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

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
Email	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

Sponsor information

University of Louisville Intramural Research Program (USA)
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
Email	vpr@louisville.edu
"ROR"	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