The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and quality of life.
The main questions it aims to answer are:
* Does a mindfulness-based intervention reduce pain intensity in people with multiple sclerosis? * Does the intervention improve fatigue, sleep quality, emotional well-being, quality of life? * Does the effectiveness of the intervention differ according to the type of pain experienced by participants? Researchers will compare a mindfulness-based intervention with an educational program to determine whether mindfulness provides additional benefits for pain management in people with multiple sclerosis.
Participants will:
* Be randomly assigned to either the mindfulness intervention group or the educational control group. * Complete assessments before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up visits. * If assigned to the mindfulness group, attend eight weekly 2.5-hour group sessions plus one 6-hour retreat, either in person or online. * If assigned to the control group, attend two 2-hour educational sessions during the study period. * Complete questionnaires evaluating pain, fatigue, physical function, anxiety, depression, sleep quality, quality of life, and mindfulness throughout the study.
Adults aged 18 to 80 years.
Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.0.
Presence of pain.
Ability to provide written informed consent.
Severe cognitive impairment.
Diagnosed psychiatric disorders (e.g., schizophrenia or personality disorders).
Participation in another non-pharmacological intervention specifically aimed at pain management.
If receiving stable pain medication, treatment must have been maintained for at least 4 months before enrollment.
Parallel
Mindfulness-based intervention
Other interventionGroup-based mindfulness intervention specifically designed for pain management in people with multiple sclerosis. The program includes pain neuroscience education, cognitive pain management strategies, guided meditation, active visualization techniques, mindfulness-based stretching exercises, and mindful yoga.The intervention consists of eight weekly group sessions lasting 2.5 hours each, followed by a 6-hour mindfulness retreat. Participants may attend the sessions either in person or online.
Educational intervention
Other interventionEducational intervention consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period.
Intensity of pain
The intensity of pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported measure of pain intensity in which participants rate their current pain on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Dimensions of pain
The dimensions of pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a 15-item instrument that assesses the qualitative characteristics of pain through 11 sensory and 4 affective descriptors, each rated on a 4-point scale from 0 (none) to 3 (severe). Total score ranges from 0 to 45, with higher scores indicating greater pain intensity and more severe pain qualities.
Impact of pain on daily functioning
The impact of pain on daily functioning will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item questionnaire designed to evaluate an individual's confidence in performing daily activities despite pain. Each item is rated on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely confident), yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.
Presence of neuropathic pain
The presence of neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The DN4 is a 10-item questionnaire consisting of 7 interview items assessing symptoms characteristic of neuropathic pain and 3 clinical examination items evaluating hypoesthesia to touch, hypoesthesia to pinprick, and pain evoked by brushing. Each item is scored as 0 (absent) or 1 (present), yielding a total score ranging from 0 to 10. A total score of ≥4 is indicative of neuropathic pain.
Physical function
Physical function will be assessed using the PROMIS-29 Profile, a patient-reported outcome measure that evaluates physical, mental, and social health, including physical function and pain interference. The PROMIS-29 consists of 29 items distributed across eight domains. The first seven domains are scored using a 5-point Likert scale, with four items per domain. The eighth domain assesses pain intensity using a single item scored on an 11-point numeric rating scale (0-10). Raw scores for each domain can be converted into standardized T-scores (mean = 50, SD = 10), with higher scores indicating more of the construct being measured.
Fatigue
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a patient-reported outcome measure that evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning.The scale consists of 21 items, each rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The total score ranges from 0 to 84, with higher scores indicating greater fatigue.
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-administered questionnaire that assesses the presence and severity of depressive symptoms over the previous two weeks. The questionnaire consists of 9 items rated on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Anxiety
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), which assesses the severity of anxiety symptoms. It consists of seven items rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 0-4 indicate minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
