Effects of a meditation program on symptoms of illness in fibromyalgia
| ISRCTN | ISRCTN34628811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34628811 |
| Protocol serial number | N/A |
| Sponsor | University of Louisville Intramural Research Program (USA) |
| Funder | University of Louisville (intramural research grant) - USA |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Pain, sleep, impairment, depressive symptoms and neuroendocrine function |
| Key secondary outcome measure(s) |
Quality of life |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
