NCT00869349

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

March 25, 2009

Results QC Date

January 23, 2014

Last Update Submit

January 31, 2017

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisIFSpsychosocialsocial support

Outcome Measures

Primary Outcomes (1)

  • RADAI Disease Activity Score

    Change in self-assessed disease activity from baseline to 21-months. Total RADAI score is 0-10 with 0 indicating no/low self-assessed disease activity and 10 indicating high self-assessed disease activity. Reference: Stucki G, Liang M, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiological research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 38;795-98,1995

    21 months

Secondary Outcomes (2)

  • Depression

    21 months

  • Self-Compassion

    21 months

Study Arms (2)

IFS Intervention Group

EXPERIMENTAL
Behavioral: IFS

Education Group

ACTIVE COMPARATOR
Other: Education

Interventions

IFSBEHAVIORAL

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.

IFS Intervention Group
EducationOTHER

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.

Education Group

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active RA symptoms
  • Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
  • Ability to attend group and individual sessions consistently

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (15)

  • 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. doi: 10.1007/BF00998870.

    PMID: 7020777BACKGROUND

  • 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. doi: 10.1002/art.10416.

    PMID: 12115160BACKGROUND

  • 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. doi: 10.1002/art.1780301004.

    PMID: 3314877BACKGROUND

  • Elenkov IJ, Chrousos GP. Stress hormones, proinflammatory and antiinflammatory cytokines, and autoimmunity. Ann N Y Acad Sci. 2002 Jun;966:290-303. doi: 10.1111/j.1749-6632.2002.tb04229.x.

    PMID: 12114286BACKGROUND

  • 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. doi: 10.1002/art.1780280612.

    PMID: 4004977BACKGROUND

  • Lundgren S, Stenstrom CH. Muscle relaxation training and quality of life in rheumatoid arthritis. A randomized controlled clinical trial. Scand J Rheumatol. 1999;28(1):47-53. doi: 10.1080/03009749950155788.

    PMID: 10092165BACKGROUND

  • O'Leary A, Shoor S, Lorig K, Holman HR. A cognitive-behavioral treatment for rheumatoid arthritis. Health Psychol. 1988;7(6):527-44. doi: 10.1037//0278-6133.7.6.527.

    PMID: 3063517BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1002/art.23010.

    PMID: 17907231BACKGROUND

  • 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. doi: 10.1016/s0304-3959(00)00379-1.

    PMID: 11166484BACKGROUND

  • Shearn MA, Fireman BH. Stress management and mutual support groups in rheumatoid arthritis. Am J Med. 1985 May;78(5):771-5. doi: 10.1016/0002-9343(85)90282-7.

    PMID: 3887910BACKGROUND

  • 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. doi: 10.1001/jama.281.14.1304.

    PMID: 10208146BACKGROUND

  • 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. doi: 10.1002/art.11210.

    PMID: 12905474BACKGROUND

  • 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. doi: 10.1001/archinte.164.15.1641.

    PMID: 15302634BACKGROUND

  • Shadick NA, Sowell NF, Frits ML, Hoffman SM, Hartz SA, Booth FD, Sweezy M, Rogers PR, Dubin RL, Atkinson JC, Friedman AL, Augusto F, Iannaccone CK, Fossel AH, Quinn G, Cui J, Losina E, Schwartz RC. A randomized controlled trial of an internal family systems-based psychotherapeutic intervention on outcomes in rheumatoid arthritis: a proof-of-concept study. J Rheumatol. 2013 Nov;40(11):1831-41. doi: 10.3899/jrheum.121465. Epub 2013 Aug 15.

    PMID: 23950186DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Limitations and Caveats

Participants declined participation due to long time frame. The attention given to the control group was less intense than the intervention group. There was greater attrition in the intervention group.

Results Point of Contact

Title
Nancy A. Shadick
Organization
Brigham and Women's Hospital
nshadick@partners.org
617-732-5266

Study Officials

  • Nancy A Shadick, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2013

Last Updated

March 20, 2017

Results First Posted

March 20, 2017

Record last verified: 2017-01

Locations

US(1)