Mindfulness Therapy App for Migraine

(UAM Trial)

Overseen By Annie Kate Reeder, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yeshiva University

Disqualifiers: Suicidal ideation, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with migraines.

Has a smartphone

I score 5 or more for anxiety on a specific test.

Exclusion Criteria

I have severe depression according to the PHQ-9 test.

Lack of group readiness

Presence of suicidal ideation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a mobile health educational app and group-based mindfulness therapy

6 weeks

6 weekly group sessions

Follow-up

Participants are monitored for changes in headache-related disability and anxiety

4 weeks

Treatment Details

Interventions

• Unwinding Anxiety

Trial Overview 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.

Participant Groups

Group I: Unwinding Anxiety Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Yeshiva University

Lead Sponsor

Trials

13

Recruited

2,600+