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Piloting a tailored program for managing alcohol use in acquired brain injury

A pilot randomised controlled trial of bioSocial Cognitive model of Occupational Functioning (biSCOF) therapy for alcohol use disorder in individuals with acquired brain injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000556448
Enrollment
5
Registered
2025-05-30
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, in-home intervention to individuals with an alcohol use disorder and acquired brain injury. It aims to generate exploratory data on treatment engagement, change in alcohol use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.

Interventions

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 Functioni

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).

Sponsors

Metro South Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 25, 2026