Unwinding Anxiety for Migraine: Pilot (UAM)

November 30, 2023 updated by: Elizabeth Seng, Yeshiva University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Rousso Building
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unwinding Anxiety
Behavioral: Unwinding Anxiety
In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 weeks
Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Assessed at 6 weeks, immediately post-intervention
Average Credibility Score from the Credibility/Expectancy Questionnaire [min = 3; max = 27; higher scores indicate higher credibility]
Assessed at 6 weeks, immediately post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety
Time Frame: Change from Week 0 to Week 10
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
Change in Headache-Related Disability
Time Frame: Change from Week 0 to Week 10
Headache Disability Inventory Score [min = 0; max = 100; higher scores indicate higher levels of headache-related disability]
Change from Week 0 to Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeshiva University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 3, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20216986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be made available to investigators with an approved IRB and DUA.

IPD Sharing Time Frame

Data will be made available 12 months after primary study completion.

IPD Sharing Access Criteria

Contact investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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