A randomised controlled trial of a self-management programme for fatig

Multi-centre parallel arm randomised controlled trial to assess the effectiveness of a group-based cognitive behavioural approach to managing fatigue in people with multiple sclerosis.

Completed (inferred)Relapsing and progressiveISRCTN76517470

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • 1. Self-reported fatigue severity The Fatigue Assessment Instrument (FAI) (Schwartz,. Jandorf, & Krupp, 1993) is an expanded version of the unidimensional Fatigue Severity Scale (FSS). The FSS is one of the best known and most used fatigue scales. It principally measures the impact of fatigue on specific types of functioning. The FAI has four subscales: fatigue severity, situation specificity, con

    FatigueMood and sleepQuality of life (reported by participants)

Other measures (1)

  • 1. Self-reported fatigue Three of the subscales from the FAI (namely, situation specificity, consequences of fatigue and responsiveness to rest/sleep) along with the total score of the FAI. 2. Self-reported fatigue impact The subscale scores of the MSIS-29 for the physical and psychological impact of MS. 3. Self-reported general quality of life 3.1. The Medical Outcomes Short-form Survey (SF-36)

    FatigueWalking and mobilityPhysical functionPainMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 1. Providing written informed consent 2. Over the age of 18 3. Clinical diagnosis of relapsing-remitting or progressive multiple sclerosis 4. Score on the Fatigue Severity Scale > 4 5. Ambulatory (score on the Adapted Patient Determined Disease Steps Scale <8) 6. Able to attend the intervention sessions 7. English speaking Exclusion: 1. Attended a specific fatigue management programme within the last year 2. Received a substantive, specific, fatigue intervention from an Occupational Therapist (OT) or other health professional, consisting of more than general advice, within the previous 3 months 3. Already involved in another research study 4. Cognitive deficits that would preclude engagement in the group format or benefit from the programme. This will be based on the judgement of health professionals/local investigators 5. A relapse within the previous 3 months 6. Individuals who have been on a disease-modifying drug or an anti-depressant for fewer than 3 months 7. Severe psychological disorders (individuals known to be currently under the care of a psychiatrist or addiction services)

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Not provided at time of registration

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2007

    2. Finished

      Jun 2010

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