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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)

Scientific title

Feasibility and Acceptability of Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ACT for ICE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Methamphetamine Use Disorder

Condition category

Condition code

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Behaviour

Comparator / control treatment

There is no control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility

Timepoint [1]

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.

Primary outcome [2]

Acceptability

Timepoint [2]

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.

Secondary outcome [1]

Preliminary Effectiveness

Timepoint [1]

Baseline, Final Session, 3 month follow up post final session

Secondary outcome [2]

Interventional Change

Timepoint [2]

Baseline, final session, 3 month follow up post final session

Secondary outcome [3]

Preliminary Effectiveness

Timepoint [3]

Baseline, Final Session, 3 month follow up post final session

Secondary outcome [4]

Preliminary Effectiveness

Timepoint [4]

Randomly generated schedule throughout the duration of the intervention from baseline to final intervention session (approx. 8 weeks).

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

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

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

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2025

Actual

Date of last participant enrolment

Anticipated

31/07/2026

Actual

Date of last data collection

Anticipated

30/11/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Tasmanian Department of Health

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Tasmania

Address

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Tasmanian Department of Health

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Tasmania Human Research Ethics Committee

Ethics committee address [1]

http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/05/2025

Approval date [1]

30/05/2025

Ethics approval number [1]

31653

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Castle

Address

The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000

Country

Australia

Phone

+61 04 55049903

Fax

[email protected]

Contact person for public queries

Name

Eleanor Vincent

Address

The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000

Country

Australia

Phone

+61 04 55049903

Fax

[email protected]

Contact person for scientific queries

Name

Eleanor Vincent

Address

The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000

Country

Australia

Phone

+61 04 55049903

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

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.

Trial Review

Documents added manually

Documents added automatically