Mindfulness Therapy App for Migraine

(UAM Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness therapy app to determine its effectiveness in reducing anxiety and disability related to migraines. Researchers aim to assess whether the app, called Unwinding Anxiety, combined with group mindfulness sessions, is practical and well-received by participants. The trial seeks individuals diagnosed with migraines, who experience anxiety, and own a smartphone. Those who frequently feel anxious and suffer from migraines may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative approaches to managing migraines and anxiety.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

What prior data suggests that this mindfulness therapy app is safe for people with migraine?

Research shows that the "Unwinding Anxiety" app is user-friendly. A study by Brown University found that this app reduced anxiety and burnout in doctors by 57%. This indicates that most users have a positive experience with it. Designed to help manage anxiety, the app has been tested for safety in similar contexts. No reports of serious side effects make it a promising option for managing anxiety and related issues like migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unwinding Anxiety app for migraines because it offers a novel approach by using mindfulness therapy delivered through a mobile app. Unlike traditional migraine treatments that often rely on medications to alleviate symptoms, this app focuses on reducing stress and anxiety, which are common migraine triggers, through guided mindfulness exercises. This method not only aims to manage migraines effectively but also empowers users with tools to improve their overall mental well-being, potentially reducing the frequency and severity of migraine attacks without the side effects associated with medications.

What evidence suggests that this mindfulness therapy app is effective for migraines?

Research has shown that the Unwinding Anxiety app, which participants in this trial will use, can help reduce anxiety. Users reported feeling 50% less anxious and burned out after one month. After three months, their anxiety dropped by 57%. Another study found that users had much lower anxiety scores than non-users. Although the app is designed to help with anxiety, it might also alleviate migraines, as stress and anxiety often lead to them. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

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

Has a smartphone

Exclusion Criteria

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

Lack of group readiness

Presence of suicidal ideation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Unwinding Anxiety Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Yeshiva University

Lead Sponsor

Trials

13

Recruited

2,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06150612

NCT06150612 | Unwinding Anxiety for Migraine: Pilot 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 ...

2. milesformigraine.org milesformigraine.org/wp-content/uploads/securepdfs/AHS_Poster_052223.pdf

Unwinding Anxiety for Migraine The Unwinding Anxiety (UA) intervention is an evidence-based mobile health app that has demonstrated efficacy to reduce generalized anxiety disorder symptoms2.

3. unwindinganxiety.com unwindinganxiety.com/research/

Unwinding Anxiety® - Research behind the Program Within a month of using the app, individuals reported approximately a 50% reduction in both anxiety and burnout. · At three months, anxiety was reported to be 57 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35969440/

Analyzing the Impact of Mobile App Engagement on Mental ... This study was a secondary analysis of engagement data from a stage 1 randomized controlled trial testing the impact of the Unwinding Anxiety mobile app.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8686411/

Clinical Efficacy and Psychological Mechanisms of an App ... In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD- ...

6. play.google.com play.google.com/store/apps/details?id=com.claritasmindsciences.UnwindingAnxiety&hl=en_US

Unwinding Anxiety® - Apps on Google Play Work with anxiety, not against it. Unwinding Anxiety® is an evidence-based app program proven to reduce anxiety so you can live life to the fullest.

7. play.google.com play.google.com/store/apps/details/Unwinding_Anxiety?id=com.claritasmindsciences.UnwindingAnxiety&hl=en_IN

Unwinding Anxiety® – Apps on Google Play Work with anxiety, not against it. Unwinding Anxiety® is an evidence-based app program proven to reduce anxiety so you can live life to the fullest.

8. drjud.com drjud.com/app-based-mindfulness-training-drops-anxiety-by-57-and-burnout-in-physicians/

Mindfulness app drops anxiety and burnout by 57% in ... In a study by Brown University, they found Dr. Jud's Unwinding Anxiety app reduced anxiety and burnout in physicians by 57%.