Mindfulness for Newly Diagnosed Multiple Sclerosis

NCT03607773 | Completed

• 1 other identifier: 111561
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in coping skills

  Brief COPE measure - was developed to assess a broad range of coping responses.28 questions with a 1-4 point scale for a total range of 28-116 with a lower score indicating better coping skills. This will be assessed at three time points and then aggregated to arrive at one reported value that represents "change in coping skills". This is indicated as an integer. Ex. Pre-MBI = 70 and Post-MBI = 50 and 6mo Post-MBI = 50 then the aggregated score would be -20.

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

Study Arms (2)

Mindfulness Behavioural Intervention (MBI) group

ACTIVE COMPARATOR

10 one-hour mindfulness sessions

Behavioral: Mindfulness Behavioural Intervention (MBI) group

Control group

NO INTERVENTION

Standard of care.

Interventions

Mindfulness Behavioural Intervention (MBI) group BEHAVIORAL

While every MBI session is different, in general they will help you develop skills in focused attention, and emotional and behavioural regulation in a group environment made up of other people with MS who may share common experiences with you. MBI sessions are group-based which means you will be attending the sessions with other people who are also in this study and facilitated by trained personnel .

Mindfulness Behavioural Intervention (MBI) group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• Use of marijuana more than 3x per week, or have other substance abuse, as determined by the PI;
• Diagnosed with other neurological disorder(s) that would prevent participation in the intervention; or
• 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).

Sponsors & Collaborators

• Sarah Morrow: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Sarah A Morrow, M.D.

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI will not know which group each participant has been randomized to, nor will the study coordinator. One study team member, who is leading the Mindfulness sessions, will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MS Specialist, Associate Professor, Primary Investigator

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 31, 2018
• Study Start: September 19, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)