Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)
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|ClinicalTrials.gov Identifier: NCT02259387|
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : December 7, 2016
|Condition or disease|
The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently report stress as their migraine trigger, stress measurement and treatment are usually beyond the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents who need structured stress management, as well as provide objective evidence for the medical community, migraineurs (i.e. individuals who experience migraines), and their families, who may be reluctant to accept stress as a migraine factor. The rationale for this research is that scientific validation of an association between stress and migraine will inform future prevention studies in the headache field and potentially identify a stress biomarker for migraine.
This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33 adolescents without migraine for 12 weeks with the following aims:
Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in adolescents with and without migraine.
Hypothesis: The association between hair cortisol and perceived stress (3 month averages) will be a positive in both adolescents with and without migraine.
Aim 2: Measure the relationship between migraine frequency with perceived stress and hair cortisol concentration in adolescents with migraine.
Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair cortisol will be positive in adolescents with migraines.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Adolescents With Migraine: What's Stress Got To Do With It?|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||October 2017|
Children with migraines will be placed into this group.
Children without migraines or headaches will be placed into this group.
- Correlation between hair cortisol and perceived stress [ Time Frame: 12 weeks ]Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.
- Correlation between headache frequency, perceived stress, and hair cortisol. [ Time Frame: 12 weeks ]Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259387
|Contact: Bryan Wallace, BSemail@example.com|
|Contact: Sita Kedia, MDfirstname.lastname@example.org|
|United States, Colorado|
|Colorado Children's Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Bryan Wallace 720-777-3293 email@example.com|
|Contact: Sita Kedia, MD 720-777-3958 firstname.lastname@example.org|
|Principal Investigator:||Sita Kedia, MD||University of Colorado, Denver|