Mind Body Intervention for Chronic Migraine Headaches
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (≥ 18 years of age)
Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
Presence of migraine headaches at least 5 days per month
Disqualifiers
Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
Diagnosis of cognitive impairment or dementia
Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
Trial design
Design model
Single group
Treatments tested in this trial
Mind-Body Intervention
BehavioralThe mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Mind-Body InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MIDAS
The 7-item Migraine Disability Assessment (MIDAS) is a commonly used and well validated self report survey for assessing migraine-related disability. Questions cover adverse life impacts (missed work, etc.), headache frequency, and headache intensity.
Time frame
baseline, 4, 8, 13 and 20 weeks2
HIT-6
The Headache Impact Test (HIT-6), a well-validated self reported survey, measures the impact of headaches on 6 aspects of health-related quality of life. A recent study has estimated that a change of 6-7 points was clinically meaningful in a cohort starting with a mean HIT-6 score of 65.0 (severe impact). The HIT-6 is a recommended NIH common data element for headache.
Time frame
baseline, 4, 8, 13 and 20 weeksSecondary outcomes
1
Brief Pain Inventory Questionnaire (Short Form)
The Brief Pain Inventory questionnaire, which has been validated by Keller et al., will be utilized to gauge pain intensity during the duration of the study. The question about current pain medications will be modified slightly to include current frequency of use.
Time frame
baseline, 4, 8, 13 and 20 weeks2
Pain Anxiety Symptom Scale (Short Form 20)
The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain. It has been validated by McCracken et al.
Time frame
baseline, 4, 8, 13 and 20 weeks3
Somatic Symptoms Score (SSS-8)
The 8 question Somatic Symptoms Score (SSS-8) is a validated, abbreviated version of the 15 question Patient Health Questionnaire (PHQ)-15. SSS-8 survey questions pertain to pain, the gastrointestinal system, fatigue, and cardiovascular complaints.
Time frame
baseline, 4, 8, 13 and 20 weeks4
Migraine Duration
We will ask participants to estimate how long, on the average, their migraine attacks lasted during the last two weeks.
Time frame
baseline, 4, 8, 13 and 20 weeksSponsors and contacts
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Source ClinicalTrials.gov