Clinical trial NCT05576467: Treatment for Migraine and Mood
Official title: Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Depressive Symptoms
Keywords: mindfulness
mindfulness-based cognitive therapy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Yeshiva University
name: Wake Forest University Health Sciences
name: The Cleveland Clinic
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-10-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
* ≥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 preventive migraine medication or anti-depressant medication within 6 weeks of intake
* Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months 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 intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use
* Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current daily meditation practice
* Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
* Unwilling to maintain stable current acute or preventive medication dosages for study duration
* Any condition that would prevent being a suitable candidate or interfere with medical care needs

Primary outcomes:
measure: Percentage of Treatment Session Adherence
timeFrame: Week 8
measure: Client Satisfaction Questionnaire - 8 (CSQ-8)
timeFrame: Week 8
Secondary outcomes:
measure: Change in Headache Disability Inventory (HDI)
timeFrame: Month 0 to Month 3
measure: Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
timeFrame: Month 0 to Month 3
measure: Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)
timeFrame: Month 0 to Month 3
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: Albert Einstein College of Medicine and Yeshiva University
name: Elizabeth K Seng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Amanda J Shallcross, M.P.H., N.D.
role: PRINCIPAL_INVESTIGATOR
References: