Multiple Sclerosis
Conditions
Keywords
mindfulness, Mindfulness-Based Cognitive Therapy
Brief summary
This study will use a waiting list randomized controlled trial design with a mixed-methods research approach, including both quantitative and qualitative methods. Randomization helps minimize research bias and controls for participant and contextual factors that might otherwise make interpretation of results challenging. We will recruit 152 people with multiple sclerosis (PwMS) with any type of MS, who also have mild-moderate depression, aged 18 or greater, and able to understand spoken and written English. For the quantitative part, we will examine how much change in depression there is following mindfulness-based cognitive therapy (MBCT), as well as whether participants attend the course and complete study measures or not, and how much participants complete MBCT home practices. We will also examine how much change there is in fatigue, sleep pain, quality of life, and anxiety. For the qualitative part of the study, we will use semi-structured interviews to explore participant experiences of online MBCT, how people used online MBCT, what worked, what didn't and why, how online MBCT impacted self-management of depression, and suggestions for improving the course to make it more relevant for PwMS with depression.
Interventions
OTHERMindfulness-Based Cognitive Therapy
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
Sponsors
Robert Simpson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
will include: * Age \>/=18 * Neurologist confirmed MS diagnosis (McDonald criteria) * Able to understand spoken and written English * A score of 14-28 on the Beck Depression Inventory-II signifying mild-moderate depression * Registered with a primary care provider (family physician or neurologist) * Residing in Canada
Exclusion criteria
will include: * Potentially life-threatening comorbidities (suicidal ideation (i.e., score of 2 or 3 on the BDI-Fast Screen suicidal ideation question), history of psychosis, terminal/life threatening inter-current illness), or those such conditions expected to significantly limit participation and adherence (pregnancy, cognitive impairment i.e. score \<26 on the Montreal Cognitive Assessment - MoCA) * Receipt of MBCT in the past 2 years (completed at least 4/8 sessions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Change in depression scores using the Hospital Anxiety and Depression Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Self-efficacy, as measured by the Generalized Self-Efficacy Scale |
| Self-management | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised |
| Stigma | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Stigma, as measured by the Stigma Scale for Chronic Illness-8 |
| Fatigue | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Fatigue as measured by the Modified Fatigue Impact Scale |
| Sleep | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Sleep as measured by the Insomnia Severity Index |
| Change in pain | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Pain as measured by the Pain Effects Scale |
| Change in quality of life | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Quality of life as measured by the Multiple Sclerosis Impact Scale-29 |
| Anxiety | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety |
| Mindfulness | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Mindfulness as measured by The Five-facet Mindfulness Questionnaire |
| Self-compassion | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Self-compassion, measured using the The Self-Compassion Scale-short form |
| Emotion regulation | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Emotion regulation, as measured by The Difficulties with Emotional Regulation Scale short-form |
| Group attendance | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Group attendance in those allocated to tailored online MBCT |
| Group climate | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Group climate using the Climate Questionnaire-Engage Scale |
| Therapeutic alliance | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Therapeutic alliance as measured by the Working Alliance Inventory |
| Depressive symptoms | Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) | Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II) |
| Implementation | Throughout the study and up to 12 months post-intervention | Implementation, as informed by the Proctor's taxonomy |
Contacts
CONTACTRobert Simpson
Outcome results
None listed