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Trial registered on ANZCTR
Registration number
ACTRN12626000787381
Ethics application status
Approved
Date submitted
15/06/2026
Date registered
1/07/2026
Date last updated
1/07/2026
Date data sharing statement initially provided
1/07/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating a Co-Designed Environmental Framework for Cognitive Rehabilitation after Traumatic Brain Injury
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Scientific title
Evaluating the Feasibility of Delivering a Co-Designed Environmental Framework for Cognitive Rehabilitation after Traumatic Brain Injury in Adults
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Additional trial identifiers [1]
317530
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Traumatic brain injury (TBI)
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Condition category
Condition code
Physical Medicine / Rehabilitation
338385
338385
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0
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Other physical medicine / rehabilitation
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Injuries and Accidents
338599
338599
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0
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Other injuries and accidents
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Neurological
338600
338600
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
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.
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Intervention code [1]
334372
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Rehabilitation
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Description of the comparator or control
There is no comparator or control group. The study will use a single-case experimental design with multiple baselines across target behaviours. As such, each participant will act as their own control.
Baseline duration will vary across each participant's three target behaviours (not across participants): a multiple-baseline A-B design will be used, with staggered baseline durations of two, three, or four weeks, informed by participant priorities identified during the initial goal-setting session, rather than a predetermined sequence.
Prior to baseline, participants will establish three rehabilitation goals with a clinician, and associated target behaviours for these goals will be identified. Baseline will involve repeated measurement of each target behaviour before the introduction of the intervention, during which participants will continue with their usual activities and any existing care, with no environmental strategies introduced. Target behaviours will be measured approximately three times per week via brief (~5-minute) phone calls conducted by a researcher with both the participant and their close other.
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Control group
Active
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Outcomes
Primary outcome [1]
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Goal attainment
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Assessment method [1]
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Goal attainment scaling. This information will be recorded in a study-specific record sheet by the researcher.
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Timepoint [1]
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Goal attainment scaling will be administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Primary outcome [2]
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Strategy use
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Assessment method [2]
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Participants use of environmental strategies will be measured using a questionnaire customised to the specific strategies from the intervention framework (i.e., prompting, feedback, communication environment modifications, setting modifications, and task adaptations). This questionnaire will be based on the scale used by the Strategy Use Measure (SUM), which is a tool for evaluating the use of compensatory behavioural strategies for cognitive impairments after brain injury. This information will be recorded in a study-specific record sheet by the researcher.
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Timepoint [2]
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Strategy use will be measured three times per week for the duration of the study (from baseline up to 18 weeks post-enrolment). Strategy use will be measured using self-report data from participants and their close others, collected via phone call. This information will be recorded in a study-specific record sheet by the researcher.
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Primary outcome [3]
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Target behaviour completion
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Assessment method [3]
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Completion of target behaviours will be measured using self-report data from participants and their close others, collected via phone call. This information will be recorded in a study-specific record sheet by the researcher.
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Timepoint [3]
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Target behaviours will be measured three times per week for the duration of the study (from baseline up to 18 weeks post-enrolment), including during the baseline, intervention, and maintenance phases.
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Secondary outcome [1]
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Community integration
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Assessment method [1]
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Community Integration Questionnaire - Revised (CIQ-R)
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Timepoint [1]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [2]
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Health-related quality of life
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Assessment method [2]
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12-Item Short-Form Health Survey (SF-12)
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Timepoint [2]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [3]
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Mood
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Assessment method [3]
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The Depression, Anxiety, and Stress Scale (DASS-21)
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Timepoint [3]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [4]
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Mood
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Assessment method [4]
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Subjective Units of Distress Scale (SUDS; a 0–10 scale to measure mood; e.g., ‘on a scale of 1–10, where 10 = best, how would you rate your mood today?’)
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Timepoint [4]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [5]
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Participation
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Assessment method [5]
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The Participation Assessment with Recombined Tools - Objective (PART-O)
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Timepoint [5]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [6]
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Quality of life
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Assessment method [6]
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The Quality of Life After Brain Injury (QOLIBRI)
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Timepoint [6]
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [7]
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Confidence
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Assessment method [7]
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A rating of participants’ confidence in completing the target behaviour (a 0–10 scale to measure confidence; e.g., ‘on a scale of 1–10, where 10 = most, how confident do you feel in your ability to complete the target behaviour?’).
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Timepoint [7]
463145
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Administered during the initial goal setting session (pre-baseline), post-intervention (6 weeks post-baseline), and at follow-up (8-weeks post-intervention completion).
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Secondary outcome [8]
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Treatment fidelity
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Assessment method [8]
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A study-specific checklist rating clinicians’ use of and adherence on a numerical scale to the components of the intervention framework - values, strategies, and processes. This will be completed by an independent assessor using audio recordings and clinical notes of sessions. Clinicians will also self-report the extent to which they delivered the intervention as planned on a study-specific checklist.
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Timepoint [8]
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Cumulative data will be assessed at the conclusion of the study enrolment period.
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Secondary outcome [9]
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Recruitment
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Assessment method [9]
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Participant recruitment rates will be gathered and reported as a percentage. This will be collected via study-specific enrolment logs.
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Timepoint [9]
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Cumulative data will be assessed at the conclusion of the study enrolment period.
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Secondary outcome [10]
463148
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Retention
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Assessment method [10]
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Participant retention rates will be gathered and reported as a percentage. This will be collected via study-specific session attendance logs.
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Timepoint [10]
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Retention rates will be assessed weekly from the initial goal setting session up to 18 weeks post-enrolment.
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Secondary outcome [11]
463149
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Acceptability
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Assessment method [11]
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The acceptability of the intervention is planned to be assessed through feedback surveys, which will include both numerical ratings and open-ended questions (approximately 10–15 minutes duration). These surveys will allow participants and their close others to evaluate their satisfaction with the intervention approach, its perceived usefulness, and their intention to continue using it.
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Timepoint [11]
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Post-intervention completion (6 weeks post-baseline) and at 8 weeks follow-up post-intervention completion.
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Secondary outcome [12]
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Acceptability
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Assessment method [12]
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Semi-structured qualitative interviews conducted with participants with TBI and close others. They will last approximately 30–45 minutes and will invite participants to share their experiences of the intervention, including its perceived usefulness, relevance to their goals, and any barriers or facilitators to its use. Participants will also be able to provide feedback about any improvements that they believe could be made to the intervention framework.
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Timepoint [12]
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At the end of the follow-up period, 8-weeks post-intervention completion.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Single case experimental design with multiple baselines across target behaviours.
The multiple-baseline design will operate across each participant's three target behaviours. Each target behaviour will follow an A-B sequence (baseline, then intervention), with intervention start times staggered across the three behaviours according to their assigned baseline duration (2, 3, or 4 weeks). Following the six-week intervention phase, participants will undergo a maintenance phase of up to eight weeks, during which they will not receive intervention sessions (other than an intervention booster session after 4 weeks of the maintenance phase).
The baseline duration assigned to each target behaviour will be determined clinically, based on the priorities each participant identifies during the goal-setting session (i.e., the relative importance the participant places on each goal will inform the length of the baseline assigned to its corresponding behaviour).
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The primary outcome measure will be GAS, with repeated measurement of target behaviours, as reported by participants and their close others, used to evaluate progress towards goals. Visual analysis, supplemented by statistical analyses, will be used to determine whether improvements occur following the intervention introduction. Secondary outcomes will examine changes in community integration, participation, quality of life, mood, and confidence completing the target behaviour. Feasibility outcomes will include recruitment, retention, treatment fidelity, and costs. Acceptability will be explored through qualitative interviews with participants.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/07/2026
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Actual
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Date of last participant enrolment
Anticipated
18/08/2026
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Actual
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Date of last data collection
Anticipated
28/12/2026
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Actual
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Sample size
Target
4
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Government Research Training Program Scholarship
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
324979
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Country [1]
324979
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/12/2025
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Approval date [1]
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05/02/2026
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Ethics approval number [1]
320621
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jessica Trevena-Peters
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Address
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Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill, VIC, 3168
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Country
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Australia
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Phone
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+61 407 806 575
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ella Waldman
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Address
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Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill, VIC, 3168
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Country
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Australia
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Phone
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+61 03 9902 4482
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ella Waldman
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Address
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Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill, VIC, 3168
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Country
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Australia
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Phone
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+61 03 9902 4482
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Fax
151076
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing 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