Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis

NCT07666594 | Not Yet Recruiting

• 1 other identifier: IUC-2025-641
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA); Anxiety; Depression Anxiety Disorder; Mobile Health Technology (mHealth)

Keywords

Rheumatoid Arthritis; Yoga; Mobile Health (mHealth); Meditation; Cost Analysis; Psychological Stress

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

• Perceived Stress Scale (PSS-10)

  Baseline (T0), Week 4 (T1), and Week 8 (T2)

• Fatigue Severity Scale (FSS)

  Baseline and Week 8

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline (T0), Week 4 (T1), and Week 8 (T2)

• Rheumatoid Arthritis Quality of Life (RAQOL)

  Baseline (T0), Week 4 (T1), and Week 8 (T2)

• Chronic Illness Self-Management (CISM) Scale

  Baseline (T0) and Week 8 (T2)

Study Arms (2)

Mobile Application Group

EXPERIMENTAL

Participants in this group will receive a personalized 8-week yoga and meditation program via the Meditopia mobile application, in addition to their usual medical care.

Behavioral: Mobile App-Based Yoga and Meditation

Control Group

NO INTERVENTION

Participants in this group will continue their usual medical follow-up and routine care without any structured digital mind-body intervention.

Interventions

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.

Mobile Application Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tugba Civi Karaaslan: lead

Study Sites (1)

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

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Anxiety Disorders; Stress, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Tuğba Çivi Karaaslan, PhD

CONTACT

+902124141500; tugba.civi@iuc.edu.tr

Pedram Shahriyari, PT

CONTACT

+905346838530

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)