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

NCT07741864 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Hospital Universitario Virgen Macarena

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-02
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741864 on ClinicalTrials.gov