Multiple SclerosisNCT01532037
Self Help for Fatigue in Multiple Sclerosis
A study testing Cognitive behavioural therapy based self help and Treatment as usual in people with Multiple Sclerosis and Fatigue, run by University of Edinburgh at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- Cognitive behavioural therapy based self help and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Fife Rehabilitation Service
Leven, Scotland, KY8 5RR
NHS Fife
Leven, Scotland, KY8 5RR
About this study
Official title: A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
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).
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- Cognitive behavioural therapy based self help, Treatment as usual
- Keywords
- Randomised controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioural Therapy, Self Help
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy based self helpOther
Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual
Treatment as usualOther
Usual care from healthcare professionals with regard to patients symptoms of fatigue
| Study group | Role | What they receive |
|---|---|---|
| Guided Self Help | Experimental | 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. Receives: Other: Cognitive behavioural therapy based self help |
| Pure Self Help | Experimental | Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone Receives: Other: Cognitive behavioural therapy based self help |
| Treatment as Usual | Placebo comparator | Participants receive usual care from healthcare professionals Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
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.
Measured: 5 time points at 0, 8, 20, 32 & 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsty Nesbitt, Principal investigator, National Health Service, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532037
- Sponsor's protocol ID
- RCT-MS-NHS-1
- Status last verified
- Jun 2021
- First submitted
- 17 Jan 2012
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01532037
- Acronym / sponsor ID
- RCT-MS-NHS-1
- Conditions
- Multiple Sclerosis, Fatigue
- Keywords
- Randomised controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioural Therapy, Self Help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Self Help | Experimental | Other: Cognitive behavioural therapy based self helpParticipant 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 | Experimental | Other: Cognitive behavioural therapy based self helpParticipant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone |
| Treatment as Usual | Placebo comparator | Other: Treatment as usualParticipants receive usual care from healthcare professionals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy based self helpComparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual | Other | Guided Self Help, Pure Self Help |
| Treatment as usualUsual care from healthcare professionals with regard to patients symptoms of fatigue | Other | Treatment as Usual |
Primary outcome
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.
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Results publicationChapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Nesbitt principal investigator
National Health Service, University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy based self help and Treatment as usual in people with Multiple Sclerosis and Fatigue, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.