Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Migraine Behavioral Treatment.
- Who it may be relevant to
- Registry conditions: Migraine, Headache, Chronic Migraine, Headache Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention
Overview
This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
Detailed description
After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -
* Choice Arm: allowed to choose from a menu of migraine behavioral treatment options * Random: randomized to migraine behavioral treatment options.
After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
Interventions
- Behavioral Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Primary outcome measures
- Feasibility in terms of recruitment and adherence rates [Time frame: 12 weeks]
Secondary outcome measures (3)
- Migraine Frequency [Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]
- Headache Self-efficacy [Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]
- Migraine Intensity [Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]
Eligibility criteria
Inclusion criteria
- have chronic migraine for a minimum of 1-year
- aged 18 years and older
Exclusion criteria
- secondary headache disorders
- children younger than 18 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Phoenix
Publications
- Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1. PMID 32071349
- Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25. PMID 26810728
- Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6. PMID 34357593
Identifiers
NCT: NCT06170281 · 24-006447 · K01NS124911