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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06416176
• Other study ID #: Acetinkaya002
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: May 2024
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Halic University	Istanbul	Eyüpsultan

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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