Rheumatoid ArthritisPhase 2NCT00071292
Meditation-Based Stress Reduction in Rheumatoid Arthritis
A Phase 2 study testing stress reduction program and meditation in people with Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- stress reduction program and meditation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;
- 18 years of age or older;
- Able to read and write English;
- Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore;
- Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week;
- Stable on rheumatoid medications for at least one month.
Who cannot join
- Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.);
- Active alcoholism or drug dependency;
- Scheduled for major surgery during the study period;
- Enrolled in randomized clinical trial for rheumatoid arthritis during the study period;
- Planning to move out of the area in the next 12 months;
- Unwilling to be enrolled in a control group;
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- Use of assistive device other than a cane;
- Serious health condition(s) that the investigator determines would make it difficult to complete the 6 month study;
- Diagnosis of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine - Kernan Hospital
Baltimore, Maryland, 21207
About this study
Official title: Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis
The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- stress reduction program, meditation
- Keywords
- rheumatoid arthritis, stress reduction, meditation, mindfulness, MBSR, mindfulness-based stress reduction, mind-body skills
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress reduction programBehavioural
meditationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2003 (estimated)
- Study startJul 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Brian Berman, MD, Principal investigator, Director, Center for Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071292
- Sponsor's protocol ID
- P50AT000084
- Other IDs
- Pradhan, Elizabeth
- Status last verified
- Mar 2008
- First submitted
- 17 Oct 2003
- Last updated
- 7 Mar 2008
- Results posted
- No
Publications
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
PubMed 7042457Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
PubMed 3897551Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
PubMed 1609875Miller JJ, Fletcher K, Kabat-Zinn J. Three-year follow-up and clinical implications of a mindfulness meditation-based stress reduction intervention in the treatment of anxiety disorders. Gen Hosp Psychiatry. 1995 May;17(3):192-200. doi: 10.1016/0163-8343(95)00025-m.
PubMed 7649463Kaplan KH, Goldenberg DL, Galvin-Nadeau M. The impact of a meditation-based stress reduction program on fibromyalgia. Gen Hosp Psychiatry. 1993 Sep;15(5):284-9. doi: 10.1016/0163-8343(93)90020-o.
PubMed 8307341
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00071292
- Acronym / sponsor ID
- P50AT000084
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, stress reduction, meditation, mindfulness, MBSR, mindfulness-based stress reduction, mind-body skills
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jul 2003
- Study completion
- Mar 2005
- First posted
- 21 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;
- 18 years of age or older;
- Able to read and write English;
- Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore;
- Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week;
Key exclusion criteria (9 listed)
- Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.);
- Active alcoholism or drug dependency;
- Scheduled for major surgery during the study period;
- Enrolled in randomized clinical trial for rheumatoid arthritis during the study period;
- Planning to move out of the area in the next 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress reduction program | Behavioural | – |
| meditation | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
- Background: PubMed 7042457Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
- Background: PubMed 3897551Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
- Background: PubMed 1609875Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
- Background: PubMed 7649463Miller JJ, Fletcher K, Kabat-Zinn J. Three-year follow-up and clinical implications of a mindfulness meditation-based stress reduction intervention in the treatment of anxiety disorders. Gen Hosp Psychiatry. 1995 May;17(3):192-200. doi: 10.1016/0163-8343(95)00025-m.
- Background: PubMed 8307341Kaplan KH, Goldenberg DL, Galvin-Nadeau M. The impact of a meditation-based stress reduction program on fibromyalgia. Gen Hosp Psychiatry. 1993 Sep;15(5):284-9. doi: 10.1016/0163-8343(93)90020-o.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Berman, MD principal investigator
Director, Center for Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stress reduction program and meditation in people with Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071292, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2008.