Trial Review

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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] 286874 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 295275 0
Gambling addiction 295329 0
Gambling behaviour 295330 0
Condition category
Condition code
Mental Health 295525 295525 0 0
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] 292052 0
Treatment: Other
Intervention code [2] 292098 0
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] 295264 0
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] 295264 0
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] 295311 0
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] 295311 0
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] 315211 0
The nine-item Problem Gambling Severity Index
Timepoint [1] 315211 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [2] 315325 0
The Gambling Urge Scale (GUS)
Timepoint [2] 315325 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [3] 315326 0
The Gambling Related Cognitions Scale (GRCS)
Timepoint [3] 315326 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [4] 315327 0
The mood and alcohol modules of the Primary Care Evaluation of the Mental Disorders (PRIME-MD)
Timepoint [4] 315327 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [5] 315328 0
Drug Abuse Screening Test (DAST)
Timepoint [5] 315328 0
Key time points for data collection are:
Baseline (pre randomisation)
12 months following randomisation.
Secondary outcome [6] 315329 0
Alcohol use (AUDIT)
Timepoint [6] 315329 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [7] 315330 0
General psychological distress: The Kessler 10 (K10) questionnaire
Timepoint [7] 315330 0
Key time points for data collection are:
Baseline (pre randomisation)
3 and 12 months following randomisation.
Secondary outcome [8] 315331 0
Quality of life as assessed by the WHOQoL-8.
Timepoint [8] 315331 0
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?
No
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] 6962 0
New Zealand
State/province [1] 6962 0

Funding & Sponsors
Funding source category [1] 291434 0
Government body
Name [1] 291434 0
Ministry of Health
Country [1] 291434 0
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] 290109 0
None
Name [1] 290109 0
Address [1] 290109 0
Country [1] 290109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292984 0
Health and Disability Ethics Committee
Ethics committee address [1] 292984 0
Ethics committee country [1] 292984 0
New Zealand
Date submitted for ethics approval [1] 292984 0
18/06/2015
Approval date [1] 292984 0
27/08/2015
Ethics approval number [1] 292984 0

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

Contacts
Principal investigator
Name 57910 0
Prof Max Abbott
Address 57910 0
AUT University
Private Bag 92006
Auckland 1142
Country 57910 0
New Zealand
Phone 57910 0
+64 9 9219894
Fax 57910 0
Email 57910 0
[email protected]
Contact person for public queries
Name 57911 0
Maria Bellringer
Address 57911 0
AUT University
Private Bag 92006
Auckland 1142
Country 57911 0
New Zealand
Phone 57911 0
+64 9 9219999
Fax 57911 0
Email 57911 0
[email protected]
Contact person for scientific queries
Name 57912 0
Alain Vandal
Address 57912 0
AUT University
Private Bag 92006
Auckland 1142
Country 57912 0
New Zealand
Phone 57912 0
+64 9 9219999
Fax 57912 0
Email 57912 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIEffectiveness of problem gambling interventions in a service setting: a protocol for a pragmatic randomised controlled clinical trial2017https://doi.org/10.1136/bmjopen-2016-013490
N.B. These documents automatically identified may not have been verified by the study sponsor.