Background
Methods
Trial design and participants
Inclusion | 1) Over 18 years of age; 2) Neurologist confirmed diagnosis of MS (Poser or McDonald criteria depending on year of diagnosis); 3) Able to understand spoken and written English; 4) A score of less than or equal to 7.0 on the Expanded Disability Status Scale (EDSS) [49] |
Exclusion | 1) Life-threatening physical or mental health comorbidities (i.e. suicidal ideation, active psychosis, or terminal/life threatening inter-current medical illness), or such conditions expected to significantly limit participation and adherence (eg dementia, pregnancy, on going substance abuse); 2) Those currently receiving another form of psychological intervention (non-pharmacological). |
Randomisation and blinding
Patient involvement
Intervention
MBSR instructors
Intervention fidelity
Domain of fidelity | How it was met |
---|---|
1. Study design | A priori study protocol; fixed number/length of MBSR sessions; recording of any protocol deviations; scripted manual for course; external monitoring by research team and MBSR instructor not part of the research project; monitoring homework completion |
2. Provider training | Qualified and experienced mindfulness teachers trained together using standardised MBSR treatment manuals; same instructors throughout; regular external provider debriefing and supervision; easy access to senior research staff (SM); participant exit interviews enquiring about intervention content |
3. Improving delivery of MBSR | Qualitative assessment of provider ‘warmth/credibility’ from participants, complaint monitoring; treatment workbook provided to all participants; |
4. Improving receipt of MBSR | Providers asked for weekly participant feedback, both verbal, and in writing (embedded questionnaire – not part of study data); completion of regular activity logs; participant and provider feedback on MBSR exercises during classes; telephone follow-up with drop-outs |
5. Improving MBSR skill enactment | Semi-structured participant interviews on completion; regular home practice and materials provided along with diary for adherence; in class discussion/post-interview discussion on ongoing use/application of MBSR skills in daily life |
Outcome objectives
Statistical analysis
Sample size calculation
Data access
Results
Objective 1 - To determine if recruitment, delivery, and retention for a large scale RCT of MBSR were feasible
Source of engagement/ recruitment | Numbers known to have been approached | Numbers (known) expressing interest | Numbers recruited into trial (n/50) | Percentage of recruitment overall |
---|---|---|---|---|
MS Specialist Nurses | 75 | 52 | 34 | 68% |
MS Revive Nurse | 6 | 6 | 6 | 12% |
Integrative Medicine Specialists | 9 | 9 | 5 | 10% |
General practitioners | 11 | 11 | 5 | 10% |
Via MS Society advertisement | Freely available online | 2 | 0 | 0% |
Via University web (Twitter/ Facebook) | Freely available online | 0 | 0 | 0% |
Via protocol (clinical trials.gov) | Freely available online | 5 | 0 | 0% |
Total | 101(+) | 85 | 50 | N/A |
Treatment adherence
MBSR sessions completed | Number of participants | Percentage (%) |
---|---|---|
All | 3 | 12% |
7 | 8 | 32% |
6 | 3 | 12% |
5 | 1 | 4% |
4 | 0 | 0% |
3 | 1 | 4% |
2 | 1 | 4% |
1 | 4 | 16% |
0 | 4 | 16% |
Baseline participant characteristics
Intervention | Control | Significance p | |
---|---|---|---|
Mean age in years (standard deviation - SD) | 43.6 (10.7) | 46.3 (11.1) | 0.37 |
Sex | Female 23 (92%) | Female 22 (88%) | 1.00 |
Ethnicity | White British 25 (100%) | White British 25 (100%) | 1.00 |
MS phenotype RRMS – relapsing remitting; SPMS – secondary progressive; PPMS – primary progressive | RRMS 22 (88%) | RRMS 18 (72%) | 0.74 |
SPMS 1 (4%) | SPMS 7 (28%) | ||
PPMS 2 (8%) | |||
Deprivation | 5.0 (2.8) | 5.4 (2.6) | 0.64 |
Education – highest level | Secondary school 3 (12%) | Secondary school 5 (20%) | 0.73 |
College 7 (28%) | College 7 (28%) | ||
University 15 (60%) | University 13 (52%) | ||
Employment | Full time 4 (16%) | Full time 7 (28%) | 0.39 |
Part time 3 (12%) | Part time 6 (24%) | ||
Unemployed 6 (24%) | Unemployed 7 (28%) | ||
Retired 5 (20%) | Retired 3 (12%) | ||
Other 7 (28%) | Other 2 (8%) | ||
Living arrangement | Lives alone 6 (24%) | Lives alone 3 (12%) | 0.54 |
With partner 9 (36%) | With partner 10 (40%) | ||
With family/friends 10 (40%) | With family/friends 12 (48%) | ||
EDSS | 4.5 (1.8) | 4.3 (1.7) | 0.64 |
Mean disease duration in years (SD) | 8.9 (8.5) | 9.6 (9.4) | 0.79 |
Mean total comorbidity count (SD) | 2.5 (2.2) | 2.3 (1.9) | 0.68 |
Mean mental health comorbidity count (SD) | 0.8 (0.83) | 0.7 (0.8) | 0.73 |
• Comorbid anxiety | 11 (44%) | 8 (32%) | 0.12 |
• Comorbid depression | 9 (36%) | 11 (44%) | 0.29 |
Mean physical health comorbidity count (SD) | 1.8 (1.5) | 1.6 (1.5) | 0.71 |
Using analgesic drugs | 19 (76%) | 17 (68%) | 0.75 |
Using disease modifying drugs | 14 (56%) | 12 (48%) | 0.78 |
Using antidepressant drugs | 12 (48%) | 11 (44%) | 1.00 |
Previous meditation/yoga experience | 17 (68%) | 10 (40%) |
0.04
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