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. Author manuscript; available in PMC: 2021 Mar 1.
Published in final edited form as: Expert Rev Neurother. 2020 Feb 12;20(3):207–225. doi: 10.1080/14737175.2020.1715212

Table 1:

Clinical Research Studies Evaluating Mindfulness-Based Interventions in Migraine

Article & Location & Yates Quality Rating Scale (YQRS) Headache Type Study Characteristics Results Strengths Limitations
Wells et al.[83] 2014
Boston, MA
YQRS=31
Episodic Migraine, 4–14 migraine days/ month Intervention: MBSR as adjunctive to pharmacological treatments
Control group: Wait-list
Sample Size: n=19
Average age: 46
• Feasible, acceptable
• Primary outcome (HA frequency):
 • Both groups decreased HA frequency, no statistical difference
• Positive secondary outcomes-MBSR group improved:
 • Migraine duration
 • Disability
 • Self-efficacy
 • Mindfulness
Strengths
• Standardized MBSR program
• Participants randomized & blinded to control group assignment
• HA diaries used
• Primary & secondary outcomes clearly defined
Limitations
• Small sample size (pilot study), underpowered
• No active control group
Seng et al.[79] 2019
Bronx & Manhattan, NY
YQRS=31
Migraine, 6–30 headache days/ month Intervention: MBCT-Individual therapist
Control Group: Waitlist/ Treatment as usual
Sample Size:n=60
Average Age: 40
• Primary outcome (disability) positive: MBCT group had improvements vs. control:
 • Migraine related disability
 • Attack level disability
• Secondary outcomes: no improvements in HA frequency or intensity
• Both groups had improvements in severe disability ratings
Strengths
• Well-defined primary outcome of disability
• Treatment fidelity measures assessed & described
• HA diaries used
• Primary & secondary outcomes clearly defined
Limitations
• No active control group
• Study stopped prior to reaching recruitment goals
• Mixed migraine population of both episodic and chronic migraine
Day et al.[85] 2014
Northport & Tuscaloosa, AL
YQRS=29
Any primary headache (migraine, tension-type, cluster, etc.) Intervention: MBCT-group based
Control Group: Delayed treatment
Sample Size: n=36
Average Age: 42
• Feasible, acceptable, tolerable
• Primary outcomes (HA frequency, duration, intensity):
 • Both groups decreased HA frequency, no statistical difference
• Secondary outcomes: MBCT group-improved:
 • Self-efficacy
 • Chronic pain acceptance
Strengths
• 1st study of MBCT in headache
• Primary & secondary outcomes clearly defined
Limitations
• Un-blinded
• Heterogeneous headache population (any primary headache condition)
Simshäuser et al.[82] 2019
Freiburg, Germany
YQRS=26
Episodic migraine, 2–15 migraines/ month Intervention: MBSR
Control Group: HA education + Behavioral (3 sessions)
Sample Size: n=62
Average Age: 44
• Primary outcome (HA frequency):
 • Both groups decreased HA frequency, no statistical difference
• Secondary outcomes: MBSR had greater improvements than control group in:
 • Psychological symptoms
 • Anxiety
 • Self-efficacy
 • Sensory component of pain
Strengths
• Standardized MBSR program
• Active control group
• HA diaries used
• 12 month follow-up
• Primary & secondary outcomes clearly defined
Limitations
• Pilot study
• High dropout rates
• Control group may have been too active
• 19% of MBSR participants had baseline HA frequency <2, no room for improvement
Tavallaei et al.[86] 2018
Tehran, Iran
YQRS=19
Tension-type or migraine headache Intervention: MBSR “internet-based bibliotherapy”
Control Group: Treatment as usual
Sample Size: n=30
Average Age: 34
• MBSR group had improvements vs. control:
 • Pain intensity
 • Disability
 • Distress
 • Mindfulness
 • Emotional pain
Strengths
• Unique self-guided approach
Limitations
• Intervention not clearly defined
• No HA outcomes measured with daily diaries
• Heterogeneous headache population (tension-type & migraine)
• Primary & secondary outcomes not clearly defined
Bakhshani et al.[87] 2015
Zahedan, Iran
YQRS=18
Chronic migraine and chronic tension-type headache Intervention: MBSR as adjunctive to pharmacological treatments
Control Group: Usual care
Sample Size: n=40
Average Age:31
• MBSR group had improvements vs. control:
 • Pain intensity
 • Short form (SF)-36
Strengths
• Chronic headache patients
Limitations
• Heterogeneous HA population (migraine & tension-type)
• No HA outcomes measured with daily diaries
• Primary & secondary outcomes not clearly defined
Hess et al. [88] 2015
Salt Lake City, UT
YQRS=18
“Recurrent headache” 4+/month Intervention: adapted MBSR
Control Group: No control group
Sample Size: n=20
Average Age:14
• Primary outcome: Safe, feasible
• Secondary outcomes: MBSR participants (without a comparison) had:
 • Improvements in depression symptoms, pain withdrawal
 • Parents of participants reported improved quality of life
Strengths
• Study in adolescent females
• Primary & secondary outcomes clearly defined
Limitations
• No control group
• Non-randomized
• High dropout rates
• HA outcomes not analyzed
• Heterogeneous headache population (“recurrent headache”)
• All females
Grazzi et al.[80] 2017
Milan, Italy
YQRS=17
Chronic migraine-medication overuse headache Intervention: Mindfulness training
Control Group: Pharmacological treatment
Sample Size: n=44
Average Age: 45
• Primary outcomes (headache frequency, use of acute medications), both groups had decreases in:
 • HA frequency
 • Medication usage
   • Secondary outcomes, both groups improved:
 • Disability
 • Depression
Strengths
• Clinically applicable
• Mindfulness compared to pharmacological treatment
• HA diaries used
• 12 month follow-up
 Limitations
• Non-randomized: participants non-blinded & chose treatment assignment

Yates Quality Rating Scale (YQRS): range 0–35, higher scores reflect strongest quality of 1) treatment; 2) study design and methods; see Table 2 for details of scoring [62]

MBSR: Mindfulness Based Stress Reduction

HA: Headache