Effects of Online Mindfulness Therapy on Pain and Stress in Adults With Chronic Migraine and Adverse Childhood Experiences
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online Mindfulness-Based Cognitive Therapy.
- Who it may be relevant to
- Registry conditions: Chronic Migraine, Adverse Childhood Experiences, Depression, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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 te
Primary outcome measures
- Reduction in Pain Intensity Measured by the Visual Analog Scale (VAS) [Time frame: Baseline, 8 weeks, 3-month follow-up]
Secondary outcome measures (1)
- Reduction in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, 8 weeks, and 3-month follow-up.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Colombia · 1 center
- International Hospital of Colombia - Fundación Cardiovascular de Colombia — Bucaramanga
Publications
- Roque-Lopez S, Llanez-Anaya E, Alvarez-Lopez MJ, Everts M, Fernandez D, Davidson RJ, Kaliman P. Mental health benefits of a 1-week intensive multimodal group program for adolescents with multiple adverse childhood experiences. Child Abuse Negl. 2021 Dec;122:105349. doi: 10.1016/j.chiabu.2021.105349. Epub 2021 Oct 7. PMID 34628152
- Kaliman P, Cosin-Tomas M, Madrid A, Roque Lopez S, Llanez-Anaya E, Papale LA, Alisch RS, Davidson RJ. Epigenetic impact of a 1-week intensive multimodal group program for adolescents with multiple adverse childhood experiences. Sci Rep. 2022 Oct 20;12(1):17177. doi: 10.1038/s41598-022-21246-9. PMID 36266402
- Webster EM. The Impact of Adverse Childhood Experiences on Health and Development in Young Children. Glob Pediatr Health. 2022 Feb 26;9:2333794X221078708. doi: 10.1177/2333794X221078708. eCollection 2022. PMID 35237713
- Anto M, Jaffee S, Tietjen G, Mendizabal A, Szperka C. Adverse Childhood Experiences and Frequent Headache by Adolescent Self-Report. Pediatr Neurol. 2021 Aug;121:51-55. doi: 10.1016/j.pediatrneurol.2021.04.004. Epub 2021 Apr 16. PMID 34147819
- Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabler. J Headache Pain. 2013 Jan 10;14(1):1. doi: 10.1186/1129-2377-14-1. No abstract available. PMID 23566305
Identifiers
NCT: NCT07033520 · CEI-2025-09350