Primary care treatment of pain-related insomnia
Research type
Research Study
Full title
Primary care treatment of pain-related insomnia: A feasibility study of a hybrid cognitive-behavioural approach
IRAS ID
157593
Contact name
Nicole Tang
Contact email
Sponsor organisation
University of Warwick
Research summary
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 stakeholders’ experience. Wisdom gained will be used to refine the RCT protocol.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/1053
Date of REC Opinion
9 Sep 2014
REC opinion
Further Information Favourable Opinion