Information for health professionals

Please note the CHESS Study is now closed to recruitment.

Study Summary

Background:

Chronic headache disorders are a major cause of pain and disability. Their main impact is in young adults many of whom have both work and family commitments. The commonest chronic headache disorders are tension type (TTH), migraine, and medication overuse headaches (MOH). TTH and migraine are primary headaches. MOH is a secondary headache that can develop in people with frequent acute headaches who take analgesic, or specific anti-migraine compounds (e.g. trip tans) on ≥10-15 days per month.

The management of episodic headaches is comparatively straightforward. A minority of those affected, however, develop a chronic headache syndrome; i.e. headaches on more than 15 days per month, for more than three months. Around 2-4% of the population have a chronic headache. Approximately 25-50% of those affected also have MOH, which has a prevalence of 1%. Around 4% of primary care consultations and 30% of neurology out-patient appointments are due to headache disorders. TTH and migraine are the second and third most common disorders globally (after dental caries of permanent teeth). The annual cost of headache disorders to the UK is £5-7 billion.

NICE guidance on headaches was published in September 2012. Besides recommendations to consider a course of acupuncture for people with chronic migraine or tension type headache, the guidance developers did not find suitable evidence to allow recommendations on non-pharmacological treatments for people with chronic headache.

Hypothesis:

Trial summary:

Inclusion Criteria:

Able and willing to comply with the study procedures and provision of written informed consent.

Aged ≥18 years or above.
Living with chronic headache; defined as headache for 15 or more days per month for at least three months.
Result of nurse classification interview confirms headache type to be definite or probable chronic migraine, or chronic tension type headache, and/or medication overuse headache.

Fluent in written and spoken English.

Exclusion criteria:

Unable to attend the group sessions.
No access to a telephone.
Has an underlying serious psychological disorder with ongoing symptoms which preclude or significantly interfere with participation in the group intervention.
Previous entry or randomisation in the present trial.
Is currently participating in another clinical trial of headache treatments, or in a trial of an unregistered medicinal product, or less than 90 days have passed since completing participation in such a trial.

Potential participants will be screened by the study team to identify those with chronic headaches; that is people who experience headaches on 15 days or more for at least the past three months. All eligible participants will be invited to complete a smartphone app to capture headache frequency, severity and duration, completed weekly for six months then monthly for a further six months.

Following receipt of baseline data and signed consent form all participants will receive a telephone classification interview with a nurse to classify their headache type. The purpose of the classification interview is to ensure that participants do not have headache types other than migraine, tension type or medication overuse and to provide a classification of headache types for reporting purposes.

The Intervention:

The CHESS intervention is an education and self-management group programme (around 10 participants per group) facilitated by a trained CHESS nurse and allied health professional.

Those randomised to the intervention arm will be asked to complete a paper headache diary for a period of up to eight weeks. Participants will be booked to attend structured group sessions which will be run over two days. The group sessions will take place on weekdays and where possible, these sessions will run during school hours to accommodate those with children. The groups will be delivered using a range of methods including: group discussions, brainstorming, sharing narratives and experiences, problem solving, watching an educational DVD, role play and taster sessions. The programme includes a range of behavioural change techniques including; barrier identification, general encouragement, instruction from the group facilitators, provision of feedback, and allowing opportunities for social comparison in the group.

Following the two day group intervention each participant will be booked to attend a one to one appointment lasting up to two hours with the CHESS trained nurse to classify their headache type, discuss medication and lifestyle factors and finally to explore SMART goals. This discussion will be backed up by written information (for patient and GP), consistent with NICE guidance, to support shared informed decision making between the patient and their GP. All participants will be offered telephone follow-up for up to eight weeks. The frequency of these follow-up calls will be individually negotiated and agreed with participants.

Outcome measures:

Study outcomes include: the 6 item Headache Impact Test (HIT-6), 14 item Chronic Headache Quality of Life Questionnaire (CHQLQ v1.0), SF-12 V2, EuroQol EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS), Pain Self Efficacy Questionnaire (PSEQ), Social Integration Subscale of the Health Education Impact Questionnaire (heiQ), and frequency, severity and duration of headache days. Adverse events and resource use (using GP records and patient self-reported data, such as over the counter medication costs). Follow up data will be collected four, eight and 12 months post randomisation. We will also carry out a process evaluation, using the MRC guidance on developing and evaluating complex interventions including an assessment of intervention fidelity.

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