The impact of mindfulness-based stress reduction, in comparison to exercise on depression symptoms and quality of life in patients with systemic lupus erythematosus

To compare the effect of two interventions, Mindfulness-Based Stress Reduction (MBSR) and exercise therapy, on depression and quality of life in patients with lupus, compared to a control group.

A randomized controlled trial with a parallel three-group design, involving 90 patients (30 per group). Block randomization with a block size of 6 and an allocation ratio of 1:1:1 was performed using SPSS software version 26. The patient follow-up period was 6 months.

This study is being conducted at the Baghaipour Rheumatology Clinic, in Yazd. Eligible patients, after providing informed consent, are randomly assigned to three groups: A (drug therapy + online MBSR), B (drug therapy + home-based exercise), and C (drug therapy alone). Assessments are conducted at baseline, 3 months, and 6 months. Blinding of patients and instructors was not feasible; however, outcome assessors and the statistical analyst were blinded to patient group allocation.

Inclusion Criteria: Age 18-60 years; at least 6 months since lupus diagnosis; education above 9th grade; not pregnant. Exclusion Criteria: Obvious psychiatric disorders; addiction; acute cardiac or pulmonary disease contraindicating physical activity; severe joint involvement; hospitalization or discontinuation of medication in the last 6 months.

Group A (Intervention): Standard lupus drug therapy + 8 sessions of 90-minute online group Mindfulness-Based Stress Reduction (MBSR) over 8 weeks. Group B (Intervention): Standard lupus drug therapy + a combined exercise program (resistance with bands and endurance) for 6 months, 5 sessions per week. Group C (Control): Standard lupus drug therapy alone, with no non-pharmacological intervention.

Depression score, Quality of life score, Disease activity score, Fatigue score

Randomization Process: An independent and impartial statistician, who had no role in the subsequent phases of the study implementation or outcome assessment, generated the random allocation sequence using specialized statistical software (SPSS, version 26). The block design parameters were defined as follows: a block size of 6 and an allocation ratio of 1:1:1 for the three groups: A (Mindfulness-Based Stress Reduction intervention), B (Exercise therapy intervention), and C (Control group). Consequently, within each block of six, the sequence of two participants in Group A, two participants in Group B, and two participants in Group C was determined completely randomly by the software. This blocked random sequence was generated for 90 participants (equivalent to 15 complete blocks of six). Subsequently, the allocation results for each of the 90 sequential sampling positions were recorded on separate sheets, placed inside opaque, sealed envelopes, and numbered consecutively from 1 to 90. All envelopes were stored in a secure location accessible to the principal investigator (who was not involved in outcome assessments). After screening each participant, confirming their eligibility for the study, and obtaining informed consent, a researcher who was unaware of the allocation sequence and had no role in subsequent participant assessments opened the envelope corresponding to the participant's sequential entry number and assigned the individual to one of the three study groups according to the instructions inside the envelope. This process was repeated sequentially for all 90 participants. Due to the non-pharmacological nature of the interventions, blinding of participants and intervention instructors was not feasible. However, the assessors of primary and secondary outcomes (including depression and quality of life questionnaires), as well as the final statistical data analyst, remained blinded to the group allocation of participants until the analysis phase was complete. This method, by employing blocked randomization, ensured optimal balance between the groups throughout the study and, through the use of numbered, sealed envelopes, fully achieved allocation concealment. These two principles, along with the blinding of assessors and the analyst, minimized the risk of selection and measurement biases, thereby strengthening the internal validity of the study results.

All individual participant data collected in this study, including baseline information (age, sex, education level, marital status), clinical data (disease activity based on the SLEDAI index, medication dosages, hospitalization history), questionnaire results (HADS depression scores, WHOQOL-BREF quality of life scores, FSS fatigue scores, GHQ-12 mental health scores, FMI-SF mindfulness scores), and anthropometric data (weight, height, body mass index, body fat percentage, skeletal muscle percentage, visceral fat percentage) will be available for sharing after complete anonymization (removal of identifying information such as name, surname, national ID, and exact address). Data from all measurement time points (baseline, month 3, and month 6) for all three study groups (first intervention, second intervention, and control) will be available for sharing. Additionally, the study protocol, informed consent form, and statistical analysis plan will be available for sharing along with the data.

Access to anonymized study data will begin 6 months after the completion of the study and publication of the primary results and will be available for a period of 1 years. The estimated start date for access is approximately April 2027.

Data and documents from this study will be accessible to all researchers affiliated with academic, research, and scientific institutions (both domestic and international) who have non-profit research purposes and intend to use the data for secondary analyses, meta-analyses, or systematic reviews.

Access to the data is conditional upon approval of the applicant's research proposal by the scientific committee of their affiliated university and signing a confidentiality agreement regarding non-disclosure of patient information. Use of the data for commercial and industrial purposes is not permitted.

Applicants can request access to the data and documents of this study through the following methods, listed in order of priority: First Method: Email (Priority 1) Send requests to the following email address: Email: sarvenaz.nsina@ssu.ac.ir Second Method: Telephone (Priority 2): Phone number: +98 912 278 4177 Third Method: In-person Visit or Postal Correspondence (Priority 3): Postal address: Baghaipour Rheumatology Clinic, adjacent to Shahid Sadoughi Hospital, Ibn Sina Boulevard, Yazd, Iran (Attn: Dr. Ali Dehghan, Supervisor) Postal Code: 8917613145 Responsible Contacts: Dr. Ali Dehghan (Supervisor and Rheumatology Subspecialist) Dr. Sarvenaz Naseri Sina (Rheumatology Fellow and Principal Investigator) Important Note: Requests must be submitted along with the approved research proposal and a confidentiality agreement.

Requests submitted to receive data and documents from this study are processed through four stages. First, the request is received and registered via email, and a confirmation of receipt is sent to the applicant within 72 hours (maximum 1 week). Next, the request, along with the research proposal and confidentiality agreement, is reviewed by the research team for alignment of research objectives and ethical considerations (maximum 2 weeks). Upon initial approval, the request is referred to the Research Ethics Committee of Shahid Sadoughi University of Medical Sciences in Yazd for final review (maximum 3 weeks). Following final approval, the anonymized data is prepared and made available to the applicant via a secure link or email (maximum 2 weeks). The total expected time from request submission to data receipt is approximately 6 to 8 weeks.