Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2011-05-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nondrug Treatment Programs for Adults With Fibromyalgia
NCT00088777
Tailored Treatments of Fibromyalgia
NCT00000422
Fibromyalgia: Interventions for Pain and Mood Regulation
NCT02683278
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
NCT00437411
Web-based Education to Enhance Fibromyalgia Management
NCT00423631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
Stress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
Thoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
Brain and Body
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Thoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Brain and Body
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 1990 ACR criteria including tender points
* 2010 ACR modified clinical criteria that does not include tender points
Exclusion Criteria
* Other serious medical conditions that can impair health status independent of FM
* Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
* Alcohol/drug dependence in past 2 years
* Cognitive impairment or dementia
* Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
* Unable to fluently read or converse in English
* Planning to move from the area in the next 14 months
* Judgment of principle investigator as not appropriate for this trial or all intervention arms
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Michigan
OTHER
St. John Providence Hospital
UNKNOWN
Wayne State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mark A. Lumley
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark A Lumley, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
St. John Providence Hospital
Southfield, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.