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

NCT06416176 | Completed

• 1 other identifier: Acetinkaya002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Mindfulness; Upper Motor Neuron Lesion

Keywords

Mindfulness; Multiple sclerosis; Fatigue; Self-efficacy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants in the experimental group received an 8-week MBSR program by an MBSR instructor.

Other: Mindfulness-Based Stress Reduction (MBSR) Program

Control group

NO INTERVENTION

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.

Interventions

Mindfulness-Based Stress Reduction (MBSR) Program OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Halic University

Istanbul, Eyüpsultan, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• İrem Çetinkaya, PhD

  Halic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 15, 2020
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)