Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study

Not yet recruitingPhase 3MS (type not specified)NCT07742579

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Mindfulness-Based Cognitive Therapy

What it measured

Main measures

  • Depression

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

    Mood and sleep

Other measures (16)

  • 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)

    Fatigue
  • Sleep

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

    Mood and sleep
  • Change in pain

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

    Pain
  • Change in quality of life

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

    Quality of life (reported by participants)
  • Anxiety

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

    Mood and sleep
  • 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)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

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).

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Aug 2026

    2. Main results due

      Nov 2028

    3. Finished

      Dec 2028

    Assembled by software from public sources.