Hopsital Universitario Virgen Macarena
Seville, Sevilla, 41009, Spain
NCT Number: NCT07741864
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Seville, Sevilla, 41009, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group-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 consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The emotional and cognitive impact of pain will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-administered questionnaire that assesses pain catastrophizing by evaluating negative thoughts and emotional responses associated with pain. It comprises three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time), yielding a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The severity of pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self-report questionnaire that assesses pain severity, pain interference with daily activities, and pain characteristics. It consists of 9 items. Pain severity is assessed using four items rated on an 11-point numeric rating scale (0 = "no pain" to 10 = "pain as bad as you can imagine"), while pain interference is assessed using seven items rated from 0 ("does not interfere") to 10 ("completely interferes"). Higher scores indicate greater pain severity.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 6a (PROMIS-SD SF 6a). The PROMIS-SD SF 6a assesses the individual's subjective perception of sleep quality, sleep depth, and sleep restoration over the previous 7 days. It consists of six items rated on a 5-point Likert scale (1 = "very poor" to 5 = "very good"). Raw scores range from 6 to 30 and are converted into standardized T-scores (mean = 50, SD = 10). Higher T-scores indicate greater sleep disturbance (i.e., poorer sleep quality), whereas lower T-scores indicate better sleep quality.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Quality of life will be assessed using the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL), which assesses health-related quality of life across nine domains in people with multiple sclerosis. It consists of 31 items and item is rated on a 5-point Likert scale (0 = "never" to 5 = "always"). Raw scores for each dimension and the overall score are transformed to a standardized scale ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS) The MAAS is a self-report questionnaire that assesses the frequency with which individuals experience lapses in attention and awareness of the present moment. It consists of 15 items rated on a 6-point Likert scale (1 = "almost always" to 6 = "almost never"). The overall score is calculated as the mean of the 15 items, ranging from 1 to 6. Higher scores indicate greater dispositional mindfulness.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-administered questionnaire that assesses sleep quality and sleep patterns over the previous month. It consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3 (0 = no difficulty, 3 = severe difficulty), yielding a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Dispositional mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a self-report instrument and it consists of 39 items distributed across five dimensions: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Items are rated on a 5-point Likert scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). Total scores range from 39 to 195, with higher scores indicating greater mindfulness.
Contact information is provided by the study sponsor or research team.
Hospital Universitario Virgen Macarena
Other
Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis
Acronym: MPIMS
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