ANZCTR - Registration

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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]

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)

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Mental Health

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

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]

Physical Function, as measures by the PROMIS Physical Function-Short Form

Timepoint [1]

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]

Pain Interference, as measured by the PROMIS Pain Interference-Short Form

Timepoint [2]

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]

Pain intensity, measured with the PROMIS Scale v1.0 - Pain Intensity

Timepoint [1]

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]

Emotional distress, using the Depression Anxiety Stress Scale (DASS-21)

Timepoint [2]

Secondary outcome [3]

Trauma symptoms using the PTSD Checklist (PCL-5)

Timepoint [3]

Secondary outcome [4]

Disability using the Patient-Specific Functional Scale (PSFS)

Timepoint [4]

Secondary outcome [5]

Pain catastrophising using the Pain Catastrophizing Scale (PCS)

Timepoint [5]

Secondary outcome [6]

Pain self-efficacy using the Pain Self Efficacy Questionnaire (PSEQ)

Timepoint [6]

Secondary outcome [7]

Health-related quality of life using the EQ-5D-5L questionnaire

Timepoint [7]

Secondary outcome [8]

Perceived recovery, using an 11-point global impression of recovery scale

Timepoint [8]

Secondary outcome [9]

Work status based on Insurance Commision of Western Australia (ICWA) data

Timepoint [9]

Secondary outcome [10]

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]

Secondary outcome [11]

Direct treatment costs incurred by ICWA for each participant will be compared using data provided by ICWA from their insurance records.

Timepoint [11]

The secondary timepoint will be at 6 months post-commencement of the intervention.

Secondary outcome [12]

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]

The secondary timepoint will be at 6 months post-commencement of the intervention.

Secondary outcome [13]

Dose of intervention, as measured by the number of appointments attended by participants according to session attendance checklists.

Timepoint [13]

The secondary timepoint will be at 6 months post-commencement of the intervention.

Secondary outcome [14]

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]

Throughout the intervention period of 6 months

Secondary outcome [15]

Number of clinicians completing training and providing treatment throughout the trial, as extracted from the study database.

Timepoint [15]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Joondalup Health Campus - Joondalup

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6027 - Joondalup

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Insurance Commission of Western Australia

Address [1]

219-221 St Georges Terrace
Perth WA 6000

Country [1]

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]

Individual

Name [1]

Dr Rob Schutze

Address [1]

School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor Anne Smith

Address [2]

School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Associate Professor Peter Kent

Address [3]

School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Dr JP Caneiro

Address [4]

School of Physiotherapy and Exercise Science
Curtin University
Kent St
Bentley WA 6102

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Professor Michele Sterling

Address [5]

RECOVER Injury Research Centre
Faculty of Health and Behavioural Sciences,
University of Queensland
St Lucia QLD 4072

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Professor Michael Nicholas

Address [6]

Pain Management Research Institute
School of Medicine, Anderson Stuart Building, The University of Sydney
Camperdown NSW 2050

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee (HREC)

Ethics committee address [1]

Kent St
Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/03/2020

Approval date [1]

25/08/2020

Ethics approval number [1]

HRE2020-0470

Summary

Brief summary

Compensable traffic injury claims in Western Australia present a $2.8 billion liability for the government insurer, with spine and neck injuries being the most frequent and costly complaint. Of these, Whiplash-Associated Disorders (WAD) are the most prevalent, placing a large burden on individuals, families and health systems because around half those with acute WAD develop persistent pain and disability. The proposed research aims to improve the outcomes of those at high risk of unresolved WAD and/or back pain by piloting an innovative integrated physiotherapy and psychology intervention – stratified Cognitive Functional Therapy (CFT). This is a patient-centred, individualised treatment led by physiotherapists and integrated with collaborative care from psychologists using a common clinical reasoning framework in cases where psychological risk factors predict poor prognosis. This time-limited non-interventional treatment uses an evidence-based self-management approach that targets modifiable risk factors. Trials in back pain show that CFT produces large, sustained improvements in functional recovery. This feasibility randomised controlled trial will test the potential for an integrated multidisciplinary version of CFT to be applied to crash-related spinal pain, including quantifying expected cost savings, compared to usual care, for the Insurance Commission of Western Australia.

Trial website

https://www.integrateclinicaltrial.com

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof John Curtin Distinguished Professor Peter O’Sullivan

Address

Curtin University
Kent St
Bentley WA 6102

Country

Australia

Phone

+61 08 9266 3629

Fax

[email protected]

Contact person for public queries

Name

Dr Rob Schütze

Address

Curtin University
Kent St
Bentley WA 6102

Country

Australia

Phone

+61 08 9266 3176

Fax

[email protected]

Contact person for scientific queries

Name

Dr Rob Schütze

Address

Curtin University
Kent St
Bentley WA 6102

Country

Australia

Phone

+61 08 9266 3176

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9793	Informed consent form			[email protected]
9794	Ethical 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.

Trial Review

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