Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000030875
Ethics application status
Approved
Date submitted
19/11/2020
Date registered
14/01/2021
Date last updated
23/05/2024
Date data sharing statement initially provided
14/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
INTEGRATE - A feasibility trial of stratified Cognitive Functional Therapy for high risk neck and back injuries following road traffic crash
Scientific title
INTEGRATE - A feasibility trial of stratified Cognitive Functional Therapy for high risk neck and back injuries following road traffic crash
Secondary ID [1] 302820 0
Project ID: RES-61386
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash-Associated Disorders (WAD) 319784 0
Condition category
Condition code
Musculoskeletal 317715 317715 0 0
Other muscular and skeletal disorders
Injuries and Accidents 318133 318133 0 0
Other injuries and accidents
Mental Health 318134 318134 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CFT is a physiotherapist-led treatment integrating behavioural psychology, neuroscience and physical therapy within an individualised treatment approach in order to facilitate self-management. This is grounded in a multidimensional clinical reasoning framework, which forms the basis for how treatment is individualised using unique formulations for each participant (P. O’Sullivan et al., 2018). There are three broad components to the intervention:

Making sense of pain: a reflective process that combines the person’s own narrative (interview) and experience (during guided behavioural experiments) to develop a personally-relevant, multidimensional understanding of pain for the patient. In this process, unhelpful beliefs and responses to pain are disconfirmed, and new helpful cognitive and behavioural responses (functional and lifestyle) to pain are identified that are linked to their personally-relevant goals.
Exposure with ‘control’: a process of behavioural change through experiential learning following a ‘graded exposure’ model, designed to challenge expectations of pain and damage consequences via guided behavioural experiments. Specifically, sympathetic nervous system responses (rapid upper chest breathing and body tension) and safety-seeking behaviours (protective muscle guarding, breath-holding, movement avoidance and propping of the hand) that manifest during exposure to painful, feared or avoided functional tasks are explicitly targeted and controlled. This provides patients with strategies to relax, control respiration, normalise postural and movement behaviours that they nominate as painful, feared or avoided. The new strategies are immediately integrated into goal orientated daily activities to build self-efficacy and body conditioning.

Lifestyle change: behavioural modification addressing unhelpful lifestyle factors aimed at increasing physical activity levels based on preference, sleep habits, regulation of stress (via relaxation techniques) and/or dietary advice, where relevant.

CFT is underpinned by a strong therapeutic alliance and motivational interviewing style (open, non-judgmental, reflective) providing validation and facilitating disclosure. An individualised self-management program will be provided, monitored and progressed that includes cognitive restructuring, progressive functional exercises and lifestyle changes, tailored to the individual’s goals. CFT has a rapidly expanding evidence base for the treatment of spinal pain, particularly low back pain, with large sustained benefits compared to traditional physiotherapy (Caneiro, Smith, Linton, Moseley, & O’Sullivan, 2019; K. O’Sullivan, Dankaerts, O’Sullivan, & O’Sullivan, 2015; P. O’Sullivan et al., 2018; Vibe Fersum et al., 2013, 2019).

Where significant psychosocial barriers are identified by the physiotherapist during assessment or later in treatment, a stepped care approach will be used, integrating treatment from a clinical psychologist. Such barriers might include: trauma-related hyperarousal; pervasive negative affect; low mood; maladaptive avoidance of pre-injury activities; motivational barriers; high levels of social stress; and co-morbid psychopathology (diagnosed or likely) such as post-traumatic stress disorder (PTSD), major depressive disorder or somatic symptom disorder. The following scores on baseline measures will also trigger consideration for psychological co-care: Scores in the ‘severe’ range on any DASS subscale (Lovibond & Lovibond, 1995); clinically significant pain catastrophising of >23 on the PCS (Scott, Wideman, & Sullivan, 2014); elevated trauma symptoms of >33 on the PCL-5 (Blevins, Weathers, Davis, Witte, & Domino, 2015). Psychological intervention will therefore not be a routine part of the CFT treatment; it will be suggested to participants where clinically indicated based on the above criteria. Participants will be encouraged to discuss any recommendation to enage with a clinical psychologist with their GP and other trusted health providers. They will be free to not pursue psychological treatment decisions and exploring these decisions is one aspect of the feasibility analysis.

A distinguishing feature of this psychological co-care is that it will be integrated into the CFT formulation, which creates a multidimensional profile for each patient based on eight factors: cognitive, emotional, physical, patho-anatomy, lifestyle, social, sensory and health. Patient-centred goals across the physiotherapy and psychology modalities will therefore be integrated into a common treatment formulation. For example, a patient with elevated post-traumatic stress symptoms and pain-provocative muscle guarding may work on pain conceptualisation, movement retraining and graded exposure with their physiotherapist to address the cognitive, physical and lifestyle domains, while simultaneously addressing the emotional and cognitive domains with their psychologist in the form of trauma-focused cognitive behaviour therapy (Creamer, Forbes, Phelps, & Humphreys, 2007). These psychological components of care will be based on guideline-consistent CBT protocols where relevant, and individualised by targeting risk and protective factors that are relevant to each participant’s unique presentation (Day, Ehde, & Jensen, 2015). Overarching these components of the integrated intervention, physiotherapists and psychologists will promote five empirically supported principles for early trauma intervention: sense of safety, calming, self-efficacy, connectedness, and hope (Hobfoll et al., 2007).

This model of integrated treatment has already been developed in clinical practice by members of the research team. The dosage will be individualised according to clinical judgement and will involve a maximum of 10 sessions of each modality within 6 months. Physiotherapy treatment frequency will be greater initially, with up to 7 sessions over the first 3 months, followed by less frequent booster sessions. This follows a similar CFT protocol to one currently being used in ‘RESTORE’, a large multisite trial of CFT for disabling back pain (ACTRN12618001396213).
All physiotherapy and psychology (where relevant) treatments will be provided in 1-hour one-on-one face-to-face appointments where possible. Given ongoing uncertainty around public health measures in 2021, there is a chance that face-to-face healthcare appointments may be restricted by the WA government during the trial period. We will follow the directives and recommendations of relevant government authorities to best protect participants and public health. Therefore, if required, we may deliver some appointments for those in the integrated rehabilitation group via telehealth rather than in person. Physiotherapists and psychologists will be trained in this following guidelines released by the Australian Physiotherapy Association and the Australian Psychological Society.

Participant adherence to the intervention will be monitored through session attendance checklists and home exercise/task completion checklists. Clinicians delivering the intervention will be trained through a combination of prescribed self-study and group workshops. They will receive ongoing mentoring/supervision throughout the trial treatment period.
Intervention code [1] 319096 0
Behaviour
Intervention code [2] 319097 0
Prevention
Intervention code [3] 319098 0
Rehabilitation
Comparator / control treatment
Usual care
This treatment will be the usual care pathway recommended by the participants’ health providers and agreed to by Insurance Commission of Western Australia (ICWA) claims officers for funded treatment. Given clinical guidelines, this is likely to include medical management by a general practitioner, physiotherapy, and a range of other modalities, possibly including psychological care. Treatment in this group will not be impacted in any way by participation in the study.
Control group
Active

Outcomes
Primary outcome [1] 325759 0
Physical Function, as measures by the PROMIS Physical Function-Short Form
Timepoint [1] 325759 0
The primary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Primary outcome [2] 325760 0
Pain Interference, as measured by the PROMIS Pain Interference-Short Form
Timepoint [2] 325760 0
The primary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [1] 389035 0
Pain intensity, measured with the PROMIS Scale v1.0 - Pain Intensity
Timepoint [1] 389035 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [2] 389036 0
Emotional distress, using the Depression Anxiety Stress Scale (DASS-21)
Timepoint [2] 389036 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [3] 389037 0
Trauma symptoms using the PTSD Checklist (PCL-5)
Timepoint [3] 389037 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [4] 389038 0
Disability using the Patient-Specific Functional Scale (PSFS)
Timepoint [4] 389038 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [5] 389039 0
Pain catastrophising using the Pain Catastrophizing Scale (PCS)
Timepoint [5] 389039 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [6] 389040 0
Pain self-efficacy using the Pain Self Efficacy Questionnaire (PSEQ)
Timepoint [6] 389040 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [7] 389041 0
Health-related quality of life using the EQ-5D-5L questionnaire
Timepoint [7] 389041 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [8] 389042 0
Perceived recovery, using an 11-point global impression of recovery scale
Timepoint [8] 389042 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [9] 389045 0
Work status based on Insurance Commision of Western Australia (ICWA) data
Timepoint [9] 389045 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [10] 389047 0
Adverse events as measured by self-reported data. Possible adverse events may include: pain exacerbations, exacerbations of other co-morbid conditions, short-term exacerbations of psychological distress. However all adverse events described by participants, included those not listed above, will be documented.
Timepoint [10] 389047 0
The secondary timepoint will be at 6 months post-commencement of the intervention. However, outcomes will also be measured at baseline (pre-intervention) and 3 months post-commencement of intervention.
Secondary outcome [11] 389048 0
Direct treatment costs incurred by ICWA for each participant will be compared using data provided by ICWA from their insurance records.
Timepoint [11] 389048 0
The secondary timepoint will be at 6 months post-commencement of the intervention.
Secondary outcome [12] 389055 0
Acceptability will be assessed both quantitatively with a validated self-report measure of treatment satisfaction, the Client Satisfaction Questionnaire (CSQ-8), and qualitatively through semi-structured interviews with participants and stakeholders, including physiotherapists, psychologists, general practitioners and ICWA claims officers.
Timepoint [12] 389055 0
The secondary timepoint will be at 6 months post-commencement of the intervention.
Secondary outcome [13] 389056 0
Dose of intervention, as measured by the number of appointments attended by participants according to session attendance checklists.
Timepoint [13] 389056 0
The secondary timepoint will be at 6 months post-commencement of the intervention.
Secondary outcome [14] 389057 0
Descriptive data will be collected documenting number of participants who: register interest in the trial; meet inclusion criteria; agree to participate; are randomised; and are retained throughout the treatment period. These data will be extracted from the study database.
Timepoint [14] 389057 0
Throughout the intervention period of 6 months
Secondary outcome [15] 389058 0
Number of clinicians completing training and providing treatment throughout the trial, as extracted from the study database.
Timepoint [15] 389058 0
The secondary timepoint will be at 6 months post-commencement of the intervention.

Eligibility
Key inclusion criteria
At least 18 years of age; spinal pain associated with road traffic crash less than 12 weeks prior; at high risk of chronic pain and disability, defined by a score of >50 on the Örebro Musculoskeletal Pain Screening Questionnaire-Short Form (OMPSQ)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or presence of ‘red flags’ for spinal pain (e.g. fracture, progressive neurological disorder, malignancy).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to the intervention or usual care group in a 1:1 ratio. A computer-generated randomisation schedule will be produced before the trial start by a biostatistician. To ensure allocation concealment, participants will be randomly assigned immediately after baseline assessment by a research assistant opening the next sealed, sequentially numbered, opaque envelope and assigning the participant to the allocated intervention enclosed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Aim 1: Descriptive statistics will be calculated with 95% confidence intervals and compared against pre-planned criteria for feasibility: at least 70% of sample can be recruited; at least 80% participants are retained; at least 80% of participants provide follow-up data at 6 months. Meeting these prespecified criteria will be considered evidence that the trial is feasible and proceeding to a definitive trial would be warranted if Aim 2 is also met.

Aim 2: Proof of concept will be estimated on an intention-to-treat basis using regression models for each outcome of interest, adjusting for baseline values. Effect sizes will be estimated as mean differences, with proof-of-concept considered acceptable if previously reported minimal clinically important differences (MCID) are within the 95% confidence interval for the mean difference between groups. To confirm appropriateness of parameters utilised in a sample size calculation for the full-scale RCT, the between-person baseline standard deviation (SD) and the within-person correlation between baseline and six-month measures of the primary outcome will be calculated. Proceeding to a definitive trial will be deemed warranted if MCID for at least one of the primary outcomes (pain or disability) falls within the 95% confidence interval of the estimated effect.

Aim 3: Costs in the two treatment groups will be documented with descriptive statistics and compared for significant differences with a simple independent samples t-test.

Aim 4: Descriptive statistics will be calculated for the CSQ-8. Qualitative interviews will be audio recorded and transcribed verbatim for analysis. Thematic analysis will be used to analyse the data, using an inductive approach. A contextualist epistemology will underlie the analysis, assuming knowledge is shaped by unique contextual factors including the researchers’ own positions. Data analysis will be iterative and involve ongoing familiarisation with the data, preliminary coding of transcripts, identification of themes, and further abstraction within the context of theory.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
3/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26570 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 26571 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 42613 0
6000 - Perth
Recruitment postcode(s) [2] 42614 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 307244 0
Government body
Name [1] 307244 0
Insurance Commission of Western Australia
Country [1] 307244 0
Australia
Primary sponsor type
Individual
Name
John Curtin Distinguished Professor Peter O’Sullivan
Address
School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 307853 0
Individual
Name [1] 307853 0
Dr Rob Schutze
Address [1] 307853 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102
Country [1] 307853 0
Australia
Secondary sponsor category [2] 307857 0
Individual
Name [2] 307857 0
Professor Anne Smith
Address [2] 307857 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102
Country [2] 307857 0
Australia
Secondary sponsor category [3] 307858 0
Individual
Name [3] 307858 0
Associate Professor Peter Kent
Address [3] 307858 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102
Country [3] 307858 0
Australia
Secondary sponsor category [4] 307859 0
Individual
Name [4] 307859 0
Dr JP Caneiro
Address [4] 307859 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102
Country [4] 307859 0
Australia
Secondary sponsor category [5] 307860 0
Individual
Name [5] 307860 0
Professor Michele Sterling
Address [5] 307860 0
RECOVER Injury Research Centre
Faculty of Health and Behavioural Sciences,
University of Queensland
St Lucia QLD 4072
Country [5] 307860 0
Australia
Secondary sponsor category [6] 307861 0
Individual
Name [6] 307861 0
Professor Michael Nicholas
Address [6] 307861 0
Pain Management Research Institute
School of Medicine, Anderson Stuart Building, The University of Sydney
Camperdown NSW 2050
Country [6] 307861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307339 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 307339 0
Ethics committee country [1] 307339 0
Australia
Date submitted for ethics approval [1] 307339 0
03/03/2020
Approval date [1] 307339 0
25/08/2020
Ethics approval number [1] 307339 0
HRE2020-0470

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

Contacts
Principal investigator
Name 106890 0
Prof John Curtin Distinguished Professor Peter O’Sullivan
Address 106890 0
Curtin University
Kent St
Bentley WA 6102
Country 106890 0
Australia
Phone 106890 0
+61 08 9266 3629
Fax 106890 0
Email 106890 0
P.Osullivan@curtin.edu.au
Contact person for public queries
Name 106891 0
Rob Schütze
Address 106891 0
Curtin University
Kent St
Bentley WA 6102
Country 106891 0
Australia
Phone 106891 0
+61 08 9266 3176
Fax 106891 0
Email 106891 0
R.Schutze@curtin.edu.au
Contact person for scientific queries
Name 106892 0
Rob Schütze
Address 106892 0
Curtin University
Kent St
Bentley WA 6102
Country 106892 0
Australia
Phone 106892 0
+61 08 9266 3176
Fax 106892 0
Email 106892 0
R.Schutze@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual quantitative participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Available following publication of the trial results.
No end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal determined on a case-by-case basis at the discretion of Primary Sponsor.
How or where can data be obtained?
Individuals may request data from the trial manager, Dr Rob Schutze, by emailing R.Schutze@curtin.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9793Informed consent form  R.Schutze@curtin.edu.au
9794Ethical approval  R.Schutze@curtin.edu.au



Results publications and other study-related documents

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