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

NCT07033520 | Not Yet Recruiting DMC

• 1 other identifier: CEI-2025-09350
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mindfulness-Based Cognitive Therapy; MBCT; Trauma; Pain; Headache; Online Psychological Intervention; Migraine; Stress-Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 8 weeks, 3-month follow-up

Secondary Outcomes (1)

• Reduction in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 8 weeks, and 3-month follow-up.

Other Outcomes (2)

• Reduction in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale

  Baseline, post-intervention, and 3-month follow-up.

• Improvement in Functional Impact of Headache Measured by the Headache Impact Test (HIT-6)

  baseline, 8 weeks, and 3-month follow-up.

Study Arms (2)

Mindfulness-Based Cognitive Therapy Group

EXPERIMENTAL

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.

Behavioral: Online Mindfulness-Based Cognitive Therapy

Control Group

NO INTERVENTION

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.

Interventions

Online Mindfulness-Based Cognitive Therapy BEHAVIORAL

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.

Also known as: MBCT Online

Mindfulness-Based Cognitive Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Universidad de Santander: collaborator

Study Sites (1)

International Hospital of Colombia - Fundación Cardiovascular de Colombia

Bucaramanga, Santander Department, 681004, Colombia

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Headache Disorders; Wounds and Injuries; Pain; Headache; Migraine Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary

Study Officials

• Elkin Rene Llanez Anaya, MD, Psychiatrist.

  Universidad de Santander

  STUDY DIRECTOR

Central Study Contacts

Valentina Gonzalez Galindo, MD, Family Medicine Resident

CONTACT

6796470; valg140795@gmail.com

Alexander Pabon Moreno, MD, Neurologist

CONTACT

6796470; Alexanderpabonmoreno@fcv.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and their treating neurologists (care providers) are blinded to the allocation group. Group assignment is concealed through coded identifiers, and only the study coordination team has access to the randomization list. All interactions and assessments are conducted without revealing group allocation to ensure unbiased clinical management and participant experience.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study follows a parallel assignment model with two arms: an intervention group receiving an 8-week online Mindfulness-Based Cognitive Therapy (MBCT) program, and a waitlist control group receiving no intervention during the study period. Participants are randomly assigned to each group and assessed at baseline, post-intervention, and at a 3-month follow-up. The design allows for comparison of outcomes between the two independent groups.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)