Rheumatoid Arthritis (RA)NCT07666594
Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis
A study testing Mobile App-Based Yoga and Meditation in people with Rheumatoid Arthritis (RA) and Anxiety, run by Tugba Civi Karaaslan at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA), Anxiety, Depression Anxiety Disorder
- What is being tested?
- Mobile App-Based Yoga and Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pedram Shahriyari, PT contact
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
Istanbul, Istanbul, 34500
Tuğba Çivi Karaaslan, PhD, +902124141500 ext. 40193, tugba.civi@iuc.edu.tr
About this study
Official title: Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.
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:
Read more
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)
- Being tested
- Mobile App-Based Yoga and Meditation
- Keywords
- Rheumatoid Arthritis, Yoga, Mobile Health (mHealth), Meditation, Cost Analysis, Psychological Stress
- Medical subject headings
- Arthritis, Rheumatoid, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App-Based Yoga and MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2).
Secondary outcomes (12)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
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.
Measured: Baseline and Week 8
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Chronic Illness Self-Management (CISM) Scale
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.
Measured: Baseline (T0) and Week 8 (T2)
Forced Vital Capacity (FVC)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Forced Expiratory Volume in 1 Second (FEV1)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
FEV1/FVC Ratio
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Peak Expiratory Flow (PEF)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Visual Reaction Time (BlazePod)
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.
Measured: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Total Direct Healthcare Costs (Partial Cost Analysis)
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.
Measured: Baseline (T0) and Week 8 (T2)
System Usability Scale (SUS)
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.
Measured: At the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tugba Civi Karaaslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tugba Civi Karaaslan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666594
- Sponsor's protocol ID
- IUC-2025-641
- Status last verified
- Apr 2026
- First submitted
- 15 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07666594
- Acronym / sponsor ID
- IUC-2025-641
- Conditions
- Rheumatoid Arthritis (RA), Anxiety, Depression Anxiety Disorder, Mobile Health Technology (mHealth)
- Keywords
- Rheumatoid Arthritis, Yoga, Mobile Health (mHealth), Meditation, Cost Analysis, Psychological Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Tugba Civi KaraaslanUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Group | Experimental | Behavioral: Mobile App-Based Yoga and MeditationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App-Based Yoga and MeditationThe 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. | Behavioural | Mobile Application Group |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedram Shahriyari, PT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App-Based Yoga and Meditation in people with Rheumatoid Arthritis (RA) and Anxiety, run by Tugba Civi Karaaslan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Çivi Karaaslan, PhD (+902124141500 ext. 40193, tugba.civi@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale - Anxiety (HADS-A) (time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.