About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Mindfulness-Based Cognitive Therapy
Other interventionOnline group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
Depression
Change in depression scores using the Hospital Anxiety and Depression Scale
Secondary outcomes
Self-efficacy
Self-efficacy, as measured by the Generalized Self-Efficacy Scale
Self-management
Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised
Stigma
Stigma, as measured by the Stigma Scale for Chronic Illness-8
Fatigue
Fatigue as measured by the Modified Fatigue Impact Scale
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Robert Simpson
Lead sponsor
University of Toronto
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: