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

A randomised controlled trial of cognitive behavioural therapy compared to relaxation therapy to reduce fatigue in patients with multiple sclerosis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000209695

Enrollment

Registered

2005-08-25

Start date

2004-01-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results