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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unwinding Anxiety | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unwinding Anxiety | Behavioral | In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Average Credibility Score from the Credibility/Expectancy Questionnaire [min = 3; max = 27; higher scores indicate higher credibility] | Assessed at 6 weeks, immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety | Patient Reported Measurement Outcome System - Anxiety Short Form Score [min = 37; Max = 83; higher scores indicate higher levels of anxiety symptoms] | Change from Week 0 to Week 10 |
| Change in Headache-Related Disability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie Kate Reeder, MA | Contact | 646-592-4368 | AReeder@mail.yu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rousso Building | The Bronx | New York | 10461 | United States |
IPD will be made available to investigators with an approved IRB and DUA.
Data will be made available 12 months after primary study completion.
Contact investigators.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Headache Disability Inventory Score [min = 0; max = 100; higher scores indicate higher levels of headache-related disability]
| Change from Week 0 to Week 10 |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |