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Mindfulness Therapy App for Migraine (UAM Trial)

N/A
Waitlist Available
Research Sponsored by Yeshiva University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 or older
Meets diagnostic criteria for migraine
Must not have
Under the age of 18
Reports severe depression on PHQ-9
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from week 0 to week 10
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore if an app and mindfulness therapy can reduce anxiety & disability from migraine.

Who is the study for?
This trial is for adults who have migraines and also feel anxious, scoring 5 or more on a specific anxiety questionnaire (GAD-7). Participants must own a smartphone. It's not suitable for those under 18, individuals with thoughts of suicide, severe depression scores on PHQ-9, or who aren't ready to be in group therapy.
What is being tested?
The study tests an educational app designed to reduce anxiety plus mindfulness therapy in groups to see if they help people with migraines. The focus is on whether this approach is practical and acceptable for participants.
What are the potential side effects?
Since the intervention involves non-medical treatments like an app and group therapy, typical medical side effects are not expected; however, some may experience discomfort or emotional distress from discussing personal experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with migraines.
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I score 5 or more for anxiety on a specific test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 years old.
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I have severe depression according to the PHQ-9 test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from week 0 to week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week 0 to week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility
Secondary study objectives
Acceptability
Other study objectives
Change in Anxiety
Change in Headache-Related Disability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Unwinding AnxietyExperimental Treatment1 Intervention

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Who is running the clinical trial?

Yeshiva UniversityLead Sponsor
11 Previous Clinical Trials
2,598 Total Patients Enrolled
1 Trials studying Migraine
144 Patients Enrolled for Migraine
~13 spots leftby Dec 2025
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