Treatment for Migraine and Mood

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).

Conditions

• Migraine
• Depressive Symptoms

Interventions

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.

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.

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.

Sponsors & Collaborators

• Yeshiva University

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Amanda Shallcross

  lead OTHER

Principal Investigators

• Elizabeth K Seng, Ph.D. · Albert Einstein College of Medicine and Yeshiva University

• Amanda J Shallcross, M.P.H., N.D. · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-17

Primary Completion

2026-03-24

Completion

2026-10-20

Countries

• United States

Study Locations