Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Simpson

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-Based Cognitive Therapy

    Other intervention

    Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Cognitive TherapyExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

Fatigue

Fatigue as measured by the Modified Fatigue Impact Scale

Time frame
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Simpson

Lead sponsor

University of Toronto

Sponsor institution

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