Development and Validation of a Headache Health Education Program to Serve as a Control Intervention for Non-Pharmacological Studies in Migraine.

As interest grows in non-pharmacologic migraine treatments, a suitable control is vital. Designing effective controls for these treatments presents significant challenges. One solution is developing a credible educational program to serve as a comparator. This study created a "Headache Health Education" program using a modified Delphi process. The program aims to control for patient engagement and natural history in trials. It consists of 14 modules, each covering a different migraine-related topic. Research personnel will deliver the program through one-on-one video conferences. Each module uses a slide deck and guided conversation based on adult learning theory. The program's design incorporates elements from polyvagal theory and motivational interviewing. After initial feedback and modifications, the program received more consistent endorsement. Key improvements included additional topics, new videos, and training for research assistants. This development and validation process serves as a foundation for future migraine studies. Clinical relevance: This research provides a validated educational program for migraine studies, enhancing trial comparability.