A hybrid implementation and effectiveness trial to assess the effectiveness of cognitive functional therapy compared to usual physiotherapy for people with chronic disabling low back pain (IMPACT-CFT trial).

Cognitive Functional Therapy (CFT). CFT is a physiotherapist-led individualised cognitive and behavioural intervention for people with disabling musculoskeletal pain. CFT is person-centred, where the individuals pain experience is validated, their pain story including their concerns, worries and fears are heard, cognitive reassurance is provided, and their goals and preferences are honoured. This helps to build a strong therapeutic relationship. Motivational approaches are used to help to guide people to engage in positive behaviour change. The clinician uses a multi-dimensional clinical reasoning framework to synthesise information from screening questionnaires and an extensive biopsychosocial interview and physical examination to identify modifiable barriers to their recovery. This allows treatment to be targeted towards the biopsychosocial drivers of the person's pain, distress and disability. These factors may include addressing a person’s pain cognitions (e.g. misconceptions about pain and the body), emotions (e.g. pain-related fear, distress and depressed mood), social factors (e.g. isolation), behaviours (e.g. movement, activity or work avoidance, over-protective muscle guarding) and lifestyle factors (e.g. inactivity, poor sleep and dietary habits). CFT is a model of care that has three broad components 1) Making sense of pain: personalised biopsychosocial pain education, helping the person understand the multiple factors that drive their pain, distress and disability. Pain exacerbation plans are provided to help people effectively manage flare-ups; 2) Graded exposure with control: a process of graded exposure to painful, feared or avoided movements and activities linked to the person's valued goals. During this process the clinician guides the person to develop pain control strategies (e.g. body relaxation, control and awareness) to gain confidence and generalised learnings to re-engage in valued activities of daily living, work and or social engagement; 3) Healthy lifestyle behaviours: engaging in regular physical activity based on their preference, improving sleep hygiene where sleep is disrupted, or employing stress management strategies such as meditation and relaxation techniques). CFT treatment sessions will be delivered one-on-one and can be delivered either in-person or online. The CFT treatment dosage (number of sessions) will be at the patient's and therapist's discretion and will be individualised based on each patient's unique treatment requirements. While there is no minimum or maximum treatment dosage, the trial will partially re-imburse up to 8 sessions and clinician training will suggest this as a rough guide for patients based on previous trials. Clinicians in the CFT arm will be encouraged to provide a booster session to reinforce the management plan and reinforce pain exacerbation plans if the patient has a flare up (e.g. 3-6 months after the initial treatment sessions), but when this occurs it will be at the patient and therapists discretion. The time taken to see patients will be approximately 60 minutes for an initial consultation and 30-45 minutes for a follow-up. Treatment frequency will start at approximately one session per 1-2 weeks, and then become less frequent. Physiotherapist CFT Training Clinicians allocated to the CFT-arm will receive a combination of online asynchronous self-directed modules and 4 weekends of synchronous training. Self-paced online training will occur in Month 1 and 2. Knowledge: covering content related to the multidimensional nature of chronic low back pain; clinical reasoning, key principles of person-centred care, and best-practice conduct of a person-centred interview and physical examination, and key elements of CFT applied to two patients with chronic disabling low back pain by a CFT expert. Self-reflections and a knowledge quiz are embedded into the online training to facilitate deeper learning. Online training will be followed by 4 face-to-face weekend workshops that will occur across the following 4 months, involving 1 peer-to-peer skills training workshop. This involves training skills in person-centred communication, screening, biopsychosocial interview, behavioural examination, clinical reasoning and CFT management. Videos of real patients will be used to facilitate this. The subsequent 3 weekends involve mentoring while each clinician works with patients with chronic low back pain. Each mentoring session is videoed and used for self-reflection. During this process, the trainers will provide guidance and personalised feedback on the clinician's performance based on a competency checklist. Rural and regional clinicians will be offered all the training online (self-directed) and via live teleconferencing (4 weekend workshops). The CFT training will be delivered by a team of physiotherapists (approximately 6) who have successfully completed a CFT trainer mentoring program and demonstrated competency in training clinicians. Two members of the research team (O’Sullivan, Caneiro) will lead and mentor the training team. All CFT clinicians in this trial will have completed all online training modules, attended weekend workshops and demonstrated competency based on the CFT competency checklist (as assessed by the CFT trainers) prior to delivering CFT in the trial.