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

Fundación Cardiovascular de Colombia

Status: Not yet enrolling

Conditions: Headache Disorders; Chronic Migraine; Depression; Anxiety; Adverse Childhood Experiences

Treatments: Behavioral: Online Mindfulness-Based Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07033520

CEI-2025-09350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy Group

Experimental group

Description:

Participants in this group will receive an 8-week online Mindfulness-Based Cognitive Therapy (MBCT) intervention. The program includes weekly virtual sessions, guided meditations, and cognitive behavioral strategies aimed at reducing pain and stress-related symptoms in individuals with chronic migraine and adverse childhood experiences.

Treatment:

Behavioral: Online Mindfulness-Based Cognitive Therapy

Control Group

No Intervention group

Description:

Participants in this group will not receive any intervention during the study period but will continue with their usual care. After study completion, they will be offered the opportunity to participate in the MBCT program.