NCT05979337

Brief Behavioral Interventions for Adults With Chronic Migraine

Active, enrolled NA Last updated 6 May 2026

What this trial tests

NA trial testing Empowered Relief in Chronic Migraine in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 October 2023

Primary endpoint
2 September 2026

1 January 2027

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	11 October 2023
Primary completion	2 September 2026
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Empowered Relief
• Health Education (HE)
• Treatment as Usual

Conditions studied

• Chronic Migraine — all drugs for Chronic Migraine →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
  Time frame: Baseline, 1 month
  The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.

Sponsor's own description

People with chronic migraine headaches face many challenges, including high levels of daily pain, disturbances to everyday activities and sleep, and problems with mood such as depression or anxiety. This trial is being completed to study whether changing an individual's behaviors may have an impact as a treatment for migraine headaches.

Eligible participants will be randomized to one of the four arms. This study will be conducted remotely without in-person contact.

Study Hypothesis:

* There is a main effect of attending either the Empowered Relief and Health Education intervention on reductions in migraine-related disability 1 month after completing either intervention
* There is a main effect of Empowered Relief and Health Education interventions on reducing pain-related catastrophizing and migraine symptom severity 1 month after completing either intervention (secondary hypothesis)
* The expected reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity will be maintained at secondary time points (2 months, 3 months, and 6 months after completing either intervention) (secondary hypothesis)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Has the COVID-19 pandemic changed characteristics, administration modalities, and implementation of psychological interventions for chronic headache? An updated systematic review.
   De Lucia A, Donisi V, Rimondini M, Del Piccolo L, et al · · 2026 · PMID 41923926 · DOI 10.1080/21642850.2026.2650006