NCT07033520

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

Effects of Online Mindfulness-Based Cognitive Therapy on Pain, Stress-Related Symptoms, and Functionality in Adults With Chronic Migraine and Adverse Childhood Experiences at the International Hospital of Colombia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fundación Cardiovascular de Colombia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial investigates the effects of an eight-week Online Mindfulness-Based Cognitive Therapy (MBCT) program on adults diagnosed with chronic migraine who also report a history of adverse childhood experiences (ACEs). The study follows a randomized controlled design with two parallel arms: an intervention group receiving MBCT and a control group on a waitlist. Participants in the MBCT group will engage in weekly online sessions, guided meditation exercises, and cognitive restructuring tasks. The primary hypothesis is that MBCT will significantly reduce self-reported pain intensity and stress-related symptoms, as well as improve functional impact related to headache, compared to the control group. Assessment tools include validated scales such as the Visual Analog Scale (VAS) for pain, Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, Generalized Anxiety Disorder 7-item scale (GAD-7), and the Headache Impact Test (HIT-6) to assess headache-related disability and functionality. Data will be collected at three time points: baseline, post-intervention (8 weeks), and follow-up (3 months after completion). The sample will consist of approximately 60 participants, recruited from the International Hospital of Colombia (IHC) and through digital outreach. This study is classified as minimal risk and has received ethical approval from the Institutional Review Board (IRB) of Fundación Cardiovascular de Colombia. The intervention is delivered entirely online to ensure accessibility and will not interfere with participants' ongoing neurological treatment plans.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-20
• Completion: 2025-11-20
• First posted: 2025-06-24
• Last updated: 2025-06-26

Locations

1 site across 1 country: Colombia