Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Prof Leone Ridsdale


Contact details

Institute of Psychiatry
16 De Crespigny Park
United Kingdom
+44 20 7848 0293

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Self-management migraine Headache Education (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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Migraine headache


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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
United Kingdom

Sponsor information


National Institute for Health Research

Sponsor details

30-32 Hyde Terrace
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in

Publication citations

Additional files

Editorial Notes

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