Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000213842
Ethics application status
Not yet submitted
Date submitted
17/02/2012
Date registered
20/02/2012
Date last updated
20/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet Self Help Therapy for Problem Drinking: Retention and Effectiveness
Scientific title
Internet Self Help Therapy for Problem Drinking: Retention and Effectiveness
Secondary ID [1] 279960 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic alcohol use 285877 0
Condition category
Condition code
Mental Health 286064 286064 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study aims to conduct a randomised controlled trial over 3 months that investigates the effectiveness of an internet-delivered alcohol intervention. The intervention consists of an interactive, internet based, self-help program comprising 5 modules, each covering a specific theme (e.g. mindfulness, cognitive restructuring). Each module was designed to take between 30 and 60 minutes to complete (i.e. approximately 5 hours in total). Participants are able to skip certain sections and can complete modules in any order. The study also aims to enhance retention rates to the online program with the addition of reminder text messages to motivate clients to continue logging on to the program. Text messages will be sent on average 3-4 times per week over the three month trial period.
Thus, the intervention condition involves open access to an online alcohol intervention and the addition of reminder text messages.
Intervention code [1] 284293 0
Behaviour
Intervention code [2] 284297 0
Treatment: Other
Comparator / control treatment
The control condition involves open access to the same online alcohol intervention, without the addition of reminder text messages.
Control group
Active

Outcomes
Primary outcome [1] 286545 0
AUDIT-C (a screener to help identify persons who are engaging in problematic alcohol use)
Timepoint [1] 286545 0
Measured at baseline, and 2, 4, 6 and 12 weeks post baseline
Secondary outcome [1] 296130 0
Kessler-10 (general well-being scale)
Timepoint [1] 296130 0
Measured at baseline, and 2, 4, 6 and 12 weeks post baseline
Secondary outcome [2] 296131 0
Quality of Life Inventory (measures quality of life)
Timepoint [2] 296131 0
Measured at baseline, and 2, 4, 6 and 12 weeks post baseline
Secondary outcome [3] 296132 0
Attrition or retention rates from the study
Timepoint [3] 296132 0
Measured at the end of the study
Secondary outcome [4] 296140 0
Participants overall engagement in the program (as measured by number of log-ins and number of pages accessed)
Timepoint [4] 296140 0
Measured at the end of the study

Eligibility
Key inclusion criteria
Participants will be included in the study if they (1) currently engage in problematic alcohol use (i.e., consumption above recommended drinking levels as suggested by the National Health and Medical Research Council of Australia: i.e. the present intake is greater than or equal to 14 standard drinks per week; or 4 standard units on a single occasion for men or 3 for women); (2) have access to the internet and a mobile phone; (3) are above the age of 18; (4) agree to undergo no other psychological treatment throughout the study; and (6) have sufficient English and literacy skills to understand the written interventions without translation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they meet criteria for other serious psychological disorders (i.e. schizophrenia or suicidality); or if they have used injected drugs in the previous month or report daily use of an illicit substance.

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 visit www.ontrack.org.au in response to referral or advertising and are led to a registration page where they are provided with information about the research and are asked to consent to participating in the study. They are also required to register to receive a screening call.
During the call a screening information sheet is read over the phone and the participant is asked for verbal consent for screening. If the participant meets screening eligibility criteria, they are invited to complete a baseline assessment. Participants are emailed a link that takes them to the online assessment questions. After they have completed all baseline assessments, they are randomly allocated to one of the two treatments and are provided with a username and password to log in to the program. Participants then complete the program at their own pace.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur via a true random number service and carried out by an independent researcher.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284727 0
University
Name [1] 284727 0
Queensland University of Technology
Country [1] 284727 0
Australia
Primary sponsor type
Individual
Name
Charlotte von Schuckmann
Address
5/45 Frederick Street, Annerley, 4103, QLD
Country
Australia
Secondary sponsor category [1] 283624 0
None
Name [1] 283624 0
Address [1] 283624 0
Country [1] 283624 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286735 0
Ethics committee address [1] 286735 0
Ethics committee country [1] 286735 0
Date submitted for ethics approval [1] 286735 0
21/02/2012
Approval date [1] 286735 0
Ethics approval number [1] 286735 0

Summary
Brief summary
The current study aims to conduct a randomised controlled trial over 3 months (with the possibility of a 6 month follow up) that compares the impact of the following two internet-delivered interventions on alcohol consumption:
1. Online alcohol intervention: includes open access to the OnTrack alcohol intervention
2. Online alcohol intervention with text messaging: includes open access to the OnTrack alcohol intervention plus the addition of text messages reminding participants to log on to the program and stay on track

The study has three major research aims:
Aim I: to investigate the impact of text messaging as a supplementary support for online treatments.
* determine to what extent the addition of text messaging impacts participants’ engagement in the program
* does the addition of text-messaging impact the effectiveness of the program
* are drop-out rates lower in the text messaging condition than in the control condition
Aim II: to determine the average dose of treatment required for improvement
* investigate the effectiveness of the intervention in relation to the amount of time spent utilising it
Aim III: to learn more about people who prematurely discontinue online treatments
* gain a better understanding of why individuals drop-out through follow-up interviews
* identify to what extent these individuals are still utilising the skills and techniques they acquired within the intervention after drop-out

It is predicted that the web-based alcohol intervention with text messaging will result in lower attrition rates, greater engagement with the program and greater utility of skills than the treatment alone condition. Further, it is predicted that the addition of text messages will improve the effectiveness of the program by reducing self-reported alcohol intake.

We also hope to determine whether the intervention improves quality of life; and general well-being and if it is considered useful, relevant, satisfying and easy to use.
Trial website
www.ontrack.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33792 0
Address 33792 0
Country 33792 0
Phone 33792 0
Fax 33792 0
Email 33792 0
Contact person for public queries
Name 17039 0
Charlotte von Schuckmann
Address 17039 0
5/45 Frederick Street, Annerley, 4103, QLD
Country 17039 0
Australia
Phone 17039 0
+61 0414652543
Fax 17039 0
Email 17039 0
c.vonschuckmann@connect.qut.edu.au
Contact person for scientific queries
Name 7967 0
Robert King
Address 7967 0
Faculty of Health, School of Psychology and Counselling (Level 5, O'Block)
Victoria Park Road, Kelvin Grove, 4059, QLD
Country 7967 0
Australia
Phone 7967 0
+61 (07) 3138 4722
Fax 7967 0
Email 7967 0
robert.king@qut.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.