The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple Sclerosis

The Effect of a Mindfulness-Based Stress Reduction Program On Fatigue, Self-Efficacy And Stress in Patients With Multiple Sclerosis: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Mindfulness; Upper Motor Neuron Lesion
• Intervention / Treatment: Other: Mindfulness-Based Stress Reduction (MBSR) Program

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyüpsultan
    • Istanbul, Eyüpsultan, Turkey, 34060
      • Halic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants in the experimental group received an 8-week MBSR program by an MBSR instructor.	Other: Mindfulness-Based Stress Reduction (MBSR) Program; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Impact Scale	It is a multidimensional fatigue scale that is frequently used in clinical and experimental investigations to assess the impact of fatigue on the body, mind, and social interactions.	at baseline and at week 8
Self-Efficacy Scale	The scale, which does not belong to any subjective domain, measures the general perception of self-efficacy.	at baseline and at week 8
Perceived Stress Scale	The scale was developed by Cohen et al in 1983 . Consisting of 14 items in total, Perceived Stress Scale is designed to measure how stressful a person's life is perceived by certain situations.	at baseline and at week 8

Collaborators and Investigators

• Sponsor: Halic University
• Investigators: Principal Investigator: İrem Çetinkaya, PhD, Halic University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): November 15, 2020

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Fatigue; Mindfulness; Self-efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Acetinkaya002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No