Randomized Trial of Self-Guided, Internet-Based, Cognitive Behavior Therapies for Migraine

Area of Science:

• Neurology
• Digital Health
• Behavioral Science

Background:

• Access to migraine treatment can be improved with self-guided internet-based cognitive behavior therapy (iCBT).
• However, robust evidence for the efficacy of these digital interventions is currently lacking.

Purpose of the Study:

• To evaluate the efficacy of two distinct self-guided iCBT programs for migraine management.
• To compare these interventions against a waitlist control group.

Main Methods:

• A three-arm randomized controlled trial was conducted.
• Participants were assigned to either a psychoeducation/skills training iCBT (SPHERE), a trigger-focused iCBT (PRISM), or a waitlist control.
• The primary outcome was a ≥50% reduction in monthly headache days at 4 months.

Main Results:

• The intention-to-treat (ITT) analysis revealed no significant difference between combined iCBTs and the waitlist (17% vs. 11.6%, p=0.20).
• However, completer analysis showed both iCBTs were superior to the waitlist (22.2% vs. 11.5%, p=0.047).
• Uptake was high, but adherence was low, with less than 20% completing core components.

Conclusions:

• Self-guided iCBTs did not demonstrate superiority over a waitlist in the primary ITT analysis.
• Low adherence rates are a potential reason for the observed lack of efficacy.
• Future research should focus on strategies to enhance adherence to iCBT interventions for migraine.