Trial reportThe journal of headache and pain2023
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).
Trial report in The journal of headache and pain, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Clinical Trial on the Efficacy and Cost-efficacy of Adding on a Mindfulness-based Therapy to Standard Medical Prophylaxis in the Treatment of Patients With Chronic Migraine Associated to Medication Overuse Following Structured Withdrawal: the Mind-CM Study
High-Density EEG-MEG-wearable EEG: Comparison of Quantitative Electroencephalographic Indicators as Neurophysiological Markers of Effectiveness of Mindfulness Therapy in Addition to Standard Treatment in Patients With High-frequency Episodic Migraine
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Effect of Educational and Behavioral Interventions on Medication-Overuse Headache: A Systematic Review and Meta-Analysis.Pain research & management · 2026Pooled it
- The effectiveness of educational, behavioural, and cognitive self-management support interventions for chronic migraine: a systematic review.Primary health care research & development · 2025Pooled it
- Network meta-analysis comparing efficacy of different strategies on medication-overuse headache.The journal of headache and pain · 2025Pooled it
- Cost-efficacy evaluation of a mindfulness-based program added to treatment as usual for the treatment of chronic migraine associated to medication overuse headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Trial
- 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 · 2024Trial
- Effects of Introvision, a self-regulation method with a mindfulness-based perception technique in migraine prevention: a monocentric randomized waiting-list controlled study (IntroMig Study).The journal of headache and pain · 2023Trial
- Migraine and Work-Disability: New Treatments Reduce Work-Related Burden Among Migraine Population.European journal of neurology · 2026Article
- Psychological interventions for migraine.Nature reviews. Neurology · 2026Review
- Chronic Migraine Resistance: A Case Report Highlights an Overlooked Factors in Family Medicine Clinics.Healthcare (Basel, Switzerland) · 2026Article
- An exploration of possible future non-pharmacological multidisciplinary treatments to potentiate withdrawal strategy and recovery from medication overuse headache (MOH): a narrative review.Journal of oral & facial pain and headache · 2026Review
- Breaking the medication overuse headache cycle: from nociplastic pain mechanisms to patient-centered interventions - the Junior Editorial Board vision.The journal of headache and pain · 2026Review
- Using Multi-Informant Qualitative Data to Inform Adaptations to Mindfulness-Based Interventions for Adolescents With Chronic Migraine.The Clinical journal of pain · 2026Article
- Article
- Has the COVID-19 pandemic changed characteristics, administration modalities, and implementation of psychological interventions for chronic headache? An updated systematic review.Health psychology and behavioral medicine · 2026Review
- Triple network disruption in medication overuse headache: functional signatures and clinical impact.The journal of headache and pain · 2025Article
- Part Of the Process, or Adverse Event? Considering the Benefits and Potential Risks of Mindfulness-based Interventions for Migraine.Current pain and headache reports · 2025Review
- Telemedicine-based cognitive behavioral therapy (TENACITY) for Veterans with chronic migraine: A pilot randomized controlled trial protocol.Cephalalgia reports · 2025Article
- Current psychological intervention alternatives for the treatment of paediatric headaches: a narrative review.Journal of oral & facial pain and headache · 2025Review
- Framing and Management of Migraines in Women: An Expert Opinion on Challenges, Current Approaches, and Future Multidisciplinary Perspectives.Healthcare (Basel, Switzerland) · 2025Article
- Neurobehavioral features in medication-overuse headache.eNeurologicalSci · 2024Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundMindfulness 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.
methodsIn 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.
resultsOut 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.
conclusionsA 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.
trial registrationMIND-CM was registered on clinicaltrials.gov (NCT03671681) on14/09/2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.