Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000209695
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
25/08/2005
Date last updated
25/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of cognitive behavioural therapy for fatigue in patients with multiple sclerosis.
Scientific title
A randomised controlled trial of cognitive behavioural therapy compared to relaxation therapy to reduce fatigue in patients with multiple sclerosis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis fatigue 292 0
Condition category
Condition code
Neurological 328 328 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 216 0
Behaviour
Comparator / control treatment
The relaxation therapy has been designed to act as a placebo condition to control for the non-specific treatment effects of therapist attention.
Control group
Active

Outcomes
Primary outcome [1] 382 0
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.
Timepoint [1] 382 0
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 [1] 848 0
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.
Timepoint [1] 848 0
Measured at baseline, end of treatment, 3 and 6 months follow –up.
Secondary outcome [2] 849 0
The Hospital Anxiety and Depression scale (HAD) (Zigmond 1983) is used to assess the degree of anxiety and depression.
Timepoint [2] 849 0
Measured at baseline, end of treatment, 3 and 6 months follow –up.
Secondary outcome [3] 850 0
The Perceived Stress Scale (PSS) (Cohen et al, 1983), is used to asses the degree to which situations are appraised as stressful.
Timepoint [3] 850 0
Measured at baseline, end of treatment, 3 and 6 months follow –up.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was achieved by placing equal numbers of the letters C (CBT) and R (relaxation) in 70 separate, opaque envelopes which were ordered according to random numbers and then sealed. These were handed onto an independent administrator (the secretary of the Psychological Medicine Department at the University of Auckland). As each new participant enters the study, the independent administrator is asked by the principal investigator to open an envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Through randomization.com a computerised randomisation programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 139 0
New Zealand
State/province [1] 139 0

Funding & Sponsors
Funding source category [1] 386 0
Charities/Societies/Foundations
Name [1] 386 0
The Neurological Foundation of New Zealand
Country [1] 386 0
New Zealand
Primary sponsor type
Individual
Name
Dr Rona Moss-Morris
Address
Country
Secondary sponsor category [1] 315 0
Individual
Name [1] 315 0
Kirsten van Kessel
Address [1] 315 0
Country [1] 315 0
Secondary sponsor category [2] 316 0
Individual
Name [2] 316 0
Dr Ernie Willoughby
Address [2] 316 0
Country [2] 316 0
Secondary sponsor category [3] 317 0
Individual
Name [3] 317 0
Prof Trudie Chalder
Address [3] 317 0
Country [3] 317 0
Secondary sponsor category [4] 318 0
Individual
Name [4] 318 0
Malcolm Johnson
Address [4] 318 0
Country [4] 318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1379 0
Neurological services, Auckland Hospital
Ethics committee address [1] 1379 0
Ethics committee country [1] 1379 0
New Zealand
Date submitted for ethics approval [1] 1379 0
Approval date [1] 1379 0
Ethics approval number [1] 1379 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35592 0
Address 35592 0
Country 35592 0
Phone 35592 0
Fax 35592 0
Email 35592 0
Contact person for public queries
Name 9405 0
Ms Kirsten van Kessel
Address 9405 0
Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 9405 0
New Zealand
Phone 9405 0
+64 9 3737599 (Ext. 84936)
Fax 9405 0
+64 9 3737013
Email 9405 0
[email protected]
Contact person for scientific queries
Name 333 0
Dr Rona Moss-Morris
Address 333 0
Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 333 0
New Zealand
Phone 333 0
+64 9 3737599 (Ext. 86756)
Fax 333 0
+64 9 3737013
Email 333 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.