Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

NCT01419301 | Completed

• 1 other identifier: Teva186557-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study. Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; glatiramer acetate; stress reduction; medication adherence

Outcome Measures

Primary Outcomes (1)

• Electronic measure of needle disposals (MEMS TrackCaps)

  During the six-week MSBR program, medication adherence will be monitored with a widely used electronic measure of needle disposals (MEMS TrackCaps) This method has been demonstrated to be more accurate in MS than data obtained from either self-report or interview. At one month intervals the patient will bring the needle container to the Study Coordinator. All patients who attend at least introduction session and one telephone session will be included in the analysis.

  Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.

Secondary Outcomes (10)

• Perceived Stress Scale-10

  Baseline, 1 X between weeks 3-7, Week 8

• Holmes and Rahe Social Readjustment Rating Scale (SRRS

  Baseline, 1 X between weeks 3-7, Week 8

• Chicago Multiscale Depression Inventory (CMDI)

  Baseline, 1 X betweeen Weeks 3-7, Week 8

• State Trait Anxiety Inventory (STAI)

  Baseline, 1 X betweeen Weeks 3-7, Week 8

• Positive and Negative Affect Scale (PANAS)

  Baseline, 1 X between Weeks 3 - 7, Week 8

Interventions

Mindfulness based stress reduction (MBSR) BEHAVIORAL

Mindfulness based stress reduction (MBSR) is program based on daily meditation practice that guides an individual towards increased awareness and self-regulation of thoughts and actions. MBSR is easier to implement and may be shown to be more effective than cognitive-behavioral stress reduction, and is more applicable to patients with chronic illness.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
• Patients on GA therapy for at least 6 months
• Age 18 - 70

You may not qualify if:

• Unwilling to comply with study procedures
• Use of other DMT in conjunction with GA
• Unable to provide informed consent.
• Current (past 30 days) substance abuse
• Newly initiated (past 30 days) psychiatry treatment
• Enrolled in another program of meditation in the past six months.

Sponsors & Collaborators

• Stony Brook University: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11786-8121, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Medication Adherence

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; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lauren B Krupp, M.D.

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: August 18, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

US (1)