Comparing the effects of mindfulness interventions based on stress reduction and cognitive behavioral therapy on emotional self-regulation, sleep quality, and self-efficacy in women with type 2 diabetes

Comparing the effects of mindfulness interventions based on stress reduction and cognitive behavioral therapy on emotional self-regulation, sleep quality, and self-efficacy in women with type 2 diabetes

sample size is 15 people in each group They will be selected by purposive sampling and randomly assigned by lottery without replacement to two experimental groups, experimental group 1 (cognitive behavioral therapy) (15 people), experimental group 2 (mindfulness-based stress reduction) (15 people), and a control group (15 people).

The present study is a quasi-experimental study with a pretest-posttest design with a control group. First, through a call and medical records, eligible individuals were identified based on the inclusion criteria (female, age 40 to 60 years, confirmed type 2 diabetes, minimum educational qualification of a high school diploma). Interventions in each group are implemented by a trained researcher during 8 90-minute weekly sessions. The study used a single-blind design.The location of the study is Semnan city.

The inclusion criteria 1. Female gender 2. Diagnosis of type 2 diabetes based on expert opinion 3. Age range between 40 and 60 years. 4. Having at least a high school diploma. The exclusion criteria 1. Not undergoing other treatment at the same time 2. Not taking psychiatric medications 3. Missing more than two treatment sessions

Experimental group 1: receiving cognitive behavioral therapy (CBT) Experimental group 2: receiving mindfulness-based stress reduction (MBSR) Control group: no intervention.

In this study, the main outcomes include: Improvement of emotional self-regulation،Increase in sleep quality،f self-efficacy

In experimental research, the minimum sample size is 15 people in each group (Delaware, 2009). In this regard, G power software was used to obtain the sample size, which is estimated to be 45 people, considering the effect size of 0.1 (Ashworm and Rankel, 2006, Lin, 2011), alpha of 0.05, and statistical power of 0.8. They will be selected by purposive sampling and randomly assigned by lottery without replacement to two experimental groups, experimental group 1 (cognitive behavioral therapy) (15 people), experimental group 2 (mindfulness-based stress reduction) (15 people), and a control group (15 people). Training sessions will be conducted by a researcher who has completed mindfulness-based stress reduction and cognitive behavioral courses and has received the necessary training to provide the intervention.

To reduce bias due to participants' awareness of their assigned group, the study was designed as a single-blind study, in which participants were unaware of the ultimate goal of the study and the type of intervention they would receive (cognitive-behavioral therapy or mindfulness-based stress reduction). To this end, participants were only informed that they were participating in one of the diabetes-related interventions, without being told which specific intervention they would receive. Also, the information provided in the introductory session was designed to avoid obvious differences between the intervention groups and to reduce participants' subjective expectations regarding the effects of the intervention.

The findings of this study, titled "Comparison of the Effectiveness of Mindfulness-Based Stress Reduction and Cognitive Behavioral Interventions on Emotion Regulation, Sleep Quality, and Self-Efficacy in Women with Type 2 Diabetes", will be published as a peer-reviewed research article in a reputable scientific journal indexed in Scopus or PubMed. Additionally, the summarized results will be included in the final thesis report submitted to the Iranian Research Institute for Information Science and Technology (IranDoc) and will be available through the university library. Upon acceptance of the article, the DOI and publication link will be provided in future updates. A summary of the results will also be shared with the study participants upon request.

Since the implementation of the study is scheduled between late April and June 2025 (Farvardin to Khordad 1404), the data and related documents will be available after the completion of statistical analysis and report writing, starting from August 2025 (Mordad 1404). The summarized results will be published as part of a scientific article and master’s thesis. Upon request, anonymized data may be shared for research purposes.

Access to the data and documents of this study will be limited to the research team, including the principal investigator, academic supervisor, and scientific advisors. In case of a formal request and approval by the ethics committee, anonymized data may be shared with qualified researchers for scientific purposes. Public access to summary results will be provided through the publication of a scientific article.

The data and documents of this study are intended to be used solely for scientific and research purposes. Their use should aim to advance knowledge in the field of psychological interventions for patients with type 2 diabetes and must not be used for commercial or personal purposes. Access will be granted only under the following conditions: a formal written request, approval by a relevant ethics committee, and strict adherence to participant confidentiality and data anonymization. Any use of the data must include appropriate citation of the original study.

o request access to the data and documents of this study, an official request should be submitted to the responsible investigator. Contact information is as follows: Name:Zahra Mirhaj Academic Title: Student of Psychology Affiliation: Semnan Islamic Azad University Email:noormirhajz@gmail.com

Any request for access to the data or documents of this study must be made through a formal written request submitted to the principal investigator or academic supervisor. The request should include the applicant’s identity, institutional affiliation, purpose of use, type of data requested, and confidentiality protection measures. Upon receipt, the following process will be followed: Verification of the applicant’s academic background and institutional affiliation Evaluation of the request’s alignment with ethical standards and scientific objectives Final approval by the principal investigator and, if necessary, the university’s ethics committee If approved, the requested data will be provided in an anonymized and limited format, suitable for scientific use. Any use of the data must respect participant confidentiality and include proper citation of the original study.