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Trial registered on ANZCTR


Registration number
ACTRN12619000134123p
Ethics application status
Submitted, not yet approved
Date submitted
18/12/2018
Date registered
30/01/2019
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
We Can Do This: Web-based therapeutic intervention for reducing methamphetamine use amongst Aboriginal and Torres Strait Islander people: Randomised wait-list control Trial
Scientific title
Novel Interventions to Address Methamphetamine Use in Aboriginal and Torres Strait Islander People (NIMAC). Phase 4: Effectiveness of a Culturally Appropriate Web-based Intervention for Methamphetamine Use.
Secondary ID [1] 296193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use 310593 0
Condition category
Condition code
Mental Health 309308 309308 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'We Can Do This' is a culturally appropriate web-based therapeutic intervention (WBTI) for methamphetamine use comprising 6 modules (described below) based on brief cognitive behavioural, motivational interviewing, Acceptance Commitment Therapy (ACT) and culturally-specific interventions.

At first log-in, participants will enter names of relevant support people into their ‘healing circle.’ These may personal contacts or professional people who may be called upon to provide support. The healing circle may be easily accessed at all times via an icon at the top right-hand corner of the screen.

Based on feedback from advisory groups, participants will not be forced to complete modules in a set order but will be able to select modules based on preference. At first and subsequent log-ins, participants will monitor their mood using a simple visual rating tool, and monitor methamphetamine use via the time-line follow-back.

Instructions will recommend that participants access the WBTI once a week for six weeks, however they are free to access the it as frequently as they wish during the intervention phase.

Participants will have the option of receiving weekly health practitioner support face to face or via phone calls from trained staff at the participating health service in their geographical area. Practitioners may be psychologists, counsellors, nurses or Aboriginal health workers/practitioners. If this option is taken up, the participant’s contact details will be forwarded to the relevant health practitioner and the participant will receive an introductory phone call during which the health practitioner will explain their support role and schedule the weekly support sessions. Alternatively, participants may choose to proceed without weekly support. In either case, participants will be prompted to consider talking to someone at the end of each module.

At the end of each module, printable summary pages of their inputs may be emailed to participants as attachments. If receiving weekly support this summary may also be emailed to their practitioner. Participants may also opt to share these summaries via email with other members of their healing circle.

Participants will be sent an email or text to remind them to log-in each week, regardless of which modules have been completed. If all modules are completed early, participants may repeat modules.

MODULE CONTENT
1. Are You Ready? (~15 mins) is an online adaptation of the decisional balance exercise that is frequently used with Motivational Interviewing although is not strictly defined as a component of motivational interviewing per se. This exercise commonly included as a component of treatment manuals for substance use using a range of therapeutic modalities. It proceeds in four sections corresponding to ‘Good things about using ice;’ ‘Bad things about using ice’; ‘Bad things about stopping ice’; and ‘Good things about stopping ice.’ A brief video illustrating relevant issues for one of the characters introduces each section. Within each section, the participant is presented with 10 items (one per page) that they rate on a slide bar as ‘not true for me,’ ‘a little bit true for me’ or ‘true for me’. After rating the final item in each section, all 10 items are presented in a list in order of relative weighting, and the participant can add additional items to the list via a text box at this point.

The ‘weighting’ for each group of items is represented by a pile of stones with the relative weighting given to each item is represented by the size of the stone (larger stones for those items rated as ‘true’; smaller stones for those rated as ‘a little bit true’). By the end of all four rating exercises, the good and bad things about using ice and stopping ice are represented visually by four piles of stones. Participants are then asked to identify the good thing about stopping ice that is most important to them and visualise the difference that stopping ice would make to this area of their lives. They have the option of scheduling an encouraging text message to themselves reminding them of this important motivator later in the week.

2. The 'Cravings and Triggers' module (~15 mins) contains exercises designed to assist the participant identify their own triggers (situations, thoughts and feelings that can lead to urges to use) and cravings (urges to use) with a view to making a plan for how to deal with them. The section begins with an informational video providing psychoeducation on methamphetamine and the brain, including explaining the nature of addiction and withdrawal. This psychoeducation provides the rationale for the subsequent exercises, which prompt the participant to reflect what cravings feel like for them, and to identify the internal (thoughts/feelings) and external (situations) triggers that lead them to use. The first exercise presents the participant with an image of a person and they are invited to tap on various body parts to read about common symptoms of cravings, alongside strategies that can help to cope with that symptom. For example, tapping on the nose will bring up the message: “Smell can bring on strong cravings. You can interfere with them by smelling something else- lemon, coffee, soaps – anything that you find calming and not related to using ice.”

The next exercise comprises a series of check-box forms (with free-text boxes to enable adding personal detail) prompting the participant to identify their own external then internal triggers. Each section is introduced with a related video and written information. Another video then introduces the question of whether some triggers may be simply avoided, and participants are prompted to consider getting rid of any ice and equipment they may have left. The participant is then prompted to make a plan to reduce stress choosing realistic and relevant strategies from a list, and to practice identifying and responding constructively and compassionately to unhelpful thoughts using Socratic questioning. In sum, the information entered into this module amount to a 'cravings plan' that may be printed or emailed.

3. 'Having a Craving? Don’t Panic!' (~5-20 mins) is a brief behavioural experiment in which the participant is prompted to rate the intensity of their craving on a scale from 0 to 10, set a timer for 5, 10 or 20 minutes, during which time they are instructed to do something else. The participant has the option of playing ‘Tetris’ on their device, as there is some evidence that playing Tetris acts as visual cognitive interference and reduces the incidence and intensity of cravings in real-world settings. When the timer finishes, the participant receives a text message prompting them to return to the exercise and re-rate their craving, after which they can repeat the exercise or move on to another module.

4. High Risk Situations (~10 mins) includes a series of questions designed to assist the participant to identify potential high-risk situations, and to make a plan to cope with them without using methamphetamine. Possible strategies include: where possible, avoiding the situation altogether, making a plan to leave if things get hard, rehearsing how to say ‘no’ to people when drugs are offered, preparing by letting people know that they have decided not to use, having support people nearby/contactable, reminding themselves of their primary motivation for reducing or stopping use.

5. 'Quiet Reflections' (~5-20 mins) contains a series of reflections and mindfulness exercises that may be selected from a ‘launch page’ within the module. These reflections emphasise connection to culture, community and identity, and provide pathways for addressing culturally situated grief and loss and connecting with cultural programs. The module also contains a basic introduction to mindfulness via psychoeducation and a brief breathing exercise.

6. 'Values-driven goal setting' (~15 mins) is an adapted version of the ‘Bullseye Values Survey’ developed by Lundgren et al. (2012) and further popularised through its routine use in ACT. This exercise does not focus on drug use specifically and is intended to help the participant build a valued life outside of their use. In our adapted version, the participant is presented with three baskets Labelled: ‘Less important; ‘Important’ and ‘Very important’. Values appear on the screen and the participant sorts them into the appropriate basket. In the next stage of the exercise, those values rated as ‘very important’ appear one by one and can be placed on a stylised image of a dart-board- close to the centre if the participant feels they are living well in accordance with that value, and further away from the centre if they are not living in line with that value. Once all the values have been placed on the board, the participant is encouraged to select a value placed further from the centre to work on in the next section. The participant is then asked to write a ‘specific, achievable action that would help them move closer to living out that value. This is followed by three questions: ‘What would be the first step towards this goal?’; ‘Who could help you do this?’ and ‘When will you do this?’. After nominating a day and time, the participant has the option to send a text message to themselves reminding them to take the first step. The participant can then choose to work on another value, print their plan or select another module.
Intervention code [1] 313039 0
Behaviour
Comparator / control treatment
Wait list control / Treatment as usual (TAU) at the participating health service until the 3-month control period is complete.
TAU will involve referral to online harm-minimisation information and contact details for alcohol and other drugs treatment services, including those offered by the participating Aboriginal health services.
Control group
Active

Outcomes
Primary outcome [1] 308271 0
Methamphetamine use over the past 4 weeks measured using the relevant item from the Australian Treatment Outcome Profile (Ryan et al., 2014)
Timepoint [1] 308271 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [1] 355084 0
General- and Actual- Help-seeking Questionnaires (Wilson et al., 2005 & Rickwood et al., 2005)
Timepoint [1] 355084 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [2] 355085 0
Readiness to Change Questionnaire (Rollnick et al., 1992)
Timepoint [2] 355085 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [3] 355086 0
Poly-drug use: Alcohol, Smoking, Substance Involement Screening Test (Humeniuk et al, 2010)
Timepoint [3] 355086 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [4] 355087 0
Severity of Dependence Scale (Gossop et al., 1995)
Timepoint [4] 355087 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [5] 355088 0
Psychological Distress (Kessler 10 - Kessler et al., 2002)
Timepoint [5] 355088 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [6] 355089 0
Days out of role role- referencing methamphetamine use rather than depression (Kessler, 1997)
Timepoint [6] 355089 0
Baseline, 1 month, 2 months, 3 months.
Secondary outcome [7] 355090 0
Feasibility / Useabiltiy / acceptabiliy- the Internet Intervention Adherence Questionnaire (Ritterband et al., 2008) which includes optional free-text to report any criticisms or other feedback.

Feasibility of the WBTI will be further assessed overall by demographics of participants, number of participants who complete the program, general uptake of the WBTI.

Qualitative interviews with health service staff and at least two WBTI users will be conducted to explore positive and negative experiences. Health service contact resulting from the online program will be verified via health service records.
Timepoint [7] 355090 0
1 month
Secondary outcome [8] 365583 0
Health service contact resulting from the online program will be verified via health service records.
Timepoint [8] 365583 0
2 months

Eligibility
Key inclusion criteria
Aboriginal and Torres Strait Islander
Used methamphetamine at least weekly over the past 3 months.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 16 years
Not using methamphetamine



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)
Central randomisation by computer will be employed. The randomization scheme has been developed by a statistician who is not involved with study participants. Subjects will be randomly allocated to the WBTI or the wait list with 1:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers has been generated using the statistical software Stata 14.0 (College Station, TX) or higher version.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control.
Control group offered treatment as usual for the study period, then have access to the treatment program following 3 month follow-up.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An intention-to-treat analysis will compare the primary and secondary outcomes for the intervention vs. placebo conditions at baseline, 1 month, 2 months and 3 months. Main effects will be evaluated using a mixed effect models that accounts for site-specific clustering effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC
Recruitment postcode(s) [1] 25195 0
4510 - Caboolture
Recruitment postcode(s) [2] 25196 0
0820 - Darwin
Recruitment postcode(s) [3] 25197 0
5290 - Mount Gambier
Recruitment postcode(s) [4] 25198 0
5606 - Port Lincoln
Recruitment postcode(s) [5] 25199 0
3630 - Shepparton
Recruitment postcode(s) [6] 25200 0
2650 - Wagga Wagga
Recruitment postcode(s) [7] 25201 0
2541 - Nowra
Recruitment postcode(s) [8] 25202 0
6701 - Carnarvon

Funding & Sponsors
Funding source category [1] 300783 0
Government body
Name [1] 300783 0
National Health and Medical Research Council
Address [1] 300783 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 300783 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide, SA, 5000

PO Box 11060
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 300331 0
None
Name [1] 300331 0
Address [1] 300331 0
Country [1] 300331 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301567 0
Aboriginal Health Council of South Australia Human Research Ethics Committee
Ethics committee address [1] 301567 0
220 Franklin St, Adelaide SA 5000
Ethics committee country [1] 301567 0
Australia
Date submitted for ethics approval [1] 301567 0
25/01/2019
Approval date [1] 301567 0
Ethics approval number [1] 301567 0
Ethics committee name [2] 302209 0
Flinders University Social and Behavioural Research Ethics Committee (SBREC)
Ethics committee address [2] 302209 0
Sturt Rd, Bedford Park SA 5042
Ethics committee country [2] 302209 0
Australia
Date submitted for ethics approval [2] 302209 0
21/01/2019
Approval date [2] 302209 0
Ethics approval number [2] 302209 0
Ethics committee name [3] 302210 0
Aboriginal Health and Medical Research Council Human Research Ethics Committee
Ethics committee address [3] 302210 0
Level 3, 66 Wentworth Ave
Surry Hills, NSW, 2010
Ethics committee country [3] 302210 0
Australia
Date submitted for ethics approval [3] 302210 0
22/01/2019
Approval date [3] 302210 0
Ethics approval number [3] 302210 0
Ethics committee name [4] 302211 0
Menzies School of Health Research Human Research Ethics Committee
Ethics committee address [4] 302211 0
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
Darwin, 0811

PO Box 41096
Casuarina NT 0811
Ethics committee country [4] 302211 0
Australia
Date submitted for ethics approval [4] 302211 0
27/02/2019
Approval date [4] 302211 0
Ethics approval number [4] 302211 0
Ethics committee name [5] 302212 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [5] 302212 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [5] 302212 0
Australia
Date submitted for ethics approval [5] 302212 0
19/02/2019
Approval date [5] 302212 0
Ethics approval number [5] 302212 0
Ethics committee name [6] 302213 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [6] 302213 0
450 Beaufort Street
Highgate
Western Australia 6003
Ethics committee country [6] 302213 0
Australia
Date submitted for ethics approval [6] 302213 0
08/02/2019
Approval date [6] 302213 0
Ethics approval number [6] 302213 0

Summary
Brief summary
Methamphetamine use is of deep concern in Aboriginal and Torres Strait Islander communities but access to culturally appropriate treatment resources and services is limited. The 'We Can Do This' web-based therapeutic intervention (WBTI) is designed to incorporate evidence-based therapies in a culturally-relevant format using narratives from Aboriginal people to contextualise the therapeutic content. The effectiveness of the WBTI will be tested in a wait-list control, randomised trial across multiple sites in urban, regional and remote locations. Participants will be Aboriginal and Torres Strait Islander people aged 16 or over recruited online and via health services. The primary outcome measure will be the number of days when the participant used methamphetamine during the treatment phase. Secondary outcomes will include readiness to change, help-seeking, severity of dependence, psychological distress and health service access. Assessment will occur at baseline, 1 month, 2 months and 3 months. If successful, the ‘We Can Do this’ WBTI will increase the range of options available to Aboriginal people seeking to reduce or stop methamphetamine use. It will provide health practitioners with a culturally-appropriate, evidence-based resource to use with clients, and may provide a pathway into treatment for people who may otherwise be disengaged with health services for a range of reasons.
Trial website
TBA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87410 0
A/Prof James Ward
Address 87410 0
South Australian Health and Medical Research Institute
North Terrace
Adelaide, SA, 5000
Country 87410 0
Australia
Phone 87410 0
+61 439605227
Fax 87410 0
Email 87410 0
james.ward@sahmri.com
Contact person for public queries
Name 87411 0
Dr Rachel Reilly
Address 87411 0
South Australian Health and Medical Research Institute
North Terrace
Adelaide, SA, 5000
Country 87411 0
Australia
Phone 87411 0
+61416119129
Fax 87411 0
Email 87411 0
rachel.reilly@sahmri.com
Contact person for scientific queries
Name 87412 0
Dr Rachel Reilly
Address 87412 0
South Australian Health and Medical Research Institute
North Terrace
Adelaide, SA, 5000
Country 87412 0
Australia
Phone 87412 0
+61416119129
Fax 87412 0
Email 87412 0
rachel.reilly@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results will be shared.
When will data be available (start and end dates)?
Data will be available immediately following publication and ending 5 years following main results publication.
Available to whom?
Data will be available on a case-by-case basis at the discretion of the primary sponsor.
Available for what types of analyses?
Data will be available for analyses that achieve the aims in the proposed protocol, or for IPD meta-analyses.
How or where can data be obtained?
Data access will be subject to approvals by Principal Investigator and there will be a requirement to sign data access agreement in line with the data management protocols of the primary sponsor.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1198 0
Study protocol
Citation [1] 1198 0
Link [1] 1198 0
Email [1] 1198 0
Other [1] 1198 0
Summary results
No Results