At a glance

ClinicalIndex Comparison Record

N/ACompleted· 79 enrolled

Drug / intervention

IFS +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869349

NCT00869349N/ACompleted

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

Brigham and Women's Hospital·interventional·Posted Mar 26, 2009·Updated Mar 20, 2017

In Brief

A clinical study evaluating IFS and Education for Rheumatoid Arthritis. Completed, enrolled 79 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRheumatoid Arthritis

CountriesUnited States

CollaboratorsBristol-Myers Squibb

Timeline

N/ACompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartSep 2008

First PostedMar 2009

Primary CompletionDec 2010

Study CompletionDec 2013

TodayJul 2026

First PostedMar 26, 2009

Enrollment StartSep 1, 2008

Primary CompletionDec 1, 2010

Study CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 17.3 years ago

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.

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.