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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011768 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:
Participants will:
Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.
Participants will complete an initial eligibility screening, and if they are eligible, they will meet with a study staff member to review study procedures and answer any questions they might have about participating. If they would like to participate following this meeting, they will provide written consent and be enrolled in the study. Following enrollment, participants will complete an in-person study visit that will last up to one hour and include a brief joint exam, blood draw, and questionnaires. After this study visit, they will be randomly assigned to "treatment-as-usual" (TAU) or the mindfulness group. If assigned to the mindfulness group, they will participate in an 8-week online mindfulness course and online focus group following the course. All participants will complete a final in-person study visit at the end of the study, which will mimic the procedures of the first study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Program | Experimental | Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). |
|
| Treatment as Usual (TAU) | No Intervention | Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Program | Behavioral | Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study | A modified version of the 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to evaluate acceptability of the mindfulness program by patients in the treatment group. A few of the words in the original CSQ-8 were changed to make the questions relevant to the mindfulness program. Scores on the CSQ-8 range from 8-32, with higher scores indicating greater satisfaction. Scores ≥ 24 indicate adequate satisfaction. We are reporting the number and percentage of MBSR-RD participants with CSQ-8 scores ≥ 24, consistent with adequate satisfaction. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MBSR Course Attendance (Intervention Adherence) | Intervention adherence will be operationalized as the percentage of participants who were randomized to the mindfulness group and attended at least six of the eight group sessions. | 8 weeks |
| Percent of Study Completers (Study Retention) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Disease Activity Index (CDAI) Pre-Post Change From Baseline to 8 Weeks | The Clinical Disease Activity Index (CDAI) is a validated measure of Rheumatoid Arthritis (RA) disease activity recommended by the American College of Rheumatology. It sums the 28 swollen joint count (SJC; 0-28), 28 tender joint count (TJC; 0-28), patient global assessment (PGA; 0-10), and provider global assessment (PrGA; 0-10) via: SJC + TJC + PGA + PrGA. For all individual components and the total 0-76 score, higher values indicate worse disease. Thresholds are: Remission (< 2.8), Low (<=10), Moderate (10-22), and High (> 22) Disease Activity. It is used in RA clinical trials and recommended for use in routine rheumatologic care. This assessment serves as an exploratory outcome in the current trial, as the study is not powered to test efficacy. The outcome reported for this variable is the change in CDAI score from baseline to post-intervention at 8 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L Patterson, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osher Center for Integrative Health | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-based Stress Reduction for Rheumatic Diseases (MBSR-RD) | Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). Mindfulness Program: Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice. |
| FG001 | Treatment as Usual (TAU) | Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants were randomized to the MBSR-RD and TAU arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-based Stress Reduction for Rheumatic Diseases (MBSR-RD) | Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). Mindfulness Program: Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All participants were randomized to the MBSR-RD and TAU arms. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study | A modified version of the 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to evaluate acceptability of the mindfulness program by patients in the treatment group. A few of the words in the original CSQ-8 were changed to make the questions relevant to the mindfulness program. Scores on the CSQ-8 range from 8-32, with higher scores indicating greater satisfaction. Scores ≥ 24 indicate adequate satisfaction. We are reporting the number and percentage of MBSR-RD participants with CSQ-8 scores ≥ 24, consistent with adequate satisfaction. | This questionnaire asked about participants' experience of the MBSR-RD course, and thus it was administered to participants enrolled in the MBSR-RD course. One participant randomized to the MBSR-RD arm was found to be inappropriate for the course by the course instructor after randomization and before the start of the course due to a poorly controlled mental health illness and thus did not enroll in the MBSR-RD course or complete surveys about course experiences. | Posted | Count of Participants | Participants | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Stress Reduction for Rheumatic Diseases (MBSR-RD) | Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). Mindfulness Program: Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Patterson | University of California, San Francisco | (415) 769-0377 | sarah.patterson@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2024 | Apr 29, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2024 | Dec 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D012216 | Rheumatic Diseases |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system.
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Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition.
|
|
Study retention will be operationalized as the number of participants who completed assessments (questionnaires and physician disease activity assessments) at the follow-up time-point divided by the number of participants who enrolled in the study, multiplied by 100. |
| 8 weeks |
| change from baseline to 8 weeks |
| DAS28-ESR Pre-Post Change From Baseline to 8 Weeks | The Disease Activity Score 28-joint Count (DAS-28) is a validated measure of Rheumatoid Arthritis (RA) disease activity frequently used in pharmaceutical trials. The Erythrocyte Sedimentation Rate (ESR) is a blood test measuring how quickly red blood cells sink in a tube; higher rates indicate more inflammation. The DAS-28 incorporates the 28 tender joint count (TJC; 0-28), 28 swollen joint count (SJC; 0-28), ESR, and patient global assessment (PGA; 0-10). It is calculated via: 0.56* √ (TJC28) + 0.28* √ (SJC28) + 0.70*ln (ESR) + 0.014* (PGA). For all components and the total 0-9.4 score, higher values indicate worse disease activity. Thresholds are: Remission (< 2.6), Low (2.6 to <= 3.2), Moderate (> 3.2 to <= 5.1), and High (> 5.1) Disease Activity. The reported outcome is the change in DAS-28 score from baseline to 8 weeks. This is an exploratory outcome as the study is not powered to assess whether MBSR-RD is effective for improving clinical outcomes. | change from baseline to 8 weeks |
| Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) Pre-Post Change From Baseline to 8 Weeks | The Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) is a validated patient-reported assessment of RA disease activity that comprises five questions on a Likert scale from 0 to 10. A higher score on the scale of 0-10 indicates worse disease activity. Remission is defined as less than 1.5, Low Disease Activity is between 1.6 and 3.0, Moderate Disease Activity is between 3.2 and 5.4, and High Disease Activity is a score greater than 5.6. We used a modified version of the Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) in which the period of recall is 2 weeks instead of 6 months. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in RADAI-5 score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities. The scores are converted to T-scores (mean = 50, SD = 10), with higher scores indicating worse pain interference. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is considered mild pain interference, 60 to 70 is considered moderate pain interference, and above 70 is considered severe pain interference. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Pain Interference T-score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale measures the experience of fatigue and associated impact on daily life. This scale is converted to a T-score (mean = 50, SD = 10), with higher scores indicating worse fatigue. A T-score less than or equal to 55 is considered within normal limits, between 55 to 60 is considered mild fatigue, 60 to 70 is considered moderate fatigue, and above 70 is considered severe fatigue. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Fatigue T-score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Mindfulness scale measures the capacity for present moment awareness. This is an exploratory outcome measure that will be used in future larger trials to determine whether mindfulness mediates improvements in clinical outcomes such as pain among participants in the active treatment group. We are reporting raw scores rather than T-scores for this PROMIS measure as the PROMIS Assessment Center has not yet released the scoring algorithms required for conversion to T-scores. The range for raw scores is 13-65, with higher scores indicating higher levels of mindfulness. The reported outcome is the change in PROMIS Mindfulness score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Perceived Stress Scale, 10-item Pre-Post Change From Baseline to 8 Weeks | Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress. The reported outcome is the change in Perceived Stress Scale score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Brief Resilience Scale Pre-Post Change From Baseline to 8 Weeks | The Brief Resilience Scale measures the perceived ability to bounce back or recover from psychological stress. The scale is scored from 1-5, where a higher score reflects a higher level of resilience to stress. This is an exploratory outcome measure and will be used to determine whether stress resilience mediates improvements in clinical outcomes such as pain among participants in the active treatment group. The reported outcome is the change in the Brief Resilience Scale score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8-item Scale Pre-Post Change From Baseline to 8 Weeks | Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8-item short form, a validated self-report measure of sleep quality and sleep-related difficulties over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse sleep disturbance. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild sleep disturbance, 60 to 70 is described as moderate sleep disturbance, and above 70 is described as severe sleep disturbance. The reported outcome is the change in PROMIS Sleep Disturbance T-score from baseline to 8 weeks. | change from baseline to 8 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression, 8-item Scale Pre-Post Change From Baseline to 8 Weeks | Depressive symptoms will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form, a validated self-report measure assessing depressive symptoms over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse depressive symptoms. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild depression, 60 to 70 is described as moderate depression, and above 70 is described as severe depression. The reported outcome is the change in PROMIS Depression T-score from baseline to 8 weeks. | change from baseline to 8 weeks |
| BG001 | Treatment as Usual (TAU) | Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Marital Status | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Education (highest level completed) | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Annual household income | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Employment status | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Rheumatoid factor positive | This is a biologic measure of the presence of antibodies against rheumatoid factor (RF). These antibodies are associated with a diagnosis of rheumatoid arthritis and while they are not required for the diagnosis, they confer prognostic information, including increased risk of extra-articular disease. | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants | No |
|
| Anti-CCP positive | This is a biologic measure of the presence of antibodies against cyclic citrullinated peptide (CCP). Though CCP positivity has low sensitivity for a diagnosis of RA, it is highly specific. CCP positivity also confers clinical prognostic value, including increased risk of extra-articular disease. | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants | No |
|
| Clinical Disease Activity Index (CDAI) | The Clinical Disease Activity Index (CDAI) is a validated measure of Rheumatoid Arthritis (RA) disease activity recommended by the American College of Rheumatology. It sums the 28 swollen joint count (SJC; 0-28), 28 tender joint count (TJC; 0-28), patient global assessment (PGA; 0-10), and provider global assessment (PrGA; 0-10) via: SJC + TJC + PGA + PrGA. For all individual components and the total score from 0-76, higher values indicate worse disease. Thresholds are Remission (< 2.8), Low (<=10), Moderate (10-22), and High (> 22) Disease Activity. It is used in clinical trials and practice. | All participants were randomized to the MBSR-RD and TAU arms. | Mean | Standard Deviation | score on a scale |
|
| Smoked >= 100 Cigarettes in Lifetime | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Current cigarette smoker | All participants were randomized to the MBSR-RD and TAU arms. | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Mindfulness-based Stress Reduction for Rheumatic Diseases (MBSR-RD) | Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). Mindfulness Program: Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice. |
| OG001 | Treatment as Usual (TAU) | Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial. |
|
|
| Secondary | MBSR Course Attendance (Intervention Adherence) | Intervention adherence will be operationalized as the percentage of participants who were randomized to the mindfulness group and attended at least six of the eight group sessions. | All participants randomized to MBSR-RD arm. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Percent of Study Completers (Study Retention) | Study retention will be operationalized as the number of participants who completed assessments (questionnaires and physician disease activity assessments) at the follow-up time-point divided by the number of participants who enrolled in the study, multiplied by 100. | All participants were randomized to the MBSR-RD or TAU arms. The total number of participants in the MBSR-RD arm who completed both final follow-up questionnaire assessments and in-person assessments was 18 as one participant completed the final questionnaires but did not return for the final in-person study visit. Study completion was 100% (38/38) for remote data collection and 97.4% (37/38) for in-person data collection. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Pre-Post Change From Baseline to 8 Weeks | The Clinical Disease Activity Index (CDAI) is a validated measure of Rheumatoid Arthritis (RA) disease activity recommended by the American College of Rheumatology. It sums the 28 swollen joint count (SJC; 0-28), 28 tender joint count (TJC; 0-28), patient global assessment (PGA; 0-10), and provider global assessment (PrGA; 0-10) via: SJC + TJC + PGA + PrGA. For all individual components and the total 0-76 score, higher values indicate worse disease. Thresholds are: Remission (< 2.8), Low (<=10), Moderate (10-22), and High (> 22) Disease Activity. It is used in RA clinical trials and recommended for use in routine rheumatologic care. This assessment serves as an exploratory outcome in the current trial, as the study is not powered to test efficacy. The outcome reported for this variable is the change in CDAI score from baseline to post-intervention at 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | Score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | DAS28-ESR Pre-Post Change From Baseline to 8 Weeks | The Disease Activity Score 28-joint Count (DAS-28) is a validated measure of Rheumatoid Arthritis (RA) disease activity frequently used in pharmaceutical trials. The Erythrocyte Sedimentation Rate (ESR) is a blood test measuring how quickly red blood cells sink in a tube; higher rates indicate more inflammation. The DAS-28 incorporates the 28 tender joint count (TJC; 0-28), 28 swollen joint count (SJC; 0-28), ESR, and patient global assessment (PGA; 0-10). It is calculated via: 0.56* √ (TJC28) + 0.28* √ (SJC28) + 0.70*ln (ESR) + 0.014* (PGA). For all components and the total 0-9.4 score, higher values indicate worse disease activity. Thresholds are: Remission (< 2.6), Low (2.6 to <= 3.2), Moderate (> 3.2 to <= 5.1), and High (> 5.1) Disease Activity. The reported outcome is the change in DAS-28 score from baseline to 8 weeks. This is an exploratory outcome as the study is not powered to assess whether MBSR-RD is effective for improving clinical outcomes. | DAS28-ESR requires laboratory data. Laboratory assessments were implemented during the second of two waves of the study, thus DAS28-ESR is available on the 18 people randomized to the second wave. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) Pre-Post Change From Baseline to 8 Weeks | The Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) is a validated patient-reported assessment of RA disease activity that comprises five questions on a Likert scale from 0 to 10. A higher score on the scale of 0-10 indicates worse disease activity. Remission is defined as less than 1.5, Low Disease Activity is between 1.6 and 3.0, Moderate Disease Activity is between 3.2 and 5.4, and High Disease Activity is a score greater than 5.6. We used a modified version of the Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) in which the period of recall is 2 weeks instead of 6 months. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in RADAI-5 score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities. The scores are converted to T-scores (mean = 50, SD = 10), with higher scores indicating worse pain interference. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is considered mild pain interference, 60 to 70 is considered moderate pain interference, and above 70 is considered severe pain interference. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Pain Interference T-score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | T-score | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale measures the experience of fatigue and associated impact on daily life. This scale is converted to a T-score (mean = 50, SD = 10), with higher scores indicating worse fatigue. A T-score less than or equal to 55 is considered within normal limits, between 55 to 60 is considered mild fatigue, 60 to 70 is considered moderate fatigue, and above 70 is considered severe fatigue. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Fatigue T-score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | T-score | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale Pre-Post Change From Baseline to 8 Weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Mindfulness scale measures the capacity for present moment awareness. This is an exploratory outcome measure that will be used in future larger trials to determine whether mindfulness mediates improvements in clinical outcomes such as pain among participants in the active treatment group. We are reporting raw scores rather than T-scores for this PROMIS measure as the PROMIS Assessment Center has not yet released the scoring algorithms required for conversion to T-scores. The range for raw scores is 13-65, with higher scores indicating higher levels of mindfulness. The reported outcome is the change in PROMIS Mindfulness score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Perceived Stress Scale, 10-item Pre-Post Change From Baseline to 8 Weeks | Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress. The reported outcome is the change in Perceived Stress Scale score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Brief Resilience Scale Pre-Post Change From Baseline to 8 Weeks | The Brief Resilience Scale measures the perceived ability to bounce back or recover from psychological stress. The scale is scored from 1-5, where a higher score reflects a higher level of resilience to stress. This is an exploratory outcome measure and will be used to determine whether stress resilience mediates improvements in clinical outcomes such as pain among participants in the active treatment group. The reported outcome is the change in the Brief Resilience Scale score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8-item Scale Pre-Post Change From Baseline to 8 Weeks | Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8-item short form, a validated self-report measure of sleep quality and sleep-related difficulties over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse sleep disturbance. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild sleep disturbance, 60 to 70 is described as moderate sleep disturbance, and above 70 is described as severe sleep disturbance. The reported outcome is the change in PROMIS Sleep Disturbance T-score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | T-score | change from baseline to 8 weeks |
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| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Depression, 8-item Scale Pre-Post Change From Baseline to 8 Weeks | Depressive symptoms will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form, a validated self-report measure assessing depressive symptoms over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse depressive symptoms. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild depression, 60 to 70 is described as moderate depression, and above 70 is described as severe depression. The reported outcome is the change in PROMIS Depression T-score from baseline to 8 weeks. | All participants were randomized to the MBSR-RD and TAU arms. | Posted | Mean | 95% Confidence Interval | T-score | change from baseline to 8 weeks |
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|
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Treatment as Usual (TAU) | Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial. | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |