ArticleGlobal advances in integrative medicine and health
Development and Validation of a Headache Health Education Program to Serve as a Control Intervention for Non-Pharmacological Studies in Migraine.
Article in Global advances in integrative medicine and health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
16 authors.
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Abstract
Background: As interest in non-pharmacologic treatments for migraine prevention increases, there is an urgent need to evaluate these treatments in well-designed randomized trials. However, designing a "control" for non-pharmacologic treatments is complex. One possible solution is to design credible educational programs to use as comparators which partially control for natural history, patient engagement, attention and positive expectancy. Objective: To develop and validate through a modified Delphi process a "Headache Health Education" (HHE) program to be used as the control arm in a pilot study of multimodal chiropractic care for episodic migraine. Methods: Leveraging existing patient educational materials, we drafted an initial HHE program with 14 modules, each covering a different migraine-related topic. Designed to be delivered by research personnel in a one-on-one video conference, each module provides education using a slide deck and guided conversation that is grounded in adult learning theory. Furthermore, to engage participants, the script-based sessions are informed by the psychological implications of polyvagal theory and motivational interviewing. The program was validated using a modified Delphi process. Modifications were made to the program based on the ratings and feedback, and a second round of review was then performed. Results: Initial endorsement of the HHE program was generally supportive but included considerable variability. After program refinement, endorsement improved with much lower score variability. Key improvements included the addition of 2 topics, selection of new videos, and training for research assistants/associates in how to use conversational style and specific prompts to engage participants. Conclusion: Initial development and validation of an HHE program to use as a comparator in trials of a non-pharmacological treatment for migraine has been completed. Future analysis will examine the fidelity and acceptability of the HHE program when used as a comparator in a randomized controlled trial of multimodal care for migraine.
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