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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change Migraine Symptom Severity Scale (MSSS)
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Change in Pain Catastrophizing Scale (PCS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Empowered Relief
2024
N/A
~100
Health Education (HE)
2003
Completed Phase 3
~780
Treatment as Usual
2016
Completed Phase 3
~2710

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,857 Previous Clinical Trials
6,436,916 Total Patients Enrolled
2 Trials studying Migraine
76 Patients Enrolled for Migraine
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
651,919 Total Patients Enrolled
9 Trials studying Migraine
1,492 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
~173 spots leftby Aug 2026
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