Effects of Online Mindfulness Therapy on Pain and Stress in Adults With Chronic Migraine and Adverse Childhood Experiences
NCT ID: NCT07033520
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-01
2025-11-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mindfulness-Based Cognitive Therapy Group
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.
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.
Control Group
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universidad de Santander
OTHER
Fundación Cardiovascular de Colombia
OTHER
Responsible Party
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Principal Investigators
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Elkin Rene Llanez Anaya, MD, Psychiatrist.
Role: STUDY_DIRECTOR
Universidad de Santander
Locations
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International Hospital of Colombia - Fundación Cardiovascular de Colombia
Bucaramanga, Santander Department, Colombia
Countries
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Central Contacts
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Valentina Gonzalez Galindo, MD, Family Medicine Resident
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CEI-2025-09350
Identifier Type: -
Identifier Source: org_study_id
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