Effectiveness of a Mindfulness-Based Intervention for Pain Management

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

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07741864

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Mindfulness-based intervention

Compared with

  • Educational intervention

What it measured

Main measures

  • Intensity of pain

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Pain

  • Dimensions of pain

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Pain

  • Impact of pain on daily functioning

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Pain

  • Presence of neuropathic pain

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Pain

  • Emotional and cognitive impact of pain

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Thinking and memoryPain

  • Severity of pain

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Pain

Other measures (9)

  • Physical function

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    PainQuality of life (reported by participants)

  • Fatigue

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Depressive symptoms

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Mood and sleep

  • Anxiety

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Mood and sleep

  • Sleep disturbance

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Mood and sleep

  • Health-Related Quality of Life

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Quality of life (reported by participants)

  • Mindfulness

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Thinking and memory

  • Sleep quality

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

    Mood and sleep

  • Dispositional mindfulness

    Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

Who could take part

MS (type not specified) · 18 to 80 · EDSS 1.0 to 7.0

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2026

    2. Main results due

      Apr 2027

    3. Finished

      Apr 2027

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