Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 102
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Tugba Civi Karaaslan
Assistant Professor
Istanbul University