Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study.

OBJECTIVES: To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia. DESIGN: Mixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial. SETTING: Primary care. PARTICIPANTS: Twenty-five adult patients with chronic pain and insomnia. INTERVENTION: Hybrid CBT or self-help control intervention. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary 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. RESULTS: Fourteen 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. CONCLUSION: Important 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 NUMBER: ISRCTN17294365.

Intensive versus standard multifactorial cardiovascular risk factor control in screen-detected type 2 diabetes: 5-year and longer-term modelled outcomes of the ADDITION-Leicester study.

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.

Development of the Pain-Related Beliefs and Attitudes about Sleep (PBAS) Scale for the Assessment and Treatment of Insomnia Comorbid with Chronic Pain.

STUDY OBJECTIVES: Dysfunctional beliefs and attitudes about sleep is a cognitive-behavioral factor central to the development and perpetuation of insomnia. Previous works to unravel the complex interrelationship between pain and insomnia have not explored the role of inflexible beliefs about the sleep-pain interaction, possibly due to a lack of a valid instrument for doing so. The current study evaluated the psychometric and functional properties of a 10-item Pain-Related Beliefs and Attitudes about Sleep (PBAS) scale. METHODS: The PBAS scale was administered to four clinical samples of chronic pain patients with comorbid insomnia: to examine the scale's psychometric properties (n = 137), test-retest reliability (n = 26), sensitivity to treatment (n = 20), and generalizability (n = 62). All participants completed the PBAS together with validated measures of pain interference, insomnia severity, and cognitive-behavioral processes hypothesized to underpin insomnia. RESULTS: The PBAS scale was found to be reliable, with adequate internal consistency and temporal stability. Factor analysis suggested a 2-factor solution representing beliefs about "pain as the primary cause of insomnia" and the "inevitable consequences of insomnia on pain and coping." The PBAS total score was positively correlated with scores from the Insomnia Severity Index (ISI) scale, Dysfunctional Beliefs and Attitudes about Sleep (DBAS) scale, and the Anxiety and Preoccupation about Sleep Questionnaire (APSQ). It was a significant predictor of insomnia severity and pain interference. A significant reduction in PBAS was also observed in patients after receiving a hybrid cognitive-behavioral intervention for both pain and insomnia. CONCLUSIONS: 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.