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

Sponsor
Robert Simpson
Study ID
NCT07742579
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 31, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness-Based Cognitive Therapy
    Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
  • No Intervention: Waitlist control
    Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection

Primary Outcome Measure

Depression [ Time Frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2) ]

Central Contacts

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