Self Help for Fatigue in Multiple Sclerosis

University of Edinburgh

Status

Completed

Conditions

Multiple Sclerosis

Fatigue

Treatments

Other: Treatment as usual

Other: Cognitive behavioural therapy based self help

Study type

Interventional

Funder types

Other

Identifiers

NCT01532037

RCT-MS-NHS-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

73 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

73 participants in 3 patient groups, including a placebo group

Guided Self Help

Experimental group

Description:

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.

Treatment:

Other: Cognitive behavioural therapy based self help

Pure Self Help

Experimental group

Description:

Participant receives usual care and cognitive behavioural therapy based self help work book for fatigue in multiple sclerosis to complete alone

Treatment:

Other: Cognitive behavioural therapy based self help

Treatment as Usual

Placebo Comparator group

Description:

Participants receive usual care from healthcare professionals