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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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This application concerns a proposed randomised controlled trial evaluating the use of Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary care.
MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental health problems are common in MS, can impair quality of life, and lead to higher rates of suicide.
Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress and diminish disease activity in MS, but effects are short-lived and there is thus a need to explore whether other psychological approaches might be more beneficial in this regard.
MBSR is another psychological stress reduction technique that is thought to operate differently to CBT, via cultivating a state of "meta-cognitive awareness" and has shown to be helpful when used in other long term conditions, such as chronic pain and anxiety, whilst Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating recurrent depression. All of these conditions are common in MS. However, mindfulness based interventions have not been well studied in MS.
The investigators propose to carry out a feasibility study to assess how acceptable and accessible MBSR is as a stress reduction technique in people with MS. The investigators would seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual care. The investigators would seek measurements of health and wellbeing before, immediately following, and 3 months following the MBSR intervention. This would include basic demographic information (age, gender, ethnicity), measures of mental health, and physical health, as well as qualitative semi-structured interviews with selected participants. After this we would offer MBSR to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR | Experimental | 8 weekly sessions each lasting 2.5 hours |
|
| Control | Other | Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction (MBSR) | Behavioral | 8 sessions of MBSR |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, accessibility, and acceptability of MBSR in people with MS | Completion rate | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress symptoms (PSS) | PSS questionnaire | 5 months |
| Health related Quality of Life | EuroQuol 5D (EQ-5D) | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Centre for Integrative Care | Glasgow | G12 0XP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29699410 | Derived | Simpson R, Simpson S, Wood K, Mercer SW, Mair FS. Using normalisation process theory to understand barriers and facilitators to implementing mindfulness-based stress reduction for people with multiple sclerosis. Chronic Illn. 2019 Dec;15(4):306-318. doi: 10.1177/1742395318769354. Epub 2018 Apr 26. No abstract available. | |
| 28511703 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| waiting list control |
| Other |
|
| Multiple Sclerosis Quality of Life Inventory (MSQLI) | Measure of a) fatigue, b) chronic pain, c) sexual function, d) urinary function, e) bowel function, f) visual impairment, g) cognitive function, h) emotional distress | 5 months |
| Simpson R, Mair FS, Mercer SW. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial. BMC Neurol. 2017 May 16;17(1):94. doi: 10.1186/s12883-017-0880-8. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |