The Effect of Mindfulness on Body Shame and Self-Stigma in patients with type 1 Diabetes referred to the Healthcare Centers of Kerman University of Medical Sciences

To determine the effect of Mindfulness on Body Shame and Self-Stigma in patients with type 1 Diabetes referred to the Healthcare Centers of Kerman University of Medical Sciences

This study is a single-blind, randomized controlled clinical trial with two groups (intervention and control), comprising 40 participants in each group. Simple randomization was performed using Open Epi software.

This study will be conducted at the healthcare centers affiliated with Kerman University of Medical Sciences, specifically the Besat and Afzali-Pour subspecialty clinics. Study outcomes will be assessed at two time points: baseline (before the intervention) and immediately after the intervention in both the intervention and control groups.

The study’s inclusion criteria comprised patients aged 16–20 years with a definitive Type 1 diabetes diagnosis confirmed at least 6 months prior to enrollment, a score >17 on the Body Image Shame Scale, and a score >21 on the Diabetes Self-Stigma Scale; conversely, the exclusion criteria included the presence of severe psychiatric disorders or suicidal ideation, a history of substance abuse, or chronic comorbidities—excluding hypertension—that might interfere with diabetes management, such as cystic fibrosis or renal and liver diseases.

Intervention Group: “The intervention group will receive an 8-week modified MBSR program (90–120 min weekly sessions) focusing on mindfulness practices and stress-coping concepts.” Control Group: “The control group will receive treatment-as-usual only, receiving no additional psychological or educational interventions. Contact will be restricted to essential administrative tasks.”

Mindfulness, Body Shame, Self-Stigma

In this study, the researcher will visit the healthcare centers of Kerman University of Medical Sciences to recruit eligible individuals. Eligible patients will be selected via convenience sampling. To allocate participants to the control and intervention groups, stratified randomization based on gender will be employed. Participants will first be stratified by gender (male and female), and then within each stratum, they will be randomly assigned to either the control or intervention group using a simple randomization method with a 1:1 allocation ratio. The randomization sequence will be generated using Open Epi software. To ensure allocation concealment, the randomization list will be held by an individual independent of the research team. Allocation for each participant will be assigned by contacting this person, ensuring that the researcher remains blinded to the group assignment until the patient is officially enrolled in the study

Due to the educational nature of the intervention, blinding of participants and the researcher is not feasible. However, since the scoring is self-reported by the patients, the potential for researcher bias in the results is minimized. Furthermore, to control for bias during the data analysis phase, the data will be analyzed by an independent statistician who is blinded to group assignments. Data for both the intervention and control groups will be entered into SPSS and labeled as ‘Group 1’ and ‘Group 2.’ The analyst will remain unaware of which group corresponds to the intervention and which to the control throughout the analysis process.