Unwinding Anxiety for Migraine: Pilot

Migraine Clinical Trial

— UAM  

Official title:

Unwinding Anxiety for Migraine: Pilot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06150612
• Other study ID #: 20216986
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Yeshiva University
• Contact: Annie Kate Reeder, MA
• Phone: 646-592-4368
• Email: AReeder[@]mail.yu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 1, 2025
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Unwinding Anxiety
In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups.

Locations

Country	Name	City	State
United States	Rousso Building	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Yeshiva University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Headache-Related Disability	Headache Disability Inventory Score [min = 0; max = 100; higher scores indicate higher levels of headache-related disability]	Change from Week 0 to Week 10
Primary	Feasibility	Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions	6 weeks
Secondary	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