Treatment for Migraine and Mood
TEAM-M
2 other identifiers
interventional
145
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
March 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2026
ExpectedApril 21, 2026
June 1, 2025
2 years
October 10, 2022
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Treatment Session Adherence
Treatment Session Adherence is a measure of treatment feasibility. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. The number of treatment sessions attended will be recorded. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average.
Week 8
Client Satisfaction Questionnaire - 8 (CSQ-8)
The CSQ-8 assesses treatment acceptability. The CSQ-8 is an 8-item self-report measure designed to assess satisfaction with mental health services. Response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. The measure has consistently demonstrated excellent reliability and validity, and is commonly used in behavioral treatment trials. For the purposes of this study, a CSQ-8 score \> 24 is considered acceptable.
Week 8
Secondary Outcomes (3)
Change in Headache Disability Inventory (HDI)
Month 0 to Month 3
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
Month 0 to Month 3
Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)
Month 0 to Month 3
Study Arms (3)
MBCT-Telephone
ACTIVE COMPARATOR8 weekly classes delivered via telephone.
MBCT-Video
ACTIVE COMPARATOR8 weekly classes delivered via video.
Enhanced Usual Care (EUC)
ACTIVE COMPARATOR8 weekly online modules delivered via web portal.
Interventions
Classes follow MBCT protocol delivered via video by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
Classes follow MBCT protocol delivered via telephone by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
Weekly online modules follow migraine and behavior principles delivered via web portal developed by a team of licensed clinical psychologists, neurologists, and mental health providers.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amanda Shallcrosslead
- Yeshiva Universitycollaborator
- Wake Forest University Health Sciencescollaborator
- The Cleveland Cliniccollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
Study Sites (3)
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101, United States
The Cleveland Clinic
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth K Seng, Ph.D.
Albert Einstein College of Medicine and Yeshiva University
- PRINCIPAL INVESTIGATOR
Amanda J Shallcross, M.P.H., N.D.
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 12, 2022
Study Start
March 17, 2024
Primary Completion
March 24, 2026
Study Completion (Estimated)
October 20, 2026
Last Updated
April 21, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.
Individual participant data will be available upon request to qualified individuals in the research community. If this research develops or improves any technologies or techniques, this work will be made available to qualified individuals in the research community.