Self Help for Fatigue in Multiple Sclerosis
A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Cognitive behavioural therapy based self help
Placebo
- Treatment as usual
What it measured
Main measures
Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.
5 time points at 0, 8, 20, 32 & 60 weeks.
Thinking and memoryFatigue
Other measures (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
PainChange 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
Mood and sleepChange 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
Who could take part
Relapsing and progressive · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
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History
Started
Jun 2012
Main results due
May 2014
Finished
May 2014