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

Abstract

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.