ANZCTR - Registration

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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

Date results information initially provided

20/11/2019

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]

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

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Change in alcohol problem severity (Alcohol Use Disorders Identification Test, AUDIT)

Timepoint [1]

3 months post baseline

Secondary outcome [1]

Change in alcohol problem severity (AUDIT)

Timepoint [1]

6 and 12-months post baseline

Secondary outcome [2]

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]

Post-minimum exposure (post-4th session, at 4-6 weeks post baseline), and at 3, 6 and 12-months post baseline

Secondary outcome [3]

Change in psychological distress (Kessler Psychological Distress Scale, K10)

Timepoint [3]

3, 6 and 12-months post baseline

Secondary outcome [4]

Change in quality of life (EUROHIS-QOL 8-item index; AQoL-6D)

Timepoint [4]

3, 6 and 12-months post baseline

Secondary outcome [5]

Treatment evaluation (Client Evaluation of Self and Treatment, CEST; qualitative feedback)

Timepoint [5]

Post-minimum exposure (post-4th session, at 4-6 weeks post baseline)

Secondary outcome [6]

Cost effectiveness (health and work performance; healthcare resource use; AQoL-6D)

Timepoint [6]

3, 6 and 12-months post baseline

Secondary outcome [7]

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]

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?

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Eastern Health

Address

5 Arnold St, Box Hill VIC 3128

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Newcastle

Address [1]

University Dr, Callaghan NSW 2308

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Deakin University

Address [2]

221 Burwood Highway
Burwood VIC 3125

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee (EC00211)

Ethics committee address [1]

5 Arnold St, Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/05/2017

Approval date [1]

04/05/2018

Ethics approval number [1]

E12-2017

Summary

Brief summary

Alcohol related harm is a significant issue for Australians. Unfortunately, few people seek help early to reduce their alcohol use, despite the effectiveness of available programs.

Many barriers to seeking help for problem alcohol use are overcome through confidential, telephone delivered programs that are available after hours. These programs may provide support options for Australians who would never seek treatment in traditional settings due to stigma, service operating hours, thinking the problem isn’t serious enough for treatment, or thinking that it will get better on its own.

People age 18+ years, who would like to reduce how much or how often they drink, are invited to take part in this study comparing two types of telephone delivered programs (1. the Ready-to-Change intervention; 2. minimal standard of care). These support programs are delivered over the telephone at times convenient to participants, from anywhere in Australia:

- Participants will receive between 4 and 6 telephone calls from their dedicated support caller
- Supporting information will be sent
- Our researcher will check in with participants at baseline and then 4 times over a 12-month period
- Participants will be paid for their time.

Trial website

https://www.turningpoint.org.au/about-us/news/ready2change-trial-currently-recruiting-participants

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Dan Lubman

Address

Turning Point
110 Church St
Richmond, VIC
3121

Country

Australia

Phone

+61 3 8413 8413

Fax

+61 3 9416 3420

[email protected]

Contact person for public queries

Name

Dr Jasmin Grigg

Address

Turning Point
110 Church St
Richmond, VIC
3121

Country

Australia

Phone

+61 3 8413 8723

Fax

+61 3 9416 3420

[email protected]

Contact person for scientific queries

Name

Dr Jasmin Grigg

Address

Turning Point
110 Church St
Richmond, VIC
3121

Country

Australia

Phone

+61 3 8413 8723

Fax

+61 3 9416 3420

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3888	Study protocol	Lubman, 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
13475	Statistical 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

Source	Title	Year of Publication	DOI
Embase	A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): Study protocol for a parallel group randomised controlled trial.	2019	https://dx.doi.org/10.1186/s13063-019-3462-9
Embase	Effectiveness of a Stand-alone Telephone-Delivered Intervention for Reducing Problem Alcohol Use: A Randomized Clinical Trial.	2022	https://dx.doi.org/10.1001/jamapsychiatry.2022.2779

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically