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Trial registered on ANZCTR


Registration number
ACTRN12616000480482
Ethics application status
Approved
Date submitted
10/04/2016
Date registered
13/04/2016
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Test of motivational treatments to reduce alcohol use.
Scientific title
A new, low-cost e-health treatment for Alcohol Use Disorder using mental imagery.
Secondary ID [1] 288551 0
1099400
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 297659 0
Condition category
Condition code
Mental Health 297846 297846 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is the first large-scale trial of Functional Imagery Training (FIT). FIT aims to enhance the effectiveness of existing best treatment for alcohol use, Motivational lnterviewing (MI), by harnessing the motivational power of mental imagery. This study examines the additive effect of embedding FIT techniques within MI when
treating Alcohol Use Disorder. There are three treatment arms:

Motivational Interviewing (MI) - delivered by phone in two 1 hour calls over 1 week. Participants discuss the advantages and feasibility of reducing drinking, and therapists elicit emotional reactions and dissonance between core values and current behaviour.

Motivational Interviewing plus Support (MI+S) – delivered by phone in 8 calls over 25 weeks (two 1 hour calls in Week 1 and six 15 minute calls in Weeks 2, 3, 5, 7, 13 and 19). Treatment contact time totals 3.5 hours. MI+S has the same initial sessions as MI. Later calls offer non-specific support and social reinforcement for progress and encourage brief relaxation practice, but do not shape new coping strategies unless a lapse occurs. A smartphone app developed for this study assists practice of progressive muscular relaxation, including an audio file to guide practice and photos of peaceful nature scenes. Participants can use the app and relaxation as often or as little as they choose.

Functional Imagery Training (FIT) – delivered by phone in 8 calls over 25 weeks (two 1 hour calls in Week 1 and six 15 minute calls in Weeks 2, 3, 5, 7, 13 and 19). Treatment contact time totals 3.5 hours. Is based on MI+S but uses imagery throughout the sessions. During sessions, participants generate multisensory images about positive outcomes from controlling drinking, past success with self-control, and strategies to control drinking. Later sessions elicit achievements, outcomes and effective strategies, rehearsing imagery and making it routine by linking it to daily tasks. Mindfulness is practised instead of relaxation. A smartphone app developed for this study assists practice of imagery, including an audio file to guide practice and the ability to take photos to facilitate practice. Participants can use the app and imagery/mindfulness as often or as little as they choose.

The treatments are manualised but are semi-structured, allowing some degree of personalisation according to the needs and circumstances of particular individuals. Therapy is delivered by postgraduate-qualified clinical psychologists and therapists receive supervision from senior clinicians throughout the trial. All sessions are audio-recorded and a random sample are rated for fidelity by appropriately qualified consultants who are independent of the trial and not involved in treatment or supervision.
Intervention code [1] 293931 0
Treatment: Other
Comparator / control treatment
The MI treatment is the active control and the MI+S treatment provides a contact control, matching contact time with the FIT intervention.
Control group
Active

Outcomes
Primary outcome [1] 297369 0
Average weekly alcohol consumption over the past 4 weeks in 10 gm ethanol units (‘standard drinks’) assessed using the Timeline Followback (TLFB).
Timepoint [1] 297369 0
3, 6 and 12 months post-Baseline.
Primary outcome [2] 297370 0
Cost-effectiveness for quality-adjusted life years measured using the Assessment of Quality of Life - 8 Dimensions (AQoL-8D).
Timepoint [2] 297370 0
12 months post-Baseline.
Secondary outcome [1] 320836 0
Average drinks/drinking day over the past 4 weeks assessed using the Timeline Followback (TLFB).
Timepoint [1] 320836 0
3, 6 and 12 months post-Baseline.
Secondary outcome [2] 320837 0
Average weekly days abstinent in the past 4 weeks assessed using the Timeline Followback (TLFB).
Timepoint [2] 320837 0
3, 6 and 12 months post-Baseline.
Secondary outcome [3] 322735 0
Motivation to control drinking assessed using the Motivational Thought Frequency Scale (MTF).
Timepoint [3] 322735 0
1 week, 3 months, 6 months and 12 months post-Baseline.
Secondary outcome [4] 322736 0
Craving for alcohol assessed using the Craving Experience Questionnaire (CEQ).
Timepoint [4] 322736 0
1 week, 3 months, 6 months, and 12 months post-Baseline.
Secondary outcome [5] 322737 0
Health related quality of life assessed using the Assessment of Quality of Life - 8 Dimensions (AQoL-8D).
Timepoint [5] 322737 0
3, 6, and 12 months post-Baseline.
Secondary outcome [6] 322738 0
Psychological distress assessed using the Kessler 10 (K10).
Timepoint [6] 322738 0
3, 6, and 12 months post-Baseline.
Secondary outcome [7] 322739 0
Relative cost-effectiveness assessed using health service utilisation questions developed for this trial.
Timepoint [7] 322739 0
3, 6 and 12 months post-Baseline.

Eligibility
Key inclusion criteria
Participants will be aged 18 years or over and report consuming >40 gm of ethanol (4 standard drinks)/day on average in the past 4 weeks. They will fulfil criteria for current DSM-5 Alcohol Use Disorder and deny intravenous drug use or >twice-weekly cannabis use in the last month. They will not be in concurrent psychological treatment for substance use, and if on naltrexone or acamprosate, will have been on a stable dose for >4 weeks. If highly dependent on alcohol or drinking >700 gm ethanol/week, they will obtain a medical assessment and agree to any medical treatment that is needed, including a medically supervised detoxification if required. They must have access to a smartphone to be able to use the treatment app.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include insufficient English to read or converse without translation, pregnancy or high dependence on medical care, unmodified hearing impairment, significant cognitive deficit, history of >3 days of psychosis, and acute current suicidality.

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)
Allocations are computer-generated and are concealed until all eligibility criteria are confirmed as fulfilled and all baseline assessment is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations are computer-generated in permuted blocks stratifying for gender, DSM-5 Alcohol Use Disorder severity (Mild=2-3 criteria; Moderate=4-5; Severe=6 or more) and presence of pharmacotherapy for alcohol use.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is powered for the primary outcome of weekly alcohol use. Using pilot data to obtain estimates of variance and intraclass correlation, the intention-to-treat sample of 480 provides Power > .90 (alpha = .05) to detect the expected difference between FIT and MI (beta = .21), based on our pilot studies and previous research. A sample of 480 will detect a beta = .14 difference at Power .90, which is smaller than differences commonly reported in comparisons of active psychological treatments. Missing data will be handled using Full Information Maximum Likelihood (FIML) estimation, which gives less biased treatment effect estimates than complete case analysis.

Primary analyses use intention-to-treat. Multi-level modelling (3 Conditions x 4 Occasions - 0, 3, 6, 12 months) tests effects on drinks per week, drinks/drinking day, days abstinent, health-related quality of life, craving and motivation to control drinking.

Quality adjusted life years (QALYs) associated with each intervention are calculated by multiplying AQoL utility scores by the duration in that health state. The incremental cost utility ratio is calculated as the difference in total costs (health care utilisation + treatment costs) between groups divided by the difference in QALYs. Uncertainty is estimated using non-parametric bootstrapping and Monte Carlo simulations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2016
Actual
Date of last participant enrolment
Anticipated
29/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292937 0
Government body
Name [1] 292937 0
National Health and Medical Research Council
Country [1] 292937 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 291701 0
Individual
Name [1] 291701 0
Professor Nicholas Graves
Address [1] 291701 0
Institute of Health and Biomedical Innovation, 60 Musk Ave, Kelvin Grove QLD 4059
Country [1] 291701 0
Australia
Secondary sponsor category [2] 292137 0
Individual
Name [2] 292137 0
Associate Professor Jason Connor
Address [2] 292137 0
The University of Queensland, Discipline of Psychiatry, K Floor Mental Health Centre, RBWH, Herston QLD 4029
Country [2] 292137 0
Australia
Secondary sponsor category [3] 292138 0
Individual
Name [3] 292138 0
Associate Professor Leanne Hides
Address [3] 292138 0
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country [3] 292138 0
Australia
Secondary sponsor category [4] 292139 0
Individual
Name [4] 292139 0
Doctor Matthew Gullo
Address [4] 292139 0
Centre for Youth Substance Abuse Research, K Floor, Mental Health Centre, RBWH, Herston QLD 4029
Country [4] 292139 0
Australia
Secondary sponsor category [5] 292140 0
Individual
Name [5] 292140 0
Doctor Jennifer Connolly
Address [5] 292140 0
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country [5] 292140 0
Australia
Secondary sponsor category [6] 292141 0
Individual
Name [6] 292141 0
Professor Jackie Andrade
Address [6] 292141 0
School of Psychology, University of Plymouth, Drake Circus, Plymouth UK PL4 8AA
Country [6] 292141 0
United Kingdom
Secondary sponsor category [7] 292142 0
Individual
Name [7] 292142 0
Professor Jon May
Address [7] 292142 0
School of Psychology, University of Plymouth, Drake Circus, Plymouth UK PL4 8AA
Country [7] 292142 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294442 0
Queensland University of Technology, University Human Research Ethics Committee
Ethics committee address [1] 294442 0
Ethics committee country [1] 294442 0
Australia
Date submitted for ethics approval [1] 294442 0
01/12/2015
Approval date [1] 294442 0
11/02/2016
Ethics approval number [1] 294442 0
1500001086

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

Contacts
Principal investigator
Name 63586 0
Prof David Kavanagh
Address 63586 0
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country 63586 0
Australia
Phone 63586 0
+61 7 3069 7327
Fax 63586 0
Email 63586 0
david.kavanagh@qut.edu.au
Contact person for public queries
Name 63587 0
Jennifer Connolly
Address 63587 0
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country 63587 0
Australia
Phone 63587 0
+61 7 3069 7543
Fax 63587 0
Email 63587 0
jennifer.connolly@qut.edu.au
Contact person for scientific queries
Name 63588 0
David Kavanagh
Address 63588 0
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Country 63588 0
Australia
Phone 63588 0
+61 7 3069 7327
Fax 63588 0
Email 63588 0
david.kavanagh@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.