The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA).
The main questions it aims to answer are:
Does an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical/psychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs?
Researchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention.
Participants in the experimental group will:
Use a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period.
Complete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.
Adults aged between 18 and 65 years.
Diagnosed with Rheumatoid Arthritis (RA) by a rheumatologist.
Disease in a stable phase (remission or low disease activity).
Access to a smartphone or tablet and sufficient proficiency in using mobile applications.
Presence of acute RA flare-ups.
Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).
Severe cognitive impairment or dementia.
Pregnancy.
Parallel
Mobile App-Based Yoga and Meditation
BehavioralThe intervention consists of an 8-week individualized program. It includes yoga sequences selected by a physiotherapist based on the patient's functional capacity and joint mobility. It also includes mindfulness-based and emotion regulation-focused meditation content selected by a clinical psychologist. Participants are expected to practice for 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week.The intervention is delivered through the Meditopia mobile application.
Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Evaluated using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A is a 7-item self-report scale scored from 0 to 21. Higher scores indicate a greater symptom burden of anxiety.
Perceived Stress Scale (PSS-10)
Measured by the Perceived Stress Scale (PSS-10), a 10-item tool (scored 0-40) assessing how unpredictable or uncontrollable patients find their lives.
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item self-report scale used to evaluate the impact of fatigue on daily functioning and social life. Each item is scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items, with a final score ranging from 1 to 7. A higher mean score indicates a greater severity of fatigue and a more significant impact of fatigue on the individual's daily activities.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess sleep quality and disturbances over a one-month time interval. It evaluates seven 'component' scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21. A total global score of greater than 5 is generally used to indicate poor sleep quality. Higher global scores represent poorer sleep quality and more significant sleep disturbances.
Rheumatoid Arthritis Quality of Life (RAQOL)
The Rheumatoid Arthritis Quality of Life (RAQOL) questionnaire is a disease-specific instrument designed to assess the quality of life in patients with rheumatoid arthritis using a needs-based model. It consists of 30 items with a binary response format (Yes/No). Each 'Yes' response is scored as 1, and each 'No' response is scored as 0. The total score ranges from 0 to 30, with higher scores representing a poorer quality of life and a greater negative impact of the disease on the individual's life. The scale focuses on various domains, including mood, social life, hobbies, everyday tasks, and physical contact.
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Tugba Civi Karaaslan
Lead sponsor
Istanbul University
Sponsor institution
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