Self Help for Fatigue in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532037
• Other study ID #: RCT-MS-NHS-1
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Cognitive behavioural therapy based self help
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
Usual care from healthcare professionals with regard to patients symptoms of fatigue

Locations

Country	Name	City	State
United Kingdom	Fife Rehabilitation Service	Leven	Scotland
United Kingdom	NHS Fife	Leven	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 time points at 0, 8, 20, 32 & 60 weeks.
Secondary	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.	5 time points at 0, 8, 20, 32 & 60 weeks
Secondary	Change from baseline on the Hospital Anxiety and Depression Scale at post measure, 3, 6 and 12 months follow up.		5 time points at 0, 8, 20, 32 & 60 weeks
Secondary	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.	5 time points at 0, 8, 20, 32 & 60 weeks