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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Pain Intensity Measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Online Mindfulness-Based Cognitive Therapy (Behavioral)
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.
结局指标
主要结局
Reduction in Pain Intensity Measured by the Visual Analog Scale (VAS)
时间窗: Baseline, 8 weeks, 3-month follow-up
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.
次要结局
- Reduction in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, 8 weeks, and 3-month follow-up.)