Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03504150
Eligibility Criteria:
Inclusion criteria:
* aged 14-40 years
* fluent in the English language (i.e., speaking, reading and writing);
* for 14-17 year olds: suffer from headaches for a minimum of three months
* for 18-40 year olds: suffer from headaches for a minimum of one year
* suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
* have a Smartphone as PRISM has been designed to be accessed from a Smartphone and SPHERE encompasses the myWHI diary which has also been designed to be used from a Smartphone
* use the Smartphone for activities other than texting and calling (e.g., email, Facebook) as the programs are designed for migraineurs who are familiar with using Smartphones and use them in their daily life
* have daily Internet access from their Smartphone, because running the programs require an Internet connection
* minimum of four headache days during 4 weeks that they are asked to use an electronic headache diary
Exclusion criteria:
* health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)
* are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding, as hormonal changes are known to exert potent influences on migraine headaches
* have an impairment which compromises their ability to give informed consent
* having been diagnosed with psychosis and/or schizophrenia, because a past or current diagnosis may likely interfere with the participants ability to fully participate in the study
* have participated in our recent three-armed pilot RCT (i.e., any participant who consented and was randomized)
* they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy when they asked to use it for 4 weeks
* More than 15 headache days during the 4 weeks that they are asked to use an electronic headache diary
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
40 Years
Study:
NCT03504150
Study Brief:
Protocol Section:
NCT03504150