Title: Primary care treatment of pain-related insomnia: A feasibility study of a hybrid cognitive-behavioural approach
Funder: Department of Health and Social Care

Abstract: Background Chronic pain is a major burden to primary care, accounting for over 4 million GP appointments each year in the UK[15]. These pain patients usually present with multiple symptoms, with insomnia being one of the most common and disruptive comorbidities[10-12]. Conventionally sleep disturbance is seen as a secondary symptom to pain, but recent research shows that it is a key driver for persistent pain and its associated distress and disability[7,8,16-18]. Along with its role in pain, untreated insomnia is also a significant risk factor for adverse health outcomes such as cardiovascular disease and diabetes[19-23]. Although better sleep has long been emphasised by pain patients as an important treatment outcome[24,25], insomnia remains a peripheral focus in pain management programmes and pharmacological interventions continue to be first-line treatments despite the limited evidence supporting their efficacy and safety beyond 6-12 months[26]. A recent NIHR-funded programme of work investigated the reciprocal relationship between sleep and pain[11,13,18,26,27]and tested a brief but intensive course of hybrid cognitive-behavioural therapy (Hybrid CBT) specifically designed to address chronic pain and insomnia simultaneously[14]. The Hybrid CBT showed promise treating patients attending specialist pain clinics, but the applicability of the intervention and the generalisability of these findings to patients in primary care remain to be determined. Aims The proposed research will test the feasibility of adapting and implementing the Hybrid CBT in primary care using a mixed-method approach. The overarching aim is to generate quantitative and qualitative information to inform the development of a definitive randomised controlled trial (RCT) evaluating the clinical outcomes and cost-effectiveness of the Hybrid CBT. Investigation plan The proposed research comprises three interlinked work packages (WPs). WP1 involves developing an adapted Hybrid CBT manual and training two health psychologists for the delivery of treatment in WP2. Focus groups and interviews will be conducted with potential service users and providers to inform the treatment adaptation and therapist training process. Insights on improving treatment acceptability and accessibility will feed into the planning of WP2. WP2 tests the feasibility of implementing the Hybrid CBT across three geographically diverse GP practices in the form of a small-scale randomised study. Forty-eight pain patients with insomnia will be randomly allocated to receive either the Hybrid CBT or a self-help control treatment and assessed on a range of patient reported and objective pain, sleep, and functioning measures at baseline, 12-week and 24-week post-randomisation. This provides the experience and preliminary data to assess the randomisation arrangement, implementation process, performance and acceptability of outcome measures, and their suitability for health economic evaluation in an adequately-powered RCT. Finally, WP3 evaluates the treatment process, with particular emphasis on the treatment context, treatment fidelity, and the stakeholders experience. It will supply first-hand information from service users and providers to direct the refinement of the RCT protocol (WP2) and the therapist training programme (WP1) Potential benefits Many chronic pain patients are severely distressed by sleep disturbance. There is a pressing need for an evidence-based non-pharmacological treatment alternative for pain-related insomnia, as hypnotics are &ldquo;unlikely to be a cost-effective use of NHS resources&rdquo;[28]. The proposed research will culminate in a well-informed RCT protocol for further funding. This is a crucial next step towards generating high-quality evidence to inform the development of future guidelines and NHS services. Compared with the conventional pain- or insomnia-specific treatments, the Hybrid CBT has the potential to improve treatment efficiency, cutting disjointed assessments and repetitions in referrals/prescriptions. By adapting the Hybrid CBT for use in primary care, considerably more patients will be given the opportunity to tackle these comorbid health issues early on before the insomnia of chronic pain becomes refractory.

Lay abstract: Chronic pain patients often also have severe problems sleeping, which amplify their pain and increase their distress and disability. These patients do request treatment for their insomnia, but such treatment is never a main focus in pain management programmes. In primary care, drugs remain first-line treatments for pain-related insomnia despite limited evidence of their long-term effectiveness and safety. Hybrid cognitive-behavioural therapy (Hybrid CBT) is a new approach to tackling pain-related insomnia. It addresses pain and sleep simultaneously, exploiting factors underpinning the persistence of both problems. Delivered as a brief but intensive treatment in secondary care, Hybrid CBT was effective in not only improving sleep and reducing pain interference, but also counteracting fatigue and depression. The improvements were also clinically meaningful, however, it is not yet known if the patient benefits could be translated to primary care. The proposed research will inform the planning and implementation of a definitive randomised controlled trial (RCT) evaluating the clinical- and cost-effectiveness of the Hybrid CBT in primary care. It has three linked components: first, focus groups and interviews will be conducted with potential service users and providers to guide treatment adaptation and therapist training. Second, a small-scale study involving 48 chronic pain patients with insomnia will be conducted to test the delivery of the adapted treatment by trained therapists in GP practices. The study will ascertain whether it is feasible to recruit, randomise and retain sufficient patients to receive the Hybrid CBT offered or an alternative self-help intervention, and whether the assessment methods are robust enough for statistical and health economic evaluations in the full trial. Finally, utilising the study s findings and additional independent assessments, the treatment process will be evaluated in the light of the treatment context, treatment fidelity and stakeholders experience. Wisdom gained will be used to refine the RCT protocol.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE