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Completed

NCT Number: NCT01532037

Self Help for Fatigue in Multiple Sclerosis

The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fife Rehabilitation Service, Leven, Scotland, United Kingdom

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About this study

Background: Fatigue is a common disabling symptom in patients with Multiple Sclerosis (MS). Cognitive behavioural therapy (CBT) has been shown to be effective in the reduction of fatigue in MS and CBT-based self-help has been shown to be effective as a low intensity intervention for anxiety and depression.

Objectives: To evaluate the effectiveness of a CBT based self-help workbook at reducing perceived impact of fatigue in a clinical sample of MS patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will be aged 18 or over
  • Will have a recognised diagnosis of relapsing remitting or primary progressive relapsing remitting Multiple Sclerosis from a neurologist
  • Cognitively able to give informed consent as deemed by referring clinician in the Fife Rehabilitation Service
  • Willing to consent to randomised control trial
  • Fatigue as a primary symptom

Exclusion criteria

  • Patients with severe anxiety or depression (assessed by cut off on HADS)
  • Patients with psychosis or personality disorders (assessed by referring clinician)
  • Patients currently receiving input from psychological services for fatigue management
  • Patients with suicidal ideation or plans (assessed by referring clinician)
  • Patients who are unable to read the workbook or standardised questionnaires due to literacy levels or cognitive abilities will be excluded from the analysis, although if patients have literacy or cognitive problems, referral to a more suitable 1-to-1 type of therapy will be made.

Treatment and study plan

Cognitive behavioural therapy based self help

Other

Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual

Treatment as Usual

Other

Usual care from healthcare professionals with regard to patients symptoms of fatigue

Primary outcomes

  1. Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.

    Time frame: 5 time points at 0, 8, 20, 32 & 60 weeks.

    The Modified Fatigue Impact Scale (MFIS) consists of 21 items selected from the Fatigue Impact Scale (FIS; Fisk, Ritvo, Ross, Haase, Murray, & Schlech, 1994), a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. The items of the MFIS can be combined into three subscales (Physical, Cognitive, and Psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a patient's activities. Measures will be taken at 5 time points to assess change over time.

Secondary outcomes

  1. Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.

    Time frame: 5 time points at 0, 8, 20, 32 & 60 weeks

    36-Item Short Form Survey Instrument (SF 36, Ware et al.1993) consists of 36 questions measuring functional health and well-being from the patient's point of view. Scores are split into two summary measures (physical health and mental health) and within the two summary measures there are eight scales which include. The eight scales are made up of; physical functioning, role limitations due to physical functioning, bodily pain, general health, vitality, social functioning, role limitations due to emotional functioning and mental health.

  2. Change from baseline on the Hospital Anxiety and Depression Scale at post measure, 3, 6 and 12 months follow up.

    Time frame: 5 time points at 0, 8, 20, 32 & 60 weeks

  3. Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.

    Time frame: 5 time points at 0, 8, 20, 32 & 60 weeks

    Is a 6-item scale which is adapted from the original 33 item scale (Lorig et al. 1996). The 6-item scale was developed so it would be less burdensome for patients. The 6- item scale covers areas of symptom control, role function, emotional functioning and communicating with physicians.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2012
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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