Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

Mindfulness Based Stress Reduction in MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419301
• Other study ID #: Teva186557-1
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: November 19, 2014
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Mindfulness based stress reduction (MBSR)
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.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Perceived Stress Scale-10	A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.	Baseline, 1 X between weeks 3-7, Week 8	No
Secondary	Holmes and Rahe Social Readjustment Rating Scale (SRRS	Stressful life events will be rated using the SRRS, which asks subjects to check if they have experienced any of a series of life events. We will use a modification of the scale used in previous MS research that eliminates several items specifically associated with MS disease activity (e.g., "major illness or injury", "sexual difficulties", "pregnancy"). The SRRS differentiates three types of stress: positive ("outstanding personal achievement"), major negative stress (death of family member), conflict and disruption in routine (e.g., family or job conflict, life changes).	Baseline, 1 X between weeks 3-7, Week 8	No
Secondary	Chicago Multiscale Depression Inventory (CMDI)	CMDI is a self-report questionnaire designed specifically for use in MS and other medical patient groups. It has vegetative, mood, and evaluative scales consisting of 14 items each. The use of the CMDI makes it possible to separate out neurovegetative symptoms of depression which are a potential confound in medical populations such as MS	Baseline, 1 X betweeen Weeks 3-7, Week 8	No
Secondary	State Trait Anxiety Inventory (STAI)	The STAI is a widely used measure of state and trait anxiety. We will focus on the measurement of state related anxiety in this study.	Baseline, 1 X betweeen Weeks 3-7, Week 8	No
Secondary	Positive and Negative Affect Scale (PANAS)	; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.	Baseline, 1 X between Weeks 3 - 7, Week 8	No
Secondary	Fatigue Severity Scale (FSS)	The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.	Baseline, 1 X between Weeks 3 - 7, Week 8	No
Secondary	MACFIMS neuropsychological battery	At baseline and study end, an abbreviated version of the MACFIMS will be administered. This is a standard neurocognitive battery used with studies of MS subjects and includes the SDMT, PASAT, SRT, BVMT, and 9-hole peg test.	Baseline and Week 8	No
Secondary	Expanded Disability Status Scale (EDSS)	Expanded Disability Status Scale is the oldest and probably the most widely utilized assessment instruments in MS for determination of neurological impairment in MS. It is the standard for characterization of MS patients and for outcomes of clinical trials. It will be used to characterize patients' level of disability.	Baseline and Week 8	No
Secondary	Physiologic Markers of Stress	DHEA, epinephrine, and norepinephrine.	Baseline and Week 8	No
Secondary	Physiologic Maker of Stress	cortisol	Baseline, 1 X between Week 3 - 7, Weeek 8	No