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Search / Trial NCT07033520

EFFECTS OF ONLINE MINDFULNESS THERAPY ON PAIN AND STRESS IN ADULTS WITH CHRONIC MIGRAINE AND ADVERSE CHILDHOOD EXPERIENCES

Launched by FUNDACIÓN CARDIOVASCULAR DE COLOMBIA · Jun 13, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Mindfulness Based Cognitive Therapy Mbct Trauma Pain Headache Online Psychological Intervention Migraine Stress Related Disorders

ClinConnect Summary

This clinical trial is studying whether an online mindfulness program can help reduce pain and stress in adults who suffer from chronic migraines and have experienced difficult or traumatic events during childhood. The program, called Mindfulness-Based Cognitive Therapy (MBCT), is designed to teach participants ways to manage their pain and stress through guided meditation and mental exercises over an eight-week period. Researchers hope this approach will improve how people feel and function compared to those who do not take part in the program.

Adults aged 18 and older who have been diagnosed with chronic migraine and have a history of adverse childhood experiences (measured by a specific questionnaire) may be eligible to join. Participants need to be able to attend online sessions held in the evenings and must be comfortable completing activities at home. People with certain health conditions, such as other neurological disorders, active cancer, or pregnancy, will not be able to participate. If you join the study, you will be randomly assigned to either the mindfulness program or a comparison group, and all sessions will be done remotely, making it convenient to participate from home. This study is not yet recruiting, but it offers a promising option for those looking for new ways to manage migraine pain and stress.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male and female patients aged 18 years or older with a diagnosis of chronic migraine according to the International Classification of Headache Disorders (ICHD-3), based on diagnostic criteria updated through 2018.
  • Willingness to participate in online sessions from 6:00 PM to 8:00 PM on the scheduled day of the intervention.
  • Male and female patients with a score of 4 or higher on the Adverse Childhood Experiences Questionnaire.
  • Patients who provide informed consent.
  • Exclusion Criteria:
  • Visual, auditory, cognitive, or functional limitations that prevent understanding of therapeutic activities or the ability to perform home tasks.
  • Presence of systemic inflammatory disorders, including rheumatic and autoimmune diseases.
  • Active malignancy.
  • Pregnancy or breastfeeding at the time of the study.
  • Pre-existing neurological conditions (e.g., epilepsy, neuromuscular disorders, metabolic diseases, among others).
  • Central nervous system tumors.
  • Diagnosis of terminal illnesses that prevent follow-up over time.

About Fundación Cardiovascular De Colombia

Fundación Cardiovascular de Colombia is a leading research institution dedicated to advancing cardiovascular health through innovative clinical trials and comprehensive patient care. Established with a commitment to improving cardiovascular outcomes, the foundation engages in cutting-edge research that fosters collaboration among healthcare professionals, researchers, and patients. By prioritizing scientific excellence and ethical standards, Fundación Cardiovascular de Colombia aims to contribute significantly to the global understanding of cardiovascular diseases, ultimately enhancing treatment options and patient quality of life.

Locations

Bucaramanga, Santander, Colombia

Patients applied

0 patients applied

Trial Officials

Elkin Rene Llanez Anaya, MD, Psychiatrist.

Study Director

Universidad de Santander

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported