Clinical Trials Directory

Trials / Completed

CompletedNCT02259387

Adolescents With Migraine: What's Stress Got To Do With It?

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Accepted

Summary

The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of the study: those with migraines (cases) and those without migraines or headaches (controls). Each arm will answer several of the same questionnaires and have hair cortisol samples taken multiple times over the course of 12 weeks.

Detailed description

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.

Conditions

Timeline

Start date
2014-09-12
Primary completion
2017-09-15
Completion
2017-10-15
First posted
2014-10-08
Last updated
2018-06-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02259387. Inclusion in this directory is not an endorsement.