ACTRN12605000209695Active, not recruitingNot Applicable
A randomised controlled trial of cognitive behavioural therapy compared to relaxation therapy to reduce fatigue in patients with multiple sclerosis.
Dr Rona Moss-Morris0 sites70 target enrollmentStarted: August 25, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- ot stated to ot stated (—)
- Sex
- All
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.
Investigators
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