Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05576467

Treatment for Migraine and Mood

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Migraine Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Depressive Symptoms Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine, The Bronx, New York, United States

Loading trial locations.

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCT-Telephone

Behavioral

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.

MBCT-Video

Behavioral

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.

enhanced usual care (EUC)

Behavioral

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.

Primary outcomes

  1. Percentage of Treatment Session Adherence

    Time frame: Week 8

    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.

  2. Client Satisfaction Questionnaire - 8 (CSQ-8)

    Time frame: Week 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.

Secondary outcomes

  1. Change in Headache Disability Inventory (HDI)

    Time frame: Month 0 to Month 3

    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.

  2. Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)

    Time frame: Month 0 to Month 3

    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.

  3. Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)

    Time frame: Month 0 to Month 3

    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.

Sponsors and collaborators

Lead sponsor

Amanda Shallcross

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • The Cleveland Clinic
  • Wake Forest University Health Sciences
  • Yeshiva University

Registry information

Official study title

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

Acronym: TEAM-M

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.