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Mindful or mind-full? An eight-week program on mental health and quality of life in people with multiple sclerosis

Mindfulness program for improving mental health and quality of life in people with multiple sclerosis: a pilot, randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001922268
Enrollment
100
Registered
2018-11-26
Start date
2019-01-14
Completion date
2019-06-03
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this pilot is to improve understanding of acceptability and benefits of an online and a face-to-face mindfulness-based cognitive therapy (MBCT) program for people with MS, and to generate preliminary data to inform the development of a larger multi-centre, randomised controlled trial (RCT) in order to promote wellness and quality of life of people with MS. This study aims to: 1) evaluate acceptability of an online and a face-to-face MBCT program against a yoga intervention, its overall effect on mental health and quality of life, and enablers and barriers to incorporating the mindfulness practice at home sustainably; 2) assess if there is improvement in mental health and quality of life in participants from baseline and immediately after the an online or a face-to-face MBCT program or against a yoga intervention and over a six-month follow-up after the program; and 3) evaluate economic data on the cost-effectiveness of the online and face-to-face MBCT program against the yoga intervention.

Interventions

Arm 1: Mindfulness-based cognitive therapy (face to face, 8x2hour sessions, once/week for 8 weeks, at MSWA office, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice) Arm 2: Mindfulness-based cognitive therapy (online, 8x2hour sessions, once/week for 8 weeks, at participants' home or their preferred place, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice) Arm 3: yoga (face to face, 8x2hours sessions, once/week for 8 weeks,

Arm 1: Mindfulness-based cognitive therapy (face to face, 8x2hour sessions, once/week for 8 weeks, at MSWA office, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice) Arm 2: Mindfulness-based cognitive therapy (online, 8x2hour sessions, once/week for 8 weeks, at participants' home or their preferred place, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice) Arm 3: yoga (face to face, 8x2hours sessions, once/week for 8 weeks, at Yoga Space studio, delivered by trained yoga teacher trainee, plus a daily 20 minute home practice) Arm 4: wait-list control group (receive yoga after 8 weeks, face to face, 8x2hours sessions, once/week for 8 weeks, at Yoga Space studio, delivered by trained yoga teacher trainee, plus a daily 20 minute home practice) The MBCT intervention includes cognitive therapy and mindfulness practice. Each of the weekly session involves learning to disengage and detach from habitual ruminative thoughts and action, being aware of the warning signs, choosing an action (instead of the habitual destructive thoughts and actions) when encountering potential stressors and maintaining mindful practices in daily routines. Participants will also have a handbook. Depending on the level of commitment the participants could commit to at the screening phase, a brief MBCT (maximum 75-90 minutes per session) might be provided instead of the full MBCT program to allow people with MS but are time-poor to participate. The brief MBCT program is based on the same model and content, but shortened and valid. It also allows people without formal diagnosis of depression to participate, which is likely to be more inclusive of most people with MS. The yoga will be similar to a stretching yoga (Hatha yoga) adaptable for wheelchair-bound participants (if any). The trained MBCT clinical psychologist will record attendance at each session. Adherence to home practice will be recorded at each four-week interval for the six-month follow-up by asking intervention participants to note in their diaries “On average, how many minutes per day and days per week did you practise active mindfulness every week, such as in the form of body scan, mindful movement or breath meditation?”, “Which practice did you use?”, “What obstacles have you experienced while trying to practise?,”, “What insights did you gain while practising (if any)?”, “Comment on overall benefit of practice since the last time".

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

people who are aged greater than or equal to 18 years, with a diagnosis of multiple sclerosis, not currently using psychotropic drugs or undergoing psychological treatment, able to speak and understand English, and have internet access

Exclusion criteria

Potential participants who score greater than or equal to 14, 10, or 17 for depression, anxiety and stress (respectively) on the Depression, Anxiety and Stress Scale (DASS-21) are in the extremely severe category and will not be invited to participate in this pilot study but will be advised to visit their doctor.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026