Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000594820
Ethics application status
Approved
Date submitted
12/03/2021
Date registered
19/05/2021
Date last updated
9/02/2024
Date data sharing statement initially provided
19/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new psychological treatment for adults after mild brain injury
Scientific title
ACTION-TBI: Effect of acceptance and commitment treatment on functional recovery after mild traumatic brain injury in adults
Secondary ID [1] 303674 0
Nil known
Universal Trial Number (UTN)
U1111-1266-0296
Trial acronym
ACTION-TBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury 321070 0
Condition category
Condition code
Neurological 318879 318879 0 0
Other neurological disorders
Injuries and Accidents 319369 319369 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention arm will receive five sessions of Acceptance and Commitment Therapy. The sessions will be delivered individually, in-person by a Registered Psychologist or Intern Psychologist (working under close supervision of a Registered Psychologist). Sessions will consist of 5x 1 hour sessions covering normalcy of human suffering, difference between goals and committed action, engaging in committed action in conjunction with values, separating self from thoughts, use of mindfulness, understanding the part of you that notices, contacting the present moment and responding to thoughts flexibly. The five session incorporating these techniques will be held once per week. Sessions will be conducted within a Psychology Clinic at a New Zealand University or concussion service. The total duration of the intervention will be 5 hours. Attendance at each session and rates of withdrawal from the intervention will be monitored.
Intervention code [1] 319972 0
Rehabilitation
Intervention code [2] 320319 0
Behaviour
Comparator / control treatment
Participants randomised to the control arm will receive five sessions of Cognitive Behaviour Therapy which is current best practice. The sessions will be delivered individually, in-person by a Registered Psychologist or Intern Psychologist (working under close supervision of a Registered Psychologist). Sessions will consist of 5x 1 hour, held once per week. The total intervention will be 5 hours over 5 weeks. and will include approaches such as psychoeducation, goal setting, relaxation techniques, identifying unhelpful thoughts, cognitive restructuring and problem solving techniques, Sessions will be conducted within a Psychology Clinic at a New Zealand University or at a concussion clinic
Control group
Active

Outcomes
Primary outcome [1] 326821 0
Total Disability Score of the WHO Disability Assessment Schedule (WHODAS 2.0)
Timepoint [1] 326821 0
Post-Intervention (5 weeks)
Secondary outcome [1] 392790 0
Depression sub-scale score of the Depression, Anxiety and Stress Scales -21
Timepoint [1] 392790 0
Post-intervention (5 weeks)
Secondary outcome [2] 392792 0
Total score from the Rivermead Post-Concussion Symptoms Questionnaire
Timepoint [2] 392792 0
Post-intervention (5 weeks)
Secondary outcome [3] 392793 0
Total score from the Valued Living Questionnaire (How consistently they have lived in accordance with values)
Timepoint [3] 392793 0
Post-intervention (5 weeks)
Secondary outcome [4] 392794 0
Total score from the Acceptance and Action Questionnaire
Timepoint [4] 392794 0
Post-intervention (5 weeks)
Secondary outcome [5] 394299 0
Anxiety sub-scale score of the Depression, Anxiety and Stress Scales -21
Timepoint [5] 394299 0
post-intervention (5 weeks)
Secondary outcome [6] 394300 0
Stress sub-scale score of the Depression, Anxiety and Stress Scales -21
Timepoint [6] 394300 0
post-intervention (5 weeks)
Secondary outcome [7] 394301 0
The numbers of participants meeting the eligibility criteria recruited per month will be recorded
Timepoint [7] 394301 0
Post-intervention (5 weeks)
Secondary outcome [8] 394302 0
Total time taken to meet the recruitment target for this feasibility study will be calculated,
Timepoint [8] 394302 0
Post-intervention (5 weeks)
Secondary outcome [9] 394303 0
Qualitative interviews will explore participant’s experiences of the intervention, their understanding of the approach and its techniques, aspects of the intervention that were helpful or unhelpful and any changes they feel would be beneficial.
Timepoint [9] 394303 0
Following post-intervention questionnaires (6-7 weeks)

Eligibility
Key inclusion criteria
1) clinical diagnosis of a mild traumatic brain injury (concussion)
2) aged between 18 and 65
3) between 14 days and 6-months post-injury
4) score of >16 on the Rivermead Post-concussion Questionnaire on screening or indictors of prolonged recovery determined by clinician
5) able to provide independent informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having an unstable comorbid mental or physical health condition that could affect participation in the trial or influence outcome

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using RedCap database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with 1:1 allocation ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility study to determine safety, cultural appropriateness and to explore and trends in efficacy for people post mild TBI and so no formal sample size calculation was conducted.
Quantitative Analyses: Descriptive data on the time in weeks between referral, pre-intervention assessment, commencement of the intervention, consent rate and timeframe of the intervention sessions will be provided. Chi square tests or Fisher’s Exact tests (where relevant) will be used to determine if there are any differences in the proportion of participants completing all intervention sessions between the two groups and consent and attrition rates of eligible Maori and Pasifika participants compared to Europeans. The numbers of participants meeting the eligibility criteria recruited per month will be recorded and total time taken to meet the recruitment target for this feasibility study will be calculated. An effect size for the full trial will be estimated based on group comparisons controlling for baseline scores to refine the power calculation for the main trial and determine the necessary sample size to ensure statistical power of the main trial.

Qualitative Analysis: Following completion of the intervention, a qualitative interview will explore participant’s experiences of the intervention, their understanding of the approach and its techniques, aspects of the intervention that were helpful or unhelpful and any changes they feel would be beneficial. Participants will be asked about the relevance of the intervention and techniques to them and whether they felt the intervention was responsive to their culture. The qualitative analysis will identify whether further modifications to the programmes or study procedures are needed. Qualitative data will be analysed using the qualitative descriptive approach to identify how the intervention helped or hindered participants recovery. The qualitative data will be used to augment the interpretation of the quantitative analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
2/08/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
29/12/2023
Date of last data collection
Anticipated
4/11/2022
Actual
6/01/2024
Sample size
Target
24
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 23531 0
New Zealand
State/province [1] 23531 0
Wellington

Funding & Sponsors
Funding source category [1] 308093 0
Government body
Name [1] 308093 0
Health Research Council of New Zealand
Country [1] 308093 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
55 Wellesley Street East, Auckland Central, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 308839 0
None
Name [1] 308839 0
Address [1] 308839 0
Country [1] 308839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308079 0
Southern Health and Disability Ethics Committee (NZ)
Ethics committee address [1] 308079 0
Ethics committee country [1] 308079 0
New Zealand
Date submitted for ethics approval [1] 308079 0
26/03/2021
Approval date [1] 308079 0
17/05/2021
Ethics approval number [1] 308079 0
21/STH/117

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

Contacts
Principal investigator
Name 109458 0
Prof Alice Theadom
Address 109458 0
AR238, AUT North Campus, Private Bag 92006. Auckland 1142 , New Zealand
Country 109458 0
New Zealand
Phone 109458 0
+64 21 2460728
Fax 109458 0
Email 109458 0
[email protected]
Contact person for public queries
Name 109459 0
Alice Theadom
Address 109459 0
AR238, AUT North Campus, Private Bag 92006. Auckland 1142 , New Zealand
Country 109459 0
New Zealand
Phone 109459 0
+64 21 2460728
Fax 109459 0
Email 109459 0
[email protected]
Contact person for scientific queries
Name 109460 0
Alice Theadom
Address 109460 0
AR238, AUT North Campus, Private Bag 92006. Auckland 1142 , New Zealand
Country 109460 0
New Zealand
Phone 109460 0
+64 21 2460728
Fax 109460 0
Email 109460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethics concerns around potential identification of participants given the small sample size for this feasibility study, recruitment from a single region and need for specific patient request to make anonymous data available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10999Study protocol  [email protected]
11000Informed consent form  [email protected]
11001Ethical approval  [email protected]



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.