Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000767404
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
18/07/2025
Date last updated
18/07/2025
Date data sharing statement initially provided
18/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Acceptance and Commitment Therapy in Mild Traumatic Brain Injury
Scientific title
Acceptance and Commitment Therapy in mild traumatic brain injury (ACTion mTBI) in individuals aged 16 to 65: a three open arm clinical trial of effectiveness
Secondary ID [1] 314361 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 337354 0
Concussion 337355 0
Condition category
Condition code
Neurological 333739 333739 0 0
Other neurological disorders
Injuries and Accidents 334402 334402 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACTion-mTBI is a manualised, five-session psychological intervention grounded in Acceptance and Commitment Therapy (ACT), specifically designed for individuals recovering from mild traumatic brain injury (mTBI), including concussion. The programme targets key outcomes such as functional disability, post-concussion symptoms, and psychological distress by enhancing psychological flexibility—the ability to remain present, open, and engaged with valued life activities despite difficult internal experiences. ACTion-mTBI was developed to align with New Zealand’s publicly funded concussion services, which typically provide five hours of psychological input under ACC contracts. As such, the programme is structured to be both brief and scalable, ensuring feasibility for real-world clinical implementation.

Each of the five one-hour sessions targets specific ACT processes while also addressing the unique challenges of mTBI. Session one, Dropping the Struggle, introduces the ACT model and teaches acceptance and present moment awareness through mindfulness and metaphors. Session two, Moving Towards, focuses on values exploration and committed action using the “choice point” model to help participants reconnect with what matters most. Session three, Unhooking from the Mind, introduces cognitive defusion techniques and highlights the role of rigid thinking patterns in maintaining distress. Session four, The Noticing Self and Committing, helps develop a flexible sense of self and links values to meaningful goals through exercises like the values bullseye and SMART goal planning. The final session, Review and Relapse Prevention, integrates all ACT components, reinforces learning, and supports long-term maintenance through personalised action plans.

Therapists delivering ACTion-mTBI are Registered Psychologists trained in the model and supported by a structured therapist manual and client workbook.

The ACTion mTBI programme was co-designed through a collaborative and iterative process involving a diverse group of stakeholders to ensure clinical relevance, cultural responsiveness, and alignment with real-world service delivery. Stakeholders included psychologists with expertise in mTBI and ACT, Maori cultural advisors, researchers, and individuals with lived experience of concussion. The co-design process was structured around three 90-minute workshops delivered over a period of four weeks.

During each workshop, participants were presented with proposed intervention content, such as ACT metaphors, session structure, and example therapeutic exercises. They were invited to provide structured and open-ended feedback on the clarity, cultural relevance, and perceived usefulness of these materials. Maori participants and cultural advisors contributed to the integration of matauranga Maori elements—such as the use of whakatauki, karakia, and Maori models of health—to enhance cultural alignment. Participants with lived experience of mTBI also shared personal insights into symptom burden and barriers to recovery, which directly informed the selection of session themes and examples used within the client workbook. Between sessions, feedback was collated and used to iteratively refine the intervention content. This included adapting language for clarity, tailoring metaphors to the mTBI context, and ensuring materials reflected diverse worldviews and values. The final intervention manual was reviewed by co-design participants before implementation in the feasibility trial.

As this is a non-randomised, pragmatic trial, group allocation is determined based on psychologist availability at the site to which the participant is referred. Participants are assigned to one of the three intervention arms—ACTion mTBI, CBT-in-mTBI, or usual psychological care—according to the therapeutic approach delivered by the psychologist operating at that particular clinic. This approach reflects real-world service delivery within New Zealand’s ACC-funded concussion services, where treatment modality is typically guided by clinician training and availability rather than patient or referrer choice. Participants are not allocated based on personal preference, physician discretion, or clinical characteristics.
Intervention code [1] 330975 0
Rehabilitation
Intervention code [2] 331440 0
Treatment: Other
Comparator / control treatment
There are two control treatment arms in this trial: CBT-in-mTBI and Usual Psychological Care. ACTion mTBI will be compared with both of these treatment arms to evaluate its effectiveness relative to (1) an established, theory-driven psychological intervention (CBT), and (2) the standard care currently delivered within concussion services. This dual comparison allows for assessment of whether ACTion mTBI offers added benefit over both evidence-based treatment and routine clinical practice, supporting conclusions about its potential to improve outcomes and be implemented more widely in real-world settings.

CBT-in-mTBI is a structured, manualised psychological intervention based on Cognitive Behavioural Therapy (CBT), adapted specifically for individuals recovering from mild traumatic brain injury (mTBI). The programme is delivered over five one-hour sessions across approximately six weeks and focuses on helping participants understand and manage the interconnection between their thoughts, emotions, behaviours, and physical symptoms following injury. Each session builds sequentially to promote insight, develop coping strategies, and enhance functional recovery.

Session 1 provides psychoeducation on mTBI and the CBT model, including how unhelpful thinking patterns can impact emotions and behaviour. Participants learn to monitor their mood and identify early warning signs of distress. Session 2 introduces the concept of thought monitoring using a simplified 7-part thought record, helping individuals identify automatic negative thoughts and cognitive distortions. Session 3 focuses on cognitive restructuring, teaching participants how to challenge and reframe unhelpful thoughts. Session 4 introduces behavioural strategies, such as activity scheduling and pacing, with a focus on re-engaging with meaningful life activities. Finally, Session 5 supports relapse prevention and goal setting, encouraging participants to consolidate the skills learned and apply them to future challenges.

CBT-in-mTBI is delivered by Registered Psychologists working within ACC-funded concussion services. All therapists are trained in the CBT-in-mTBI protocol and supervised to ensure fidelity to the treatment model, assessed using the Comparative Psychotherapy Process Scale. The intervention may be delivered either face-to-face or via secure telehealth (video conferencing), depending on participant preference and geographical access. Maori cultural elements, including whakatauki and culturally adapted metaphors, are embedded within the content to enhance cultural responsiveness and relevance.

The Usual Psychological Care arm reflects the standard psychological input currently provided within ACC-funded concussion services in Aotearoa New Zealand. In this arm, participants receive five one-hour sessions with a Registered Psychologist, consistent with the typical level of support funded for mTBI rehabilitation. The content and approach of these sessions are not standardised across clinicians or sites; instead, psychologists deliver care based on their own clinical judgment, training, and preferred therapeutic modalities.

This may include elements of psychoeducation about mTBI, supportive counselling, stress management strategies, relaxation training, behavioural pacing, or other therapeutic techniques commonly used in concussion rehabilitation. The approach is generally eclectic and responsive to individual client needs, rather than being tied to a manualised or structured intervention model like ACT or CBT. Cultural responsiveness is also at the discretion of the psychologist, and the inclusion of Maori health models or tikanga may vary depending on clinician experience and training.
Control group
Active

Outcomes
Primary outcome [1] 341327 0
Functional Disability
Timepoint [1] 341327 0
Pre treatment, post treatment and six month follow up (post treatment)
Secondary outcome [1] 447119 0
Post concussion symptoms,
Timepoint [1] 447119 0
Pre treatment, post treatment and six month follow up (post treatment)
Secondary outcome [2] 449544 0
Mental Health
Timepoint [2] 449544 0
Pre treatment, post treatment and six month follow up
Secondary outcome [3] 449545 0
Psychological Inflexibility
Timepoint [3] 449545 0
Pre treatment, post treatment and six month follow up
Secondary outcome [4] 449546 0
Experiential Avoidance
Timepoint [4] 449546 0
Pre-treatment, post treatment and six month follow up
Secondary outcome [5] 449547 0
Valued Living
Timepoint [5] 449547 0
Pre treatment, post treatment, six month follow up

Eligibility
Key inclusion criteria
Aged between 16 and 65 years

Medical diagnosis of mild traumatic brain injury (mTBI)

Between 14 days and 12 months post-injury

Currently referred to psychological therapy as part of treatment within ACC-funded concussion services

Clinically significant post-concussion symptoms impacting daily functioning (BIST Symptom Scale score >66)

Elevated psychological distress (as indicated by self-report on the DASS-21 or clinical judgement by the referring clinician)

Able to provide informed consent
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of an unstable, serious comorbid mental or physical health condition (as determined during the concussion service initial assessment) which could affect participation in the intervention and/or influence outcome

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
29/08/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2028
Actual
Date of last data collection
Anticipated
31/03/2029
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 27033 0
New Zealand
State/province [1] 27033 0

Funding & Sponsors
Funding source category [1] 318881 0
University
Name [1] 318881 0
Victoria University of Wellington
Country [1] 318881 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Country
New Zealand
Secondary sponsor category [1] 321344 0
Other
Name [1] 321344 0
Evolution Healthcare
Address [1] 321344 0
Country [1] 321344 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317495 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317495 0
Ethics committee country [1] 317495 0
New Zealand
Date submitted for ethics approval [1] 317495 0
23/05/2025
Approval date [1] 317495 0
11/07/2025
Ethics approval number [1] 317495 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141238 0
Dr Josh Faulkner
Address 141238 0
Te Herenga Waka - Victoria University of Wellington. 20 Kelburn Parade. Wellington, 6012
Country 141238 0
New Zealand
Phone 141238 0
+64 21424607
Fax 141238 0
Email 141238 0
[email protected]
Contact person for public queries
Name 141239 0
Josh Faulkner
Address 141239 0
Te Herenga Waka - Victoria University of Wellington. 20 Kelburn Parade. Wellington, 6012
Country 141239 0
New Zealand
Phone 141239 0
+6421424607
Fax 141239 0
Email 141239 0
[email protected]
Contact person for scientific queries
Name 141240 0
Josh Faulkner
Address 141240 0
Te Herenga Waka - Victoria University of Wellington. 20 Kelburn Parade. Wellington, 6012
Country 141240 0
New Zealand
Phone 141240 0
+6421424607
Fax 141240 0
Email 141240 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to the sensitive nature of the clinical data,a this will not be shared.



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.