Treatment for Migraine and Mood (TEAM-M)

Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine; Depressive Symptoms
• Intervention / Treatment: Behavioral: MBCT-Telephone; Behavioral: MBCT-Video; Behavioral: 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).

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Wake Forest University School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MBCT-Telephone; 8 weekly classes delivered via telephone.	Behavioral: MBCT-Telephone; 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.
Active Comparator: MBCT-Video; 8 weekly classes delivered via video.	Behavioral: MBCT-Video; 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.
Active Comparator: Enhanced Usual Care (EUC); 8 weekly online modules delivered via web portal.	Behavioral: Enhanced Usual Care (EUC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Headache Disability Inventory (HDI)	The HDI is a 25-item self-report survey which assesses perceived emotional and functional impact of headache on daily activities. Sample items include, "Because of my headaches I feel restricted in performing my routine daily activities," with response options of "Yes," "Sometimes," and "No." Total scores range from 0-100, with higher scores indicating higher disability. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study.	Month 0 to Month 3
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)	The MSQ is a 14-item self-report survey which assesses quality of life over the past 4 weeks in people with migraine. Items comprise three subscales: Role Restriction, Role Prevention, and Emotion Function. Each item is scored on a Likert-type scale from 1 ("None of the time") to 6 ("All of the time"). Total scores range from 14-84. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study.	Month 0 to Month 3
Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)	The QIDS-SR16 measures depressive symptom domains during the prior 7 days. Each item is scored on a scale from 0 to 3 points. Total scores range from 0 to 27. Score cutoffs are: 1-5 for no depression, 6-10 for mild depression, 11-15 for moderate depression, 16-20 for severe depression, and 17-27 for very severe depression. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study.	Month 0 to Month 3

Collaborators and Investigators

• Sponsor: Amanda Shallcross
• Collaborators: The Cleveland Clinic; Wake Forest University Health Sciences; National Center for Complementary and Integrative Health (NCCIH); Yeshiva University
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): March 17, 2024
• Primary Completion (Actual): March 24, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Headache Disorders, Primary; Headache Disorders; Behavior; Migraine Disorders; Depression
• Other Study ID Numbers: 20225608; R01AT011005 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No