Self Help for Fatigue in Multiple Sclerosis
A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
1 other identifier
interventional
73
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Jun 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 13, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 23, 2021
June 1, 2021
1.9 years
January 17, 2012
June 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.
5 time points at 0, 8, 20, 32 & 60 weeks
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
Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.
5 time points at 0, 8, 20, 32 & 60 weeks
Study Arms (3)
Guided Self Help
EXPERIMENTALParticipant 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.
Pure Self Help
EXPERIMENTALParticipant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone
Treatment as Usual
PLACEBO COMPARATORParticipants receive usual care from healthcare professionals
Interventions
Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual
Usual care from healthcare professionals with regard to patients symptoms of fatigue
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fife Rehabilitation Service
Leven, Scotland, KY8 5RR, United Kingdom
NHS Fife
Leven, Scotland, KY8 5RR, United Kingdom
Related Publications (1)
Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirsty Nesbitt
National Health Service, University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2012
First Posted
February 13, 2012
Study Start
June 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 23, 2021
Record last verified: 2021-06