Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2012-06-30
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Guided Self Help
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.
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
Pure Self Help
Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone
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
Participants receive usual care from healthcare professionals
Treatment as usual
Usual care from healthcare professionals with regard to patients symptoms of fatigue
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Kirsty Nesbitt
Role: PRINCIPAL_INVESTIGATOR
National Health Service, University of Edinburgh
Locations
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Fife Rehabilitation Service
Leven, Scotland, United Kingdom
NHS Fife
Leven, Scotland, United Kingdom
Countries
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References
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Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf
Other Identifiers
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RCT-MS-NHS-1
Identifier Type: -
Identifier Source: org_study_id
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