MIND-CM
(2023)Objective
To assess the efficacy of a six-session mindfulness-based treatment added to treatment as usual (TaU) versus TaU alone in patients with chronic migraine and medication overuse headache.
Study Summary
• TaU+MIND group showed superior improvements in headache frequency, quality of life, disability, headache impact, loss of productive time, and medication intake
• TaU+MIND reduced total, indirect, and direct healthcare costs compared to TaU alone
• No adverse events reported in either group
Intervention
Six weekly 90-minute group mindfulness sessions plus 7-10 minutes daily self-practice, added to standard treatment as usual (drug withdrawal, education, tailored prophylaxis).
Inclusion Criteria
Adults with diagnosis of both Chronic Migraine and Medication Overuse Headache (ICHD-3 codes 1.3 and 8.2), with ≥15 headache days/month for the previous 3 months, ≥8 with migraine-like features, and overuse of one or more classes of symptomatic medications.
Study Design
Arms: Treatment as Usual (TaU) alone (n=89) vs TaU + Mindfulness-based intervention (n=88)
Patients per Arm: TaU: 89; TaU+MIND: 88
Outcome
• Superior improvement in headache frequency, QoL, disability, and headache impact in TaU+MIND
• Lower medication intake and reduced loss of productive time with TaU+MIND
• Reduced total, indirect, and direct healthcare costs with TaU+MIND
• Drop-out rates similar between groups (12.4% TaU vs 13.6% TaU+MIND)
Bottom Line
In patients with chronic migraine and medication overuse headache, adding a six-week mindfulness-based intervention with daily 7-10 minute self-practice to treatment as usual significantly increased the proportion achieving ≥50% headache frequency reduction at 12 months (78.4% vs 48.3%, p<0.0001) and improved quality of life, disability, medication intake, and disease costs.
Major Points
- Phase-III single-blind RCT of 177 patients with chronic migraine and medication overuse headache randomized 1:1 to TaU vs TaU + mindfulness
- Primary endpoint of ≥50% headache frequency reduction at 12 months was significantly higher with mindfulness add-on: 78.4% vs 48.3% (p<0.0001)
- TaU+MIND was superior across multiple secondary outcomes including QoL, disability, headache impact, productivity, and medication use
- Direct, indirect, and total healthcare costs were lower in the TaU+MIND group
- No adverse events reported; drop-out rates were similar between groups (~12-14%)
- Mindfulness intervention was a brief, 6-week program (90-minute weekly group sessions) plus brief daily home practice — practical to implement
Study Design
- Study Type
- Phase-III single-blind randomized-controlled trial
- Randomization
- Yes
- Blinding
- Single-blind (evaluating neurologist blinded to allocation)
- Sample Size
- 177
- Follow-up
- 12 months (assessments at 3, 6, and 12 months)
- Centers
- 1
- Countries
- Italy
Primary Outcome
Definition: Achievement of ≥50% reduction in headache frequency at 12 months compared to baseline
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 43/89 (48.3%) | Reported as 78.4% in TaU+MIND group | - | <0.0001 |
Limitations & Criticisms
- Single-center Italian specialty headache center may limit generalizability
- Single-blind design — patients aware of allocation could influence subjective outcomes
- Patients with prior mindfulness experience were excluded, limiting external validity
- COVID-19 pandemic required some assessments via tele-visit, potentially affecting data collection consistency
- Mindfulness instructor was also a study neurologist (L.G.), introducing potential performance bias
Citation
Grazzi et al. The Journal of Headache and Pain (2023) 24:86