Condition category
Musculoskeletal Diseases
Date applied
15/04/2006
Date assigned
22/06/2006
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes