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.
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.
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.
Parallel
Online Mindfulness-Based Cognitive Therapy
BehavioralThe 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.
Reduction in Pain Intensity Measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed using a numerical Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their average pain intensity over the past week. The VAS will be administered in digital format at baseline, post-intervention (8 weeks), and 3-month follow-up.
Reduction in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-administered questionnaire. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score from 0 to 27.
Reduction in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated self-report scale. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21.
Improvement in Functional Impact of Headache Measured by the Headache Impact Test (HIT-6)
The Headache Impact Test (HIT-6) will be used to assess the impact of headache on daily functioning and quality of life. The scale includes 6 items scored on a 5-point Likert scale, yielding a total score between 36 and 78.
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Fundación Cardiovascular de Colombia
Lead sponsor
Universidad de Santander
Collaborator
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