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Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by University Hospital Freiburg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00106275
First received: March 21, 2005
Last updated: January 30, 2006
Last verified: November 2005
  Purpose

Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the main symptoms. There is no commonly accepted efficacious treatment modality. Training in mindfulness-based stress reduction (MBSR) is a structured, 8-week, cognitively and affectively oriented intervention program, and has been shown to produce health benefits in a number of studies.

We plan to conduct a randomized, controlled, clinical study with the aim of testing the efficacy of MBSR for fibromyalgia. Because fibromyalgia is almost exclusively a female disorder, we will limit this investigation to women. 180 female, fibromyalgia patients will be randomized into three groups:

  1. Mindfulness training
  2. Active control
  3. Wait-list control.

The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life (QOL), and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables. This index will be generated from data gathered via an ambulatory psychophysiological monitoring system, which comprises parameters of mobility, sleep quality, and cardiovascular well-being. These and other relevant variables (depression score, general QOL, pain quality, anxiety, mindfulness, compliance, other therapeutic measures) will be assessed at the beginning and end of the training, as well as at 4- and 12-months post-treatment. A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation.


Condition Intervention
Fibromyalgia
Behavioral: Mindfulness Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia: A Three-Armed Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ)
  • Biobehavioral Fibromyalgia Index

Secondary Outcome Measures:
  • Quality of Life (PLC)
  • Pain sensation (SES)
  • Depression (ADS)
  • Anxiety (STAI-G)
  • Quality of sleep (SF-B)
  • Mindfulness (FIM)
  • Concomitant therapies
  • Compliance
  • Autonomic regulation
  • Physical activity measures
  • Sleep related measures

Estimated Enrollment: 180
Study Start Date: November 2003
Estimated Study Completion Date: November 2006
Detailed Description:

Background:

Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the main symptoms. There is no commonly accepted efficacious treatment modality. Training in mindfulness meditation or mindfulness-based stress reduction(MBSR) is based on procedures derived from Buddhist insight meditation and developed into an eight-week structured program by Kabat-Zinn (e.g. 1982, Gen Hosp Psychiat 4:33-47). However, although mindfulness meditation derives from Buddhist practices, the procedures are completely nonesoteric and nonsectarian. In essence, it may be largely characterized in terms of a cognitively and affectively oriented intervention program, and has been shown to produce health benefits in a number of pilot studies, uncontrolled observational studies, and randomized investigations. Promising pilot data are also available for fibromyalgia patients. In a meta-analysis conducted by the PI (principal investigator), clinically important and statistically significant health benefits were found across individuals with a wide range of conditions.

Hypotheses:

  1. A mindfulness-based stress reduction program (MBSR) is effective in improving the quality of life, psychological well-being and diminishing fibromyalgia-related symptoms in chronically ill patients;
  2. the mindfulness component of the MBSR, a spiritual-based method, allows the patient to receive the energy of love which is then transformative; 3) the effects of the mindfulness training will be visible in physiologic measurements including autonomic nervous system activity.

Method and Results:

This is a randomized, controlled, clinical study with the aim of testing the efficacy of an MBSR for fibromyalgia. Because fibromyalgia is almost exclusively a female disorder, the investigation is limited to 180 female, fibromyalgia patients who will be randomized into three groups: Mindfulness training, Active control and Wait-list Control.

The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life, and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables. This index will be generated from data parameters of mobility, sleep quality, and cardiovascular well-being. These and other relevant variables (depression score, general QOL, pain quality, anxiety, mindfulness, compliance, and other therapeutic measures) will be assessed at the beginning and end of the training, as well as at 4- and 12-months post-treatment. A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation.

Anticipated Results:

MBSR will be proven to be a reliable and efficacious treatment for fibromyalgia as reflected in an improvement in patient reported health variables. It is also expected that a better understanding of the autonomic nervous system in the process of generating and maintaining fibromyalgia will be achieved.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand the German language
  • Basic motivation to undergo a MBSR or similar training
  • Motivation to participate in a clinical trial, especially to answer thoroughly the questionnaires
  • Verified diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

  • Life threatening disease
  • Suppressed immune system
  • Participation in other clinical trials
  • Psychological or psychiatric disorders which constrain a normal interaction (assessed in an interview)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106275

Locations
Germany
University Hospital Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Samueli Institute for Information Biology
Investigators
Principal Investigator: Paul Grossman, PhD University Hospital Freiburg
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00106275     History of Changes
Other Study ID Numbers: Fibromyalgia & Mindfulness
Study First Received: March 21, 2005
Last Updated: January 30, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
Fibromyalgia
Meditation
Stress, Psychological
Monitoring, Ambulatory
Electrocardiographie, Ambulatory
Psychophysiology

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 23, 2014