Active (not recruiting)
Not applicable
NCT05576467
Treatment for Migraine and Mood
No applicable phase (e.g. observational)
Conditions:
Migraine
Depressive Symptoms
Sponsor: Amanda Shallcross
trial.available_in:
БГ
Overview
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
Description
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).
Who can participate
Inclusion Criteria:
* Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
* Self-reported 4-20 headache days per month
* Score between 5-19 on the PHQ-8
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* ≥1 year of migraine
Exclusion Criteria:
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post- traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
* Changes in anti-depressant medication within 6 weeks of intake
* Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks of intake
* Changes in acute migraine treatment started within 4 weeks of enrollment
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current daily meditation practice
* Unwilling to maintain stable current acute or preventive medication dosages for study duration
* Any condition that would prevent being a suitable candidate for the group intervention
* Medication overuse headache with migraine treatment