Condition category
Nervous System Diseases
Date applied
07/11/2012
Date assigned
08/11/2012
Last edited
06/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Migraine is a common health condition, affecting around 18% of women and 8% of men in the UK. It is usually in the form of a severe headache at the front or side of the head, but can also cause symptoms in the rest of the body such as nausea, dizziness and even paralysis (inability to move). Migraines can be severely disabling, affecting personal, social and wok life. The current standard treatment for migraine is medication, however due to a strong link with mental health, it is thought to also be influenced by emotional factors. Previously, cognitive behavioural therapy (a type of talking therapy aiming to change the pay a person thinks and behaves) and relaxation techniques (such as deep breathing and muscle relaxation) have been found separately to be effective at treating headaches. Self-management headache education (SHE) is a therapy programme which combines these two techniques and has been developed for people suffering from migraines. The aim of this study is to investigate the effectiveness of SHE in the treatment of migraines compared to standard medical care alone.

Who can participate?
Adults who have been suffering from migraines at least three days a month for the last six months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard medical care alone. Those in the second group receive standard medical care and self-management headache education (SHE). This involves three face-to-face one-to-one sessions every two weeks with two telephone calls between sessions. The sessions themselves involve teaching participants about identifying and managing triggers of migraines, including stress, as well as learning relaxation techniques. Participants in both groups complete a number of questionnaires after 4 and 8 weeks. They are also interviewed in order to describe their view of their migraine headache and their experience of its management, and suggest any changes to the SHE intervention, as well as provide feedback on how they value the questionnaires used.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
King’s College London (UK)

When is the study starting and how long is it expected to run for?
March 2012 to March 2013

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Profgessor Leone Ridsdale
leone.ridsdale@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leone Ridsdale

ORCID ID

Contact details

Institute of Psychiatry
P043
16 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7848 0293
leone.ridsdale@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11265

Study information

Scientific title

Self-management migraine Headache Education (SHE)

Acronym

SHE

Study hypothesis

The aim of this study is to evaluate the efficacy of Self-management Headache Education (SHE) in the treatment of migraines.

Ethics approval

South East London regional ethics committee, 17/12/2010, ref: 10/H0805/79

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Migraine headache

Intervention

Participants are randomly allocated to receive SHE plus standard medical care or standard medical care alone.

SHE comprises of three face-to-face sessions on a one-to-one basis with the nurse, at approximately two-week intervals, with 2 telephone calls in-between. Each session lasts for approximately 50 minutes. Each phone call takes 10-20 minutes. The nurse reviews homework, and discusses individual triggers, worrying thoughts and the impact of migraine on work and social life. New homework with relaxation and headache diary-keeping is assigned, and subsequently reviewed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Headache frequency (days per month) at 8 weeks and 4 months

Secondary outcome measures

1. Headache impact (HIT-6) at 8 weeks and 4 months
2. Health costs (Client Services Receipt Inventory) at 4 months
3. Migraine disability (MIDAS) at 8 weeks and 4 months
4. Patients' headache related beliefs (Illness Perception Questionnaire-Revised) at 8 weeks and 4 months
5. Psychological morbidity (Hospital Anxiety and Depression Scale) at 8 weeks and 4 months

Overall trial start date

01/03/2012

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (men and women), aged 18 -75
2. Years with migraine which started at least 6 months previously, and occurred on 4 or more days in the previous month.
3. A reasonable level of the English language is expected

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. A physical condition likely to cause headache, with symptoms and signs like subacute progressive focal neurological deficit, newonset seizures, headaches accompanied by vomiting plus papilloedema and the presence of cranial nerve palsy.
2. Pregnancy
3. An organic brain syndrome
4. Current psychotic illness or substance dependency
5. Currently undergoing psychological therapy
6. Being unable to complete a self report questionnaire for whatever reason including inability to speak and read English

Recruitment start date

01/03/2012

Recruitment end date

31/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

National Institute for Health Research

Sponsor details

30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/12/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26477023

Publication citations

Additional files

Editorial Notes

06/05/2016: Publication reference and plain English summary added.