Living Well With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00869349
• Other study ID #: 2002-P-001762
• Status: Active, not recruiting
• Phase: N/A
• First received: March 25, 2009
• Last updated: February 4, 2013
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: February 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the Living Well with RA program is to perform a proof-of-concept study and evaluate the efficacy of an Internal Family Systems-based psychotherapeutic intervention improve Rheumatoid Arthritis subjects' disease activity, independence and other health outcomes. This study will also assess the efficacy of an IFS-based program in improving RA subjects' mental health symptoms. We hypothesize that the IFS model will improve RA subjects self-management of their disease and subsequently their health outcomes will improve as well as compared to a group focusing on arthritis education.

Description:

Subjects will be selected from the Brigham & Women's Hospital Arthritis Center and include those enrolled in the BRASS study and then once recruited randomly assigned to either the IFS intervention group or the education group. Both the IFS intervention and education group will participate in their respective programs simultaneously over 9 months.

Subject reported measures:

Incorporated into the questionnaires are several subject-reported measures, including: The Self-Compassion Scale, Beck Depression Index (BDI-II), SF-12 Health Survey, State-Trait Anxiety Inventory (STAI), RA Disease Activity Index (RADAI), and Arthritis Self-Efficacy Scale. These measures report emotional states, degree and location of arthritis pain, and how that pain affects their daily lives. A monthly encounter form will also be completed by the subject.

Physician measures:

The physicians who will be monitoring subject health are blind to the study and complete the same measures for subjects in both the IFS intervention and education groups. They will complete a joint count, Global Assessment of health, duration of morning stiffness and ACR functional status.

Laboratory testing:

Subjects will give blood at the beginning, 3, 6 and 9-month points of the program. This sample will be laboratory-tested for C-reactive protein.

Data collection schedule:

Subjects will complete a questionnaire at baseline, then at 3, 6 and 9 months. They will give blood samples and undergo a routine physical examination, focusing on their joints at the initial meeting, again at 3, 6, and 9 months into the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

Inclusion Criteria:

• Active RA symptoms

• Member of the BRASS registry at the Brigham and Women's Arthritis Clinic

• Ability to attend group and individual sessions consistently

Exclusion Criteria:

• RA has been in remission for one year

• Subjects who are currently enrolled in the Arthritis Foundation Self- Management course or any similar type of course

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• IFS
The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months. Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline.

Other:
• Education
The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (14)

Achterberg J, McGraw P, Lawlis GF. Rheumatoid arthritis: a study of relaxation and temperature biofeedback training as an adjunctive therapy. Biofeedback Self Regul. 1981 Jun;6(2):207-23. — View Citation

Astin JA, Beckner W, Soeken K, Hochberg MC, Berman B. Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2002 Jun 15;47(3):291-302. — View Citation

Bradley LA, Young LD, Anderson KO, Turner RA, Agudelo CA, McDaniel LK, Pisko EJ, Semble EL, Morgan TM. Effects of psychological therapy on pain behavior of rheumatoid arthritis patients. Treatment outcome and six-month followup. Arthritis Rheum. 1987 Oct;30(10):1105-14. — View Citation

Elenkov IJ, Chrousos GP. Stress hormones, proinflammatory and antiinflammatory cytokines, and autoimmunity. Ann N Y Acad Sci. 2002 Jun;966:290-303. Review. — View Citation

Lorig K, Lubeck D, Kraines RG, Seleznick M, Holman HR. Outcomes of self-help education for patients with arthritis. Arthritis Rheum. 1985 Jun;28(6):680-5. — View Citation

Lundgren S, Stenström CH. Muscle relaxation training and quality of life in rheumatoid arthritis. A randomized controlled clinical trial. Scand J Rheumatol. 1999;28(1):47-53. — View Citation

O'Leary A, Shoor S, Lorig K, Holman HR. A cognitive-behavioral treatment for rheumatoid arthritis. Health Psychol. 1988;7(6):527-44. — View Citation

Parker, J. C., K.L. Smarr, S.P. Bucklew, R.C. Stucky-Ropp, J.E. Hewett (1995).

Pradhan EK, Baumgarten M, Langenberg P, Handwerger B, Gilpin AK, Magyari T, Hochberg MC, Berman BM. Effect of Mindfulness-Based Stress Reduction in rheumatoid arthritis patients. Arthritis Rheum. 2007 Oct 15;57(7):1134-42. — View Citation

Sharpe L, Sensky T, Timberlake N, Ryan B, Brewin CR, Allard S. A blind, randomized, controlled trial of cognitive-behavioural intervention for patients with recent onset rheumatoid arthritis: preventing psychological and physical morbidity. Pain. 2001 Jan;89(2-3):275-83. — View Citation

Shearn MA, Fireman BH. Stress management and mutual support groups in rheumatoid arthritis. Am J Med. 1985 May;78(5):771-5. — View Citation

Smyth JM, Stone AA, Hurewitz A, Kaell A. Effects of writing about stressful experiences on symptom reduction in patients with asthma or rheumatoid arthritis: a randomized trial. JAMA. 1999 Apr 14;281(14):1304-9. — View Citation

Warsi A, LaValley MP, Wang PS, Avorn J, Solomon DH. Arthritis self-management education programs: a meta-analysis of the effect on pain and disability. Arthritis Rheum. 2003 Aug;48(8):2207-13. — View Citation

Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004 Aug 9-23;164(15):1641-9. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in health status, RA disease activity, and self-efficacy.	Health status, function and RA disease activity will be documented by the swollen and tender joint count, CRP level and VAS scores. Self-efficacy will be measured with the Arthritis self-efficacy questionnaire.	Baseline,3, 6 and 9 months	No
Secondary	Improvement in depression and anxiety scores as well as self compassion		Baseline, 3, 6 and 9 months	No