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Not yet recruiting NCT07666594

Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis

No phase Interventional Rheumatoid Arthritis (RA) Anxiety Depression Anxiety Disorder Mobile Health Technology (mHealth)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile App-Based Yoga and Meditation.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA), Anxiety, Depression Anxiety Disorder, Mobile Health Technology (mHealth). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Mobile App-Based Yoga and Meditation
    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 applicatio

Primary outcome measures

  • Hospital Anxiety and Depression Scale - Anxiety (HADS-A) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2).]
Secondary outcome measures (12)
  • Perceived Stress Scale (PSS-10) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Fatigue Severity Scale (FSS) [Time frame: Baseline and Week 8]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Rheumatoid Arthritis Quality of Life (RAQOL) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Chronic Illness Self-Management (CISM) Scale [Time frame: Baseline (T0) and Week 8 (T2)]
  • Forced Vital Capacity (FVC) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • FEV1/FVC Ratio [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Peak Expiratory Flow (PEF) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Visual Reaction Time (BlazePod) [Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Total Direct Healthcare Costs (Partial Cost Analysis) [Time frame: Baseline (T0) and Week 8 (T2)]
  • System Usability Scale (SUS) [Time frame: At the end of the 8-week intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Med — Istanbul

Identifiers

NCT: NCT07666594 · IUC-2025-641

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗