Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
NCT ID: NCT00762125
Last Updated: 2014-12-02
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
266 participants
INTERVENTIONAL
2005-12-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Although there is no cure, FMS can be treated to reduce the severity or presence of symptoms. One of the most reliable ways to do this is through progressive exercise, which involves starting at low levels of exercise and building up to longer and more strenuous levels. Despite the benefit of exercise, FSM sufferers often drop out of supervised exercise programs or discontinue exercise once they are no longer supervised. Some FMS patients may have a fear-based avoidance of exercise, believing it will provoke pain or deterioration of their condition and experiencing significant negative emotional arousal when they exercise. This may be due to a prior painful or uncomfortable experience while exercising.
This study will employ multiple treatments that are usually used for treatment of phobias and will aim to reduce fear, increase exercising, and improve FMS symptoms. Under the purview of cognitive behavioral therapy (CBT) are multiple types of treatments. Cognitive restructuring (CR) and coping skills training (ST) paired together address maladaptive beliefs and facilitate the development of more effective coping strategies. Exposure therapy (ET) reduces the level of emotional arousal when patients are exposed to the feared stimulus, in this case exercising. Attention control (AC) treatment, not a type of CBT, provides patients with support and controls for nonspecific factors related to exposure to their feared stimulus. AC will be used as the control treatment in this study.
Participation in this study will last 4 months. After recruitment and an initial evaluation, participants will be placed on a waiting list for 8 weeks to determine whether their symptoms improve or change naturally. They will then be reassessed and randomly assigned to one of the following groups for 8 weeks of treatment:
1. CR+ST: This group will help participants develop adaptive ways of thinking and acting to alter maladaptive beliefs in general and beliefs about certain exercises in specific.
2. ET: This group will help participants to decrease their fear response during specific exercises through progressive, controlled exposure to the feared stimulus.
3. COMB: This group will combine CR+ST and ET treatment plans so that adaptive thoughts and behaviors will be emphasized in the first 4 weeks, and exposure to feared stimuli will be emphasized in the second 4 weeks.
4. AC: This group will offer participants non-directive, supportive counseling. Each treatment group will meet in weekly 90-minute group sessions for the first 4 weeks and in weekly 60-minute individual sessions for the second 4 weeks. Participants will have 60-minute physical therapy sessions accompanying every treatment session. Participants will also be given weekly homework assignments specific to their treatment group.
Participants will undergo a series of assessments that include self-report measures, medical and psychological evaluations, and a physical capability evaluation by a physical trainer. These assessments will be performed at recruitment, after the 8-week waiting period, after treatment, at 1- and 3-month mail and telephone follow-ups, and at a 6-month follow-up in the treatment clinic. They will assess fear, health, physical ability, and psychological health.
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.
Cognitive restructuring and coping skills training (CR+ST)
CR+ST
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
Exposure therapy (ET)
ET
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Combination (COMB) treatment
CR+ST
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
ET
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Attention control (AC) treatment
AC treatment
Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CR+ST
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
ET
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
AC treatment
Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to comply with functional assessment and treadmill exercise
Exclusion Criteria
* Evidence of severe psychiatric disorder that would prevent participation
* Medical conditions, such as significant cardiac disease, that make it medically unsuitable for participation in a progressive exercise program
* A medical condition, such as multiple sclerosis, that has a high likelihood of obscuring effects of the experimental treatments
* Anxiety or mood disorders in which symptoms are severe enough to prevent participation
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dennis Turk
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dennis C. Turk, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.