Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study).
Licia Grazzi, Domenico D'Amico, Erika Guastafierro, Greta Demichelis, Alessandra Erbetta, Davide Fedeli, Anna Nigri, Emilio Ciusani, Corso Barbara, Alberto Raggi
The Journal of Headache and Pain July 14, 2023 DOI: 10.1186/s10194-023-01630-0 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Phase-III single-blind randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 177 |
| Population | Patients with chronic migraine and medication overuse headache at a specialty Italian headache center |
| Interventions | education on proper medication use and lifestyle tailored prophylaxis) |
| Duration | Six group sessions with 7-10 minutes daily self-practice; primary endpoint at 12 months |
| Topics | Meditation |
| Keywords | Chronic migraine Cost of illness Disability Medication overuse headache Migraine prophylaxis Quality of life |
| Registration | NCT03671681 |
| Key findings | Adding a six-session mindfulness-based intervention with brief daily self-practice to treatment as usual more than doubled the likelihood of achieving at least a 50% reduction in headache frequency at 12 months (78.4% vs. 48.3%). The mindfulness group also improved more on quality of life, disability, headache impact, lost productive time, medication intake, and healthcare costs. |
Abstract
Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headache frequency, medication intake, quality of life, disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. In this Phase-III single-blind RCT carried out in a specialty Italian headache center, 177 patients with CM and MOH were randomized 1:1 to either TaU (withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis) or mindfulness-based intervention added to TaU (TaU + MIND). The mindfulness-based intervention consisted of six group session of mindfulness practice and 7-10 min daily self-practice. The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared to baseline, and was analyzed on an intention-to-treat principle using Pearson's Chi-Squared test. Secondary endpoints included medication intake, quality of life (QoL), disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. The secondary endpoints were analyzed using per-protocol linear mixed models. Out of the 177 participants 89 were randomized to TaU and 88 to TaU + MIND. Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p < 0.0001), and showed superior improvement in headache frequency, QoL and disability, headache impact, loss of productive time, medication intake, and in total, indirect and direct healthcare costs. A mindfulness-based treatment composed of six-week session and 7-10 min daily self-practice added on to TaU is superior to TaU alone for the treatment of patients with CM and MOH. MIND-CM was registered on clinicaltrials.gov (NCT03671681) on14/09/2018.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 6
- Longitudinal neurofunctional changes in medication overuse headache patients after mindfulness practice in a randomized controlled trial (the MIND-CM study). The Journal of Headache and Pain June 11, 2024
- Neurotransmitter-related functional connectivity changes in serotonin and dopamine systems after mindfulness in medication overuse headache. Cephalalgia June 1, 2025
- [Mindfulness-based cognitive therapy for individuals with chronic headaches]. Orvosi hetilap December 1, 2024
- The effectiveness of mindfulness as a complementary therapy in headache patients: a preliminary interventional study Confinia Cephalalgica December 16, 2025
- Part Of the Process, or Adverse Event? Considering the Benefits and Potential Risks of Mindfulness-based Interventions for Migraine. Current Pain and Headache Reports September 16, 2025
and 1 more in the library
Cites 11
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis Cephalalgia June 4, 2018
- Mindfulness in migraine: A narrative review Expert Review of Neurotherapeutics January 14, 2020
- Efficacy of mindfulness-based intervention for the treatment of chronic headaches: A systematic review and meta-analysis. Annals of Medicine and Surgery June 2022
- Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial International Journal of Behavioral Medicine December 21, 2021
and 6 more in the library