NCT06150612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 20, 2023

Last Update Submit

November 30, 2023

Conditions

MigraineAnxiousness

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions

    6 weeks

Secondary Outcomes (1)

  • Acceptability

    Assessed at 6 weeks, immediately post-intervention

Other Outcomes (2)

  • Change in Anxiety

    Change from Week 0 to Week 10

  • Change in Headache-Related Disability

    Change from Week 0 to Week 10

Study Arms (1)

Unwinding Anxiety

EXPERIMENTAL
Behavioral: Unwinding Anxiety

Interventions

Unwinding AnxietyBEHAVIORAL

In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups.

Unwinding Anxiety

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • Meets diagnostic criteria for migraine
  • Reports anxiety symptoms of 5 or more on GAD-7
  • Has a smartphone

You may not qualify if:

  • Under the age of 18
  • Presence of suicidal ideation
  • Reports severe depression on PHQ-9
  • Lack of group readiness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rousso Building

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Migraine DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental Disorders

Central Study Contacts

Annie Kate Reeder, MA

CONTACT

646-592-4368AReeder@mail.yu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 29, 2023

Study Start

January 3, 2024

Primary Completion

July 15, 2024

Study Completion

January 1, 2025

Last Updated

December 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be made available 12 months after primary study completion.
Access Criteria
Contact investigators.

Locations

US(1)