Self-management migraine Headache Education (SHE)
| ISRCTN | ISRCTN53460881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53460881 |
| Secondary identifying numbers | 11265 |
- Submission date
- 07/11/2012
- Registration date
- 08/11/2012
- Last edited
- 06/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Contact information
Scientific
Institute of Psychiatry
P043, 16 De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 20 7848 0293 |
|---|---|
| leone.ridsdale@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Self-management migraine Headache Education (SHE) |
| Study 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(s) | South East London regional ethics committee, 17/12/2010, ref: 10/H0805/79 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2012 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| 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 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
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
Government
30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
"ROR" |
https://ror.org/0187kwz08 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |
Editorial Notes
06/05/2016: Publication reference and plain English summary added.
