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Not yet recruiting NCT07742579

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

Phase III Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Cognitive Therapy.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Depression [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
Secondary outcome measures (12)
  • Self-efficacy [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Self-management [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Stigma [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Fatigue [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Sleep [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Change in pain [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Change in quality of life [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Anxiety [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Mindfulness [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Self-compassion [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Emotion regulation [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Group attendance [Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742579 · 00049655

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗