INTEGRATE - A feasibility trial of stratified Cognitive Functional Therapy for high risk neck and back injuries following road traffic crash

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.