Pain and Stress Management for People With Rheumatoid Art... | NCT00088764

Studies
Pain and Stress Management for People With Rheumatoid Arthritis

NCT00088764

Sponsor

Wayne State University

Status

Completed

Last Update Posted

Aug 15, 2013Estimated

Enrollment

280Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

Coping skills training
Written emotional disclosure
Arthritis education
Health behavior writing

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
R01AR049059	U.S. NIH Grant/Contract		View source
1R01AR049059	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2013

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

Feb 2005

Primary Completion Date

Apr 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Aug 4, 2004

First Submission Date that Met QC Criteria

Aug 4, 2004

First Posted Date

Aug 5, 2004Estimated

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

Aug 13, 2013

Last Update Posted Date

Aug 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark A. Lumley, Professor, Wayne State UniversityPrincipal Investigator

Lead Sponsor

Wayne State UniversityOTHER

Collaborators

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure (ED), coping skills training (CST), or a combination of both may benefit people with RA. The purpose of this study is to determine the benefits of ED, CST, or CST and ED together in adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan and Duke University Medical Center in Durham, North Carolina.

Detailed Description

Two self-management strategies hold promise for improving the health of people with RA: ED (writing about stress, RA, and coping options) and CST (learning six pain and stress coping skills). A strategy integrating ED with CST may be more effective than either intervention alone. This study will compare the effectiveness of ED, CST, ED in combination with CST, and control groups in alleviating the symptoms of RA.

This study will last until May 2009. Participants with RA will be randomly assigned to 1 of 4 treatment groups. Each participant will receive 3 writing sessions and 8 training sessions. Group 1 will receive ED writing followed by CST; Group 2 will receive ED writing followed by arthritis education; Group 3 will receive health behavior writing followed by CST; and Group 4 will receive health behavior writing followed by arthritis education.

Participants will be evaluated at baseline and at Months 1, 4, and 12 for pain, physical disability, psychological impairment, and disease activity. In addition, participants will record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood prior to each of the evaluations. Changes in health status over time will be compared among groups.

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

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Education: Either coping skills training or arthritis education interventions	Behavioral: Coping skills training Behavioral: Arthritis education
2	Experimental	Writing: Either emotional disclosure writing or health behavior writing	Behavioral: Written emotional disclosure Behavioral: Health behavior writing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coping skills training	Behavioral	8 sessions of pain and stress coping skills training	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Joint count		one year

Secondary Outcomes

Measure	Description	Time Frame
Psychological impairment		one year
Pain		one year
Physical disability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet American College of Rheumatology (ACR) 1987 criteria for RA

Exclusion Criteria:

Other disorders that would significantly affect function (e.g., lupus, chronic obstructive pulmonary disease [COPD], congestive heart failure [CHF], cancer)
Judged by the physician to have cognitive impairment (dementia, retardation, psychosis) or illiteracy
Has experienced recent (last 6 months) significant stressor resulting in substantial emotional instability
Currently in psychotherapy or a formal behavioral pain management program
Unable to walk. Participants who use walking aids are not excluded.
Physically unable to write

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A. Lumley, PhD	Wayne State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wayne State University		Detroit	Michigan	48202	United States
Duke University Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9237085	Background	Kelley JE, Lumley MA, Leisen JC. Health effects of emotional disclosure in rheumatoid arthritis patients. Health Psychol. 1997 Jul;16(4):331-40. doi: 10.1037//0278-6133.16.4.331.
20535796	Derived	Somers TJ, Shelby RA, Keefe FJ, Godiwala N, Lumley MA, Mosley-Williams A, Rice JR, Caldwell D. Disease severity and domain-specific arthritis self-efficacy: relationships to pain and functioning in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Jun;62(6):848-56. doi: 10.1002/acr.20127.

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