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
ACTRN12614000718640
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
7/07/2014
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Date results information initially provided
29/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Test of a phone-delivered motivational intervention for alcohol misuse, incorporating use of electronic devices to set reminders.
Scientific title
Pilot study of phone-delivered Functional Imagery Training as a motivational treatment to reduce weekly drinks consumed for Australian adults with risky drinking.
Secondary ID [1] 284914 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 292384 0
Condition category
Condition code
Mental Health 292699 292699 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’, or ‘FIT’), 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. This study is an uncontrolled pilot that tests a phone-delivered version of FIT with 30 participants, following them over a 6-month period, and collecting alcohol-related outcomes and qualitative responses. Results underpin a planned NHMRC Project Grant application for 2014.
Participants receive 3 phone sessions each spaced one week apart. Session 1 runs for 45 minutes and elicits motivation for change and previous self-control achievements and introduces imagery training. Session 2 runs for 45 minutes and consolidates their goal and assists them to develop a plan, using imagery to reinforce each step. Session 3 runs for 30 minutes and prepare for rehearsal of imagery at home. An additional 4 support phone calls lasting 15 minutes each are delivered in weeks 7, 13, 19 and 25. These calls reinforce achievements and imagery rehearsal. SMSs in weeks 5, 11 and 15 remind participants to think about their goals, rehearse imagery and review their session summaries. 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 phone-delivered sessions, allowing greater potential reach, and employing the use of any available technology to take pictures and set reminders to cue functional motivations and related behaviours in the natural environment.
Intervention code [1] 289733 0
Treatment: Other
Intervention code [2] 289734 0
Behaviour
Comparator / control treatment
Nil (Pilot study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292542 0
Reduction in the number of standard drinks consumed weekly, as measured by the Timeline Follow Back
Timepoint [1] 292542 0
6 months following initial screening
Secondary outcome [1] 309187 0
Increase in salience of cues consistent with abstinence/reduced drinking (as measured by the Goal Motivation Scale).
Timepoint [1] 309187 0
6 months following baseline evaluation
Secondary outcome [2] 309188 0
Increase in elaboration of adaptive thoughts about alcohol (as measured by the Goal Motivation Scale).
Timepoint [2] 309188 0
6 months following baseline evaluation
Secondary outcome [3] 309189 0
Increase in vividness of imagery (as measured by participant-reported ratings of vividness following in-session imagery practice).
Timepoint [3] 309189 0
6 months following baseline evaluation

Eligibility
Key inclusion criteria
Weekly alcohol intake of over 140gm ethanol units in total (14 Australian Standard Drinks) and more than 40gm ethanol units (4 Standard Drinks) on one occasion at least once in past 4 weeks.
Personal access to an electronic device capable of taking pictures and setting reminders.
Minimum age
18 Years
Maximum age
75 Years
Gender
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 (lasting >3 days), traumatic brain injury, organic brain disease, intellectual disorder, or dementia.
Current pregnancy
High dependence on medical care
Acute current suicide risk
Self harm requiring treatment within the previous 12 months
Current engagement in other treatment for alcohol use (including recent commencement or dosage change of pharmacotherapy; those on stable doses for at least 4 weeks before entering the study are not excluded).

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
Nil
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
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] 289541 0
University
Name [1] 289541 0
Institute of Health and Biomedical Innovation, Queensland University of Technology
Address [1] 289541 0
60 Musk Ave
Kelvin Grove
Qld 4059
Country [1] 289541 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] 288227 0
None
Name [1] 288227 0
Address [1] 288227 0
Country [1] 288227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291282 0
QUT Human Research Ethics Committee
Ethics committee address [1] 291282 0
Level 4
88 Musk Ave
Kelvin Grove
Qld 4059
Ethics committee country [1] 291282 0
Australia
Date submitted for ethics approval [1] 291282 0
Approval date [1] 291282 0
11/03/2014
Ethics approval number [1] 291282 0
Ethics Variation -- 1200000637

Summary
Brief summary
Alcohol misuse has significant impact on user's lives. 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. This study is an uncontrolled pilot that tests a phone-delivered version of FIT with 30 participants, following them over a 6-month period, and collecting alcohol-related outcomes and qualitative responses. Results underpin a planned NHMRC Project Grant application for 2014.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 49666 0
Prof David Kavanagh
Address 49666 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 49666 0
Australia
Phone 49666 0
+61 7 3069 7327
Fax 49666 0
Email 49666 0
david.kavanagh@qut.edu.au
Contact person for public queries
Name 49667 0
Dr Jennifer Connolly
Address 49667 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 49667 0
Australia
Phone 49667 0
+61 7 3069 7543
Fax 49667 0
Email 49667 0
jennifer.connolly@qut.edu.au
Contact person for scientific queries
Name 49668 0
Prof David Kavanagh
Address 49668 0
Centre for Children's Health Research, Queensland University of Technology, 62 Graham St, South Brisbane, QLD, 4101
Country 49668 0
Australia
Phone 49668 0
+61 7 3069 7327
Fax 49668 0
Email 49668 0
david.kavanagh@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The data are not yet published and so will not be shared at this time. Following publication, the appropriateness of sharing the data will be decided.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 13 0
Presentation
Citation/DOI/link/details [1] 13 0
The results have been provided within presentations related to the treatment approach in general in a variety of contexts, e.g., training sessions with health practitioners, to academics in related fields, at conferences. There are not specific citations related to the outcomes of this particular study however.
Attachments [1] 13 0
Results – basic reporting
Results – plain English summary
Samples from this trial and the trial of 12614000720617 were combined for the analysis. FIT gave substantial reductions in alcohol consumption, which were similar to or greater than within-condition effects obtained in studies with similar samples that offered extensive alcohol control skills training. At the final assessment, all but 11% had some reduction in weekly drinking below Baseline levels, although only 22% were below both weekly and single-occasion criteria for risky drinking over the previous month.