Rheumatoid ArthritisPhase 2NCT00088764
Pain and Stress Management for People With Rheumatoid Arthritis
A Phase 2 study testing Coping skills training, Written emotional disclosure and Arthritis education in people with Rheumatoid Arthritis, run by Wayne State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Coping skills training, Written emotional disclosure and Arthritis education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2005to Jun 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet American College of Rheumatology (ACR) 1987 criteria for RA
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wayne State University
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27708
About this study
Official title: Disclosure and Skills Training for Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Coping skills training, Written emotional disclosure, Arthritis education, Health behavior writing
- Keywords
- Stress, Coping, Expressive Writing, Self-Efficacy, Disclosure
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping skills trainingBehavioural
8 sessions of pain and stress coping skills training
Written emotional disclosureBehavioural
4 sessions of writing about stress
Arthritis educationBehavioural
8 sessions of learning about rheumatoid arthritis
Health behavior writingBehavioural
4 sessions of writing about various health behaviors
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Education: Either coping skills training or arthritis education interventions Receives: Behavioral: Coping skills training; Behavioral: Arthritis education |
| 2 | Experimental | Writing: Either emotional disclosure writing or health behavior writing Receives: Behavioral: Written emotional disclosure; Behavioral: Health behavior writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint count
Measured: one year
Secondary outcomes (5)
Psychological impairment
Measured: one year
Pain
Measured: one year
Physical disability
Measured: one year
C-reactive protein
Measured: one year
Fatigue
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startFeb 2005
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Factorial
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A. Lumley, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088764
- Sponsor's protocol ID
- NIAMS-122
- Other IDs
- R01AR049059, 1R01AR049059
- Status last verified
- Aug 2013
- First submitted
- 4 Aug 2004
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9237085Somers 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.
PubMed 20535796
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosure and Skills Training for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00088764
- Acronym / sponsor ID
- NIAMS-122
- Conditions
- Rheumatoid Arthritis
- Keywords
- Stress, Coping, Expressive Writing, Self-Efficacy, Disclosure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Aug 2004 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Coping skills training, Behavioral: Arthritis educationEducation: Either coping skills training or arthritis education interventions |
| 2 | Experimental | Behavioral: Written emotional disclosure, Behavioral: Health behavior writingWriting: Either emotional disclosure writing or health behavior writing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet American College of Rheumatology (ACR) 1987 criteria for RA
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Coping skills training8 sessions of pain and stress coping skills training | Behavioural | 1 |
| Written emotional disclosure4 sessions of writing about stress | Behavioural | 2 |
| Arthritis education8 sessions of learning about rheumatoid arthritis | Behavioural | 1 |
| Health behavior writing4 sessions of writing about various health behaviors | Behavioural | 2 |
Primary outcome
Joint count
Time frame: one year
5 secondary outcomes
Psychological impairment
Time frame: one year
Pain
Time frame: one year
Physical disability
Time frame: one year
C-reactive protein
Time frame: one year
Fatigue
Time frame: one year
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 15 Aug 2013.
- Background: PubMed 9237085Kelley 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.
- Derived from this study: PubMed 20535796Somers 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.
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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.
Mark A. Lumley, PhD principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coping skills training, Written emotional disclosure and Arthritis education in people with Rheumatoid Arthritis, run by Wayne State University at 2 sites 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 1 inclusion and 6 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 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Joint count (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088764, which also lists 2 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 15 Aug 2013.