Chronic headaches Signs and Symptoms Chronic headaches
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able and willing to comply with the study procedures and provision of written informed consent 2. Aged 18 years or above 3. Living with chronic headache; defined as headache for 15 or more days per month for at least three months. 4. 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 5. Fluent in written and spoken English
Exclusion criteria
Exclusion criteria: 1. Unable to attend treatment programme 2. No access to a telephone 3. Has an underlying serious psychiatric or psychological disorder that precludes participation in the group intervention 4. Known secondary cause of headache other than medication overuse headache; e.g. primary or secondary brain tumour 5. Is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 04/05/2017: Feasibility study: Headache impact measured using the Headache Impact Test (HIT-6) as a self-complete postal questionnaire at baseline, 2 weeks and 12 weeks. Randomised controlled trial: Headache impact measured using the Headache Impact Test (HIT-6) as a self-complete postal questionnaire at baseline, 4, 8 and 12 months Original Primary outcome measure: Headache specific outcome measure collected by self-completed postal questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility study: 1. Migraine Disability measured using the Migraine Disability Assessment (MIDAS) as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 2. Health related quality of life measured using the 12-Item Short Form Health Survey (SF-12) - at baseline, 2 weeks and 12 weeks 3. Mood measured using the Hospital Anxiety and Depression Scale at as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 4. Self –efficacy measured using the Self-efficacy and Pain Self –Efficacy Questionnaire as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 5. Headache quality of life measured using Chronic Headache Quality of Life Questionnaire (CHQLQ) a headache-specific modification of the Migraine Specific Quality of Life Questionnaire (MSQ) completed as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 6. Health utility measured using EQ-5D as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 7. Social activity measured using the Health Education Impact Questionnaire (Social Integration sub-scale) as a self-complete questionnaire at baseline, 2 weeks and 12 weeks 8. Health service activity measured as self-complete questionnaire: GP consultations, secondary care consultations, imaging, non-NHS treatments (e.g. acupuncture), over-the-counter medication for headaches, days lost from normal activities (e.g. work, study), loss of income and out of pocket expenses completed at baseline, 2 weeks and 12 weeks 9. Headache frequency, duration and severity measured via a smartphone App weekly for 12 weeks 10. Health service activity; consultations, outpatient appointments, imaging and medication use of acute and prophylactic headache treatments collected from GP records at 3 months Randomised controlled trial: 1. Participant demographic data completed as a self-complete questionnaire at baseline 2. General Health including fatigue, sleep quality and bodily pain measured by the troublesomeness grid as a self-complete | — |
Countries
England, United Kingdom