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Piloting a tailored telehealth program for managing stimulant use in traumatic brain injury

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000925448
Enrollment
2
Registered
2025-08-25
Start date
2026-04-13
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, 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.

Interventions

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 u

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).

Sponsors

Griffith University
Lead SponsorUniversity

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 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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 25, 2026