Self Help for Fatigue in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532037

Contacts
Contact: Kirsty Nesbitt kirstynesbitt@nhs.net

Locations
United Kingdom
Fife Rehabilitation Service Recruiting
Fife, Scotland, United Kingdom, KY8 5RR
Contact: Kirsty Nesbitt       kirstynesbitt@nhs.net   
Principal Investigator: Kirsty Nesbitt         
National Health 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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014