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Behavioral Intervention
Mindfulness Therapy for Migraines (TEAM-M Trial)
N/A
Recruiting
Led By Amanda J Shallcross, M.P.H., N.D.
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 0 to month 3
Awards & highlights
TEAM-M Trial Summary
This trial proposes using mindfulness therapy to help people with mental health issues via phone, video, or online modules.
Who is the study for?
This trial is for adults over 18 who have migraines 4-14 days a month and mild to moderate depression. They must meet specific migraine criteria, be able to read/speak English, consent to participate, and keep a headache diary. Excluded are those with certain psychiatric conditions, recent changes in migraine or antidepressant medications, prior mindfulness therapy experience, daily meditation practice, or unstable medication use.Check my eligibility
What is being tested?
The study tests Mindfulness-Based Cognitive Therapy (MBCT) for treating migraines and mood issues. It's delivered in three ways: by phone calls (Telephone), video sessions (Video), or through online education modules (Online). Participants will be randomly assigned to one of these methods.See study design
What are the potential side effects?
Since the interventions involve non-invasive therapies like telephone calls, video sessions, and online modules focused on mindfulness and cognitive therapy techniques rather than drugs or medical procedures; significant side effects are not expected.
TEAM-M Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 0 to month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 0 to month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Client Satisfaction Questionnaire - 8 (CSQ-8)
Percentage of Treatment Session Adherence
Secondary outcome measures
Change in Headache Disability Inventory (HDI)
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
Mental Depression
TEAM-M Trial Design
3Treatment groups
Active Control
Group I: TelephoneActive Control1 Intervention
8 weekly classes delivered via telephone.
Group II: OnlineActive Control1 Intervention
8 weekly online modules delivered via web portal.
Group III: VideoActive Control1 Intervention
8 weekly classes delivered via video.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I started a new migraine treatment less than 4 weeks ago.I haven't changed my migraine prevention plan in the last 3 months.I am willing to keep my medication doses the same during the study.I have participated in mindfulness or meditation programs before.I haven't changed my migraine or antidepressant medication in the last 6 weeks.I have had migraines for over a year.I experience 4-14 headache days monthly, with at least one being a migraine.I am able to understand and agree to the study's procedures and risks.I experience 4-14 headache days monthly, with at least one being a migraine.I meditate every day.
Research Study Groups:
This trial has the following groups:- Group 1: Telephone
- Group 2: Online
- Group 3: Video
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment currently accept individuals to partake in the trial?
"Per the details on clinicaltrials.gov, this research study is presently recruiting patients. The trial was initially made available to the public on January 1st 2023 and has been amended as recently as November 11th of that same year."
Answered by AI
How many individuals have been selected to participate in this clinical experimentation?
"Affirmative. Per the data published on clinicaltrials.gov, this medical study is actively searching for participants as of January 11th 2023. The trial was posted on 1st January 2021 and aims to recruit 144 people through one location."
Answered by AI
Who else is applying?
What site did they apply to?
Albert Einstein College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
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