ACTIVE_NOT_RECRUITING

Brief Interventions in Chronic Migraine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

People with chronic migraine headaches face many challenges, including high levels of daily pain, disturbances to everyday activities and sleep, and problems with mood such as depression or anxiety. This trial is being completed to study whether changing an individual's behaviors may have an impact as a treatment for migraine headaches. Eligible participants will be randomized to one of the four arms. This study will be conducted remotely without in-person contact. Study Hypothesis: * There is a main effect of attending either the Empowered Relief and Health Education intervention on reductions in migraine-related disability 1 month after completing either intervention * There is a main effect of Empowered Relief and Health Education interventions on reducing pain-related catastrophizing and migraine symptom severity 1 month after completing either intervention (secondary hypothesis) * The expected reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity will be maintained at secondary time points (2 months, 3 months, and 6 months after completing either intervention) (secondary hypothesis)

Official Title

Brief Behavioral Interventions for Adults With Chronic Migraine

Quick Facts

Study Start:2023-10-11
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05979337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-reported neurologist diagnosis of chronic migraine
  2. * Meets diagnostic criteria for chronic migraine according to the Identify Chronic Migraine (IDCM) self-reported instrument
  3. * English-speaking
  4. * Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
  5. * Age 18 years or older
  1. * Currently receiving cognitive-behavioral therapy for pain or migraine
  2. * Open litigation regarding a medical condition, as assessed in preliminary study screening
  3. * Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols
  4. * Failure to complete at least 7 out of 14 pre-intervention daily diaries

Contacts and Locations

Principal Investigator

John Sturgeon, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • John Sturgeon, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-10-11
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Health Education
  • Migraine-related disability
  • Empowered Relief

Additional Relevant MeSH Terms

  • Chronic Migraine