Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, IFS, psychosocial, social support
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.
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.
Interventions
BEHAVIORALIFS
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.
OTHEREducation
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.
Sponsors
Bristol-Myers Squibb
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RADAI Disease Activity Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 21 months | 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 |
| Self-Compassion | 21 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IFS Intervention Group 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. | 39 |
| Education Group 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. | 40 |
| Total | 79 |
Baseline characteristics
| Characteristic | IFS Intervention Group | Total | Education Group |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 13.8 | 58.1 years STANDARD_DEVIATION 12.8 | 58.5 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 73 Participants | 38 Participants |
| Region of Enrollment United States | 39 participants | 79 participants | 40 participants |
| Sex: Female, Male Female | 36 Participants | 71 Participants | 35 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
Primary
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
Time frame: 21 months
Population: Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IFS Intervention Group | RADAI Disease Activity Score | -0.4 units on a scale | Standard Deviation 1.1 |
| Education Group | RADAI Disease Activity Score | 0.1 units on a scale | Standard Deviation 1.2 |
Comparison: Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.p-value: 0.0495% CI: [-1.1, 0]t-test, 2 sided
Secondary
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
Time frame: 21 months
Population: Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IFS Intervention Group | Depression | -2.6 units on a scale | Standard Deviation 4.3 |
| Education Group | Depression | 0.6 units on a scale | Standard Deviation 5.6 |
Comparison: Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.p-value: 0.0195% CI: [-5.6, -0.8]t-test, 2 sided
Secondary
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
Time frame: 21 months
Population: Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IFS Intervention Group | Self-Compassion | 1.8 units on a scale | Standard Deviation 3 |
| Education Group | Self-Compassion | 0 units on a scale | Standard Deviation 2.5 |
Comparison: Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.p-value: 0.0195% CI: [0.5, 3.1]t-test, 2 sided