email/text messages
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) use of injectable drugs in the previous month
2) daily use of an illicit substance
3) history of psychosis lasting more than 2 days
4) diagnosis of bipolar disorder
5) acutely suicidal
6) highly dependent on alcohol

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)
participants will view www.ontrack.org.au in response to a referral or advertising and will be guided to complete some screening questionnaires online. after completing the quizzes participants receive feedback and, if appropriate, referral to the alcohol and depression program, where they register to receive a screening call. During the call they are given information about the research. If they're interested in participating the screening information sheet is read over the phone and the participant provides verbal consent for screening. If they meet screening eligibility requirements they are sent an email link that takes them to the consent form and online assessment questionnaires. Following this they receive a baseline assessment phone call. Once all baseline assessments are completed they are randomly allocated to one of the three treatment groups and provided with a username and password to access the online program. Allocations are computer generated and occur automatically once the person's access is activated. The assessor has no way of controlling or predicting assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permutations of 6 and 9 - computersised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256250 0
Government body
Name [1] 256250 0
National Health and Medical Research Council
Country [1] 256250 0
Australia
Primary sponsor type
University
Name
Institute of Health and Biomedical Innovation, Queensland University of Technology
Address
60 Musk Ave,
Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 251578 0
University
Name [1] 251578 0
e-Therapy Unit, Swinburne University of Technology
Address [1] 251578 0
PO Box 218
Hawthorn, VIC, 3122
Country [1] 251578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258341 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 258341 0
GPO Box 2434, Brisbane QLD 4000
Ethics committee country [1] 258341 0
Australia
Date submitted for ethics approval [1] 258341 0
Approval date [1] 258341 0
29/05/2009
Ethics approval number [1] 258341 0
EC00171

Summary
Brief summary
The current study aims to evaluate the efficacy of an internet based psychological program for people who are concurrently depressed and drinking alcohol at harmful levels. This study is a randomised controlled trial with 3 comparison treatment, each with 200 participants who will be followed up for 12 months.

The 3 treatments to be compared are:
1) brief intervention (BI) (1 module of motivation enhancement)
2) BI + self-guided modules (SG) (1 module of motivation enhancement + 5 modules of self-guided integrated treatment
3) BI + therapist-support (TS) (1 module of motivation enhancement + 5 modules of integrated treatment with email support from a therapist)

Primary predictions are that 1) TS and SG interventions will have superior alcohol and depression outcomes at 3, 6, 9 and 12 months compared with BI and 2) TS will elicit greater client satisfaction and completion rate than SG, but SG will have similar treatment outcomes.
Trial website
www.ontrack.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30666 0
Address 30666 0
Country 30666 0
Phone 30666 0
Fax 30666 0
Email 30666 0
Contact person for public queries
Name 13913 0
Jennifer Connolly
Address 13913 0
Institute of Health and Biomedical Innovation, Queensland University of Technology, GPO Box 2434, Brisbane QLD 4000
Country 13913 0
Australia
Phone 13913 0
+ 61 7 3138 0048
Fax 13913 0
Email 13913 0
[email protected]
Contact person for scientific queries
Name 4841 0
Prof David Kavanagh
Address 4841 0
Institute of Health and Biomedical Innovation, Queensland University of Technology, GPO Box 2434, Brisbane QLD 4000
Country 4841 0
Australia
Phone 4841 0
+ 61 7 3138 6143
Fax 4841 0
Email 4841 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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