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Self Help for Fatigue in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive behavioural therapy based self help
Treatment as usual
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Randomised controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioural Therapy, Self Help

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fife Rehabilitation Service
  • NHS Fife

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Guided Self Help

Pure Self Help

Treatment as Usual

Arm Description

Participant receives usual care and 4, 45 minute sessions with a therapist to support them to complete the cognitive behavioural therapy based workbook for fatigue in Multiple Sclerosis.

Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone

Participants receive usual care from healthcare professionals

Outcomes

Primary Outcome Measures

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

Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.
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.
Change from baseline on the Hospital Anxiety and Depression Scale at post measure, 3, 6 and 12 months follow up.
Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.
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.

Full Information

First Posted
January 17, 2012
Last Updated
June 17, 2021
Sponsor
University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01532037
Brief Title
Self Help for Fatigue in Multiple Sclerosis
Official Title
A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue
Keywords
Randomised controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioural Therapy, Self Help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Self Help
Arm Type
Experimental
Arm Description
Participant receives usual care and 4, 45 minute sessions with a therapist to support them to complete the cognitive behavioural therapy based workbook for fatigue in Multiple Sclerosis.
Arm Title
Pure Self Help
Arm Type
Experimental
Arm Description
Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Participants receive usual care from healthcare professionals
Intervention Type
Other
Intervention Name(s)
Cognitive behavioural therapy based self help
Intervention Description
Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Usual care from healthcare professionals with regard to patients symptoms of fatigue
Primary Outcome Measure Information:
Title
Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.
Description
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.
Time Frame
5 time points at 0, 8, 20, 32 & 60 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.
Description
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.
Time Frame
5 time points at 0, 8, 20, 32 & 60 weeks
Title
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
Title
Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.
Description
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.
Time Frame
5 time points at 0, 8, 20, 32 & 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsty Nesbitt
Organizational Affiliation
National Health Service, University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fife Rehabilitation Service
City
Leven
State/Province
Scotland
ZIP/Postal Code
KY8 5RR
Country
United Kingdom
Facility Name
NHS Fife
City
Leven
State/Province
Scotland
ZIP/Postal Code
KY8 5RR
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf
Results Reference
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Self Help for Fatigue in Multiple Sclerosis

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