A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache

Abstract

This preliminary analysis of a single-blind phase-III RCT aims to compare the feasibility and short-term efficacy of mindfulness as an add-on to treatment as usual (TaU) in the management of patients with chronic migraine (CM) and medication overuse headache (MOH). Patients were randomized to either TaU (structured withdrawal of overused drugs, patient education and pharmacological prophylaxis) or TaU + MIND, wherein patients additionally received six 90 min weekly group sessions of mindfulness-based therapy. Repeated measures analyses were used to test whether patients in the two arms showed different course with regard to headache frequency and medication intake over a three-month period. Drop-out rates were not different between the two groups: 6/89 (6.7%) and 9/88 (10.2%) among those in TaU and TaU + MIND, respectively. A significant effect of time for all variables was shown, together with a significant effect of time by group, favoring TaU + MIND condition for headache frequency (p = 0.025) and NSAID intake (p = 0.007), controlling for age and CM duration. In total, 45/83 (54.2%) and 69/79 (75.9%) of the patients allocated to TaU and TaU + MIND, respectively, achieved 50% or more headache-day reduction (chi-squared 8.38, p = 0.004). Our preliminary analysis indicates that adding six mindfulness-based sessions to TaU was feasible and showed short-term efficacy in the treatment of patients with CM and MOH.

Medication-Overuse Headache

“…Techniques such as relaxation training, mindfulness training, biofeedback, cognitive behavioral therapy, acceptance and commitment therapy, and motivational interviewing may show efficacy alone but can also support medical management. 42,43 Access to providers with expertise in these therapies can be limited and treatment can take time to implement. Also, depending on the health care system involved, there may be financial barriers to accessing these treatments.…”

“…Biobehavioral management is important as well, especially in patients with comorbid psychiatric conditions like anxiety, depression, and obsessive-compulsive disorder. Techniques such as relaxation training, mindfulness training, biofeedback, cognitive behavioral therapy, acceptance and commitment therapy, and motivational interviewing may show efficacy alone but can also support medical management 42,43 . Access to providers with expertise in these therapies can be limited and treatment can take time to implement.…”

Alternative and complementary treatments for migraine

“…По данным систематических обзоров и метаанализов, посвященных эффективности этих двух направлений майндфулнесс при мигрени, были сделаны следующие выводы [41,42]: а) майндфулнесс -это перспективный психологический метод, который можно комбинировать со стандартным лечением и получать бо ' льшую пользу, чем от монотерапии стандартным лечением или от монотерапии майндфулнесс; б) майндфулнесс значимо улучшает эмоциональное состояние пациентов, снижает уровень страдания, связанного с заболеванием, и улучшает качество жизни. У пациентов с мигренью и ЛИГБ в период отмены абузусных препаратов проведение терапии майндфулнесс имеет эффективность, сходную с традиционным профилактическим лечением [43,44].…”

Chronic Migraine as a Primary Chronic Pain Syndrome and Recommended Prophylactic Therapeutic Options: A Literature Review

“…Behavioral therapies, namely relaxation, biofeedback, cognitive behavioral therapy (CBT), and mindfulness-based cognitive therapy, are helpful methods for minimizing the role of risk factors in CM patients. A phase 3 RCT comparing the feasibility and short-term efficacy of mindfulness added to treatment as usual and usual treatment alone for CM patients indicated that adding mindfulness to treatment as usual was feasible with short-term efficacy versus treatment without mindfulness [ 150 ]. A clinical study aimed at examining neuropsychological and neuropsychiatric characteristics of CM patients during the interictal phase concluded that CM patients showed a higher rate compared to healthy controls in cognitive domains (such as sustained attention, information processing speed, visuospatial episodic memory, working memory, and verbal fluency) and depressive and anxiety symptoms [ 151 ].…”