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Not yet recruiting NCT07741864

Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis (MPIMS).

No phase Interventional Multiple Sclerosis Pain Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-based intervention, Educational intervention.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Pain, Pain Management. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis

Overview

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.

Interventions

  • Other Mindfulness-based intervention
    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.
  • Other Educational intervention
    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.

Primary outcome measures

  • Intensity of pain [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Dimensions of pain [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Impact of pain on daily functioning [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Presence of neuropathic pain [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Emotional and cognitive impact of pain [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Severity of pain [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
Secondary outcome measures (9)
  • Physical function [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Fatigue [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Depressive symptoms [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Anxiety [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Sleep disturbance [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • 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 [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Sleep quality [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
  • Dispositional mindfulness [Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Unwillingness to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hopsital Universitario Virgen Macarena — Seville

Publications

  • Cebolla A, García-Palacios A, Soler J, Guillen V, Baños R, Botella C. Propiedades psicométricas de la validación es-pañola del Cuestionario de las Cinco Facetas de Mindful-ness (FFMQ). European Journal of Psychiatry. 2012;26(2):118-126.
  • Cebolla A, Luciano JV, DeMarzo MP, Navarro-Gil M, Campayo JG. Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia. Health Qual Life Outcomes. 2013 Jan 14;11:6. doi: 10.1186/1477-7525-11-6. PMID 23317306
  • 23. Macías Fernández JA, Royuela Rico A. La versión española del Índice de Calidad de Sueño de Pittsburgh. Informaciones Psiquiátricas. 1996;(146):465-472.
  • Full KM, Malhotra A, Crist K, Moran K, Kerr J. Assessing psychometric properties of the PROMIS Sleep Disturbance Scale in older adults in independent-living and continuing care retirement communities. Sleep Health. 2019 Feb;5(1):18-22. doi: 10.1016/j.sleh.2018.09.003. Epub 2018 Oct 28. PMID 30670160
  • Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8. PMID 20089179
  • Beswick E, Quigley S, Macdonald P, Patrick S, Colville S, Chandran S, Connick P. The Patient Health Questionnaire (PHQ-9) as a tool to screen for depression in people with multiple sclerosis: a cross-sectional validation study. BMC Psychol. 2022 Nov 28;10(1):281. doi: 10.1186/s40359-022-00949-8. PMID 36443880
  • Munguia-Izquierdo D, Segura-Jimenez V, Camiletti-Moiron D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, Aparicio VA, Carbonell-Baeza A, Delgado-Fernandez M. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):94-102. Epub 2012 Dec 14. PMID 23261007
  • Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish. PMID 19007576

Identifiers

NCT: NCT07741864 · SICEIA-2025-002466

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗