None listed
Conditions
Brief summary
This study will use a single-case experimental design (SCED) to investigate the feasibility and preliminary effectiveness of ENVIRO, a co-designed environmental cognitive rehabilitation intervention for adults with traumatic brain injury (TBI). A multiple-baseline A-B design across behaviours will be used, with up to three tiers, staggering the introduction of the intervention across three target behaviours of each participant. Prior to baseline, participants will undergo a brief cognitive assessment and clinical interview. Participants will then collaboratively establish up to three rehabilitation goals with a clinician. Goals will be operationalised using Goal Attainment Scaling (GAS) and associated target behaviours will be identified. Baseline will involve repeated measurement of each target behaviour, with baseline durations staggered across behaviours (two, three, or four weeks). The intervention phase will involve the sequential introduction of the ENVIRO intervention framework to each target behaviour over six weeks. An up to eight-week maintenance phase will follow, including a one-hour booster session. It is hypothesised that using the ENVIRO intervention will assist participants to make progress towards their goals, and will be a feasible and acceptable approach for people with TBI and their close others.
Interventions
What is the intervention:
The intervention is a co-designed cognitive rehabilitation framework, ‘ENVIRO’. The ENVIRO framework is designed as a practical resource for multidisciplinary clinicians working collaboratively with adults with traumatic brain injury (TBI) and their support networks, to adapt the environment to support cognition in daily life. It is grounded in the best available evidence and the perspectives of TBI survivors, their close others, and clinicians, and aligns with establi
What is the intervention: The intervention is a co-designed cognitive rehabilitation framework, ‘ENVIRO’. The ENVIRO framework is designed as a practical resource for multidisciplinary clinicians working collaboratively with adults with traumatic brain injury (TBI) and their support networks, to adapt the environment to support cognition in daily life. It is grounded in the best available evidence and the perspectives of TBI survivors, their close others, and clinicians, and aligns with established frameworks and principles of cognitive rehabilitation. Rather than a structured program (e.g., a session-by-session manual), it is intended to be used as a flexible guide that can be tailored to the individual and their goals and context. The framework is structured across three integrated levels. At its core, the Values (ENVIRO; level 1) underpin the use of all environmental approaches. These include empower, network of supports, value strengths, individualise, reduce complexity, and ongoing use and review. The Strategy Toolkit (level 2) outlines specific environmental strategies that can be selected and developed to suit each individual, including prompting, communication environment adaptations, feedback, physical setting modifications, and task adaptations. The Process (level 3) provides flexible steps to guide clinicians in implementing these strategies. These are getting to know the person, setting goals, selecting and developing strategies, setting up strategies and planning for generalisation, personalising resources, promoting consistent strategy use, evaluating progress, building independence, applying effective strategies across contexts, and reviewing and updating the approach over time. These intervention components will not all be implemented across every session, and will instead be applied flexibly, depending on the individual's needs and preferences. Individualisation will occur in the selection and application of strategies from the framework. The specific goals, target behaviours, and environmental strategies used to address them will differ according to each participant’s preferences and needs. This reflects the ENVIRO framework's design as a flexible guide rather than a fixed protocol. Individualisation will begin prior to the baseline, with an introductory assessment (cognitive assessment and clinical interview with the participant and close other) and a goal-setting session in which up to three goals will be collaboratively established and operationalised using Goal Attainment Scaling. These goals will determine which strategies from the toolkit are selected, developed, and set up during the intervention phase, guided by relevant steps from the framework's Process (e.g., getting to know the person, selecting and developing strategies, personalising resources). Strategies will then be reviewed and adjusted as needed throughout the intervention phase in response to participant progress, feedback, and barriers, including during the booster session. Who delivers it and their relevant expertise: The intervention will be delivered by a dual registered clinical neuropsychologist and occupational therapist with experience in cognitive rehabilitation. How it is delivered: The intervention will be delivered individually in one-to-one sessions. Close others (e.g., family members or support workers) may be involved in sessions where relevant to facilitate the development and implementation of strategies. How often and for how long: The intervention will be delivered over approximately six weeks, likely involving six weekly 1-hour sessions. The intervention phase will involve the sequential introduction of the ENVIRO intervention framework to each target behaviour. An up to eight-week maintenance phase is planned to follow the delivery of the intervention, with a 1-hour intervention booster session. During the maintenance phase, participants will not attend any sessions with the clinician (other than the booster session). They will be encouraged to continue to utilise the environmental strategies that were developed and set-up during the intervention phase. The booster intervention session will involve participants meeting with the clinician to identify and target any barriers they may have encountered to the continued use of environmental strategies during the maintenance phase. This intervention booster session will be conducted at the same time point for all participants where possible (approximately 4 weeks into the maintenance phase). Where it is delivered: Sessions will be conducted either in participants’ homes, in the clinic space at the Turner Clinics, or via Zoom videoconferencing, depending on participants’ needs and preferences. Adherence: Participant adherence to the intervention will be monitored by the clinician and documented in session records. Clinician adherence will be monitored using intervention-specific fidelity checklists documenting the delivery of core intervention components.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants with TBI: - Be at least 18 years of age. - Have sustained a moderate to severe TBI. - Be a minimum of two months post-injury and have fully emerged from post-traumatic amnesia. - Be living in a community setting. - Have adequate English language skills. - Living in metropolitan Melbourne, Australia. - Be able and willing to participate in an up to 18-week study. - Have a close other who is willing to assist with data collection and research activities. - Have adequate internet to participate in Zoom sessions if this is their preferred method of involvement. Close others: - Be at least 18 years of age. - Have a relationship with the person with TBI (e.g., family member, partner, friend, or support worker) and either live with them or have contact with them more than once per week. - Be willing and able to participate in the study by assisting with data collection activities and, where possible and needed, supporting the delivery of environmental strategies during the intervention. - Have adequate English language skills. - Have the capacity to provide independent informed consent. - Living in metropolitan Melbourne, Australia. - Have adequate internet to participate in Zoom sessions if this is their preferred method of involvement.
Exclusion criteria
Participants with TBI: - Have a progressive neurological condition or significant medical history that would prevent the completion of research assessment or treatments. - Have severe psychiatric symptoms or active substance use that would prevent the completion of research assessment or treatments. - Are currently engaged in another cognitive rehabilitation program targeting similar goals and thus do not have an identified clinical need for further cognitive rehabilitation via the study. - Are unable to attend in-person or tele-health sessions as required. - Do not have a close other available and willing to participate in the study. Are currently inpatient in a hospital. Close others: - Have a cognitive, neurological, or psychiatric condition that would likely significantly impair their ability to understand study information or complete the required activities. - Are currently experiencing high levels of psychological distress that would make participation inappropriate. - Do not have regular contact with the person with TBI or are unable to assist with the completion of data collection tasks and other study activities.
Outcome results
None listed