Anxiousness, Migraine
Conditions
Brief summary
This is a pilot study that aims to understand the feasibility and acceptability of a mobile health educational app plus group-based mindfulness therapy on anxiety and migraine-related disability among people with migraine.
Interventions
BEHAVIORALUnwinding Anxiety
In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups.
Sponsors
Yeshiva University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or older * Meets diagnostic criteria for migraine * Reports anxiety symptoms of 5 or more on GAD-7 * Has a smartphone
Exclusion criteria
* Under the age of 18 * Presence of suicidal ideation * Reports severe depression on PHQ-9 * Lack of group readiness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 6 weeks | Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Assessed at 6 weeks, immediately post-intervention | Average Credibility Score from the Credibility/Expectancy Questionnaire \[min = 3; max = 27; higher scores indicate higher credibility\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety | Change from Week 0 to Week 10 | Patient Reported Measurement Outcome System - Anxiety Short Form Score \[min = 37; Max = 83; higher scores indicate higher levels of anxiety symptoms\] |
| Change in Headache-Related Disability | Change from Week 0 to Week 10 | Headache Disability Inventory Score \[min = 0; max = 100; higher scores indicate higher levels of headache-related disability\] |
Countries
United States
Contacts
Primary ContactAnnie Kate Reeder, MA
Outcome results
None listed