Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 152
- Primary Endpoint
- Depression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Outcomes
Primary Outcomes
Depression
Time Frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in depression scores using the Hospital Anxiety and Depression Scale
Secondary Outcomes
- Self-efficacy(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Self-management(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Stigma(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Fatigue(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Sleep(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Change in pain(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Change in quality of life(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Anxiety(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Mindfulness(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Self-compassion(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Emotion regulation(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Group attendance(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Group climate(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Therapeutic alliance(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Depressive symptoms(Baseline (T0), immediately post MBCT (T1), and 3 months later (T2))
- Implementation(Throughout the study and up to 12 months post-intervention)
Investigators
Robert Simpson
Associate Professor
University of Toronto