Clinical trial NCT01532037: Self Help for Fatigue in Multiple Sclerosis
Official title: A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Keywords: Randomised controlled trial
Multiple Sclerosis
Fatigue
Cognitive Behavioural Therapy
Self Help
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.
timeFrame: 5 time points at 0, 8, 20, 32 & 60 weeks.
Secondary outcomes:
measure: Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.
timeFrame: 5 time points at 0, 8, 20, 32 & 60 weeks
measure: Change from baseline on the Hospital Anxiety and Depression Scale at post measure, 3, 6 and 12 months follow up.
timeFrame: 5 time points at 0, 8, 20, 32 & 60 weeks
measure: Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.
timeFrame: 5 time points at 0, 8, 20, 32 & 60 weeks
Other outcomes:
Locations:
city: Leven
country: United Kingdom
facility: Fife Rehabilitation Service
state: Scotland
city: Leven
country: United Kingdom
facility: NHS Fife
state: Scotland
Study officials:
affiliation: National Health Service, University of Edinburgh
name: Kirsty Nesbitt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapter 4 in https://era.ed.ac.uk/bitstream/handle/1842/21011/Gallen2015.pdf