Unwinding Anxiety for Migraine: Pilot

Not Applicable

Not yet recruiting

• Conditions: Migraine; Anxiousness
• Interventions: Behavioral: Unwinding Anxiety

• Registration Number: NCT06150612
• Lead Sponsor: Yeshiva University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-08
• Study Start: 2024-01-03
• Primary Completion: 2024-07-15
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unwinding Anxiety	Unwinding Anxiety	-

Primary Outcome Measures

Name	Time	Method
Feasibility	6 weeks	Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions

Secondary Outcome Measures

Name	Time	Method
Acceptability	Assessed at 6 weeks, immediately post-intervention	Average Credibility Score from the Credibility/Expectancy Questionnaire \[min = 3; max = 27; higher scores indicate higher credibility\]

Trial Locations

Locations (1)

Rousso Building; 🇺🇸 Bronx, New York, United States