Meditation-Based Stress Reduction in Rheumatoid Arthritis | NCT00071292

Studies
Meditation-Based Stress Reduction in Rheumatoid Arthritis

NCT00071292

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Mar 7, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

stress reduction program
meditation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Pradhan, Elizabeth

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005

First Submitted Date

Oct 17, 2003

First Submission Date that Met QC Criteria

Oct 20, 2003

First Posted Date

Oct 21, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2008

Last Update Posted Date

Mar 7, 2008Estimated

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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.

Exclusion criteria:

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;
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Berman, MD	Director, Center for Integrative Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland School of Medicine - Kernan Hospital		Baltimore	Maryland	21207	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7042457	Background	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.
3897551	Background	Kabat-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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Name	Type	Description	Arm Group Labels	Other Names
stress reduction program	Behavioral
meditation	Behavioral