ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000637549

Ethics application status

Approved

Date submitted

8/06/2015

Date registered

19/06/2015

Date last updated

21/05/2021

Date data sharing statement initially provided

18/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effectiveness of problem gambling interventions in a service setting: A pragmatic randomised clinical trial

Scientific title

The effectiveness of motivational interviewing, compared to cognitive behavoural therapy with exposure, on days gambled (self-reported number of days gambled in the previous month) and money lost (self-reported money lost per day in the previous month), in problem gamblers accessing a face-to-face therapy service.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Problem gambling

Gambling addiction

Gambling behaviour

Condition category

Condition code

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This project is a single blind pragmatic randomised clinical trial (RCT) of two psychological interventions for problem gambling, with and without the addition of text-message support.
The interventions comprise:
Face-to-face Cognitive Behavioural Therapy (CBT), using a balanced and flexible application of cognitive restructuring and graded imaginal and live cue-exposure. Participants will receive up to ten face-to-face CBT sessions over a 12 week period. The approximate duration of each CBT session will be 60 to 90 minutes. The therapy incorporates imaginal and real-life cue-exposure to gambling triggers and habituation/urge extinction. It also includes interventions directed towards understanding randomness and erroneous beliefs, awareness of inaccurate perceptions, and cognitive correction to erroneous perceptions. Regular homework sessions will also take place, focusing both on behavioural and cognitive goals, and recorded in diaries. This will be discussed in face-to-face sessions and progress reinforced.

Face-to-face Motivational Interviewing (MI) plus a cognitive behavioural self-instructional workbook (W) and follow-up telephone booster sessions (B). Participants will receive one face-to-face motivational interview session structured to encourage clients to build a commitment to change by emphasising the reasons why change is desirable. The approximate duration of The MI session will be 60 to 90 minutes. Interviews end with a summary of participants’ stated reasons for changing and specific therapeutic goals. Participants will be given a self-help workbook based on a cognitive–behavioral model of problem gambling and relapse prevention techniques. The content of the workbook includes the following sections: Self-assessment, goal setting, strategies, maintenance and other resources for additional support. In addition, they will receive five follow-up motivational booster telephone sessions of 10-15 minutes duration at approximately one, two, four, eight and 12 weeks. These sessions will focus on motivation of, and reinforcement for, behaviour change through the use of the workbook.

The CBT and MI interventions will be delivered by specialised problem gambling counselors at a problem gambling service.

Half of the participants in the MI condition and half in the CBT condition will also be allocated to receive weekly text messages (an average of two a week) from the 12 week assessment until the 12 month assessment. Message content will be influenced by messaging that has been effective in alcohol and smoking reduction/cessation programmes and the growing literature on mobile health. The messages will be designed to sustain therapeutic gains and facilitate ongoing behaviour change including relapse prevention and recovery. Messages will be tailored to be consistent with each of the two treatment approaches. MI participants will receive messages that encourage self-reflection on treatment goals and workbook use. CBT participants will receive encouragement for using cognitive and behavioural strategies.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Primary efficacy investigation:
This project will evaluate the relative effectiveness of two of the best developed and most promising forms of therapy for problem gambling, namely face-to-face motivational interviewing combined with a self-instruction booklet and follow-up telephone ‘booster’ sessions (MI+W+B) and face-to-face cognitive behaviour therapy (CBT).

Control group

Active

Outcomes

Primary outcome [1]

Self-reported number of days spent gambling in the previous month (Days gambled). A timeline follow-back interview will be conducted to capture the number of days gambling during the follow-up period. Pre-treatment scores will be calculated, averaged over the two months prior to entry. Post-treatment scores will be calculated for the month following entry into the trial, in the period from one to three months and in the interval from three to 12 months. The corresponding averages at three and 12 months will be used in most analyses with weights proportional to the number of measures thus averaged.

Timepoint [1]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
The corresponding primary endpoint will be Days gambled at 12 months post-randomisation.

Primary outcome [2]

Self-reported average amount of money lost per day gambling in the previous month (Money lost). A timeline follow-back interview will be conducted to capture the amount of money lost on each gambling occasion during the follow up period. Pre-treatment scores will be calculated, averaged over the two months prior to entry. Post-treatment scores will be calculated for the month following entry into the trial, in the period from one to three months and in the interval from three to 12 months. The corresponding averages at three and 12 months will be used in most analyses with weights proportional to the number of measures thus averaged.

Timepoint [2]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
The corresponding primary endpoints will be Money lost at 12 months post-randomisation.

Secondary outcome [1]

The nine-item Problem Gambling Severity Index

Timepoint [1]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [2]

The Gambling Urge Scale (GUS)

Timepoint [2]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [3]

The Gambling Related Cognitions Scale (GRCS)

Timepoint [3]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [4]

The mood and alcohol modules of the Primary Care Evaluation of the Mental Disorders (PRIME-MD)

Timepoint [4]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [5]

Drug Abuse Screening Test (DAST)

Timepoint [5]

Key time points for data collection are:
Baseline (pre randomisation)
12 months following randomisation.

Secondary outcome [6]

Alcohol use (AUDIT)

Timepoint [6]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [7]

General psychological distress: The Kessler 10 (K10) questionnaire

Timepoint [7]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Secondary outcome [8]

Quality of life as assessed by the WHOQoL-8.

Timepoint [8]

Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.

Eligibility

Key inclusion criteria

Minimum age of 18 years
Self-perception of having a gambling problem
Willing to read materials related to the study (to ensure reading ability),
Willing to participate in counselling and other treatment components (including owning a mobile phone with ability to receive text messages),
Willing to have counselling sessions recorded, and provide follow-up data on gambling.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will be the presence of active psychosis or active suicidal intent.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

This project is a single blind pragmatic randomised clinical trial (RCT) of two interventions, with and without the addition of text-messages. Trial assessments take place pre-treatment, at three months and 12 months.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2015

Actual

24/11/2015

Date of last participant enrolment

Anticipated

Actual

1/04/2019

Date of last data collection

Anticipated

Actual

1/06/2020

Sample size

Target

300

Accrual to date

Final

227

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Health

Address [1]

No 1 The Terrace
PO Box 5013
Wellington

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Professor Max Abbott

Address

AUT University
North Shore Campus
90 Akoranga Drive
Northcote
Auckland 0627

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

18/06/2015

Approval date [1]

27/08/2015

Ethics approval number [1]

Summary

Brief summary

The primary purpose of this study is to evaluate the relative effectiveness of two of the best developed and most promising forms of therapy for problem gambling, namely face-to-face motivational interviewing combined with a self-instruction booklet and follow-up telephone ‘booster’ sessions (MI+W+B) and face-to-face cognitive behaviour therapy (CBT).

Other aims are: a) to evaluate how effective gambling-related post-treatment text messaging is in preventing relapse and sustaining treatment gains at 12 months; b) to look at how other common issues such as mental health problems change following therapy; c) Identify which, if either, of the interventions is more effective for a variety of client groups including Maori and Pacific ethnic groups, and groups identified by the severity of their problem; and c) Identify the relationship between changes in other possible factors affecting response to treatment (e.g. mental health issues and alcohol or drug use) and gambling and problem gambling.

The primary hypothesis is that CBT participants will show greater clinically meaningful reductions in gambling and problem gambling than MI+W+B participants at 12 months. 

Secondary hypotheses include that:
1.	CBT and MI+W+B will be equivalent with respect to reductions in gambling and problem gambling at three months.
2.	Participants allocated to the post-treatment text messaging conditions, in both the CBT and MI+W+B groups, will show greater clinically meaningful reductions in gambling and problem gambling at 12 months than those in the non-text messaging condition.
3.	CBT participants will have greater reductions in depression and anxiety than MI+W+B participants at 12 months.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Max Abbott

Address

AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 9219894

Fax

mabbott@aut.ac.nz

Contact person for public queries

Name

Maria Bellringer

Address

AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 9219999

Fax

maria.bellringer@aut.ac.nz

Contact person for scientific queries

Name

Alain Vandal

Address

AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 9219999

Fax

alain.vandal@auckland.ac.nz

Data sharing statement

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

Yes

What data in particular will be shared?

Deidentified data, in alignment with New Zealand National Ethical Standards for Health and Disability Research and related standards/guidelines for protecting patient confidentiality.

When will data be available (start and end dates)?

Data will be available by application to a review committee (MOH and AUT), after the final report has been approved by the Ministry of Health, and appropriate data deidentification procedures undertaken - approximately 2022.

Available to whom?

Investigators whose proposed use of the data has been approved by a review committee (MOH and AUT) would be permitted to access the data.

Available for what types of analyses?

Analyses approved by a review committee (MOH and AUT).

How or where can data be obtained?

Mechanisms to be developed together with successful applicants, in alignment with New Zealand National Ethical Standards for Health and Disability Research and related standards/guidelines for protecting patient confidentiality.

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

Source	Title	Year of Publication	DOI
Dimensions AI	Effectiveness of problem gambling interventions in a service setting: a protocol for a pragmatic randomised controlled clinical trial	2017	https://doi.org/10.1136/bmjopen-2016-013490

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

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