Clinical trial NCT06416176: The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple Sclerosis
Official title: The Effect of a Mindfulness-Based Stress Reduction Program On Fatigue, Self-Efficacy And Stress in Patients With Multiple Sclerosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Mindfulness
Upper Motor Neuron Lesion
Keywords: Mindfulness
Multiple sclerosis
Fatigue
Self-efficacy
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of an mindfulness-based stress reduction (MBSR) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (MS).

Thirty members of the Multiple Sclerosis Society with multiple sclerosis were randomized as experimental and control groups. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Outcome measurements consisted of Fatigue Impact Scale (FIS), Self-Efficacy Scale and Perceived Stress Scale.

Detailed description: The use of mindfulness-based interventions to reduce fatigue in individuals with MS is supported by meta-analytic evidence. A systematic review concluded that mindfulness-based interventions effectively improves the quality of life in MS patients. To characterize the best formatting, mechanisms of action, and outcomes in MS patients with a wider range of social, educational, and clinical backgrounds, more research is necessary.

Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded.

The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Furthermore, the control group received an invitation to participate in an identical MBSR program session following the study's conclusion.

Eligibility criteria: Inclusion Criteria:

* diagnosis of relapsing-remitting MS or progressive MS
* over 18 years of age,
* neurologist confirmed diagnosis of MS,
* a score of less than or equal to 7.0 on the Expanded Disability Status Scale (EDSS).

Exclusion Criteria:

* comorbidities with life-threatening physical or mental health (such as active psychosis, suicidal ideation, or terminal or life-threatening co-occurring medical diseases), or disorders that are predicted to severely restrict participation and adherence (e.g., dementia, pregnancy, ongoing substance abuse);
* individuals who are presently undergoing non-pharmacological psychological treatments or prior formal training in mindfulness

Primary outcomes:
measure: Fatigue Impact Scale
timeFrame: at baseline and at week 8
measure: Self-Efficacy Scale
timeFrame: at baseline and at week 8
measure: Perceived Stress Scale
timeFrame: at baseline and at week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
state: Eyüpsultan
Study officials:
affiliation: Halic University
name: İrem Çetinkaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: