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NCT Number: NCT07666594

Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

Istanbul, 34500, Turkey (Türkiye)

Location contact

Tuğba Çivi Karaaslan, PhD

CONTACT

[email protected]

+902124141500 ext. 40193

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Cognitive sufficiency to provide written and verbal informed consent in Turkish.

Exclusion criteria

  • Presence of acute RA flare-ups.
  • Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).
  • Severe cognitive impairment or dementia.
  • Pregnancy.
  • Regular practice of meditation or mindfulness within the last 6 months.
  • Participation in any other stress management program within the last 3 months.
  • Receipt of mental health services within the last 6 months.

Treatment and study plan

Mobile App-Based Yoga and Meditation

Behavioral

The 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.

Primary outcomes

  1. Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2).

    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.

Secondary outcomes

  1. Perceived Stress Scale (PSS-10)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    Measured by the Perceived Stress Scale (PSS-10), a 10-item tool (scored 0-40) assessing how unpredictable or uncontrollable patients find their lives.

  2. Fatigue Severity Scale (FSS)

    Time frame: Baseline and Week 8

    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.

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    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.

  4. Rheumatoid Arthritis Quality of Life (RAQOL)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    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.

  5. Chronic Illness Self-Management (CISM) Scale

    Time frame: Baseline (T0) and Week 8 (T2)

    The Chronic Illness Self-Management (CISM) scale is a 23-item tool designed to assess the self-management behaviors and perceptions of individuals living with chronic conditions. It consists of four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Healthcare Effectiveness (5 items), and Treatment Adherence (6 items). Each item is evaluated based on the patient's experience, providing a comprehensive measure of how well the individual manages the challenges associated with their illness. Higher scores in specific domains indicate better self-management capabilities and adaptation to the chronic condition.

  6. Forced Vital Capacity (FVC)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    Quantitative measurement of respiratory function will be performed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. FVC (expressed in Liters) will be recorded in a seated position to assess the presence and severity of extra-articular pulmonary involvement. The best of at least three acceptable maneuvers will be used for analysis.

  7. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. FEV1 measures the volume of air exhaled in the first second of the forceful exhalation.

  8. FEV1/FVC Ratio

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    The ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity, calculated from the spirometry maneuver to assess obstructive or restrictive pulmonary patterns.

  9. Peak Expiratory Flow (PEF)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. PEF measures the maximum speed of expiration.

  10. Visual Reaction Time (BlazePod)

    Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)

    Visual reaction time will be measured using the BlazePod device, a portable visual-cognitive technology designed to assess response speed to light stimuli. Simple and selective reaction time tasks will be performed where participants respond by touching or tapping the pod when it illuminates. To ensure reliability, each participant will complete multiple trials (typically 5-10), and the average reaction time in milliseconds will be calculated after excluding outliers. The testing procedure will be standardized regarding lighting conditions, distance, and participant positioning. This measurement serves as a neurocognitive performance indicator to evaluate the systemic and cognitive effects of the intervention.

  11. Total Direct Healthcare Costs (Partial Cost Analysis)

    Time frame: Baseline (T0) and Week 8 (T2)

    A partial cost analysis will be conducted from a healthcare system perspective to evaluate the short-term economic impact of the digital intervention. Data on healthcare resource utilization-including the number of planned or unplanned rheumatology/internal medicine outpatient visits, emergency room admissions, and the number and duration of hospitalizations-will be collected retrospectively for the 8-week period using a structured 'Healthcare Utilization Questionnaire'. To calculate the total direct medical cost per patient, these frequency data will be multiplied by official unit costs derived from the current Social Security Institution (SGK) Health Implementation Communiqué (SUT) tariffs and supported by relevant cost-of-illness literature in Turkey. This analysis aims to provide preliminary empirical evidence on the cost-effectiveness of integrating mobile mind-body interventions into the routine management of Rheumatoid Arthritis.

  12. System Usability Scale (SUS)

    Time frame: At the end of the 8-week intervention

    The System Usability Scale will be administered only to participants in the intervention group to evaluate the usability, ease of use, and overall acceptability of the digital system used during the intervention. The SUS is a validated 10-item questionnaire scored on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating better perceived usability and user satisfaction with the system.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedram Shahriyari, PT

CONTACT

+905346838530

Tuğba Çivi Karaaslan, PhD

CONTACT

[email protected]

+902124141500 ext. 40193

Sponsors and collaborators

Lead sponsor

Tugba Civi Karaaslan

Other

Registry information

Official study title

Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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