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

Fibromyalgia Clinical Trial

Official title:

Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia: A Three-Armed Randomized Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00106275
• Other study ID #: Fibromyalgia & Mindfulness
• Status: Active, not recruiting
• Phase: N/A
• First received: March 21, 2005
• Last updated: January 30, 2006
• Start date: November 2003
• Est. completion date: November 2006

Study information

• Verified date: November 2005
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Mindfulness Based Stress Reduction

Locations

Country	Name	City	State
Germany	University Hospital Freiburg	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Samueli Institute for Information Biology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)
Primary	Biobehavioral Fibromyalgia Index
Secondary	Quality of Life (PLC)
Secondary	Pain sensation (SES)
Secondary	Depression (ADS)
Secondary	Anxiety (STAI-G)
Secondary	Quality of sleep (SF-B)
Secondary	Mindfulness (FIM)
Secondary	Concomitant therapies
Secondary	Compliance
Secondary	Autonomic regulation
Secondary	Physical activity measures
Secondary	Sleep related measures

External Links

•   German Homepage of the Study with background information for patients