Rheumatoid ArthritisNCT00869349
Living Well With Rheumatoid Arthritis
A study testing IFS and Education in people with Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- IFS and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active RA symptoms
- Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
- Ability to attend group and individual sessions consistently
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.
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.
Read the detailed 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- IFS, Education
- Keywords
- Rheumatoid Arthritis, IFS, psychosocial, social support
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFSBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| IFS Intervention Group | Experimental | Not described Receives: Behavioral: IFS |
| Education Group | Active comparator | Not described Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 months
Secondary outcomes (2)
Depression
Change in the Beck Depression Scale from baseline to 21-months. The BDI-II (Reference: BDI- II Manual by Aaron T. Beck, Robert A. Steer, and Gregory K. Brown) is a 21-item scale for measuring negative attitudes about the future. Add up each of the items marked in the direction keyed for "hopelessness" to get a total score.
Each of 21 items is summed to give single score for BDI-II.
- There is 4-point scale ranging from 0 - 3. On 2 items (16, 18)
- There are 7 options to indicate either increase or decrease of appetite and sleep. These are still scored 0 - 3 - answers are 0,1a,1b,2a,2b,3a,3b.
- Cut score guidelines for the BDI-II are given with recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II. 0 - 13 minimal 14 - 19 mild 20 - 28 moderate 29 - 63 severe
Measured: 21 months
Self-Compassion
Change in the Neff Self Compassion scale from baseline to 21-months. This is a 26-item scale. The total self-compassion score ranges from 0 (no self-compassion) - 30 (high self-compassion). Reference: Neff, K.D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Nancy Shadick, Brigham and Women's Hospital
- Investigators
- Nancy A Shadick, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869349
- Sponsor's protocol ID
- 2002-P-001762
- Status last verified
- Jan 2017
- First submitted
- 25 Mar 2009
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 7020777Astin 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.
PubMed 12115160Bradley 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.
PubMed 3314877Elenkov 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.
PubMed 12114286Lorig 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.
PubMed 4004977Lundgren 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.
PubMed 10092165O'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.
PubMed 3063517Parker, 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. doi: 10.1002/art.23010.
PubMed 17907231Sharpe 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.
PubMed 11166484Shearn 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.
PubMed 3887910Smyth 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.
PubMed 10208146Warsi 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.
PubMed 12905474Warsi 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.
PubMed 15302634Shadick 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.
PubMed 23950186
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.
- ClinicalTrials.gov ID
- NCT00869349
- Acronym / sponsor ID
- 2002-P-001762
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, IFS, psychosocial, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFS Intervention Group | Experimental | Behavioral: IFS |
| Education Group | Active comparator | Other: Education |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active RA symptoms
- Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
- Ability to attend group and individual sessions consistently
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| IFSThe 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. | Behavioural | IFS Intervention Group |
| EducationThe 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. | Other | Education Group |
Primary outcome
RADAI Disease Activity Score
Time frame: 21 months
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
2 secondary outcomes
Depression
Time frame: 21 months
Self-Compassion
Time frame: 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7020777Achterberg 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.
- Background: PubMed 12115160Astin 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.
- Background: PubMed 3314877Bradley 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.
- Background: PubMed 12114286Elenkov 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.
- Background: PubMed 4004977Lorig 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.
- Background: PubMed 10092165Lundgren 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.
- Background: PubMed 3063517O'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.
- BackgroundParker, J. C., K.L. Smarr, S.P. Bucklew, R.C. Stucky-Ropp, J.E. Hewett (1995).
- Background: PubMed 17907231Pradhan 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.
- Background: PubMed 11166484Sharpe 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.
- Background: PubMed 3887910Shearn 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.
- Background: PubMed 10208146Smyth 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.
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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.
Nancy A Shadick, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IFS and Education in people with Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site 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 3 inclusion and 2 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
RADAI Disease Activity Score (time frame: 21 months). 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 NCT00869349, which also lists 15 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 20 Mar 2017.