Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000931471
Ethics application status
Approved
Date submitted
22/07/2025
Date registered
28/08/2025
Date last updated
28/08/2025
Date data sharing statement initially provided
28/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
IMPACT - Internet delivered CBT for methamphetamine
Scientific title
Feasibility of a web-based self-management program ‘IMPACT’ to help adults change their relationship with methamphetamine
Secondary ID [1] 314951 0
None
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 338270 0
Methamphetamine use disorder 338271 0
Condition category
Condition code
Mental Health 334569 334569 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a six-week web-based self-management program called IMPACT, designed to help individuals change their relationship with methamphetamine. The program is grounded in cognitive behavioural therapy (CBT) and includes one pre-lesson and five weekly modules delivered sequentially via a secure online platform.

Each module introduces and builds upon core CBT strategies including motivational enhancement, behavioural activation, cognitive restructuring, and relapse prevention. Content includes psychoeducation, interactive activities, downloadable worksheets, and animated videos tailored to methamphetamine use. Intervention adherence will be monitored through the collection of website analytics and module completion data. Each module will take approximately 30 minutes each day or 3.5 hours total to complete.

The program is self-guided and fully automated. Participants receive email prompts to begin each module and reminders if they do not engage. No clinician involvement is included. A bonus module on sleep hygiene is made available after the main program but is not part of the intervention being formally evaluated.

Feasibility outcomes (including uptake, engagement, safety, and acceptability) and clinical outcomes (e.g. methamphetamine use, cravings, psychological distress) are measured through validated online self-report questionnaires administered at baseline and at six-week follow-up. Qualitative interviews with a subset of participants will further explore feasibility and acceptability.
Intervention code [1] 331554 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342246 0
Program uptake
Timepoint [1] 342246 0
This outcome will be assessed on day 36 after consenting to participate
Primary outcome [2] 342445 0
Acceptability (composite measure including: participant satisfaction, perceived usefulness, and ease-of-use)
Timepoint [2] 342445 0
This outcome will be assessed on day 36 after consenting to participate
Primary outcome [3] 342446 0
Participant safety
Timepoint [3] 342446 0
Assessed on day 8, 15, 22, 29 and 36 following consent to participate
Secondary outcome [1] 450846 0
Completion rates (this is an additional primary outcome)
Timepoint [1] 450846 0
Day 36 following consent to participate
Secondary outcome [2] 450847 0
Drop-out (this is an additional primary outcome)
Timepoint [2] 450847 0
Day 36 following consent to participate
Secondary outcome [3] 450848 0
Pre-post changes in methamphetamine use
Timepoint [3] 450848 0
Baseline, Day 36 following consent to participate
Secondary outcome [4] 450849 0
Pre-post changes in psychological wellbeing
Timepoint [4] 450849 0
Baseline, Day 36 following consent to participate

Eligibility
Key inclusion criteria
Participants are eligible to participate in this study if they:

Are aged 18 or older,
Used methamphetamine at least once in the last month,
Currently reside in Australia,
Have access to a computer with internet access, and
Are willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not meeting all of the inclusion criteria are not eligible to participate. There are no additional exclusion criteria.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319510 0
Other
Name [1] 319510 0
National Centre for Clinical Research on Emerging Drugs (NCCRED)
Country [1] 319510 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 322008 0
None
Name [1] 322008 0
Address [1] 322008 0
Country [1] 322008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318085 0
The University of New South Wales Committee B
Ethics committee address [1] 318085 0
Ethics committee country [1] 318085 0
Australia
Date submitted for ethics approval [1] 318085 0
12/05/2025
Approval date [1] 318085 0
20/06/2025
Ethics approval number [1] 318085 0
iRECS8429

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

Contacts
Principal investigator
Name 143062 0
Dr Kathryn Fletcher
Address 143062 0
UNSW Randwick Campus, 22 - 32 King Street Randwick NSW 2031
Country 143062 0
Australia
Phone 143062 0
+61293482770
Fax 143062 0
Email 143062 0
[email protected]
Contact person for public queries
Name 143063 0
Kathryn Fletcher
Address 143063 0
UNSW Randwick Campus, 22 - 32 King Street Randwick NSW 2031
Country 143063 0
Australia
Phone 143063 0
+61293482770
Fax 143063 0
Email 143063 0
[email protected]
Contact person for scientific queries
Name 143064 0
Kathryn Fletcher
Address 143064 0
UNSW Randwick Campus, 22 - 32 King Street Randwick NSW 2031
Country 143064 0
Australia
Phone 143064 0
+61293482770
Fax 143064 0
Email 143064 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: All participants will be anonymous. Only group data will be used in any analysis or publications.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    IMPACT_ethicsapproval_email.pdf
Informed consent form    [CURRENT] PISCF Clinical Trials v.03.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.