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IRCT20250519065797N1 IRCT 2025-06-25 Islamic Azad University 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 WD 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 2025-05-30 anticipated 30 Complete https://irct.ir/trial/83865 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Women with Type 2 Diabetes experiencing difficulties in emotional regulation, sleep quality, and psychological self-efficacy. 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.. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Zahra mirhaj
Unit 72, First Floor, Phoenix Tower, Imam Ali Square, Semnan
Semnan Iran (Islamic Republic of) ۳۵۱۹۷۷۳۰۵۳ +98 935 276 4613 noormirhajz@gmail.com Islamic Azad University scientific Zahra mirhaj
Unit 72, First Floor, Phoenix Tower, Imam Ali Square, Semnan
Semnan Iran (Islamic Republic of) ۳۵۱۹۷۷۳۰۵۳ +98 935 276 4613 noormirhajz@gmail.com Islamic Azad University Iran (Islamic Republic of) Diagnosis of type 2 diabetes based on expert opinion Age range between 40 and 60 years. Having at least a high school diploma 40 years 60 years Female Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar I disorder, or major depressive disorder with suicidal ideation) Ongoing or recent participation (within the past 3 months) in structured psychological interventions, including CBT or mindfulness-based therapies Concurrent enrollment in another interventional clinical study Presence of severe chronic medical conditions (e.g., end-stage renal disease, active cancer, or serious cardiovascular disease) Lack of informed consent or unwillingness to voluntarily participate in the study E11 Type 2 diabetes mellitus Treatment - Other 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. Emotional self-regulation is considered the primary outcome variable of this study. It refers to the individual’s ability to identify, control, and manage their emotions effectively and adaptively. This variable will be measured using validated psychometric questionnaires. The main goal of the study is to assess changes in emotional self-regulation levels following mindfulness-based stress reduction and cognitive-behavioral therapy interventions. Timepoint: Baseline (Pre-intervention):Farvardin 1404 (April 2025)Post-intervention: First week of Khordad 1404 (May 2025). Method of measurement: The emotional self-regulation variable will be measured using the Emotion Regulation Questionnaire (ERQ) developed by Gross & John. This tool includes 10 items assessing two emotional regulation strategies: cognitive reappraisal and expressive suppression. Participants respond using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree."The ERQ has demonstrated good validity and reliability in both international and local studies. Total scores indicate the degree of use of emotion regulation strategies. Data will be collected at two time points (pre-test, post-test) and analyzed. Sleep Quality. Timepoint: Baseline (Pre-intervention):Farvardin 1404 (April 2025)Post-intervention: First week of Khordad 1404 (May 2025). Method of measurement: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This standardized self-report instrument includes 19 items that measure seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.The PSQI has demonstrated high validity and reliability in both international and Iranian studies. Data will be collected at two time points: pre-test, post-test, and follow-up. Self efficacy. Timepoint: Baseline (Pre-intervention):Farvardin 1404 (April 2025)Post-intervention: First week of Khordad 1404 (May 2025). Method of measurement: Self-efficacy will be assessed using the General Self-Efficacy Scale (GSE) developed by Sherer and Maddux. This scale includes 10 items designed to evaluate an individual's belief in their ability to cope with a variety of demanding situations. Responses are rated on a 4-point Likert scale ranging from “Not at all true” to “Exactly true.”The GSE is one of the most widely used and validated instruments for measuring general self-efficacy and has demonstrated strong reliability and validity in both international and Iranian studies. The total score indicates the individual’s perceived self-efficacy level. This variable will be measured at two time points: pre-test, post test. Me Approved 2025-03-12 Ethics Committee of Semnan Azad University of Medical Sciences Unit 72, First Floor, Phoenix Tower, Imam Ali Square, Semnan Semnan Semnan Iran (Islamic Republic of)