Acceptance and commitment therapy for high frequency episodic migraine without aura: Findings from a randomized pilot investigation.

OBJECTIVE: We compared the incremental effects of adding acceptance and commitment therapy (ACT) to pharmacological treatment as usual (TAU) in a sample of patients with high frequency episodic migraine without aura (HFEM), assessing impact on a spectrum of measures across multiple domains. BACKGROUND: Patients with HFEM are at risk of developing chronic migraine and medication overuse headache. ACT has been shown to be effective for the treatment of various chronic pain conditions, but little attention has been given to its therapeutic value in the management of recurring headaches. METHODS: In this single-blind (masking for outcome assessor), open-label, randomized clinical trial, 35 patients with HFEM, with a monthly headache frequency ranging from 9 to 14 days, were recruited at the headache center of C. Besta Neurological Institute and randomized to either TAU (patient education and pharmacological prophylaxis; n = 17) or TAU + ACT (n = 18). Patients assigned to the combined treatment arm additionally received six 90-min weekly group sessions of ACT therapy and two supplementary "booster" sessions. All patients were on a stable course of prophylactic medication in the 3 months prior to initiating either treatment. Monthly headache frequency served as the primary outcome measure, with all other data collected being considered as secondary measures (medication intake, disability, headache impact, anxiety and depression, catastrophizing, allodynia, cognitive inflexibility, pain acceptance, mindful attention and awareness). RESULTS: A total of 35 patients were enrolled: 17 randomized to TAU, of whom three dropped out, and 18 to TAU + ACT (no dropouts in this group). Headache frequency and medication intake decreased in both groups over 12 months, with patients in the TAU + ACT group showing statistically significant reduction earlier, that is, by month 3. Headache frequency was reduced by 3.3 days (95% CI: 1.4 to 5.2) among those randomized to ACT + TAU, whereas it increased by 0.7 days (95% CI: -2.7 to 1.3) among those randomized to TAU only (p = 0.007, partial η2  = 0.21), the difference being 4 days (95% CI: 1.2 to 6.8). Medication intake was reduced by 4.1 intakes (95% CI: 2.0 to 6.3) among those randomized to ACT + TAU and by 0.4 intakes (95% CI: -1.8 to 2.5) among those randomized to TAU only (p = 0.016; partial η2  = 0.17), the difference being 3.8 intakes (95% CI: 0.7 to 6.8). At 6 and 12 months, the variations were not different between the two groups for headache frequency and medication intake. The opposite was found for measures of headache impact and pain acceptance, where the differences over time favored patients allocated to TAU. Both groups improved with regard to measures of disability, anxiety and depression, catastrophizing, and cognitive inflexibility, whereas measures of allodynia and pain acceptance were stable over time. CONCLUSIONS: Our preliminary findings indicate that supplementing TAU with ACT can enhance the main clinical outcomes, namely headache frequency and medication intake of patients with HFEM.

A prospective pilot study of the effect on catecholamines of mindfulness training vs pharmacological prophylaxis in patients with chronic migraine and medication overuse headache.

AIM: To address whether, in patients with chronic migraine and medication overuse headache, mindfulness-based treatment is associated with changes in plasma levels of catecholamines and elusive amines that are similar to those observed in patients undergoing pharmacological prophylaxis. METHODS: In this non-randomized, clinic-based effectiveness study, patients aged 18-65, with a history of chronic migraine ≥ 10 years and overuse of triptans or non-steroidal anti-inflammatory drugs ≥ 5 years, were enrolled. Upon completion of a structured withdrawal program, patients received either pharmacological prophylaxis or six weekly sessions of mindfulness-based treatment and were followed for 12 months. Daily headache diaries were used to record headache frequency and medication intake; catecholamines (noradrenaline, epinephrine and dopamine) and levels of elusive amines were assayed from poor platelet plasma. RESULTS: Complete follow-up data were available for 15 patients in the pharmacological prophylaxis-group (14 females, average age 44.1) and 14 in the mindfulness treatment-group (all females, average age 46.4), and all variables were comparable between groups at baseline. At 12 months, significant improvement ( p < .001) was found in the pharmacological prophylaxis group for headache frequency and medication intake (by 51% and 48.7%, respectively), noradrenaline, epinephrine and dopamine (by 98.7%, 120.8% and 501.9%, respectively); patients in the mindfulness treatment-group performed similarly. For elusive amines, no longitudinal changes were found. CONCLUSIONS: The similar improvement trends observed in the two groups of patients further support the utility of mindfulness-based treatment in migraine care, and reinforce the hypothesis that alteration and normalization of tyrosine metabolism are implicated in migraine chronification and in remission of chronic migraine.

A Short Review of the Non-invasive Transcutaneous Pericranial Electrical Stimulation Techniques and their Application in Headache.

PURPOSE OF REVIEW: In this short review, the most common non-invasive neuromodulatory techniques will be described, along with their advantages and disadvantages and their application in headache. Available preventive treatments can be unhelpful or may have unpleasant side effects; moreover, the rate of response to preventive drugs does not exceed 50%, lower in chronic migraine; alternative options would be welcome. Though the concept of neuromodulation was originally developed with invasive methods, newer non-invasive techniques are appearing. RECENT FINDINGS: The novel neuromodulatory techniques have been developed with encouraging results: compared with traditional pharmacotherapy, advantages of non-invasive neuromodulation include reduced incidence of adverse effects, improved adherence, and safety and ease of use. The results are encouraging for acute or preventive treatment of different kinds of headache. A variety of neuromodulatory approaches is expanding fastly and has opened new possibilities for treatment of patients suffering from many forms of headache, especially those who have failed traditional pharmacotherapy. The non-invasive treatments can be seen as supplementing traditional management in refractory patients. Current study results are encouraging but preliminary and larger and more rigorous trials are needed to clarify benefit and mode of action.

Mindfulness and pharmacological prophylaxis have comparable effect on biomarkers of inflammation and clinical indexes in chronic migraine with medication overuse: results at 12 months after withdrawal.

Chronic migraine (CM) is a disabling condition arising from a complex mixture of interconnected biological, psychological and social factors, and is often associated with medication overuse (MO). Mindfulness is emerging as a helpful treatment for pain, and one study showed that the longitudinal 12 months' course of CM-MO patients that attended mindfulness-based treatment alone was similar to that of patients receiving medical prophylaxis alone; in this study, we describe the course of biomarkers of inflammation. Our results provide initial evidence of sustained similar effects on reduced concentration of biomarkers of inflammation, although not sizeable enough to reach statistical significance. Whether more intensive treatment and/or larger samples would lead to greater changes is unknown, but these encouraging preliminary findings suggest further research is warranted.

Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up.

BACKGROUND: Chronic Migraine (CM) is a disabling condition, worsened when associated with Medication Overuse (MO). Mindfulness is an emerging technique, effective in different pain conditions, but it has yet to be explored for CM-MO. We report the results of a study assessing a one-year course of patients' status, with the hypothesis that the effectiveness of a mindfulness-based approach would be similar to that of conventional prophylactic treatments. METHODS: Patients with CM-MO (code 1.3 and 8.2 of the International Classification of Headache Disorders-3Beta) completed a withdrawal program in a day hospital setting. After withdrawal, patients were either treated with Prophylactic Medications (Med-Group), or participated in a Mindfulness-based Training (MT-Group). MT consisted of 6 weekly sessions of guided mindfulness, with patients invited to practice 7-10 min per day. Headache diaries, the headache impact test (HIT-6), the migraine disability assessment (MIDAS), state and trait anxiety (STAI Y1-Y2), and the Beck Depression Inventory (BDI) were administered before withdrawal and at each follow-up (3, 6, 12 after withdrawal) to patients from both groups. Outcome variables were analyzed in separate two-way mixed ANOVAs (Group: Mindfulness vs. Pharmacology x Time: Baseline, 3-, 6-, vs. 12-month follow-up). RESULTS: A total of 44 patients participated in the study, with the average age being 44.5, average headache frequency/month was 20.5, and average monthly medication intake was 18.4 pills. Data revealed a similar improvement over time in both groups for Headache Frequency (approximately 6-8 days reduction), use of Medication (approximately 7 intakes reduction), MIDAS, HIT-6 (but only for the MED-Group), and BDI; no changes on state and trait anxiety were found. Both groups revealed significant and equivalent improvement with respect to what has become a classical endpoint in this area of research, i.e. 50% or more reduction of headaches compared to baseline, and the majority of patients in each condition no longer satisfied current criteria for CM. CONCLUSIONS: Taken as a whole, our results suggest that the longitudinal course of patients in the MT-Group, that were not prescribed medical prophylaxis, was substantially similar to that of patients who were administered medical prophylaxis.

Mindfulness and headache: A "new" old treatment, with new findings.

Background Mindfulness refers to a host of procedures that have been practiced for centuries, but only recently have begun to be applied to varied pain conditions, with the most recent being headache. Methods We reviewed research that incorporated components of mindfulness for treating pain, with a more in depth focus on headache disorders. We also examined literature that has closely studied potential physiological processes in the brain that might mediate the effects of mindfulness. We report as well preliminary findings of our ongoing trial comparing mindfulness alone to pharmacological treatment alone for treating chronic migraine accompanied by medication overuse. Results Although research remains in its infancy, the initial findings support the utility of varied mindfulness approaches for enhancing usual care for headache management. Our preliminary findings suggest mindfulness by itself may produce effects comparable to that of medication alone for patients with chronic migraine and medication overuse. Conclusions Much work remains to more fully document the role and long term value of mindfulness for specific headache types. Areas in need of further investigation are discussed.