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Behavioural Intervention

Behavioral Interventions for Chronic Migraine

N/A

Recruiting

Led By John Sturgeon, PhD

Research Sponsored by University of Michigan

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 baseline, 6 month

Awards & highlights

Study Summary

This trial is exploring if changing behaviors can help reduce the severity of migraine headaches. Participants will join a remote intervention to try to reduce pain, disability, and symptoms.

Who is the study for?

This trial is for individuals with a neurologist's diagnosis of chronic migraine, who meet specific criteria and can communicate in English. They must have internet access for remote participation. People currently in cognitive therapy for pain or involved in medical litigation, or those unable to consent due to cognitive issues are excluded.Check my eligibility

What is being tested?

The study examines if behavior changes through 'Empowered Relief' or 'Health Education' interventions reduce migraine-related disability and symptom severity. Participants will be randomly assigned to one of the groups and followed up remotely at various intervals after completing the intervention.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like health education and behavioral therapy, typical drug side effects are not expected. However, participants may experience discomfort from changing their usual habits or stress from participating in regular online sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change Migraine Symptom Severity Scale (MSSS)

Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores

Change in Pain Catastrophizing Scale (PCS)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment as Usual (TAU)Experimental Treatment1 Intervention

Group II: Health Education (HE) classExperimental Treatment1 Intervention

Group III: Empowered Relief (ER) class and Health Education (HE) classExperimental Treatment2 Interventions

If randomized to both classes, the HE class will occur first with a week break in between to the ER class.

Group IV: Empowered Relief (ER) classExperimental Treatment1 Intervention

Daily Diaries

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education (HE)

2003

Completed Phase 3

~780

Treatment as Usual

2016

Completed Phase 3

~2710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,838 Total Patients Enrolled

2 Trials studying Migraine

76 Patients Enrolled for Migraine

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,289 Total Patients Enrolled

8 Trials studying Migraine

1,242 Patients Enrolled for Migraine

John Sturgeon, PhDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Empowered Relief (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05979337 — N/A

Migraine Research Study Groups: Empowered Relief (ER) class, Health Education (HE) class, Empowered Relief (ER) class and Health Education (HE) class, Treatment as Usual (TAU)

Migraine Clinical Trial 2023: Empowered Relief Highlights & Side Effects. Trial Name: NCT05979337 — N/A

Empowered Relief (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05979337 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to take part in the experiment?

"Clinicaltrials.gov reports that this trial is no longer actively enrolling participants, as the posting was first made on August 1st 2023 and last updated 28th July 20203. However, there are still 169 trials recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brief Interventions in Chronic Migraine

John Sturgeon 2023. "Brief Interventions in Chronic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979337.

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