Clinical trial NCT06690060: Mind Body Intervention for Chronic Migraine Headaches
Official title: Mind Body Intervention for Chronic Migraine Headaches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraines
Chronic Pain
Keywords: Migraines
Headaches
Chronic Pain
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a cohort study in which all participants will receive the mind-body intervention. This is an exploratory study to help hone elements of the protocol through participant feedback and to determine variance and optimal survey measurement tools. We will not modify participant medication regimens and no pain or other medication prescriptions will be issued by the research team.
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Adult (≥ 18 years of age)
2. Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
3. A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
4. Presence of migraine headaches at least 5 days per month
5. Willing to engage in a Mind-Body intervention
6. Willing/able to participate in remote sessions

Exclusion Criteria:

1. Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
2. Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
3. Diagnosis of cognitive impairment or dementia
4. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
5. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.

Primary outcomes:
measure: MIDAS
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: HIT-6
timeFrame: baseline, 4, 8, 13 and 20 weeks
Secondary outcomes:
measure: Brief Pain Inventory Questionnaire (Short Form)
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: Pain Anxiety Symptom Scale (Short Form 20)
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: Somatic Symptoms Score (SSS-8)
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: Migraine Duration
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: NRS-11
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: GAMS
timeFrame: baseline, 4, 8, 13 and 20 weeks
measure: Feedback on protocol
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References: