Effects of a meditation program on symptoms of illness in fibromyalgia
| ISRCTN | ISRCTN34628811 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34628811 | 
| Secondary identifying numbers | N/A | 
- Submission date
 - 15/04/2006
 - Registration date
 - 22/06/2006
 - Last edited
 - 17/12/2014
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Musculoskeletal Diseases
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Sandra Sephton
Scientific
                                        Scientific
                                                University of Louisville
Department of Psychology
Suite 317
Jouett Hall
Suite 100
2301 South Third Street
Louisville, KY
40292
United States of America
                                                
| Phone | +1 502 852 1166 | 
|---|---|
| sephton@louisville.edu | 
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Treatment | 
| Scientific title | Effects of a meditation program on symptoms of illness in fibromyalgia | 
| Study objectives | Participation in a mindfulness-based stress reduction will reduce symptoms of illness in fibromyalgia | 
| Ethics approval(s) | University of Louisville; full ethical approval details not yet received as of 22/06/06 | 
| Health condition(s) or problem(s) studied | Fibromyalgia syndrome | 
| Intervention | Mindfulness-based stress reduction (MBSR) versus usual care | 
| Intervention type | Other | 
| Primary outcome measure | Pain, sleep, impairment, depressive symptoms and neuroendocrine function | 
| Secondary outcome measures | Quality of life | 
| Overall study start date | 01/01/2000 | 
| Completion date | 01/01/2003 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Adult | 
| Lower age limit | 18 Years | 
| Sex | Female | 
| Target number of participants | 91 | 
| Key inclusion criteria | 1. Over age 18 2. Confirmed American College of Radiology (ACR) diagnosis of fibromyalgia 3. Available to participate in a weekly group program for eight weeks  | 
| Key exclusion criteria | Active psychosis | 
| Date of first enrolment | 01/01/2000 | 
| Date of final enrolment | 01/01/2003 | 
Locations
Countries of recruitment
- United States of America
 
Study participating centre
                                            University of Louisville
                                        
                                        
                                            
                                            Louisville, KY
40292
United States of America
                                    40292
United States of America
Sponsor information
                                            University of Louisville Intramural Research Program (USA)
University/education
                                        University/education
                                                University of Louisville
Jouett Hall
Suite 100
2301 South Third Street
Louisville, KY
40202
United States of America
                                                
| Phone | +1 502 852 6512 | 
|---|---|
| vpr@louisville.edu | |
| https://ror.org/01ckdn478 | 
Funders
Funder type
University/education
                                                University of Louisville (intramural research grant) - USA
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan | 
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? | 
|---|---|---|---|---|---|
| Results article | results | 15/02/2007 | Yes | No | |
| Results article | results | 01/06/2015 | Yes | No |