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Behavioral Intervention
Mindfulness Therapy for Migraines (TEAM-M Trial)
N/A
Recruiting
Led By Elizabeth K Seng, Ph.D.
Research Sponsored by Amanda Shallcross
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
No Placebo-Only Group
Summary
This trial is testing a type of therapy called Mindfulness-Based Cognitive Therapy, provided over the phone, through video calls, or as part of regular care with added support. It aims to help people with migraines and depressive symptoms by teaching them to focus on the present moment and understand their thought patterns better. Mindfulness-Based Cognitive Therapy (MBCT) was developed to prevent relapse in recurrent depression by combining cognitive behavioral therapy and meditative techniques.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Client Satisfaction Questionnaire - 8 (CSQ-8)
Percentage of Treatment Session Adherence
Secondary study objectives
Change in Headache Disability Inventory (HDI)
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
Mental Depression
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: MBCT-TelephoneActive Control1 Intervention
8 weekly classes delivered via telephone.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
8 weekly online modules delivered via web portal.
Group III: MBCT-VideoActive Control1 Intervention
8 weekly classes delivered via video.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mindfulness-Based Cognitive Therapy (MBCT) works by increasing patients' awareness and acceptance of their thoughts and feelings through mindfulness practices and cognitive therapy techniques. This approach helps patients to break the cycle of depressive relapse by teaching them to observe their thoughts non-judgmentally and to develop a different relationship with their negative thoughts and emotions.
This matters for depression patients as it empowers them with skills to manage their symptoms and reduce the likelihood of future depressive episodes. Other common treatments for depression include pharmacotherapy, which typically involves antidepressants that alter neurotransmitter levels in the brain to improve mood, and various forms of psychotherapy such as Cognitive Behavioral Therapy (CBT), which focuses on changing negative thought patterns and behaviors.
These treatments are crucial as they offer different mechanisms to address the complex nature of depression, providing patients with multiple options to find the most effective approach for their individual needs.
Find a Location
Who is running the clinical trial?
Amanda ShallcrossLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,401 Previous Clinical Trials
2,460,161 Total Patients Enrolled
38 Trials studying Depression
35,882 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,692 Total Patients Enrolled
65 Trials studying Depression
33,291 Patients Enrolled for Depression
Yeshiva UniversityOTHER
11 Previous Clinical Trials
2,478 Total Patients Enrolled
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,616 Total Patients Enrolled
10 Trials studying Depression
2,683 Patients Enrolled for Depression
Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,688,809 Total Patients Enrolled
8 Trials studying Depression
1,634 Patients Enrolled for Depression
Elizabeth K Seng, Ph.D.Principal InvestigatorAlbert Einstein College of Medicine and Yeshiva University
2 Previous Clinical Trials
80 Total Patients Enrolled
Amanda J Shallcross, M.P.H., N.D.Principal InvestigatorThe Cleveland Clinic
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: MBCT-Telephone
- Group 2: Enhanced Usual Care (EUC)
- Group 3: MBCT-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.