Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000828224
Ethics application status
Approved
Date submitted
4/05/2018
Date registered
16/05/2018
Date last updated
8/10/2021
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ready-to-Change: A telephone-based intervention for alcohol misuse
Scientific title
A randomised controlled trial of the Ready-to-Change telephone-based intervention to reduce harmful drinking in adults with alcohol problems.
Secondary ID [1] 294102 0
NHMRC #1125026
Universal Trial Number (UTN)
Trial acronym
R2C
Linked study record
Best, D., Hall, K., Guthrie, A., Abbatangelo, M., Hunter, B. and Lubman, D., 2015. Development and implementation of a structured intervention for alcohol use disorders for telephone helpline services. Alcoholism Treatment Quarterly, 33(1), pp.118-131.

This paper describes the findings of a feasibility study examining an earlier iteration of the Ready-to-Change Intervention program.

Health condition
Health condition(s) or problem(s) studied:
Alcohol misuse 306692 0
Condition category
Condition code
Public Health 305791 305791 0 0
Health promotion/education
Mental Health 306798 306798 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:

- Telephone-delivered intervention: 4 plus 2 sessions of (approximately) weekly, integrated, structured counselling (30-50 minutes in duration), delivered by the same counsellor each session (a qualified psychologist or social worker trained in the R2C protocol by the developer, Clinical Psychologist Dr Kate Hall). R2C incorporates core elements from evidence-based interventions, such as motivational interviewing (MI), cognitive behavioural therapy (CBT) and acceptance and commitment therapy (ACT). Behaviour change modules cover strategies such as self-monitoring, management of cravings, routine scheduling and psychoeducation about triggers to drink. Motivational enhancement modules cover core principles from MI, including generating change talk, highlighting strengths and creating discrepancies. Relapse prevention modules cover identification and management of triggers for relapse. Eight skills training modules address coping skill deficits, including managing anxiety, controlling impulses, improving mood and managing anger. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants. Call duration will be recorded. SMS messages will be sent to remind participants of all pre-arranged telephone sessions. All participants will be encouraged to take part in a minimum of 4, and optimally 6 R2C sessions to benefit from the program.

- Self-help resource: Self-help workbooks containing cognitive behavioural exercises presented as node-link maps (a clinical strategy to facilitate communication and problem solving) will be mailed to participants, and completed between sessions, thereby serving as an ongoing self-help resource. Use of the self-help workbooks will be queried and recorded using a pro forma during each R2C phone session.

1. My R2C Workbook Skills Training (Hall, Simpson & Best 2013, Copyright Turning Point, ISBN 13: 978-1-74001-017-7
2. My R2C Workbook Ready 2 Change (Hall, Simpson & Best 2013, Copyright Turning Point, ISBN-13: 978-1-74001-018-4)

- Alcohol consumption & stress management pamphlets will be mailed to participants (so that R2C is provided in addition to the minimal standard of care received by the control group).
Intervention code [1] 300381 0
Behaviour
Intervention code [2] 301122 0
Treatment: Other
Intervention code [3] 301123 0
Lifestyle
Comparator / control treatment
Arm 2:

Alcohol consumption & stress management pamphlets will be mailed to participants in the control group, providing minimal input self-help information. Participants will receive 4 brief telephone calls from the research team to control for frequency of contact across treatment arms. The researcher will provide participants in the control group with information about who to contact if they feel they need urgent further support.

1. Reduce Your Risk: New National Guidelines for Alcohol Consumption (Australian Government, Department of Health and Ageing, 2009)
2. Understanding and Managing Stress (Australian Psychological Society, 2012)
Control group
Active

Outcomes
Primary outcome [1] 304859 0
Change in alcohol problem severity (Alcohol Use Disorders Identification Test, AUDIT)
Timepoint [1] 304859 0
3 months post baseline
Secondary outcome [1] 343396 0
Change in alcohol problem severity (AUDIT)
Timepoint [1] 343396 0
6 and 12-months post baseline
Secondary outcome [2] 345012 0
Change in drinking patterns (i.e. number of drinking days; number of days where more than 2 standard drinks were consumed; number of days where more than 4 standard drinks were consumed; total number of standard drinks in the past month) (Timeline Follow-back, TLFB)
Timepoint [2] 345012 0
Post-minimum exposure (post-4th session, at 4-6 weeks post baseline), and at 3, 6 and 12-months post baseline
Secondary outcome [3] 345014 0
Change in psychological distress (Kessler Psychological Distress Scale, K10)
Timepoint [3] 345014 0
3, 6 and 12-months post baseline
Secondary outcome [4] 345016 0
Change in quality of life (EUROHIS-QOL 8-item index; AQoL-6D)
Timepoint [4] 345016 0
3, 6 and 12-months post baseline
Secondary outcome [5] 345017 0
Treatment evaluation (Client Evaluation of Self and Treatment, CEST; qualitative feedback)
Timepoint [5] 345017 0
Post-minimum exposure (post-4th session, at 4-6 weeks post baseline)
Secondary outcome [6] 345087 0
Cost effectiveness (health and work performance; healthcare resource use; AQoL-6D)
Timepoint [6] 345087 0
3, 6 and 12-months post baseline
Secondary outcome [7] 346433 0
Adverse events

Some participants may find that discussing their alcohol use triggers cravings for alcohol or psychological distress. Although this is uncommon and any distress is usually minor and transient, the research team will be looking out for such possible adverse effects using a pro forma containing general (e.g. “Have you felt unwell or different since the last time you since last time you had telephone contact for this study?”) and specific questions (e.g. “Has your alcohol use changed?”).
Timepoint [7] 346433 0
Post-minimum exposure (post-4th session, at 4-6 weeks post baseline), and at 3, 6 and 12-months post baseline

Eligibility
Key inclusion criteria
- Hazardous/harmful alcohol use indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of >6/7 for women/men
- Greater than or equal to 18 years of age
- English as a first language or fluent
- Educated to high school level
- Regular access to a telephone, a postal address (to receive the workbooks)
- Able to provide informed consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently attending or has intention to attend other treatment for alcohol problems
- Hearing impairment sufficient to prohibit a telephone interview
- Current or past history of psychosis
- Actively suicidal
- Acquired brain injury
- Pregnancy
- Severe alcohol dependence requiring urgent medically assisted treatment (history of severe withdrawal symptoms, plus Severity of Alcohol Dependence Questionnaire [SADQ-C] score greater than or equal to 31 = severe alcohol dependence)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations will be concealed in individual envelopes labelled with the unique identification code, and opened (in consecutive order) by the designated researcher (Researcher 1, who plays no part in follow-up assessments) after the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by gender and will use a standard computer generated,
“permuted blocks of variable size” scheme for each stratum.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to randomise 172 subjects to each arm of the study (total N=344). The primary outcome measure (the AUDIT score 3-months post-intervention) can range from 0 to 40 and will be analysed via a mixed linear model. Using data from our pilot work, we found that the between-subject variance component in the AUDIT score was 23.8, the within subject variance component was 49.8 and the estimated improvement (decline) in the AUDIT score was 11.2 (SE=1.69). We estimate, conservatively, that by 3 months, there will be an improvement of at least 8 in the R2C arm and that the control arm could exhibit a modest improvement of 4. If these improvements are sustained at 6 and 12 months, then with 120 evaluable subjects in each arm, and assuming an independence model for measurement variation, the F-test, conducted at the 5% significance level, for this treatment by time interaction will have 90% power (and the two-sided, 5% level, t-test for the interaction contrast at 3 months will have 85% power). If these conjectured improvements by 3 months are not durable and, for example, deteriorate by 50% at 6 months, and the scores return, on average, to their baseline levels at 12 months, then this treatment by time interaction scenario will be detected with 85% power, and the power of the two-sided, 5% level t-test for the interaction contrast at 3 months remains unchanged at 85%. The target sample size has been inflated from 120 per arm to 172 per arm to allow for approximately 30% drop-out which is based on the attrition rate reported in the Swedish helpline study (Heinemans et al. 2014) and the experiences of the study CIs where attrition in trials of face-to-face psychosocial interventions with this population average around 20% at 12 months (Baker et al. 2014).

Data will be collated, cleaned and validated, using programmed edit checks, in a database that will be locked prior to the unblinding of the study statistician. The primary analysis will take place after all subjects, not known to have withdrawn or not deemed lost to follow-up, have had their 12- month assessments, based on the intention to treat principle (i.e., subjects’ data are analysed as randomised and as stratified). A “per-protocol” sensitivity analysis will be restricted to those subjects with at least one post-baseline assessment, and, for subjects randomised to the R2C arm, participation in at least one telephone counselling session. The repeated measurements of the outcome variables will be analysed by fitting linear mixed models using restricted maximum likelihood (REML) - this will allow the most suitable variance-covariance model for the repeated measures to be selected, using Akaike’s Information Criterion, and commonality of nonlinear trends over time to be explored via splines. The F-test will be used to test for an overall group by time interaction and the primary comparison, between groups, of their changes from baseline to 3 months follow-up will be based on a t-test of the corresponding interaction contrast – this t-test will utilise the predicted means and their variance-covariance matrix that are recovered from the fitted mixed model. Diagnostic plots of residuals will be assessed and if deemed necessary, variance-stabilising transformations, such as the empirical logistic transformation, will be applied to the outcome variables and inferences will be based on the analyses conducted on the transformed scale. In a series of exploratory analyses, mixed models with covariates for gender, illicit drug use, extent of exposure to the intervention, exposure to other treatments or programs, level of psychological distress and level of alcohol use at baseline, will be fitted, including their interactions with treatment group, in order to identify moderating factors. Analyses will be conducted using the most appropriate procedures in GenStat, R and STATA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
31/05/2018
Date of last participant enrolment
Anticipated
2/12/2019
Actual
2/10/2019
Date of last data collection
Anticipated
2/12/2020
Actual
10/09/2020
Sample size
Target
344
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298734 0
Government body
Name [1] 298734 0
National Health and Medical Research Council (NHMRC)
Country [1] 298734 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold St, Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 297928 0
None
Name [1] 297928 0
Address [1] 297928 0
Country [1] 297928 0
Other collaborator category [1] 280097 0
University
Name [1] 280097 0
The University of Newcastle
Address [1] 280097 0
University Dr, Callaghan NSW 2308
Country [1] 280097 0
Australia
Other collaborator category [2] 280098 0
University
Name [2] 280098 0
Deakin University
Address [2] 280098 0
221 Burwood Highway
Burwood VIC 3125
Country [2] 280098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299677 0
Eastern Health Human Research Ethics Committee (EC00211)
Ethics committee address [1] 299677 0
Ethics committee country [1] 299677 0
Australia
Date submitted for ethics approval [1] 299677 0
29/05/2017
Approval date [1] 299677 0
04/05/2018
Ethics approval number [1] 299677 0
E12-2017

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

Contacts
Principal investigator
Name 81262 0
Prof Dan Lubman
Address 81262 0
Turning Point
110 Church St
Richmond, VIC
3121
Country 81262 0
Australia
Phone 81262 0
+61 3 8413 8413
Fax 81262 0
+61 3 9416 3420
Email 81262 0
[email protected]
Contact person for public queries
Name 81263 0
Jasmin Grigg
Address 81263 0
Turning Point
110 Church St
Richmond, VIC
3121
Country 81263 0
Australia
Phone 81263 0
+61 3 8413 8723
Fax 81263 0
+61 3 9416 3420
Email 81263 0
[email protected]
Contact person for scientific queries
Name 81264 0
Jasmin Grigg
Address 81264 0
Turning Point
110 Church St
Richmond, VIC
3121
Country 81264 0
Australia
Phone 81264 0
+61 3 8413 8723
Fax 81264 0
+61 3 9416 3420
Email 81264 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
No patient permission to share data outside this study, other than for related projects conducted by the research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3888Study protocolLubman, D.I., Grigg, J., Manning, V., Hall, K., Volpe, I., Dias, S., Baker, A., Staiger, P.K., Reynolds, J., Harris, A. and Tyler, J., 2019. A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial. Trials, 20(1), p.515.https://link.springer.com/article/10.1186/s13063-019-3462-9 
13475Statistical analysis plan    374551-(Uploaded-14-09-2021-13-59-04)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): Study protocol for a parallel group randomised controlled trial.2019https://dx.doi.org/10.1186/s13063-019-3462-9
EmbaseEffectiveness of a Stand-alone Telephone-Delivered Intervention for Reducing Problem Alcohol Use: A Randomized Clinical Trial.2022https://dx.doi.org/10.1001/jamapsychiatry.2022.2779
N.B. These documents automatically identified may not have been verified by the study sponsor.