NCT00088764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

4.2 years

First QC Date

August 4, 2004

Last Update Submit

August 13, 2013

Conditions

Rheumatoid Arthritis

Keywords

StressCopingExpressive WritingSelf-EfficacyDisclosure

Outcome Measures

Primary Outcomes (1)

  • Joint count

    one year

Secondary Outcomes (5)

  • Psychological impairment

    one year

  • Pain

    one year

  • Physical disability

    one year

  • C-reactive protein

    one year

  • Fatigue

    one year

Study Arms (2)

1

EXPERIMENTAL

Education: Either coping skills training or arthritis education interventions

Behavioral: Coping skills trainingBehavioral: Arthritis education

2

EXPERIMENTAL

Writing: Either emotional disclosure writing or health behavior writing

Behavioral: Written emotional disclosureBehavioral: Health behavior writing

Interventions

Coping skills trainingBEHAVIORAL

8 sessions of pain and stress coping skills training

1
Written emotional disclosureBEHAVIORAL

4 sessions of writing about stress

2
Arthritis educationBEHAVIORAL

8 sessions of learning about rheumatoid arthritis

1
Health behavior writingBEHAVIORAL

4 sessions of writing about various health behaviors

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (2)

  • 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.

    PMID: 9237085BACKGROUND

  • 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.

    PMID: 20535796DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mark A. Lumley, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

February 1, 2005

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

US(2)