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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
152
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
Depression
Change in depression scores using the Hospital Anxiety and Depression Scale
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-efficacy
Self-efficacy, as measured by the Generalized Self-Efficacy Scale
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-management
Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Stigma
Stigma, as measured by the Stigma Scale for Chronic Illness-8
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Fatigue
Fatigue as measured by the Modified Fatigue Impact Scale
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Sleep
Sleep as measured by the Insomnia Severity Index
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in pain
Pain as measured by the Pain Effects Scale
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in quality of life
Quality of life as measured by the Multiple Sclerosis Impact Scale-29
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Anxiety
Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Mindfulness
Mindfulness as measured by The Five-facet Mindfulness Questionnaire
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-compassion
Self-compassion, measured using the The Self-Compassion Scale-short form
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Emotion regulation
Emotion regulation, as measured by The Difficulties with Emotional Regulation Scale short-form
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group attendance
Group attendance in those allocated to tailored online MBCT
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group climate
Group climate using the Climate Questionnaire-Engage Scale
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Therapeutic alliance
Therapeutic alliance as measured by the Working Alliance Inventory
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Depressive symptoms
Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II)
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Implementation
Implementation, as informed by the Proctor's taxonomy
Time frame: Throughout the study and up to 12 months post-intervention
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