ObjectivesTo test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.DesignMixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial.SettingPrimary care.ParticipantsTwenty-five adult patients with chronic pain and insomnia.InterventionHybrid CBT or self-help control intervention.Primary and secondary outcome measuresPrimary outcomes measures were the Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI). Secondary outcomes measures were the present pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L.ResultsFourteen participants were randomised to receive Hybrid CBT, 11 to receive the self-help control treatment. Of the 14 in the Hybrid CBT group, 9 (64%) completed all four treatment sessions (4 discontinued due to poor health; 1 due to time constraints). Adherence to the self-help control treatment was not monitored. The total number of participants completing the 12-week and 24-week follow-ups were 12 (6 in each group; Hybrid CBT: 43%; self-help: 55%) and 10 (5 in each group; Hybrid CBT: 36%; self-help: 45%). Based on the data available, candidate outcome measures appeared to be sensitive to changes associated with interventions. Thematic analysis of pre-postintervention interview data revealed satisfaction with treatment content among those who completed the Hybrid CBT, whereas those in the self-help control treatment wanted more contact hours and therapist guidance. Other practical suggestions for improvement included shortening the duration of each treatment session, reducing the amount of assessment paperwork, and minimising the burden of sleep and pain monitoring.ConclusionImportant lessons were learnt with regard to the infrastructure required to achieve better patient adherence and retention. Based on the qualitative feedback provided by a subset of treatment completers, future trials should also consider lowering the intensity of treatment and streamlining the data collection procedure.Trial registration numberISRCTN17294365.
Pain-related sleep beliefs appear to be an integral part of chronic pain patients' insomnia experience. The PBAS is a valid and reliable instrument for evaluating the role of these beliefs in chronic pain patients.
Aims Diabetes treatment algorithms recommend intensive intervention in those with a shorter duration of disease. Screening provides opportunities for earlier multifactorial cardiovascular risk factor control. Using data from the ADDITION‐Leicester study (NCT00318032), we estimated the effects of this approach on modelled risk of diabetes‐related complications in screen‐detected patients. Methods A total of 345 (41% South Asian) people with screen‐detected type 2 diabetes were cluster randomised to receive 5 years of (1) intensive multifactorial risk factor intervention or (2) standard treatment according to national guidance. Estimated 10 to 20‐year risk of ischaemic heart disease, stroke, congestive cardiac failure, and death was calculated using UK‐PDS risk equations. Results Compared with standard care, mean treatment differences for intensive management at 5 years were −11.7(95%CI: −15.0, −8.4) and −6.6(−8.8, −4.4) mmHg for systolic and diastolic blood pressure, respectively; −0.27 (−0.66, −0.26) % for HbA1c; and −0.46(−0.66; −0.26), −0.34 (−0.51; −0.18), and −0.19 (−0.28; −0.10) mmol/L for total cholesterol, LDL‐cholesterol, and triglycerides, respectively. There was no significant weight gain in the intensive group despite additional medication use. Modelled risks were consistently lower for intensively managed patients. Absolute risk reduction associated with intensive treatment at 10 and 20 years were 3.5% and 6.2% for ischaemic heart disease and 6.3% and 8.8% for stroke. Risk reduction for congestive heart failure plateaued after 15 years at 5.3%. No differences were observed for blindness and all‐cause death. Conclusion Intensive multifactorial intervention in a multi‐ethnic population with screen‐detected type 2 diabetes results in sustained improvements in modelled ischaemic heart disease, stroke, and congestive cardiac failure.
Background Chronic pain and insomnia have a complex, bidirectional relationship – addressing sleep complaints alongside pain may be key to alleviating patient-reported distress and disability. Healthcare professionals have consistently reported wanting to offer psychologically informed chronic pain management at the primary care level. Research in secondary care has demonstrated good treatment efficacy of hybrid CBT for chronic pain and insomnia. However, primary care is typically the main point of treatment entry, hence may be better situated to offer treatments using a multidisciplinary approach. In this study, primary care service providers’ perception of feasibility for tackling pain-related insomnia in primary care was explored. Methods The data corpus originates from a feasibility trial exploring hybrid CBT for chronic pain and insomnia delivered in primary care. This formed three in-depth group interviews with primary care staff (n = 9) from different primary care centres from the same NHS locale. All interviews were conducted on-site using a semi-structured approach. Verbal data was recorded, transcribed verbatim and analysed using the thematic analysis process. Results Eight themes were identified – 1) Discrepant conceptualisations of the chronic pain-insomnia relationship and clinical application, 2) Mismatch between patients’ needs and available treatment offerings, 3) Awareness of psychological complexities, 4) Identified treatment gap for pain-related insomnia, 5) Lack of funding and existing infrastructure for new service development, 6) General shortage of psychological services for complex health conditions, 7) Multidisciplinary team provision with pain specialist input, and 8) Accessibility through primary care. These mapped onto four domains - Current understanding and practice, Perceived facilitators, Perceived barriers, Ideal scenarios for a new treatment service – which reflected the focus of our investigation. Taken together these provide key context for understanding challenges faced by health care professionals in considering and developing a new clinical service. Conclusions Primary care service providers from one locale advocate better, multidisciplinary treatment provision for chronic pain and insomnia. Findings suggest that situating this in primary care could be a feasible option, but this requires systemic support and specialist input as well as definitive trials for success.
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