Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001605189
Ethics application status
Approved
Date submitted
1/11/2019
Date registered
21/11/2019
Date last updated
10/12/2019
Date data sharing statement initially provided
21/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An randomised control trial of a cognitive behavioural therapy mobile health app [Manaaki] aimed at reducing gambling symptom severity and supporting people experiencing gambling problems.
Scientific title
An randomised control trial of a cognitive behavioural therapy mobile health app [Manaaki] aimed at reducing gambling symptom severity and supporting people experiencing gambling problems.
Secondary ID [1] 299140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gambling Problems 314206 0
Condition category
Condition code
Mental Health 312565 312565 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: A BESPOKE DESIGNED MOBILE APP
Involves an intervention app that has an evidence based CBT program embeded within it comprising of six modules, a shared forum, a webchat component and a diary.
The Modules are:
1. KNOWING MYSELF (and my gambling): Designed to provide personalised feedback, goal setting, and understanding of gambling motivations, triggers, and/or consequences
2. GETTING READY (to make changes): Designed to enhance readiness and confidence to gamble less, helping to shape my thoughts and values to help make change
3. TAKING CONTROL (right now): Designed to identify strategies that can be used to “contain” the gambling in the short-term, directs to other useful tools such as venue exclusions.
4. TAKING ACTIONS (that last) : Designed to identify strategies and skills that can be used to ensure longer-term success in gambling less. Activating personal strengths and resources and enhancing belief for successful change
5. MANAGING URGES (to cope with real situations): Designed to cope with gambling urges and cravings
6. CHANGE FOR GOOD (and building a new future): Relapse prevention strategies designed to prevent gambling relapses in the future.
Participants can navigate through the modules and module subtopics in the order that they find appropriate. Each subtopic can take between 10mins to 30 minutes to work through. Each module has a mix of short and long subtopics and the participant is prompted to take time to absorb and put into practice some of the skills before moving to the next module, although they are not stopped from moving on.
The SHARED FORUM: peer support is an important element in gambling addiction recovery. This tool allows the user to share experiences with other intervention participants, much like they might do if they participated in a face-to-face group session.
The CHAT FEATURE: connects the user to the national gambling helpline chat service which is a 24/7 service staffed by professional councillors.
The DIARY: is a personalised tool that the user can capture their journey as they journey to being gambling harm free. The user can post the outcomes from their module activity or record positive thoughts and reminders.
PROCEDURE: All eligible participants will be informed of the study requirements and consent within the app. Baseline data will be collected and this will generate a randomised outcome to either Intervention or Control.
DOSE: this is a pragmatic trial and as such participants in the intervention arm can use the app for as much or as little as they want over the 12 week study period. Participants decide where they wish to start and as they progress suggestions will be provided on strategies to develop or additional learning elsewhere in the app that they might find useful.
MEASURES: measures will be collected at 4, 8 and 12 weeks. App analytics will be utilised to capture frequency of use and time using the app, navigation journey and modules/subtopic completions, event capture if data entered, and use of the support tools such as the chat function.
LOCATION: this is a national study and participants can use the app where and whenever they wish.
PERSONALISATION: Throughout the app, the participant’s name is used i.e. So, [John] … , to provide a more tailored feel to the intervention. Summaries and interpretations are also based on their participant’s responses to the Modules and subtopics so that the participant receives information relevant to them. Notifications are also personalised with the participant’s name and where appropriate uses a greeting that is appropriate to the participant and linked to their demographics.


Intervention code [1] 315955 0
Behaviour
Intervention code [2] 316034 0
Treatment: Devices
Intervention code [3] 316035 0
Treatment: Other
Comparator / control treatment
Control: A waitlist control app. The control group will have access to the full app after they completed their 12 week study period.
The app contains the data capture points for 4, 8 and 12 weeks.
A link to existing resources such that would be available to them if they searched on the internet.. Notifications will be sent prior to each data collection point to prompt the participant to submit their responses. Resourses are only URLs to existing tools. These are the NZ National Gambling Help Service,the Gambling Help website -Choice Not Chance and a link to a lins to gambling treatment servcies.
Proceedures; Eligible participants will be informed of the study requirements and consent within the app. Baseline data will be collected and this will generate a randomised outcome to either Intervention or Control.
Dose: the app is not designed for active use, but for data collection only.
Measures: measures will be collected at 4, 8 and 12 weeks.
Location: this is a national study and participants can use the app where and whenever they wish.
Control group
Placebo

Outcomes
Primary outcome [1] 321852 0
Gambling Symptom Severity: The Gambling Symptom Assessment Scale (G-SAS) will be used to measure the severity of gambling symptoms. The primary outcome on which the study is powered is a change of 5 points in the Gambling Symptom Assessment Scale (G-SAS) at 12 weeks.
Timepoint [1] 321852 0
12 weeks post-treatment commencement
Secondary outcome [1] 376476 0
Frequency of gambling behaviour over past 4 weeks (days) post-treatment commencement by asking about the frequncy of gambling over past 4 weeks in days.
Timepoint [1] 376476 0
at 4, 8, 12 weeks post-treatment commencement
Secondary outcome [2] 376477 0
Time spent gambling over past 4 weeks (hours) post-treatment commencement is captured by a self reported tool asking them to record the time spent gambling.
Timepoint [2] 376477 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [3] 376478 0
Amount spent gambling over past 12 weeks ($) post-treatment commencement is captured by a self reported tool asking them to record the $ amount spent when gambling.
Timepoint [3] 376478 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [4] 376479 0
Self reported Readiness to change using 0-10 likert scale at each data point
Timepoint [4] 376479 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [5] 376480 0
Self reported willingness to change using 0-10 scale at each time points
Timepoint [5] 376480 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [6] 376481 0
Self reported ability to change, 0-10 scale at each time point
Timepoint [6] 376481 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [7] 376482 0
Self reported health seeking behaviour at each time point using a 0-100 scale
Timepoint [7] 376482 0
4, 8, 12 weeks post-treatment commencement
Secondary outcome [8] 376483 0
Continueously through-out the study epriod until 12 weeks post-treatment commencement, Within app analytics have been developed and unique participants app utilisaiton patterns will be collected and saved to the secure server. This will include all elements of active use of the app and all screens, modules viewed and completed, dates and time spent on activities.,
Timepoint [8] 376483 0
12 weeks post-treatment commencement
Secondary outcome [9] 376484 0
App engagement will be measured continuousely with final outcome using FITT framework (Frequency, Intensity, Time and Type). This data is collected continuously using unique user app analystics. Frequency = number of times the app is used, time = how long was taken for each active use, Intensity = how many of the activities were done for each use and Type = what did participant use
Timepoint [9] 376484 0
12 weeks post-treatment commencement

Eligibility
Key inclusion criteria
• have an interest in seeking help for their gambling;
• reside in New Zealand;
• are aged 18 years or over;
• have access to a smart phone that is capable of downloading an app and have access
to the internet;
• possess adequate knowledge of the English language;
• are able to provide informed consent (e-consent via the app);
• have an email address or are able to create an email address for the trial
• are willing to participate in the study and provide follow-up information at the
scheduled points of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any that do not meet the eligibility criteria above.

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)
All randomisation is created using a programme emdeded within the app and activiated in the app after completing the baseline criterai. The allocation algorythm is stored on a secure server and no resesarcher has access or visibility of this.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation (created by study statistician), using block sizes of 2 and 4 will be used to randomly allocate participants.
To ensure balance on potential confounders, randomisation will be stratified by
1. Sex - M/F
2 Ethnicity - Maori, Pacific, Other
3. G-SAS - score under 30 and 31-40
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We hypothesise that exposure to the Manaaki intervention will result in at least a 5-point change (reduction) in the baseline score on the Gambling Symptom Assessment Score (G-SAS) for the participants in the intervention group. With 90% power, two-sided alpha at 5%, an attrition rate of 40% will require a sample size of 284 (142 per group), to detect a minimum of a 5-point reduction on the G-SAS (standard deviation = 10).

The sample size was determined by an a priori power analysis. We found only a few previous trials on which to base our power calculations; we considered it appropriate to be conservative and expect a medium effect. A moderate to high level of loss to follow-up is not atypical in gambling studies with a weighted average of 31% found in a review of internet-based treatment studies for psychological disorders.95 We estimate the required sample size will be able to be recruited over a 9 month period. The sample size is feasible given the number of people experiencing mild to moderate levels of gambling-related harm, the likely proportion interested in being involved in research, the likely drop-out rate over the primary 12-week study end.
All statistical analyses will be performed using SAS version 9.4 (SAS Institute Inc. Cary NC) Data analyses will be specified a priori in a statistical analysis plan (SAP) prepared by the trial statistician. The data will be imported into SAS for analysis. No interim analyses are planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
30/05/2021
Actual
Sample size
Target
284
Accrual to date
Final
Recruitment outside Australia
Country [1] 21980 0
New Zealand
State/province [1] 21980 0
National

Funding & Sponsors
Funding source category [1] 303680 0
Government body
Name [1] 303680 0
Health Research Council
Country [1] 303680 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 920189
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 304395 0
None
Name [1] 304395 0
Address [1] 304395 0
Country [1] 304395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304201 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 304201 0
Ethics committee country [1] 304201 0
New Zealand
Date submitted for ethics approval [1] 304201 0
07/11/2019
Approval date [1] 304201 0
06/12/2019
Ethics approval number [1] 304201 0
19/STH/204

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

Contacts
Principal investigator
Name 96134 0
Ms Gayl Humphrey
Address 96134 0
National Institute for Health Innovation
Univerisity of Auckland
Private Bag 92019
Auckland 1142
Country 96134 0
New Zealand
Phone 96134 0
+64 21 1100901
Fax 96134 0
Email 96134 0
[email protected]
Contact person for public queries
Name 96135 0
Gayl Humphrey
Address 96135 0
National Institute for Health Innovation
Univerisity of Auckland
Private Bag 92019
Auckland 1142
Country 96135 0
New Zealand
Phone 96135 0
+64 21 1100901
Fax 96135 0
Email 96135 0
[email protected]
Contact person for scientific queries
Name 96136 0
Gayl Humphrey
Address 96136 0
National Institute for Health Innovation
Univerisity of Auckland
Private Bag 92019
Auckland 1142
Country 96136 0
New Zealand
Phone 96136 0
+64 21 1100901
Fax 96136 0
Email 96136 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?
Currently, as per the data share policy only individual participant data of primary outcomes will be made available. It will be avaialable after the main study findings have been published.
When will data be available (start and end dates)?
Requests can be made after the main study findings have been published which is anticipated to be at the end of 2022. No end date of IPD availablility has been determined as yet.
Available to whom?
post-treatment commencement
Requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the trial steering committee, and the requestor is willing to sign a data access agreement.
Available for what types of analyses?
As approved by the Steering Group and maintaining the integrety of the data purpose.
How or where can data be obtained?
A request to prinicple investigator can be made. Projects requesting to share data should have been assessed by an appropriate ethical review.


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.