Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000556448p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
30/05/2025
Date last updated
8/06/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting a tailored program for managing alcohol use in acquired brain injury
Scientific title
A pilot randomised controlled trial of bioSocial Cognitive model of Occupational Functioning (biSCOF) therapy for alcohol use disorder in individuals with acquired brain injury
Secondary ID [1] 314231 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 337135 0
Acquired Brain Injury 337136 0
Condition category
Condition code
Mental Health 333558 333558 0 0
Addiction
Neurological 333559 333559 0 0
Other neurological disorders
Injuries and Accidents 334000 334000 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment comprises 10 x 1-hour weekly in-home, face-to-face sessions with a psychologist and occupational therapist (week 1-10), followed by 2 x 1hr telehealth 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 alcohol use and helps individuals develop effective coping strategies for them to facilitate pursuit of goals and strengthen confidence in the ability to control their alcohol 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 alcohol use and impede occupational performance and participation.

Key elements will include craving management, learning to identify and manage high-risk situations for drinking, learning to identify and modify exaggerated positive expectations of alcohol use, motivational enhancement, and increasing non-substance related activities. Based on CBT for alcohol use disorder manuals (e.g., 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).

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).
Intervention code [1] 331110 0
Treatment: Other
Intervention code [2] 331187 0
Behaviour
Comparator / control treatment
Wait-list control group who will receive the intervention after 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 341541 0
Alcohol Use
Assessment method [1] 341541 0
Change in alcohol use in quantity (grams ethanol per drinking day) and frequency (percentage days drank; percentage days drank greater than or equal to 40/50 grams [women/men]) measured by the Time Line Follow Back (TLFB) interview schedule that uses a timeframe of the past 28 days
Timepoint [1] 341541 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Primary outcome [2] 341542 0
Severity of Alcohol Use Disorder
Assessment method [2] 341542 0
Change in DSM-5 Alcohol 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].
Timepoint [2] 341542 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Primary outcome [3] 341547 0
Community participation
Assessment method [3] 341547 0
Changes in scores on the Participation Index of the Mayo-Portland Adaptability Inventory-4 (M2PI) to reflect participants' changes in community participation.
Timepoint [3] 341547 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [1] 447887 0
Quality of Life
Assessment method [1] 447887 0
Change in scores on Assessment of Quality of Life-8D (AQoL-8D)
Timepoint [1] 447887 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [2] 447888 0
Self-reported social participation
Assessment method [2] 447888 0
Change in scores on Neuro-QoL: Ability to Participate in Social Roles and Activities – Short Form
Timepoint [2] 447888 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [3] 447889 0
Caregiver-reported social participation
Assessment method [3] 447889 0
Change in scores on Neuro-QoL: Ability to Participate in Social Roles and Activities – Short Form
Timepoint [3] 447889 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [4] 447890 0
Self-reported wellbeing
Assessment method [4] 447890 0
Change in scores on Neuro-QoL: Positive Affect and Wellbeing - Short Form
Timepoint [4] 447890 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [5] 447891 0
Caregiver-reported wellbeing
Assessment method [5] 447891 0
Change in scores on Neuro-QoL: Positive Affect and Wellbeing - Short Form
Timepoint [5] 447891 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [6] 447892 0
Depression
Assessment method [6] 447892 0
Change in scores on DASS-21 Depression Subscale (7 items)
Timepoint [6] 447892 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [7] 447893 0
Anxiety
Assessment method [7] 447893 0
Change in scores on the Generalised Anxiety Disorder Assessment (GAD-7)
Timepoint [7] 447893 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [8] 447894 0
Reward Drive
Assessment method [8] 447894 0
Change in scores on Sensitivity to Reward Scale - Short Form
Timepoint [8] 447894 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [9] 447895 0
Rash Impulsiveness
Assessment method [9] 447895 0
Change in scores on the I7 (Impulsiveness) scale
Timepoint [9] 447895 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [10] 447896 0
Occupational Performance and Participation
Assessment method [10] 447896 0
Change in scores on the Canadian Occupational Performance Measure (COPM).
Timepoint [10] 447896 0
Assessment will be conducted by the Occupational Therapist in Session 1, 10 and 12 (Week 1, 10 and 18).
Secondary outcome [11] 447897 0
Past-week alcohol use
Assessment method [11] 447897 0
Change in quantity (grams of ethanol) and frequency (days used) of alcohol use will be measured by the Time Line Follow Back (TLFB) interview schedule that uses a timeframe of the past 7 days.
Timepoint [11] 447897 0
Every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only)
Secondary outcome [12] 447898 0
Recent alcohol use
Assessment method [12] 447898 0
Breath Alcohol Test using AlcoVUE DDS-ALV-100
Timepoint [12] 447898 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23). Plus, every in-person treatment session: Weeks 1-10 (Treatment group only).
Secondary outcome [13] 447899 0
Craving
Assessment method [13] 447899 0
5-item Craving Experience Questionnaire (CEQ)
Timepoint [13] 447899 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23). Plus, every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only).
Secondary outcome [14] 447901 0
Drinking Refusal Self-Efficacy
Assessment method [14] 447901 0
Change in scores on Drinking Refusal Self Efficacy Questionnaire Revised (DRSEQ-R)
Timepoint [14] 447901 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23). Plus, every treatment session: Weeks 1-10 (Treatment group only), and Weeks 14, 18 (Treatment group only).
Secondary outcome [15] 447902 0
Positive alcohol expectancies
Assessment method [15] 447902 0
Change in scores on Positive Alcohol Outcome Expectancy Scale - Short Form
Timepoint [15] 447902 0
Baseline (Week 0), Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [16] 447903 0
Acceptability of Intervention
Assessment method [16] 447903 0
Score on Acceptability of Intervention Measure (AIM)
Timepoint [16] 447903 0
Treatment Group only at Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [17] 447904 0
Intervention Appropriateness
Assessment method [17] 447904 0
Score on Intervention Appropriateness Measure (IAM)
Timepoint [17] 447904 0
Treatment Group only at Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [18] 447905 0
Feasibility of Intervention
Assessment method [18] 447905 0
Score on Feasibility of Intervention Measure (FIM)
Timepoint [18] 447905 0
Treatment Group only at Post-Treatment (Week 11), Follow-Up (Week 23).
Secondary outcome [19] 447906 0
Telehealth Feasibility
Assessment method [19] 447906 0
Scores on Telehealth Usability Questionnaire (TUQ) Questionnaire (TUQ)
Timepoint [19] 447906 0
Treatment Group only at Follow-Up (Week 23).

Eligibility
Key inclusion criteria
Participants will have an acquired brain injury (ABI), be aged greater than or equal to 18 years, and meet criteria for a DSM-5-TR Alcohol Use Disorder. Participants must have the capacity to provide informed consent without a substitute decision maker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current intravenous drug use, concurrent psychosocial substance use disorder treatment, and, if on alcohol pharmacotherapy, are on a stable dose for 700gm ethanol/week, individuals must obtain a physical assessment and agree to any medical treatment required. Other exclusion criteria: insufficient English to read or converse without translation, insufficient cognitive ability to complete questionnaires and therapy tasks (even with carer assistance), unmodified hearing impairment, history of >3 days of psychosis, acute current suicidality, and residing >25km away from Princess Alexandra Hospital.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially Numbered Opaque Sealed Envelopes
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]
.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
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
4/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318747 0
Government body
Name [1] 318747 0
Metro South Study, Education and Research Trust Account (SERTA)
Country [1] 318747 0
Australia
Funding source category [2] 319032 0
Government body
Name [2] 319032 0
National Injury Insurance Scheme, Queensland (NIISQ)
Country [2] 319032 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health
Country
Australia
Secondary sponsor category [1] 321497 0
Individual
Name [1] 321497 0
Associate Professor Matthew Gullo, Princess Alexandra Hospital
Country [1] 321497 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317362 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317362 0
Ethics committee country [1] 317362 0
Australia
Date submitted for ethics approval [1] 317362 0
17/04/2025
Approval date [1] 317362 0
Ethics approval number [1] 317362 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 140806 0
A/Prof Matthew Gullo
Address 140806 0
Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Ipswich Road, Woolloongabba QLD 4102
Country 140806 0
Australia
Phone 140806 0
+61731765191
Email 140806 0
matthew.gullo@health.qld.gov.au
Contact person for public queries
Name 140807 0
Matthew Gullo
Address 140807 0
Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Ipswich Road, Woolloongabba QLD 4102
Country 140807 0
Australia
Phone 140807 0
+61731765191
Email 140807 0
matthew.gullo@health.qld.gov.au
Contact person for scientific queries
Name 140808 0
Matthew Gullo
Address 140808 0
Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Ipswich Road, Woolloongabba QLD 4102
Country 140808 0
Australia
Phone 140808 0
+61731765191
Email 140808 0
matthew.gullo@health.qld.gov.au

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: matthew.gullo@health.qld.gov.au

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.