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

NCT00106275 | Unknown

• 1 other identifier: Fibromyalgia & Mindfulness
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Meditation; Stress, Psychological; Monitoring, Ambulatory; Electrocardiographie, Ambulatory; Psychophysiology

Outcome Measures

Primary Outcomes (2)

• Fibromyalgia Impact Questionnaire (FIQ)

• Biobehavioral Fibromyalgia Index

Secondary Outcomes (11)

• Quality of Life (PLC)

• Pain sensation (SES)

• Depression (ADS)

• Anxiety (STAI-G)

• Quality of sleep (SF-B)

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Life threatening disease
• Suppressed immune system
• Participation in other clinical trials
• Psychological or psychiatric disorders which constrain a normal interaction (assessed in an interview)

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (1)

• Grossman P, Deuring G, Walach H, Schwarzer B, Schmidt S. Mindfulness-Based Intervention Does Not Influence Cardiac Autonomic Control or the Pattern of Physical Activity in Fibromyalgia During Daily Life: An Ambulatory, Multimeasure Randomized Controlled Trial. Clin J Pain. 2017 May;33(5):385-394. doi: 10.1097/AJP.0000000000000420.

  PMID: 27518489 DERIVED

Related Links

• Study Description on the homepage of the funding institute

MeSH Terms

Conditions

Fibromyalgia; Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Paul Grossman, PhD

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2005
• First Posted: March 22, 2005
• Study Start: November 1, 2003
• Study Completion: November 1, 2006
• Last Updated: January 31, 2006

Record last verified: 2005-11

Locations

DE (1)