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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000690459
Ethics application status
Approved
Date submitted
26/05/2025
Date registered
30/06/2025
Date last updated
30/06/2025
Date data sharing statement initially provided
30/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)
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Scientific title
Feasibility and Acceptability of Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)
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Secondary ID [1]
314492
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None
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Universal Trial Number (UTN)
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Trial acronym
ACT for ICE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder
337536
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Condition category
Condition code
Mental Health
333898
333898
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Recovery and Support Program (RaSP) is 45 sessions long, with 3 sessions covered twice per week over 8 weeks. Each session runs for approximately 1-hour comprising of activities, games and breaks. Some topics covered in the intervention include Present Moment Awareness, Acceptance, Defusion, Values, Committed Action and Self-as-Context. Participants receive a participant manual that they will work through and reference throughout the duration of the program. This manual has been designed for the trial and is not publicly available. The program structure has been adapted for individual delivery in a face to face format. Facilitators will be alcohol and drug clinicians with relevant experience working with individuals using methamphetamine. Adherence to the sessions will be monitored through attendance, participation and engagement.
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Intervention code [1]
331116
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Behaviour
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Comparator / control treatment
There is no control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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The following feasibility measures will be assessed together as a composite outcome: - Consent obtained as measured by an audit of study records. - Sessions attended as measured by an analysis of study database Session rating scale (SRS) as measures by an analysis of study database - Qualitive interviews with participants and staff exploring satisfaction, engagement, motivation, barriers and enablers. The qualitative interviews will be between 30mins-1hr, open-ended, one on one, audio-recorded and transcribed.
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Timepoint [1]
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consent obtained - end of study period session attendance - collected for the duration of the intervention from baseline SRS - collected for the duration of the intervention from baseline Qualitative interviews - completed between completion of the intervention and 3-month follow up post final session for participants and at the conclusion of the trial period for staff.
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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The following acceptability measures will be assessed together as a composite outcome: - Completeness of data as determined by session attendance and completion of screening, baseline, intervention and outcome measures via an analysis of the study database. - Qualitive interviews with participants and staff exploring satisfaction, engagement, motivation, barriers and enablers. The qualitative interviews will be between 30mins-1hr depending on participant capacity, open-ended, one on one, audio-recorded and transcribed.
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Timepoint [2]
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Completeness of data assessed at the end of the intervention period for each participant qualitative interviews completed between completion of the intervention and 3-month follow up post final session for participants and at the conclusion of the trial period for staff.
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Secondary outcome [1]
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Preliminary Effectiveness
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Assessment method [1]
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Time Line Follow Back (TLFB)
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Timepoint [1]
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Baseline, Final Session, 3 month follow up post final session
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Secondary outcome [2]
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Interventional Change
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Assessment method [2]
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Acceptance and Action Questionnaire for Substance Abuse (AAQ-SA)
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Timepoint [2]
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Baseline, final session, 3 month follow up post final session
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Secondary outcome [3]
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Preliminary Effectiveness
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Assessment method [3]
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Australian Treatment Outcomes Profile (ATOP)
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Timepoint [3]
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Baseline, Final Session, 3 month follow up post final session
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Secondary outcome [4]
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Preliminary Effectiveness
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Assessment method [4]
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Oral Fluid Testing (Drug Wipes)
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Timepoint [4]
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Randomly generated schedule throughout the duration of the intervention from baseline to final intervention session (approx. 8 weeks).
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Eligibility
Key inclusion criteria
All participants must be over the age of 18.
Meet DSM-5 criteria for primary Methamphetamine Use Disorder, moderate or severe as determined by a member of the research team.
Be female, non-binary, or woman-identifying (i.e., trans-women included)
Must be deemed to have capacity to provide informed consent and to follow study instructions and procedures (determined by the clinical judgement of program staff and the MOCA).
Ability to understand the PICF
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
If the individual needs acute psychiatric care or has an unstable psychiatric condition (e.g., for suicidality or acute psychosis) that would reasonably prevent them from engaging in and/or benefiting from the intervention.
If the individual needs acute care for intoxication or in need of medically supervised detoxification that would reasonably prevent them from engaging in and/or benefiting from the intervention.
If the individual has a cognitive impairment that would reasonably prevent them from engaging in and/or benefiting from the intervention
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
31/07/2026
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Actual
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Date of last data collection
Anticipated
30/11/2026
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Tasmanian Department of Health
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Tasmania
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Tasmanian Department of Health
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Address [1]
321496
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Country [1]
321496
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317640
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University of Tasmania Human Research Ethics Committee
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Ethics committee address [1]
317640
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http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu
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Ethics committee country [1]
317640
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Australia
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Date submitted for ethics approval [1]
317640
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16/05/2025
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Approval date [1]
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30/05/2025
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Ethics approval number [1]
317640
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31653
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Summary
Brief summary
The ACT for ICE project uses an Acceptance and Commitment Therapy based intervention called the Recovery and Support Program (RaSP) to support women with a diagnosis of methamphetamine use disorder. The purpose of this study is to look at how well the RaSP program works in alcohol and drug treatment. This will include looking at how many people participate, their scores on some questionnaires, what they liked and did not like about the program, whether they can think more flexibly after completing the program and whether they are using less methamphetamine.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof David Castle
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Address
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The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
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Country
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Australia
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Phone
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+61 04 55049903
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Eleanor Vincent
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Address
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The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
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Country
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Australia
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Phone
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+61 04 55049903
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
141660
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Eleanor Vincent
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Address
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The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
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Country
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Australia
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Phone
141660
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+61 04 55049903
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Fax
141660
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Email
141660
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
Letter of Approval.pdf
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.
Download to PDF