headache migraine headache
Conditions
Interventions
The internet training *MyMigraine* is grafted on an evidence-based SMT
protocol, tailored to the format of an Internet-delivered intervention.
Potential participants can enrol via the website www.my
2) use
of physiological and cognitive-behavioural self-regulation skills. The main BT
techniques for migraine are relaxation training (mean ES = 5.5) and
cognitive-behavioural training (mean ES = 5
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are included according to the scientific guidelines of the International Headache Society (IHS) subcommittee on clinical trials. Participants have to be between 18 and 65 years old, fulfil the IHS criteria for migraine with (G43.1) or without (G43.0) aura, and have an attack frequency of 2-6 per month.
Exclusion criteria
Exclusion criteria: Participants are excluded in case of a migraine duration of less than one year, a migraine onset at an age above 50 years referring to underlying organic disease, headache occurring on 15 or more days per month, medication overuse (identified by four weeks of headache monitoring), and an above score (>178) on the Symptom Checklist 90R (SCL-90R); an extended questionnaire to establish psychopathology and psychological comorbidity. Patients that have participated in the group version of the SMT in the Mérelle study (2008), are also excluded. Furthermore, pregnant women or women who expect to get pregnant during the study are excluded, because of the hormonal influence on migraine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine improvement The primary study parameter is reduction in migraine headaches, calculated as the number of migraine attacks according to the HIS criteria as well as the number of headache days per month. This will be measured by the electronic headache diary and migraine monitor, the content of which is equivalent to the paper diary employed in the former SMT trial (Mérelle, (2008) conform the guidelines for, respectively, clinical trials in prophylactic treatment (Tfelt-Hansen et al., 2000) and behavioural trials (Penzien et al., 2005) in headache research. The headache diary also yields accounts of medication use for headache, which can be separately assessed regarding abortive, analgesic and prophylactic. Empowerment Empowerment is divided in to measurements: perceived control en self-efficacy. Perceived control over migraine will be assessed with a Dutch translation of the Headache-Specific Locus of Control scale (HSLC; Martin, Holroyd, & Penzien, 1990). The HSLC is a 33-item scale that has responses ranging from 1 (strongly disagree) to 5 (strongly agree). It consists of one Internal Locus of Control subscale and two subscales for External Locus of Control: Health Care Professionals and Chance. An example of an internal locus of control item is: *If I remember to relax, I can avoid some of my headaches*. An example of a health care professionals locus of control item is: *Only my doctor can give me ways to prevent me headaches*. An example of a change locus of control question is: *When I have a headache, there is nothing I can do to affect its course*. The sum score for internal control reflects the degree of perceived control over migraine (range 11-55), while the sum score for external control indicates the degree to which migraine is perceived as being due to chance (range 11-55). Self-confidence in attack prevention (self-efficacy) will be assessed with a Dutch translation of the Headache Management Self-Efficacy questionna | — |
Secondary
| Measure | Time frame |
|---|---|
| Intensity and duration of the migraine attacks These two factors will be derived from the 4-week electronic headache diary and migraine monitor. An average score will be calculated per attack.The effect of abortive medication will be taken into account. Migraine-specific quality of life Migraine-specific quality of life is measured by the Dutch version of the Migraine Specific Quality of Life Questionnaire (MSQOL; Passchier, Mourik, McKenna, Van den Berg, Erdman, 2001). The questionnaire consists of 20 items, which are scored on a 4-point scale, ranging form 1 (very much) to 4 (not at all). An example of a question is: *I feel powerless when a migraine attack starts*. A higher score on this instrument reflects a better quality of life between attacks (range 20-80). Migraine disability Migraine disability is assessed with a Dutch translation of the Migraine Disability Assessment Scale (MIDAS; Stewart, Lipton, Dowson, Sawyer, 2001). It consists of five questions concerning the number of days lost to migraine in the past 3 months. The sum score reflects the number of productive days in the workplace and at home. The sum score is divided in 4 groups: a score ranging from 1-5 means little nuisance, 6-10 indicates mild nuisance, 11-20 moderate nuisance and an above score of 21 indicates severe nuisance. Cost-effectiveness We seek to make an economic evaluation of internet-delivered SMT compared to waitlist in chronic migraine. We will base our procedure on a recent approach, outlined for internet intervention for depression Warmerdam, et al, 2010). This study includes estimates of costs induced by, respectively, healthcare uptake (we will explicitly and separately consider medication use), loss of productivity in terms of work loss days and work cutback days, out of pocket expenses for the patient and his/her family, and the intervention. In the present study a sound preliminary indication of these four points can be retrieved from the questio | — |
Countries
Netherlands
Outcome results
None listed