Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain

The following are members of the MUSICIAN study team: Gary Macfarlane (Principal Investigator), John McBeth (Investigator), Deborah Symmons (Investigator), Karina Lovell (investigator), Philip Keeley (Investigator), Phil Hannaford (Investigator), Chrysa Gkazinou (Trial manager), Marcus Beasley (Research Assistant), Elizabeth Jones (PhD student), Gordon Prescott (Statistician), and Steve Woby (Investigator). We are grateful to the practices and patients in Aberdeen city and Cheshire, which participated in the study: Carden medical centre, Elmbank medical practice, Great Western Road medical practice, Garthdee medical group, Readesmoor medical group practice, Lawton House surgery, Bollington medical practice, Park Lane surgery. The Scottish Primary Care Research Network facilitated access to patient information at the practices in Aberdeen city. Charlie Stockton was the study manager and Ashraf El-Metwally an Investigator during the setting up and for part of the conduct of the study. John Norrie was originally an investigator of the MUSICIAN study while Director of the Centre for Health Care Randomised Trials (CHART) at the University of Aberdeen. We are grateful for the input of members of the Health Services Research Unit (HSRU) at The University of Aberdeen in the conduct of the study: Alison MacDonald and Gladys McPherson. We are grateful to the project assistants who worked on the survey: Dev Acharya, Jennifer Bannister, Flora Joyce, Michelle Rein., Karen Kane, and Rowan Jasper. Alison Littlewood was responsible for study management at the Cheshire site. Finally, we thank the independent members of the trial steering committee (Professor Matthew Hotopf, Professor Tracey Howe, Professor Martin Underwood) and data monitoring committee (Dr. Marwan Bukhari, Professor Hazel Inskip, Dr. Chris Edwards). Funding details The study was funded by Arthritis Research UK, grant number 17292.Peer reviewedPublisher PD

Long-term effects of cognitive behaviour therapy and exercise for chronic widespread pain

Background Cognitive behaviour therapy (CBT) and exercise have been shown to improve short-term outcomes for chronic widespread pain (CWP) patients. There is little data on whether improvement maintains long-term. Methods or theme The MUSICIAN Trial was a 2 x 2 factorial randomised controlled trial. A survey of general practitioner (GP)-registers identified CWP patients consulting their GP in the last year. Random assignation was to four study arms: the Cognitive Behavior Therapist (tCBT), exercise, combined treatment, or treatment as usual (TAU). tCBT participants had eight weekly telephone sessions and three and six month follow-up calls. Exercise group participants followed an individual fitness-instructor designed program over six months with monthly review. Combined treatment participants received both interventions. TAU participants received usual care. Follow-up by postal questionnaire or telephone was 24 months post-treatment. Positive outcome was patient-reported change in health of ‘much’ or ‘very much’ better. Analysis was by logistic regression and odds ratios (ORs) with 95% confidence intervals (CIs) are reported. Results Totally 442 persons participated (median age 57 years, 69% female) – 361 had 24-month follow-up. Of 94 respondents, 12 (12.8%) in TAU reported positive outcomes, 29 of 82 in tCBT (35.4%), 27 of 92 in exercise (29.3%) and 29 of 93 in combined treatment (31.2%). ORs compared to TAU were: tCBT, OR 4.0 (95% CI, 1.8–8.7); exercise, 2.9 (1.4–6.3); combined, 3.5 (1.6–7.5). Improvement odds did not differ across active treatments – there was no advantage in receiving both interventions. Conclusions tCBT and/or exercise for CWP are associated with long-term patient-reported health improvements. These are amongst the largest, longest-term benefits reported for CWP and offer potential management strategies

A Randomised Controlled Trial (RCT) of Telephone Delivered Cognitive Behaviour Therapy (tCBT) and Exercise In The Management Of Chronic Widespread Pain (CWP): Identifying Long-Term Outcome and Who Benefits From Which Treatment

Background/Purpose: CWP is challenging for rheumatologists to manage and results from long-term epidemiological studies demonstrate that improvement in symptoms is uncommon. Recent reviews have, however, suggested that non-pharmacological therapies such as behaviour therapy and exercise may be effective, at least in the short-term. The aim of the current study is to determine whether tCBT, exercise, or both treatments combined deliver long-term health benefits to patients with CWP in comparison to treatment as usual (TAU) and to characterise patients who benefit from each specific treatment. Methods: A 2 x 2 factorial RCT. Patients with CWP were identified from a population screening survey of 45, 994 adults in the UK. Eligible individuals met the ACR definition of CWP and reported disability. They had consulted their family physician in the last year with pain, and with no cause identified which required specific treatment. Participants were randomly assigned to a) 8 sessions of tCBT over 6 weeks, and refresher sessions at 3 and 6 months, b) an individually tailored exercise programme with monthly review over 6 months at a local fitness centre c) a combination of these treatments, or d) TAU. Participants were followed up at the end of treatment and 3 and 24 months later. The primary outcome was self reported “change in health since entering the study” and a positive outcome was at least 6 (“I felt much better”) on a scale from 0 (“I feel very much worse”) to 7 (“I feel very much better”). Analysis was intention-to-treat with longitudinal logistic regression using generalised estimating equations (GEE). Results are presented as Odds ratios (OR) with 95% Confidence Intervals (CI). Additional models were run to assess the effect of baseline characteristics in predicting the response to the specific treatments received. Results: A total of 442 persons (median age 57 years, 69% female) entered the study and 361 persons (82%) provided information at final follow-up. At 24 months post-treatment, the proportion of patients reporting a positive outcome was: tCBT 35.4%, Exercise 29.4%, combined treatment 31.2%, TAU 12.8%. Response, after adjustment for age, sex, baseline psychological distress, pain intensity and disability was significantly more likely for exercise (OR 2.5, 95% CI (1.2, 5.4), tCBT (3.6; 1.7-7.6) and the combination (2.9; 1.4,6.0) compared to TAU. Baseline characteristics associated with significantly greater response to tCBT (compared to those not receiving tCBT) were: high psychological distress, a passive coping style, high intensity and/or disabling pain and moderate levels of fatigue. Older persons responded significantly better to the exercise intervention, although this was evident at the end of treatment but not subsequently. Conclusion: A six month programme of exercise or tCBT is associated with long-term improvements in the health of patients with CWP. The size of effect was similar with each treatment, and there was no advantage in subjects receiving both. However we identified specific characteristics associated with response to tCBT which can potentially allow future targeting of therapy