Clinical trial NCT06170281: Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
Official title: A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Headache
Chronic Migraine
Headache Disorders
Keywords: migraine
headache
behavioral intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-12-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Feasibility in terms of recruitment and adherence rates
timeFrame: 12 weeks
Secondary outcomes:
measure: Migraine Frequency
timeFrame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
measure: Headache Self-efficacy
timeFrame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
measure: Migraine Intensity
timeFrame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Yohannes W Woldeamanuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.