A randomised controlled trial of cognitive behavioural therapy for fatigue in patients with multiple sclerosis.

INTERVENTION: This study aims to evaluate the effectiveness of cognitive behavioural therapy (CBT) in reducing fatigue in Multiple Sclerosis in a randomised controlled clinical trial. Seventy participants who provide informed consent will be randomised to attend 8 weekly individual sessions of either CBT or relaxation therapy. The CBT includes gradual exposure to consistent activity and rest, stress and sleep management, and cognitive restructuring. CONDITION: Multiple sclerosis fatigue PRIMARY OUTCOME: The primary outcomes are the Chalder Fatigue Scale (Chalder et al 1993), which measures the severity of fatigue, and provides subscale scores for both mental and physical fatigue and the self‐rated clinical global impression scale. SECONDARY OUTCOME: The Hospital Anxiety and Depression scale (HAD) (Zigmond 1983) is used to assess the degree of anxiety and depression. The Perceived Stress Scale (PSS) (Cohen et al, 1983), is used to asses the degree to which situations are appraised as stressful. The Work and Social Adjustment Scale (WSAS) (Mundt et al 2002), is used to measure the impact of fatigue on the person’s day to day life. INCLUSION CRITERIA: (a) A definite diagnosis of MS. (b) A Kurtzke EDSS score of 6 or less (Kurtze, 1983). A score of 6 or less identifies patients who are still ambulatory without aid or rest for about 100 metres. (c) A Chalder fatigue score of 4 or greater. A cut‐off of 4 on the fatigue scale has been identified as a case level of fatigue. (d) Patients on interferon will be included if they have taken the medication for a minimum period of three months. (e). Patients currently using medication for the treatment of depression will be included if they have been on a stable dose of the medication for at least two months and intend to continue that dosage during the duration of the study. (f) A willingness to abstain from taking on any new psychological or pharmacological treatment during the duration of the study.