Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT07033520
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.
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.
Study:
NCT07033520
Study Brief:
Protocol Section:
NCT07033520