# Supplemental Evidence and Data Request on Behavioral Interventions for Migraine Prevention
**AGENCY:**
Agency for Healthcare Research and Quality (AHRQ), HHS.
**ACTION:**
Request for supplemental evidence and data submissions.
**SUMMARY:**
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Behavioral Interventions for Migraine Prevention, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
**DATES:**
*Submission Deadline* on or before March 20, 2023.
**ADDRESSES:**
*Email submissions: [email protected]* .
*Print submissions:*
*Mailing Address:* Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
*Shipping Address (FedEx, UPS, etc.):* Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.
**FOR FURTHER INFORMATION CONTACT:**
Jenae Benns, Telephone: 301-427-1496 or Email: *[email protected]* .
**SUPPLEMENTARY INFORMATION:**
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Behavioral Interventions for Migraine Prevention. AHRQ is conducting this systematic review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( *e.g.,* details of studies conducted). We are looking for studies that report on Behavioral Interventions for Migraine Prevention, including those that describe adverse events. The entire research protocol is available online at: *https://effectivehealthcare.ahrq.gov/products/behavioral-interventions-migraine-prevention/protocol* .
This is to notify the public that the EPC Program would find the following information on Behavioral Interventions for Migraine Prevention helpful:
A list of completed studies that your organization has sponsored for this indication. In the list, please *indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number* .
*For completed studies that do not have results on ClinicalTrials.gov,* a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
*A list of ongoing studies that your organization has sponsored for this indication.* In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute *ALL Phase II and above clinical trials* sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: *https://www.effectivehealthcare.ahrq.gov/email-updates* .
*The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.*
**Key Questions (KQ)**
*KQ 1:* What are the benefits and harms of behavioral interventions, either alone or in combination with other preventive strategies (including pharmacologic therapy), for migraine prevention compared to inactive control for children and adults?
*KQ 1a:* What are the benefits and harms of behavioral interventions delivered via telehealth and digital health (e/mHealth) technology compared to inactive control?
*KQ 2:* What is the comparative effectiveness and harms of a behavioral intervention for migraine prevention compared to either (a) a pharmacologic preventive agent or (b) another behavioral intervention for children and adults?
*KQ 2a:* What is the comparative effectiveness and harms of behavioral interventions delivered via telehealth and digital health (e/mHealth) technology compared to (a) pharmacologic prevention or (b) other behavioral interventions?
*KQ 3:* For multicomponent or combined behavioral interventions, what are the effects of individual behavioral intervention components?
*KQ 4:* What are the benefits and harms of non-headache focused behavioral interventions ( *e.g.,* CBT for insomnia, CBT for depression/anxiety, parent training) for migraine prevention in children and adults with migraine?
*KQ 5:* For key questions 1-4, how do the findings vary by baseline biopsychosocial factors ( *e.g.,* sex, socioeconomic status, co-occurring mental health conditions)?
**Contextual Questions**
*CQ 1:* What evidence is available on the benefits of behavioral preventive treatments for children and adults with migraine that include intervention components targeting caregivers ( *e.g.,* parents, spouses, and other key support people)?
*CQ 2:* What are patient and provider perceptions of the benefits, harms, and barriers to engaging with behavioral treatments for migraine prevention in children and adults?
| PICOTS | Inclusion | Exclusion |
| --- | --- | --- |
| Patients | All KQs: | All KQs: |
| | • Children (age 6 to 11), adolescents (12 to 17), and adults (18 or older) with migraine headache (episodic or chronic) | Studies conducted exclusively |
| | We will not require studies to only include individuals with an International Classification of Headache Disorders diagnosis of migraine headache | • Among individuals in institutions (
psychiatric inpatients, long-term care facilities, incarcerated populations). |
| | • ≥80% of study participants had migraine headache, or the study reports a subgroup analysis comprised of at least 80% migraine patients | • Parents, for studies with interventions targeting children and adolescents. |
| | • We will include studies with participants with other headache types (
medication overuse headache, tension type headache, cluster headache, etc.) in addition to migraine, as long as ≥80% of participants have migraine | • Individuals with psychotic disorders. |
| Interventions | KQs 1-3 | |
| | Migraine-focused behavioral interventions used for prevention, administered either alone or with pharmacotherapy, delivered in-person, via telehealth, or with e- or mHealth | We will exclude studies focused solely on the following interventions: |
| | 1. CBT | |
| | • Cognitive behavioral therapy | |
| | • Cognitive therapy | • Physical therapy. |
| | 2. Biofeedback | |
| | • Thermal/temperature biofeedback (Hand warming/Thermal biofeedback) (often feedback of skin temperature from finger) | |
| | • Electromyographic (EMG) biofeedback (feedback of electrical activity from muscles of scalp, neck, or upper body) | |
| | 3. Relaxation. | |
| | 4. Mindfulness based stress reduction. | |
| | 5. Third wave CBT. | |
| | 6. Education. | |
| | • Education (skills, lifestyle, exercise, nutrition, hydration, stress management, sleep hygiene) | |
| | 7. Hypnotherapy | |
| | 8. Trauma-informed therapy. | |
| | 9. Dialectical behavioral therapy (DBT) | |
| | 10. Motivational interviewing and stages of change | |
| | 11. Professionally led support groups/peer support | |
| | 12. Combination therapies | |
| | KQ1a and KQ2a: The above interventions delivered via telehealth or with e- or mHealth | |
| | KQ 4. | |
| | KQ5 Interventions included for KQs 1-4 | |
| Comparisons | KQs 1 | Comparators not listed as included. |
| | KQs 2-4. | |
| | KQ 2-4. | |
| | • Alpha agonists. | |
| | • Calcium channel blockers. | |
| | KQ5 Comparators in KQs 1-4 | |
| Outcomes | All KQs. | |
| | Functional Status/Disability. | |
| | Quality of Life (QOL). | |
| | Adverse effects such as dropout and any reported | |
| | Emotional Status. | |
| | Other: | |
| | KQ 4. Additional outcomes: | |
| Study Design Criteria | All KQs: | All KQs: |
| Setting | • Any non-inpatient setting | Hospitalized patients. |
| Timing | Studies must report a primary outcome at 4 weeks or longer after treatment initiation | |
Dated: February 14, 2023.
Marquita Cullom,
Associate Director.