Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Mindfulness Program for Migraines (also known as: BREATHE-Migraine) is an effective treatment?
The available research shows that mindfulness programs can be effective for treating migraines. In one study, patients with chronic migraines who participated in mindfulness sessions combined with another therapy showed better results in reducing headache impact compared to those who did not receive the additional therapy. Another study found that adding mindfulness to regular treatment helped reduce headache frequency and improved quality of life for patients with chronic migraines and medication overuse headaches. These findings suggest that mindfulness can be a helpful addition to traditional migraine treatments.
12345What safety data exists for the mindfulness program for migraines?
The mindfulness-based stress reduction (MBSR) program, evaluated in several studies, has been shown to be safe for migraine patients. It is described as having no known side effects and is feasible as an add-on treatment. Drop-out rates in trials were similar between groups receiving usual care and those receiving mindfulness, indicating good tolerability. Overall, the studies suggest that MBSR is a safe intervention for managing migraines.
26789Is the treatment BREATHE-Migraine a promising treatment for migraines?
Yes, BREATHE-Migraine, which is a mindfulness-based stress reduction program, is a promising treatment for migraines. It is inexpensive, has no known side effects, and has shown positive results in reducing migraine symptoms in several studies.
456710Eligibility Criteria
This trial is for adolescents aged 13 to 18 who suffer from chronic migraines, experiencing at least 8 headache days per month and have a mild headache-related disability. They must be diagnosed with migraine by a medical provider but cannot have major health issues like cancer or epilepsy, active psychosis, suicidal thoughts, or be in frequent therapy sessions.Inclusion Criteria
My headaches cause some level of disability.
I have been diagnosed with migraine by a doctor.
I experience 8 or more headache days each month.
+1 more
Exclusion Criteria
I have a major health condition like cancer or epilepsy.
I do not have active psychosis or thoughts of harming myself.
I am receiving weekly or bi-weekly therapy from a licensed mental health professional.
+1 more
Participant Groups
The study is testing 'BREATHE-Migraine,' a mindfulness-based intervention tailored for teenagers with chronic migraines. The aim is to see if this approach is practical and well-received as groundwork for future trials focused on how it affects headache symptoms.
1Treatment groups
Experimental Treatment
Group I: BREATHE-MigraineExperimental Treatment1 Intervention
Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital ColoradoAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
Children's Hospital ColoradoCollaborator
References
Effects of Synergism of Mindfulness Practice Associated With Transcranial Direct-Current Stimulation in Chronic Migraine: Pilot, Randomized, Controlled, Double-Blind Clinical Trial. [2021]Chronic migraine is a difficult disease to diagnose, and its pathophysiology remains undefined. Its symptoms affect the quality of life and daily living tasks of the affected person, leading to momentary disability. This is a pilot, randomized, controlled, double-blind clinical trial study with female patients between 18 and 65 years old with chronic migraine. The patients underwent twelve mindfulness sessions paired with anodal transcranial direct-current stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC), with current intensity of 2 mA applied for 20 min, three times a week for 4 weeks. In addition, 20 min of mindfulness home practices were performed by guided meditation audio files. A total of 30 participants were evaluated after the treatment, and these were subdivided into two groups-active tDCS and sham tDCS, both set to mindfulness practice. The FFMQ-BR (Five Facet of Mindfulness Questionnaire), MIDAS (Migraine Disability Assessment), and HIT-6 (Headache Impact Test) questionnaires were used to evaluate the outcomes. After the treatment, the active mindfulness and tDCS group showed better results in all outcomes. The sham group also showed improvements, but with smaller effect sizes compared to the active group. The only significant difference in the intergroup analysis was the outcome evaluated by HIT-6 in the post treatment result. Our results provide the first therapeutic evidence of mindfulness practices associated with left DLPFC anodal tDCS with a consequent increase in the level of full attention and analgesic benefits in the clinical symptoms of patients with chronic migraine.
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). [2023]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.
A meta-analytic review of acceptance-based interventions for migraine. [2023]To determine the efficacy of acceptance and mindfulness-based interventions on migraine disability, medication use, and attack frequency.
Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. [2022]Evaluate whether the benefits of Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) on headache disability differs among people with episodic and chronic migraine (CM).
Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. [2023]To understand the mechanisms of mindfulness' impact on migraine.
Meditation for migraines: a pilot randomized controlled trial. [2022]Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines.
Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). [2020]Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial.
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. [2023]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.
Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. [2023]Patients with migraine suffer from high morbidity related to the repeated headache attacks, characteristic of the disorder, poor sleep, and a high prevalence of comorbid psychosocial disorders. Current pharmacological therapies do not address these aspects of migraine, but nonpharmacological treatments such as mindfulness-based stress reduction (MBSR) have been shown to improve both pain and psychological well-being. In this secondary analysis, we examined the change over time in sleep quality and psychosocial outcomes from the magnetic resonance imaging outcomes for mindfulness meditation clinical trial and assessed how these mediated treatment response (50% reduction in headache frequency postintervention). We also examined the relationship between baseline values and treatment response. The trial (primary outcomes previously reported) included 98 patients with episodic migraine randomized to either enhanced MBSR (MBSR+) or stress management for headache. They completed psychosocial questionnaires and headache diaries at baseline (preintervention), midintervention (10 weeks after baseline), and postintervention (20 weeks after baseline). There was a significant improvement in sleep quality from baseline to postintervention (P = 0.0025) in both groups. There were no significant changes from baseline or between groups in anxiety, depression, and stress. There was also no significant association between baseline scores and treatment response. Mediation analysis showed a significant indirect effect of 6% for sleep: In other words, small improvements in sleep may have contributed to the efficacy of MBSR+.Trial registration: NCT02133209.
Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up. [2022]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.