Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000720617
Ethics application status
Approved
Date submitted
11/08/2013
Date registered
8/07/2014
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Test of a new motivational intervention for alcohol misuse,
incorporating mobile phone reminders
Scientific title
Pilot study of Functional Imagery Training as a motivational treatment to reduce weekly drinks consumed for Australian adults with risky drinking.
Secondary ID [1] 282846 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risky alcohol use 289653 0
Condition category
Condition code
Mental Health 289971 289971 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alcohol misuse is endemic and has significant impact. This proposal refines and tests an innovative motivational treatment (‘Functional Imagery Training’), based on the applicants’ Elaborated Intrusion Theory of desire. A key focus is on individually tailored imagery to consolidate motivation, interfere with craving, rehearse coping strategies and enhance self-efficacy. The proposal develops a mobile phone app that cues commitment and coping when alcohol control is under threat, using pictures, icons and brief descriptions. This study is an uncontrolled pilot with 12 participants, following them over 6 months, and collecting alcohol-related outcomes and qualitative responses.

Participants attend 2 face-to-face treatment sessions at QUT, within one week of each other. Session 1 runs for 1.5 to 2 hours and provides normative assessment feedback, explores reasons for change and hypothetical goals, and introduces imagery training. Session 2 runs for 1.5 hours and provides further training in imagery, consolidates goal commitment and instructs participants in the use of the FIT mobile app which they begin using in their usual environment. Participants receive four 10-minute phone calls 1, 5, 11 and 23 weeks after session 2. Calls review and refine use of imagery and of the app. At each contact, participants are given general encouragement to continue using the app regularly. To monitor adherence, participants are asked specifically about their use of the app and its various functions during each phone session. All sessions are conducted by clinically trained and registered Psychologists.

Critical to successfully addressing any dysfunctional behaviour is enlistment of motivation. So important is this factor that brief advice for addictive behaviors can be as effective as more extensive counselling (Kaner et al., 2009). The most highly developed approach to eliciting change is motivational interviewing (MI, Miller & Rollnick, 2002). Rather than trying to convince people to adopt new behaviours, MI provides an empathic context where they consider options. It encourages them to explore competing motivations and concerns, amplifying inconsistencies between their behaviours and valued goals. MI has strong empirical support (Ruba et al., 2005), not only as a prelude to other treatment, but as a stand-alone intervention (Miller & Wilbourne, 2002). However, effect sizes still have substantial room for improvement: A recent trial on alcohol misuse and depressive mood on which the current investigators collaborated, found a within-group reduction of only 0.25 SD in weekly alcohol intake to 18 weeks from a session of MI (Baker et al., 2010). Our recent internet-based trial on a similar sample obtained a fall in weekly consumption of 0.69 SD to 6 weeks from the motivational module (Kavanagh et al., in preparation).

The Elaborated Intrusion (EI) Theory of desire (Kavanagh, Andrade & May, 2005) provides a roadmap for enhancing MI. EI theory emphasises the roles of intrusive thoughts and cognitive elaboration, especially involving imagery, in motivation generally and craving specifically. Intensity of craving is greater when sensory imagery is more vivid and salient (Kavanagh, May, & Andrade, 2009). Goals and motivation to attain them, are sustained by imagery (Andrade, May, & Kavanagh, 2012). Conversely, craving is reduced when a concurrent task (such as other novel or episodic imagery) competes for the same limited working memory resources (May, Andrade, Panabokke & Kavanagh, 2010).

Enhancing functional motivation therefore requires:
(i) increasing the salience of cues and strengthening the link between cues and the functional goal to boost thoughts about the goal,
(ii) increasing the salience of these thoughts to increase the likelihood that they are elaborated, and
(iii) enhancing the vividness of imagery about the functional goal and awareness of associated affect. This positive imagery is the critical goal of our innovation: it strengthens motivation towards the functional goal and simultaneously interferes with imagery about the dysfunctional target.
Functional Imagery Training (FIT) implements these theoretical and empirical advances in our understanding of motivation, and how it is maintained (Andrade et al., 2012). It retains the spirit and typical elements of MI, but employs imagery throughout face-to face sessions, and uses a mobile phone app to cue functional motivations and related behaviours in the natural environment.
Intervention code [1] 287537 0
Treatment: Other
Intervention code [2] 287538 0
Behaviour
Comparator / control treatment
Nil (Pilot study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290024 0
Reduction in the number of standard drinks consumed weekly, as measured by the Timeline Follow Back
Timepoint [1] 290024 0
6 months following initial screening
Secondary outcome [1] 303791 0
Increase in:
*Salience of cues consistent with abstinence/reduced drinking (as measured by the Goal Motivation Scale).
Timepoint [1] 303791 0
6 months following baseline evaluation
Secondary outcome [2] 309172 0
Increase in:
*Elaboration of adaptive thoughts about alcohol (as measured by the Goal Motivation Scale).
Timepoint [2] 309172 0
6 months following baseline evaluation
Secondary outcome [3] 309173 0
Increase in:
*Vividness of imagery (as measured by participant-reported ratings of vividness following in-session imagery practice).
Timepoint [3] 309173 0
6 months following baseline evaluation

Eligibility
Key inclusion criteria
Weekly alcohol intake of greater than 140g in total (14 Australian standard drinks)
Access to an iPhone or iPad
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Injected drug use in the past month
Daily use of illicit substances
History of psychosis, brain injury, intellectual disorder, or dementia
Current pregnancy
High dependence on medical care
Current suicide risk
Self harm requiring treatment within the previous 12 months
Current engagement in other treatment for alcohol use

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is not random
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this study is a pilot study, only a small sample was recruited.

Quantitative data are analysed using repeated measures ANOVAs, with multiple imputation used in cases of any missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/09/2012
Actual
7/02/2013
Date of last participant enrolment
Anticipated
22/02/2013
Actual
4/10/2013
Date of last data collection
Anticipated
Actual
19/02/2014
Sample size
Target
12
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7266 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 287769 0
University
Name [1] 287769 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
Country [1] 287769 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] 286496 0
None
Name [1] 286496 0
Address [1] 286496 0
Country [1] 286496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289716 0
QUT Human Research Ethics Committee
Ethics committee address [1] 289716 0
Ethics committee country [1] 289716 0
Australia
Date submitted for ethics approval [1] 289716 0
Approval date [1] 289716 0
08/01/2013
Ethics approval number [1] 289716 0
1200000637

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41490 0
Prof David Kavanagh
Address 41490 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41490 0
Australia
Phone 41490 0
+61 7 3069 7327
Fax 41490 0
Email 41490 0
[email protected]
Contact person for public queries
Name 41491 0
Jennifer Connolly
Address 41491 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41491 0
Australia
Phone 41491 0
+61 7 3069 7543
Fax 41491 0
Email 41491 0
[email protected]
Contact person for scientific queries
Name 41492 0
Jennifer Connolly
Address 41492 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 41492 0
Australia
Phone 41492 0
+61 7 3069 7543
Fax 41492 0
Email 41492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The results have not yet been published so data sharing arrangements are yet to be decided.


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.