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IRCT20250713066470N1 IRCT 2025-07-21 Kashan University of Medical Sciences The Effect of Mindfulness-Based Stress Reduction (MBSR) on Anxiety Sensitivity, Perceived Stress, Emotion Dysregulation, and Blood Oxidative and Antioxidative Markers MBSR The Effectiveness of Mindfulness-Based Stress Reduction Therapy on Perceived Stress, Anxiety Sensitivity, Emotion Regulation Difficulties, and Oxidative Stress Factors (Oxidant/Antioxidant) in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2025-09-06 anticipated 30 Complete https://irct.ir/trial/84747 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: participants will be divided into two groups: the experimental group will receive a psychological intervention ( mindfulness based stress reduction) while the control group will not receive any psychological treatment. this designe aims to evaluate the effectiveness of the intervention. N/A chronic obstructive pulmonary disease. Intervention 1: Intervention group: 8-week mindfulness-based stress reduction (MBSR). Intervention 2: Control group: The control group does not receive any intervention or treatment. Yes - There is a plan to make this available What will be shared: Only de-identified summary data related to the primary outcomes (such as scores on perceived stress, anxiety sensitivity, and emotional dysregulation questionnaires) may be made available upon reasonable request. No personal or identifying data will be shared. When: The data will be available starting 6 months after the publication of the results and will be accessible for at least one year, with the possibility that the duration may change depending on future decisions. To whom: Access to the data and study documents will be granted only to qualified researchers who submit a reasonable request and agree to comply with ethical and confidentiality requirements. Conditions: Access to de-identified participant data and study documents will be granted only to qualified researchers upon reasonable request and after signing a data use agreement. Data will be shared solely for the purpose of verifying published results or conducting additional analyses related to the original study objectives. Any other use, such as commercial use or sharing with unauthorized third parties, is prohibited. Researchers must comply with all applicable ethical guidelines and maintain confidentiality. Data access requests will be reviewed by the study’s principal investigator or ethics committee to ensure compliance with these conditions. Where to obtain: Access to data will be provided upon reasonable request via the corresponding author of the published article or the principal investigator at the Kashan University of Medical Sciences. Contact details will be provided in the published paper How to obtain: Applicants must submit a formal written request or email including their full name, institutional affiliation, purpose of data use, and the type of analysis they intend to perform. Requests will be reviewed by the principal investigator, and if approved, the data will be shared within 2 to 4 weeks. Data will only be shared under conditions ensuring confidentiality and limited to the declared purpose of use. Comments:
public Sara Habibi
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715981151 +98 71 3736 9497 habibisara422@gmail.com Kashan University of Medical Sciences scientific Sara
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
Kashan Iran (Islamic Republic of) 8715981151 +98 71 3736 9497 habibisara422@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Having chronic obstructive pulmonary disease based on the diagnosis of the lung specialist Participants aged between 18 to 60 years Having a written informed consent to participate in the study Participants must have no diagnosis of major depressive disorder or any anxiety disorders Participants must have no prior history of receiving psychological interventions ( especially mindfulness-based interventions) by a psychologist or psychiatrist Participants must have no prior diagnosis of arthritis in the medical history Participants must have no history of metabolic disorders, including diabetes or hypertension in their medical history Participants must not use vitamin D,C,E supplements or any other dietary suuplements that influence plasma oxidative and antioxidant factor levels 18 years 60 years Both Participants with absence from more than two treatment sessions Participants who incompletely compllete the questionnaris Use of psychiatric medications Any changes in medication use or treatment during the study Participants will be excluded if they develop an acute or emergency medical condition during the implement of the study J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Other N/A Intervention group: 8-week mindfulness-based stress reduction (MBSR) Control group: The control group does not receive any intervention or treatment THE perceived stress score in the Cohen perceived stress scale. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (after the intervention). Method of measurement: Cohen perceived stress scale. The anxiety sesitivity score in the Floyd anxiety sensitivity scale. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (after the intervention). Method of measurement: Floyd anxiety sensitivity inventory. The emotion dysregulation score in the 16-item Difficulties in Emotion Regulation Scale. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (after the intervention). Method of measurement: The 16-item Difficulties in Emotion Regulation Scale (DERS-16) by Bjureberg. Levels of oxidative and antioxidant blood factors (MDA, TOS, TAC, Thiol groups) measured using diagnostic assy kits. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (after the intervention). Method of measurement: Assy kits for TAC, MDA, TOS, Thiol groups. Kashan University of Medical Sciences Approved 2025-07-03 Kashan University of medical sciences Ethnics Committee Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran Kashan Isfehan Iran (Islamic Republic of)