Contact information
Type
Scientific
Primary contact
Dr Sandra Sephton
ORCID ID
Contact details
University of Louisville
Department of Psychology
Suite 317
Jouett Hall
Suite 100
2301 South Third Street
Louisville
KY
40292
United States of America
+1 502 852 1166
sephton@louisville.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of a meditation program on symptoms of illness in fibromyalgia
Acronym
Study hypothesis
Participation in a mindfulness-based stress reduction will reduce symptoms of illness in fibromyalgia
Ethics approval
University of Louisville; full ethical approval details not yet received as of 22/06/06
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Fibromyalgia syndrome
Intervention
Mindfulness-based stress reduction (MBSR) versus usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain, sleep, impairment, depressive symptoms and neuroendocrine function
Secondary outcome measures
Quality of life
Overall trial start date
01/01/2000
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
91
Participant exclusion criteria
Active psychosis
Recruitment start date
01/01/2000
Recruitment end date
01/01/2003
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Louisville
Louisville, KY
40292
United States of America
Sponsor information
Organisation
University of Louisville Intramural Research Program (USA)
Sponsor details
University of Louisville
Jouett Hall
Suite 100
2301 South Third Street
Louisville
KY
40202
United States of America
+1 502 852 6512
vpr@louisville.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Louisville (intramural research grant) - USA
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17266067
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25425224
Publication citations
-
Results
Sephton SE, Salmon P, Weissbecker I, Ulmer C, Floyd A, Hoover K, Studts JL, Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: results of a randomized clinical trial., Arthritis Rheum., 2007, 57, 1, 77-85, doi: 10.1002/art.22478.