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Trial registered on ANZCTR


Registration number
ACTRN12617000873325
Ethics application status
Approved
Date submitted
26/05/2017
Date registered
15/06/2017
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Holyoake's Methamphetamine Programs In Reducing Drug-Related Harms
Scientific title
An Evaluation of Holyoake's Methamphetamine Programs In Reducing Drug-Related Harms In Adults
Secondary ID [1] 291999 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine dependnence 303361 0
Drug-related harms 303362 0
Condition category
Condition code
Mental Health 302787 302787 0 0
Addiction
Public Health 302788 302788 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those in the intervention arm will receive counselling based on cognitive behaviour therapy (drawing on the approaches of Baker et al 2003 “A Brief Cognitive Behavioural Intervention for Regular Amphetamine Users” and Lee et al 2007 Turning Point clinical guidelines on “Methamphetamine dependence and treatment”). The intervention is delivered face-to-face and is a combination of individual counselling and / or group counselling sessions. The program will typically offer weekly contact, with 60 minute sessions as required, although initial sessions may be shorter if the cognitive deficits commonly found during methamphetamine withdrawal necessitate shorter sessions. The first 4 sessions are based on the Baker 2003 manual and cover commitment to change, coping with cravings, controlling thoughts and relapse prevention. Subsequent sessions have greater flexibly based on client needs. The total number of sessions will be based on the counsellors experience and clients requirements, with the expected minimum duration of treatment being 1 month to a maximum of 6 months.
Assertive follow-up occurs in standard care for those who opt to receive this: in the new intervention, assertive follow-up is a constituent part of the new intervention and will be used to contact those who relapse or drop out of treatment early. Staff will attempt to contact clients after any missed sessions both through their own telephone number and also numbers of family members provided by the client as contact points.
Those in the intervention arm, but not the control group, will also be offered and have access to additional services facilitated. These include an in-house clinician (GP) and clinical nurse with alcohol and other drug expertise to treat both general health and specific drug related problems. Holyoake will also undertake intensive case management to link people with other key services such as accommodation, legal and employment services as required. All of these additional services will be offered as required, based on the individual decision of the counsellor and client during treatment. Peer- and family-support workers will also be available outside counselling sessions to encourage engagement with the service and to model self-advocacy and empowerment. Family support workers provide these services to family and significant others of the client.
Other than the number and type of sessions, plus use of additional services, fidelity of intervention content is not evaluated. However, clinical review of cases by the counselling team will occur after session 4 to consider the progress to date and future direction for each case plus any other services required. Each client is subsequently reviewed every 4-6 weeks thereafter.
Counselling is delivered in a clinic setting. All counsellors (in both the active and control arms) have relevant tertiary qualifications (e.g. Psychology, Counselling, Social Work) and are experienced alcohol and other drug counsellors.
Intervention code [1] 298120 0
Behaviour
Intervention code [2] 298208 0
Treatment: Other
Comparator / control treatment
Active control - participants receive treatment as usual which is a combination of individual counselling and / or group counselling sessions. Counsellors draw on a range of established therapeutic approaches including motivational interviewing, CBT and social learning theory delivered typically over 6 to 12 sessions of about 60 minutes per session. Sessions are typically delivered once per week, with the exact number of sessions determined by clinical need assessed by the counsellor and client.
Control group
Active

Outcomes
Primary outcome [1] 302174 0
The primary outcome measure is the change in the number of symptoms endorsed under stimulant related problems in the Composite International Diagnostic Interview. Reference period "last 30 days"
Timepoint [1] 302174 0
Baseline, four weeks and six months
Primary outcome [2] 302198 0
Change in Kessler-10 score
Timepoint [2] 302198 0
Baseline, four weeks and six months
Secondary outcome [1] 335075 0
Change in Family Assessment Device score
Timepoint [1] 335075 0
Baseline, four weeks and six months
Secondary outcome [2] 335076 0
Change in scores on the Personal Wellbeing Index
Timepoint [2] 335076 0
Baseline, four weeks and six months
Secondary outcome [3] 335077 0
Change in the Alcohol, Smoking and Substance Involvement Screening Test score (items on last 3 months use)
Timepoint [3] 335077 0
Baseline, four weeks and six months
Secondary outcome [4] 335078 0
Descriptive data on major adverse events. These data will include details on hospital admissions, emergency department presentations and deaths.
NB Assessing the WA Data Linkage System requires a second consent from study participants: these data will only be available for those who give this second consent..
NB Funding has yet to be obtained for this outcome.
Timepoint [4] 335078 0
Baseline to 12 months (all events over this period)
Secondary outcome [5] 335079 0
Self-esteem (single item 5 point likert scale)
Timepoint [5] 335079 0
Baseline, four weeks and six months
Secondary outcome [6] 335155 0
Change in social indicators: Housing status
Timepoint [6] 335155 0
Baseline, four weeks and six months
(study specific question
Has your housing situation
Got better 1
Stayed the same 2
Got worse 3)
Secondary outcome [7] 335362 0
Change in social indicators: employment
Timepoint [7] 335362 0
Baseline, four weeks and six months
(study specific question
Has your employment situation
Got better 1
Stayed the same 2
Got worse 3)
Secondary outcome [8] 335363 0
Change in social indicators: financial status
Timepoint [8] 335363 0
Baseline, four weeks and six months
(study specific question
Has your financial situation
Got better 1
Stayed the same 2
Got worse 3)

Eligibility
Key inclusion criteria
To be eligible for entry into the research project, participants must be aged 18 years or older or if aged 16-17 years can enter the study with just their consent if they have been deemed as mature minors by Juvenile Justice. In addition, they must report methamphetamine as their primary drug of concern or significant methamphetamine use disclosed during initial counselling sessions, have either a mobile phone, a landline phone or arrange telephone access at clinic. Clients must be new to the service or not have received service from Holyoake in the last one month. Due to the difficulty of retaining them in treatment and research, not currently experiencing acute mental health issues..
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not currently receiving key types of pharmacotherapy (e.g. naltrexone, bupropion/Zyban, modafinil, or mirtazapine which are currently under investigation for methamphetamine dependence), or receiving any other treatment for stimulant use (e.g. alcohol or other drug counselling from another service).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no effective concealment. Participants are recruited at separate clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable, based on study site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intervention participants are drawn from one clinical site: control participants from two clinical sites in the same geographical region.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The main analyses will use a multi-level mixed effects regression model with a random intercept term. This will control for clustering of variance within individuals over the repeated measures and clinic site. The main analysis will assess the group (new versus standard program) by time (baseline, 4 week and 6 months) change in i) CIDI score and ii) change in K-10 score.
The sample size was determined for 3 time points (baseline, 1 and 6 months) to test a between group (new versus standard program) interaction. Using G power, with a small to medium effect size (f=0.15), alpha 0.05, to achieve a power of 0.8 requires a total of 74 people. However, because of the clustered design, the effective sample size is reduced. If we recruited 120 people across the three clusters with an intra cluster correlation of 0.01, the effective sample size would be equivalent to a study with 75 people. In terms of K-10 scores this equates to a difference in means of 3 (SD=8).

However, some outcomes, such as change in employment status or housing status may be rare and will probably just be presented as descriptive data: if possible, we will model these outcomes using generalized estimating equations with multinomial logistic regression (e.g. improved: stable: declined).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/07/2017
Actual
26/06/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
5/06/2018
Date of last data collection
Anticipated
6/12/2018
Actual
Sample size
Target
120
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8194 0
Holyoake Northam - Northam
Recruitment hospital [2] 8195 0
Holyoake Merredin - Merredin
Recruitment hospital [3] 8196 0
Holyoake Narrogin - Narrogin
Recruitment postcode(s) [1] 16141 0
6401 - Northam
Recruitment postcode(s) [2] 16142 0
6415 - Merredin
Recruitment postcode(s) [3] 16143 0
6312 - Narrogin
Recruitment postcode(s) [4] 16144 0
6510 - Moora

Funding & Sponsors
Funding source category [1] 296513 0
Other
Name [1] 296513 0
Western Australian Primary Health Alliance
Country [1] 296513 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia 6102
Postal address
GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 295475 0
None
Name [1] 295475 0
Address [1] 295475 0
Country [1] 295475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297734 0
Curtin University
Ethics committee address [1] 297734 0
Kent Street, Bentley, Perth, Western Australia 6102
Postal address
GPO Box U1987, Perth WA 6845
Ethics committee country [1] 297734 0
Australia
Date submitted for ethics approval [1] 297734 0
25/05/2017
Approval date [1] 297734 0
14/06/2017
Ethics approval number [1] 297734 0
approval recived

Summary
Brief summary
The study aims to evaluate an evidence based approach to the design of a new treatment service for users of methamphetamine. Traditionally, services were designed for heroin or alcohol using clients who have different treatment needs and problems to methamphetamine users. Holyoake will implement an intensive case management model including medical, peer and family support for methamphetamine users at one site (Northam) but will offer its standard service at other regional sites (Narrogin and Merredin). We will compare outcomes for the new and standard programs (target to recruit 120 people in total) in terms of changes in substance use, mental health, wellbeing and social indicators (i.e. employment and housing status). Participants will be followed up by telephone at 4 weeks and 6 months and by record linkage at 12 months. We hypothesize that those receiving the intensive intervention will show greater improvement in key measures that the standard care group. We also plan telephone interviews with a close family member (e.g. partner, parent) to evaluate improved wellbeing for that person.
Trial website
none
Trial related presentations / publications
none
Public notes
Postcodes listed are indicative of the target area and not an exhaustive list - e.g. these are not part of the exclusion criteria.
We also plan to interviewing a significant other (e.g. family member or partner) of each participant to assess change in K-10, Personal wellbeing, Family assessment device and self-esteem scores at baseline, 4 weeks and 6 months.

Contacts
Principal investigator
Name 74978 0
Dr Robert tait
Address 74978 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102
Post
GPO Box U1987, Perth WA 6845
Country 74978 0
Australia
Phone 74978 0
+61892661610
Fax 74978 0
+61892661611
Email 74978 0
[email protected]
Contact person for public queries
Name 74979 0
Robert Tait
Address 74979 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102
Post
GPO Box U1987, Perth WA 6845
Country 74979 0
Australia
Phone 74979 0
+61892661610
Fax 74979 0
+61892661611
Email 74979 0
[email protected]
Contact person for scientific queries
Name 74980 0
Robert Tait
Address 74980 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102
Post
GPO Box U1987, Perth WA 6845
Country 74980 0
Australia
Phone 74980 0
+61892661610
Fax 74980 0
+61892661611
Email 74980 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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