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Effects of Online Mindfulness Therapy on Pain and Stress in Adults With Chronic Migraine and Adverse Childhood Experiences

NCT07033520 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-26

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of an online Mindfulness-Based Cognitive Therapy (MBCT) program in reducing pain, stress-related symptoms, and improving functionality in adults with chronic migraine and a history of adverse childhood experiences (ACE). Participants will be randomly assigned to either the MBCT intervention group or a control group. The intervention is delivered entirely online over eight weeks. The study hypothesizes that MBCT will result in significant improvements in pain perception and stress-related symptoms compared to the control condition.

Conditions

  • Chronic Migraine
  • Adverse Childhood Experiences
  • Depression
  • Anxiety
  • Headache Disorders

Interventions

BEHAVIORAL

Online Mindfulness-Based Cognitive Therapy

The intervention consists of an 8-week Online Mindfulness-Based Cognitive Therapy (MBCT) program for adults with chronic migraine and adverse childhood experiences. Participants attend one 90-minute virtual group session per week via video conferencing, led by a trained therapist. Daily home practice is encouraged, including 20-30 minutes of guided mindfulness exercises provided as audio files. The program includes cognitive restructuring, body scans, breathing awareness, and acceptance-based techniques. The intervention is fully remote and requires no in-person contact.

Sponsors & Collaborators

  • Universidad de Santander

    collaborator OTHER

  • Fundación Cardiovascular de Colombia

    lead OTHER

Principal Investigators

  • Elkin Rene Llanez Anaya, MD, Psychiatrist. · Universidad de Santander

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-20
Completion
2025-11-20

Countries

  • Colombia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033520 on ClinicalTrials.gov