Investigating the effects of mindfulness-based stress reduction (MBSR) in groups and online setting on the severity of pemphigus vulgaris disease and treatment compliance in patients with pemphigus vulgaris

Investigating the effects of mindfulness-based stress reduction (MBSR) in groups and online setting on the severity of pemphigus vulgaris disease and treatment compliance in patients with pemphigus vulgaris

This study is a randomized, double-blind, placebo-controlled trial with parallel groups. 26 patients with pemphigus vulgaris are randomly assigned to the intervention or control group using block randomization.

This study is a randomized, double-blind, controlled clinical trial conducted at Imam Reza Hospital, Mashhad. 26 patients with pemphigus vulgaris will be randomly assigned to either the intervention group (receiving online MBSR) or the control group (receiving a 30-minute educational session on the disease). Participants will complete the MMAS and DASS-21 scales before and after the intervention.

Inclusion criteria ؛Diagnosis of pemphigus vulgaris through clinical and cytopathological examination, aged 20-60, at least middle school education, stress score above 8, anxiety score above 15 on Depression, Anxiety, and Stress Scale - 21(DASS-21), no major psychiatric history, and consent to participate. Exclusion criteria :Missing more than two sessions.

In the intervention group, participants will complete an 8-week program, with weekly 90-minute online sessions in groups of five, led by a psychiatry resident trained in Mindfulness-Based Stress Reduction (MBSR) and supervised by an instructor. The control group will receive a 30-minute educational session on pemphigus vulgaris guided by a dermatologist's advice.

Morisky Medication Adherence Scale Score؛ Depression, Anxiety؛ and Stress Scale 21 Score؛

Patients are randomly assigned to two groups: intervention and control. They are randomly allocated (using random blocks) to either the intervention or control group (via the Sealed Envelope website). The assigned codes (A/B) are written separately on pieces of paper, which are folded in a way that prevents the code from being visible (allocation concealment). It is important to note that, with the enrollment of each eligible patient and after obtaining informed consent, one piece of paper is randomly selected, and based on the code inside (A/B), the patient is placed in either the intervention or control group

control group. Randomization is carried out through a randomization system (for example, using the Sealed Envelope website), where the allocations are written as concealed codes (A/B). The allocation codes (A/B) are written on separate pieces of paper, which are then folded and kept concealed from the researchers. These papers are randomly drawn from the envelope by the researchers, and based on the code inside, the patient is assigned to either the intervention or control group. Patients are unaware of which group (intervention or control) they belong to. They only know that they are receiving an intervention or treatment but are not informed of which specific treatment group they are in. Those assessing the outcomes, such as disease severity or treatment compliance, do not know which group the patient belongs to. This ensures that the evaluations are carried out impartially and without any preconceived bias