Stressinsietokyvyn ja mindfulnessin vaikutusten määrittely nivelreumassa (DREAMER)

Kokeellinen: Mindfulness-ohjelma

Mindfulness-ryhmän henkilöt suorittavat 8 viikon mindfulness-kurssin, joka on mukautettu henkilöille, joilla on reumasairauksia (MBSR-RD).

Käyttäytyminen: Mindfulness-ohjelma

Osallistujat saavat kahdeksan viikoittaista 2,5 tunnin ryhmäistuntoa ja yhden päivän mittaisen hiljaisen retriitin verkossa toimitettuna. Interventiosisältöön kuuluvat MBSR-ohjelma, jota on tutkittu laajasti monilla erilaisilla kroonisilla sairauksilla, sekä lisäravinteet henkilöille, joilla on reumasairauksia. Jokainen MBSR-istunto sisältää meditaatioharjoituksia (esim. istumameditaatio, kehon skannaus, lempeä hathajooga, kävelymeditaatio, päivittäisten toimintojen huomioiminen, tietoisuus miellyttävistä ja epämiellyttävistä tapahtumista) ja kotiharjoitusten tarkastelu. Osallistujat suorittavat päivittäisiä kotiharjoituksia noin 45 minuuttia päivässä ja kirjaavat harjoituksensa.

Muut nimet:

• MBSR
• Mindfulness-pohjainen stressin vähentäminen
• MBSR-RD

Ei väliintuloa: Tavallinen hoito (TAU)

TAU-ryhmän henkilöt jatkavat rutiinihoitoa ja heitä pyydetään pidättäytymään osallistumisesta mindfulness-ohjelmiin kokeen aikana.

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.

MBSR-kurssien osallistuminen (interventioon sitoutuminen)

Interventioon sitoutuminen operatiivistetaan niiden osallistujien prosenttiosuutena, jotka satunnaistettiin mindfulness-ryhmään ja osallistuivat vähintään kuuteen kahdeksasta ryhmäistunnosta.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.