Self Help for Fatigue in Multiple Sclerosis
This study is currently recruiting participants.
Verified June 2012 by University of Edinburgh
Sponsor:
University of Edinburgh
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01532037
First received: January 17, 2012
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis Fatigue |
Other: Cognitive behavioural therapy based self help Other: Treatment as usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by University of Edinburgh:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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. [ Time Frame: 5 time points at 0, 8, 20, 32 & 60 weeks ] [ Designated as safety issue: No ]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. [ Time Frame: 5 time points at 0, 8, 20, 32 & 60 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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
|
|
Experimental: Pure Self Help
Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone
|
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
|
|
Placebo Comparator: Treatment as Usual
Participants receive usual care from healthcare professionals
|
Other: Treatment as usual
Usual care from healthcare professionals with regard to patients symptoms of fatigue
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532037
Contacts
| Contact: Kirsty Nesbitt | kirstynesbitt@nhs.net |
Locations
| United Kingdom | |
| National Health Service | Recruiting |
| Fife, Scotland, United Kingdom, KY8 5RR | |
| Contact: Kirsty Nesbitt kirstynesbitt@nhs.net | |
| Principal Investigator: Kirsty Nesbitt | |
| Fife Rehabilitation Service | Recruiting |
| Fife, Scotland, United Kingdom, KY8 5RR | |
| Contact: Kirsty Nesbitt kirstynesbitt@nhs.net | |
| Principal Investigator: Kirsty Nesbitt | |
Sponsors and Collaborators
University of Edinburgh
Investigators
| Principal Investigator: | Kirsty Nesbitt | National Health Service, University of Edinburgh |
More Information
No publications provided
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01532037 History of Changes |
| Other Study ID Numbers: | RCT-MS-NHS-1 |
| Study First Received: | January 17, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by University of Edinburgh:
|
Randomised controlled trial Multiple Sclerosis Fatigue Cognitive Behavioural Therapy Self Help |
Additional relevant MeSH terms:
|
Fatigue Multiple Sclerosis Sclerosis Signs and Symptoms Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013