MigraineUAMNCT06150612
Unwinding Anxiety for Migraine: Pilot
A study testing Unwinding Anxiety in people with Migraine and Anxiousness, run by Yeshiva University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Anxiousness
- What is being tested?
- Unwinding Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Meets diagnostic criteria for migraine
- Reports anxiety symptoms of 5 or more on GAD-7
- Has a smartphone
Who cannot join
- Under the age of 18
- Presence of suicidal ideation
- Reports severe depression on PHQ-9
- Lack of group readiness
Trial locations and contacts
1 site in 1 country.
United States1 site
Rousso Building
The Bronx, New York, 10461
Annie Kate Reeder, MS, 646-592-4368, AReeder@mail.yu.edu
About this study
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.
- Conditions
- Migraine, Anxiousness
- Being tested
- Unwinding Anxiety
- Medical subject headings
- Migraine Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unwinding AnxietyBehavioural
In the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups.
| Study group | Role | What they receive |
|---|---|---|
| Unwinding Anxiety | Experimental | Not described Receives: Behavioral: Unwinding Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions
Measured: 6 weeks
Secondary outcomes (1)
Acceptability
Average Credibility Score from the Credibility/Expectancy Questionnaire [min = 3; max = 27; higher scores indicate higher credibility]
Measured: Assessed at 6 weeks, immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start3 Jan 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeshiva University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Seng, Yeshiva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150612
- Sponsor's protocol ID
- 20216986
- Acronym
- UAM
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to investigators with an approved IRB and DUA.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unwinding Anxiety for Migraine: Pilot
- ClinicalTrials.gov ID
- NCT06150612
- Acronym / sponsor ID
- UAM / 20216986
- Conditions
- Migraine, Anxiousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yeshiva UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unwinding Anxiety | Experimental | Behavioral: Unwinding Anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or older
- Meets diagnostic criteria for migraine
- Reports anxiety symptoms of 5 or more on GAD-7
- Has a smartphone
Key exclusion criteria (4 listed)
- Under the age of 18
- Presence of suicidal ideation
- Reports severe depression on PHQ-9
- Lack of group readiness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unwinding AnxietyIn the Unwinding Anxiety arm, participants will receive 6 weeks of an educational app and weekly facilitated mindfulness groups. | Behavioural | Unwinding Anxiety |
Primary outcome
Feasibility
Time frame: 6 weeks
Average number of facilitated mindfulness group sessions attended out of 6 weekly sessions
1 secondary outcome
Acceptability
Time frame: Assessed at 6 weeks, immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Yes. IPD will be made available to investigators with an approved IRB and DUA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unwinding Anxiety in people with Migraine and Anxiousness, run by Yeshiva University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Kate Reeder, MA (646-592-4368, AReeder@mail.yu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.