Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
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
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000925448
Ethics application status
Approved
Date submitted
15/08/2025
Date registered
25/08/2025
Date last updated
25/08/2025
Date data sharing statement initially provided
25/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Piloting a tailored telehealth program for managing stimulant use in traumatic brain injury
Query!
Scientific title
A pilot randomised controlled trial of bioSocial Cognitive model of Occupational Functioning (biSCOF) therapy for stimulant use disorder in individuals with traumatic brain injury
Query!
Secondary ID [1]
315138
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stimulant Use Disorder
338565
0
Query!
Traumatic Brain Injury
338566
0
Query!
Condition category
Condition code
Mental Health
334867
334867
0
0
Query!
Addiction
Query!
Neurological
334868
334868
0
0
Query!
Other neurological disorders
Query!
Injuries and Accidents
334869
334869
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment comprises 10 x 1hr weekly telehealth sessions with a psychologist and occupational therapist (week 1-10), followed by 2 x 1hr booster sessions occurring in weeks 14 and 18. The treatment is a synthesis of cognitive behaviour therapy (CBT) and occupational therapy with co-designed optimisation for individuals with a brain injury and substance use disorder (Gullo & Gullo, 2024, Diagrammatic representation of the bioSocial Cognitive model of Occupational Functioning (biSCOF) - substance use. doi:10.6084/m9.figshare.27713220). The treatment addresses person and environment factors involved in stimulant use and helps individuals develop effective coping strategies for them to facilitate pursuit of goals and strengthen confidence in the ability to control their stimulant use (i.e., refusal self-efficacy). Therapists will develop a collaborative relationship with participants (and carers) to work together as a team to modify personal and environmental factors that lead to stimulant use and impede occupational performance and participation. Therapists express empathy and reinforce participant autonomy in sessions, while having a structured agenda.
Key elements will include craving management, learning to identify and manage high-risk situations for using (e.g., high anxiety, social pressure), learning to identify and modify exaggerated positive expectations of stimulant use (e.g., “Only stimulants can…reduce my anxiety” or “...make a party fun”), motivational enhancement, and increasing non-substance related activities. Consistent with gold-standard CBT for substance use disorder manuals (e.g., Carroll, A cognitive-behavioral approach: Treating cocaine addiction, U.S. Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 1998; Kadden, R., Carrol, K., Donovan, D., Cooney, N., Monti, P., Abrams, D., Litt, M., & Hester, R. (1995). Cognitive-behavioral Coping Skills Therapy Manual: A Clinical Research Guide for Therapists Treating Individuals with Alcohol Abuse and Dependence. National Institute on Alcohol Abuse and Alcoholism. NIH Publication No. 94–3724), the beginning phase of intervention will involve case formulation, assessment and personalised feedback, and psychoeducation (sessions 1-4). It will also include immediate strategies to reduce access to substances and stimulus control (i.e., removing craving triggers). The second phase will involve a personalised sequence of modules that is based on the case formulation (e.g., managing unhelpful thoughts, craving management) and participation goals (sessions 5-9). The final phase focuses on long-term relapse prevention and maintaining progress towards participation goals (session 10).
In addition to utilising saliva drug tests to validate participants are not intoxicated during treatment or assessment sessions, financial reinforcement of negative (“clean”) saliva tests will be incorporated into the intervention, i.e., Contingency Management. Each session will involve an on-camera saliva drug test to confirm self-report of substance use/abstinence and facilitate rescheduling of sessions for intoxicated participants. In order to better accommodate and support the remote, telehealth delivery of the 10-week intervention, additional twice weekly check-in video calls will be made to observe an on-camera drug saliva test. Participants will be asked to self-administer and share results of the oral fluid testing device by positioning it in front of the camera used for synchronous video during the telehealth session. Participants will receive AUD$15 per negative (“clean”) test result and, after three in a row, earn a bonus AUD$10 (i.e., maximum AUD$55 per week per participant). Amounts are in line with existing evidence and our co-design input from consumers (Gullo et al., in preparation; Clay et al., 2023; Ronsley et al., 2020). Incentives will be provided in the form of gift vouchers.
Treatment sessions will be videotaped for review in therapist supervision to assist in maintaining fidelity (fortnightly, provided by senior psychologist researcher). Participants may refuse to have their sessions recorded during the informed consent process or at any time without comment or penalty. Participants may also ask to pause the recording at any time during sessions if there are some parts of the session that they do not want recorded. For reporting purposes, a random session will be selected each month for fidelity rating by a member of the research team (greater than or equal to 15% sessions rated).
Query!
Intervention code [1]
331763
0
Treatment: Other
Query!
Intervention code [2]
331764
0
Behaviour
Query!
Comparator / control treatment
Wait-list control group who will receive the intervention after 37 weeks.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
342495
0
Methamphetamine Use
Query!
Assessment method [1]
342495
0
Change in methamphetamine use frequency (percentage days used) measured by the Time Line Follow Back (TLFB) interview schedule that uses a timeframe of the past 28 days
Query!
Timepoint [1]
342495
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Primary outcome [2]
342496
0
Severity of Stimulant Use Disorder
Query!
Assessment method [2]
342496
0
Change in DSM-5 Stimulant Use Disorder criteria count and severity level (calculated by criteria count) as measured by the Research Version of the Structured Clinical Interview for the DSM-5 (SCID-5-RV), using a timeframe of the past 30 days [Kiluk, B. D., Frankforter, T. L., Cusumano, M., Nich, C., & Carroll, K. M. (2018). Change in DSM-5 Alcohol Use Disorder Criteria Count and Severity Level as a Treatment Outcome Indicator: Results from a Randomized Trial. Alcoholism, Clinical and Experimental Research. https://doi.org/10.1111/acer.13807].
Query!
Timepoint [2]
342496
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Primary outcome [3]
342497
0
Community participation
Query!
Assessment method [3]
342497
0
Changes in scores on the Participation Index of the Mayo-Portland Adaptability Inventory-4 (M2PI) to reflect participants' changes in community participation.
Query!
Timepoint [3]
342497
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [1]
451042
0
Quality of Life
Query!
Assessment method [1]
451042
0
Change in scores on Assessment of Quality of Life-8D (AQoL-8D)
Query!
Timepoint [1]
451042
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [2]
451043
0
Self-reported social participation
Query!
Assessment method [2]
451043
0
Change in scores on Neuro-QoL: Ability to Participate in Social Roles and Activities – Short Form
Query!
Timepoint [2]
451043
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [3]
451044
0
Caregiver-reported social participation
Query!
Assessment method [3]
451044
0
Change in scores on Neuro-QoL: Ability to Participate in Social Roles and Activities – Short Form
Query!
Timepoint [3]
451044
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [4]
451045
0
Self-reported wellbeing
Query!
Assessment method [4]
451045
0
Change in scores on Neuro-QoL: Positive Affect and Wellbeing - Short Form
Query!
Timepoint [4]
451045
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [5]
451046
0
Caregiver-reported wellbeing
Query!
Assessment method [5]
451046
0
Change in scores on Neuro-QoL: Positive Affect and Wellbeing - Short Form
Query!
Timepoint [5]
451046
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [6]
451047
0
Depression
Query!
Assessment method [6]
451047
0
Change in scores on DASS-21 Depression Subscale (7 items)
Query!
Timepoint [6]
451047
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [7]
451048
0
Anxiety
Query!
Assessment method [7]
451048
0
Change in scores on the Generalised Anxiety Disorder Assessment (GAD-7)
Query!
Timepoint [7]
451048
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [8]
451049
0
Reward Drive
Query!
Assessment method [8]
451049
0
Change in scores on Sensitivity to Reward Scale - Short Form
Query!
Timepoint [8]
451049
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [9]
451050
0
Rash Impulsiveness
Query!
Assessment method [9]
451050
0
Change in scores on the I7 (Impulsiveness) scale
Query!
Timepoint [9]
451050
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [10]
451051
0
Occupational Performance and Participation
Query!
Assessment method [10]
451051
0
Change in scores on the Canadian Occupational Performance Measure (COPM).
Query!
Timepoint [10]
451051
0
Assessment will be conducted by the Occupational Therapist in Session 1, 10 and 12 (Week 1, 10 and 18).
Query!
Secondary outcome [11]
451052
0
Past-week methamphetamine use
Query!
Assessment method [11]
451052
0
Change in frequency (days used) of methamphetamine use will be measured by the Time Line Follow Back (TLFB) interview schedule that uses a timeframe of the past 7 days.
Query!
Timepoint [11]
451052
0
Every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only)
Query!
Secondary outcome [12]
451053
0
Recent methamphetamine use
Query!
Assessment method [12]
451053
0
OnSite Diagnostics Saliva Check Advanced 6/Saliva Swipe 8 Advanced
Query!
Timepoint [12]
451053
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36). Plus, 3 times per week during the 10-week treatment period: Weeks 1-10 (Treatment group only).
Query!
Secondary outcome [13]
451054
0
Craving
Query!
Assessment method [13]
451054
0
5-item Craving Experience Questionnaire-Frequency, Stimulant (CEQ-FS)
Query!
Timepoint [13]
451054
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36). Plus, every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only).
Query!
Secondary outcome [14]
451055
0
Stimulant Refusal Self-Efficacy
Query!
Assessment method [14]
451055
0
Change in scores on Stimulant Refusal Self-Efficacy Questionnaire (SRSEQ)
Query!
Timepoint [14]
451055
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36). Plus, every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only).
Query!
Secondary outcome [15]
451056
0
Positive stimulant expectancies
Query!
Assessment method [15]
451056
0
Change in scores on Stimulant Effect Expectancy Questionnaire modified for ABI (SEEQ-ABI)
Query!
Timepoint [15]
451056
0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [16]
451057
0
Acceptability of Intervention
Query!
Assessment method [16]
451057
0
Score on Acceptability of Intervention Measure (AIM)
Query!
Timepoint [16]
451057
0
Treatment Group only at Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [17]
451058
0
Intervention Appropriateness
Query!
Assessment method [17]
451058
0
Score on Intervention Appropriateness Measure (IAM)
Query!
Timepoint [17]
451058
0
Treatment Group only at Post-Treatment (Week 11), Follow-Up (Week 36).
Query!
Secondary outcome [18]
451059
0
Telehealth Feasibility
Query!
Assessment method [18]
451059
0
Scores on Telehealth Usability Questionnaire (TUQ)
Query!
Timepoint [18]
451059
0
Treatment Group only at Post-Treatment (Week 11)
Query!
Eligibility
Key inclusion criteria
Participants will have a traumatic brain injury (TBI), be aged greater than or equal to 18 years, and meet criteria for a DSM-5-TR Stimulant Use Disorder and seeking to reduce their methamphetamine use. Participants must have the capacity to provide informed consent without a substitute decision maker.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Undergoing other substance use treatment at the time of enrolling in the trial (including pharmacotherapy for substance use disorders), pregnancy, a diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder). If an alcohol user and highly dependent on alcohol or drinking >700gm ethanol/week, or engaged in other substance use that may require medical assessment prior to treatment, they will obtain a physical assessment and agree to any medical treatment required. Other exclusions are insufficient English to read or converse without translation, insufficient cognitive ability to complete questionnaires and therapy tasks (even with carer assistance), unmodified hearing impairment, acute current suicidality, and insufficient technology to access and participate in video telehealth sessions.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially Numbered Opaque Sealed Envelopes
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random allocation. Random permutations, stratifying for gender, will be generated by the Random Allocation Software to ensure balanced groups [Saghaei, M. (2004). Random allocation software for parallel group randomized trials. BMC Medical Research Methodology, 4, 26. https://doi.org/10.1186/1471-2288-4-26].
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/10/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
10
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Funding & Sponsors
Funding source category [1]
319715
0
Government body
Query!
Name [1]
319715
0
National Injury Insurance Scheme, Queensland (NIISQ)
Query!
Address [1]
319715
0
Query!
Country [1]
319715
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Griffith University
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
322223
0
Individual
Query!
Name [1]
322223
0
Associate Professor Matthew Gullo, Princess Alexandra Hospital
Query!
Address [1]
322223
0
Query!
Country [1]
322223
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
318268
0
Metro South Human Research Ethics Committee
Query!
Ethics committee address [1]
318268
0
https://www.metrosouth.health.qld.gov.au/research/research-ethics-and-governance/human-research-ethics-committee
Query!
Ethics committee country [1]
318268
0
Australia
Query!
Date submitted for ethics approval [1]
318268
0
12/06/2025
Query!
Approval date [1]
318268
0
14/08/2025
Query!
Ethics approval number [1]
318268
0
Query!
Summary
Brief summary
This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, telehealth intervention to individuals with a stimulant use disorder and traumatic brain injury. It aims to generate exploratory data on treatment engagement, change in stimulant use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
143646
0
A/Prof Matthew Gullo
Query!
Address
143646
0
School of Applied Psychology, Griffith University, Brisbane South (Mt Gravatt), 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
143646
0
Australia
Query!
Phone
143646
0
+61 737351069
Query!
Fax
143646
0
Query!
Email
143646
0
[email protected]
Query!
Contact person for public queries
Name
143647
0
Matthew Gullo
Query!
Address
143647
0
School of Applied Psychology, Griffith University, Brisbane South (Mt Gravatt), 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
143647
0
Australia
Query!
Phone
143647
0
+61 737351069
Query!
Fax
143647
0
Query!
Email
143647
0
[email protected]
Query!
Contact person for scientific queries
Name
143648
0
Matthew Gullo
Query!
Address
143648
0
School of Applied Psychology, Griffith University, Brisbane South (Mt Gravatt), 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
143648
0
Australia
Query!
Phone
143648
0
+61 737351069
Query!
Fax
143648
0
Query!
Email
143648
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires a scientifically sound proposal or protocol
•
Requires approval by an ethics committee
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
15
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
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