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

Active, not recruiting

• Conditions: Multiple sclerosis fatigue; Neurological - Multiple sclerosis

• Registration Number: ACTRN12605000209695
• Lead Sponsor: Dr Rona Moss-Morris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 70

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.

Exclusion Criteria

(a) Patients who have any serious psychological disorders for whom treatment would be inappropriate including psychotic disorders or active substance abuse. (b) Patients who have any serious chronic illness which may be contributing to their fatigue such as a malignancy or thyroid disorder. (c). Non-English speakers and people who are unable to read and write English. (d) Should any participants alter their medication during this time period, or begin a course of anti-depressant medication or interferon, their data will not be included in the final analysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[The fatigue scale is measured at baseline, end of treatment, 3 and 6 months follow-up and the global impression scale at end of treatment and at 3 & 6 months follow-up.]

Secondary Outcome Measures

Name	Time	Method
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. [Measured at baseline, end of treatment, 3 and 6 months follow –up.];The Hospital Anxiety and Depression scale (HAD) (Zigmond 1983) is used to assess the degree of anxiety and depression.[Measured at baseline, end of treatment, 3 and 6 months follow –up.];The Perceived Stress Scale (PSS) (Cohen et al, 1983), is used to asses the degree to which situations are appraised as stressful.[Measured at baseline, end of treatment, 3 and 6 months follow –up.]