MigrainesNCT06690060
Mind Body Intervention for Chronic Migraine Headaches
A study testing Mind-Body Intervention in people with Migraines and Chronic Pain, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraines, Chronic Pain
- What is being tested?
- Mind-Body Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing to engage in a Mind-Body intervention
- Willing/able to participate in remote sessions
Who cannot join
- 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
- Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Ashley Scafetta, 617-754-2882, ascafett@bidmc.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Migraines, Chronic Pain
- Being tested
- Mind-Body Intervention
- Keywords
- Migraines, Headaches, Chronic Pain
- Medical subject headings
- Migraine Disorders, Chronic Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body InterventionBehavioural
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Intervention | Experimental | A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions Receives: Behavioral: Mind-Body Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4, 8, 13 and 20 weeks
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.
Measured: baseline, 4, 8, 13 and 20 weeks
Secondary outcomes (7)
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.
Measured: baseline, 4, 8, 13 and 20 weeks
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.
Measured: baseline, 4, 8, 13 and 20 weeks
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.
Measured: baseline, 4, 8, 13 and 20 weeks
Migraine Duration
We will ask participants to estimate how long, on the average, their migraine attacks lasted during the last two weeks.
Measured: baseline, 4, 8, 13 and 20 weeks
NRS-11
The 11-point Numeric Rating Scale (NRS-11) for headache pain intensity asks the patient to rate their pain intensity from 0 (no pain) to 10 (worst pain imaginable). The NRS-11 is recommended by the International Headache Society (IHS) for assessment of this parameter in clinical trials.
Measured: baseline, 4, 8, 13 and 20 weeks
GAMS
The single question Global Assessment of Migraine Severity (GAMS) captures a patient's assessment of their overall disease severity. The GAMS is being tested at this stage because there is an abundance of published baseline and variance data for comparison.
Measured: baseline, 4, 8, 13 and 20 weeks
Feedback on protocol
We will be receiving qualitative feedback on the protocol
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start15 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigrainesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690060
- Sponsor's protocol ID
- 2024P000778A
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Intervention for Chronic Migraine Headaches
- ClinicalTrials.gov ID
- NCT06690060
- Acronym / sponsor ID
- 2024P000778A
- Conditions
- Migraines, Chronic Pain
- Keywords
- Migraines, Headaches, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Intervention | Experimental | Behavioral: Mind-Body InterventionA Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Willing to engage in a Mind-Body intervention
Key exclusion criteria (5 listed)
- 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
- Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body InterventionThe 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. | Behavioural | Mind-Body Intervention |
Primary outcome
MIDAS
Time frame: baseline, 4, 8, 13 and 20 weeks
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.
HIT-6
Time frame: baseline, 4, 8, 13 and 20 weeks
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.
7 secondary outcomes
Brief Pain Inventory Questionnaire (Short Form)
Time frame: baseline, 4, 8, 13 and 20 weeks
Pain Anxiety Symptom Scale (Short Form 20)
Time frame: baseline, 4, 8, 13 and 20 weeks
Somatic Symptoms Score (SSS-8)
Time frame: baseline, 4, 8, 13 and 20 weeks
Migraine Duration
Time frame: baseline, 4, 8, 13 and 20 weeks
NRS-11
Time frame: baseline, 4, 8, 13 and 20 weeks
GAMS
Time frame: baseline, 4, 8, 13 and 20 weeks
Feedback on protocol
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Migraines
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Intervention in people with Migraines and Chronic Pain, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Scafetta (617-754-2882, ascafett@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIDAS (time frame: baseline, 4, 8, 13 and 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.