Mindfulness Group Intervention for Newly Diagnosed Persons With Multiple Sclerosis: A Pilot Study

CompletedNot a drug-phase studyRelapsing MSNCT03607773

What it found

No results found

We found no results in the registry or in papers.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Mindfulness Behavioural Intervention (MBI) group

What it measured

Main measures

  • Change in coping skills

    Within 1 month Pre-MBI sessions; Within 1 month Post-MBI sessions; 6 months post-MBI sessions.

Who could take part

Relapsing MS · 18 to 59

Show the full criteria

Inclusion criteria

1. Recently diagnosed with RRMS; 2. Must be within 1 year of an RRMS diagnosis at the time of the first MBI session; 3. Between 18-59 years of age inclusive; and 4. Fluent in English.

Exclusion criteria

1. Have bipolar disorder, schizophrenia, post-traumatic stress disorder, dissociation disorders or untreated depression or other psychiatric disease (at the PI's discretion) that could affect the study outcomesa major psychiatric disease such as bipolar disorder, schizophrenia or untreated severe major depressive disorder; 2. Use of marijuana more than 3x per week, or have other substance abuse, as determined by the PI; 3. Diagnosed with other neurological disorder(s) that would prevent participation in the intervention; or 4. Unable to attend at least 80% (8 of 10) of the MBI sessions (missing more than 20% of the sessions will result in removal from the study).

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

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is a chronic neurological disease often diagnosed in a person's 20s or 30s, at a time when most people are starting careers and families. In relapsing remitting (RR) MS new neurological symptoms suddenly develop over hours to days during relapses, and they do not start to resolve for days to weeks. Relapse symptoms may not completely disappear, such that disability accumulates over time. Further, most persons with RRMS will enter a progressive phase years after diagnosis. It is unpredictable when the transition to the progressive phase will occur and how quickly this progression will happen. Thus, receiving an MS diagnosis is a highly stressful event. Persons with MS (PwMS) often suffer from mood symptoms, which can further impair quality of life (QOL). PwMS need support and the skills to effectively cope with the distress that comes with the uncertainty of a new MS diagnosis, as well as to minimize or prevent the onset of negative mood symptoms. One promising approach is mindfulness - a mental state of paying attention with intention, and accepting the present moment as it is without judgment. Scientific evidence supports the use of mindfulness based interventions (MBIs) in other chronic diseases to reduce stress, anxiety and depression, leading to improved physical function and QOL. MBIs decreased stress-related symptoms and the levels of stress hormones in the blood. As such, MBIs have the potential to lessen the negative consequences of stress in newly diagnosed PwMS.

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History

    1. Started

      Sept 2018

    2. Main results due

      Jan 2020

    3. Finished

      Jan 2020

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