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)
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General information
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chainging the sampling location
chainging the sampling location
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تغییر مکان نمونه گیری
تغییر مکان نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Shahid beheshti hospital and other medical centers affiliated with Kashan university of medical scie
Name of recruitment center - Persian: بیمارستان شهید بهشتی و سایر مراکز درمانی وابسته به دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Sara Habibi
Full name of responsible person - Persian: سارا حبیبی
Street address - English: Kashan, Ghotbe ravandi, Hekmat 55 street, Shahid Helli Boulevard, Kashsn university of medical science
Street address - Persian: کاشان، قطب راوندی، خیابان حکمت 55، بولوار شهید هلی دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715981151
Phone: +98 71 3736 9497
Fax:
Email: habibisara422@gmail.com
Web page address:
Name of recruitment center - English: Shahid Motahari Clinic in Shiraz
Name of recruitment center - Persian: درمانگاه شهید مطهری واقع در شهر شیراز
Full name of responsible person - English: Sara Habibi
Full name of responsible person - Persian: سارا حبیبی
Street address - English: Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
Street address - Persian: ایران، استان اصفهان، شهر کاشان، بولوار قطب راوندی، خیابان حکمت 56، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715981151
Phone: +98 71 3736 9497
Fax:
Email: habibisara422@gmail.com
Web page address:
Name of recruitment center - English: Shahid beheshti hospital and other medical centers affiliated with Kashan university of medical scieMotahari Clinic in Shiraz Name of recruitment center - Persian: بیمارستاندرمانگاه شهید بهشتی و سایر مراکز درمانی وابسته به دانشگاه علوم پزشکی کاشانمطهری واقع در شهر شیراز Full name of responsible person - English: Sara Habibi Full name of responsible person - Persian: سارا حبیبی Street address - English: Kashan, Ghotbe ravandi University of Medical Sciences, Hekmat 55 street56 Street, Shahid HelliQotb Ravandi Boulevard, Kashsn university of medical scienceKashan, Isfahan Province, Iran Street address - Persian: ایران، استان اصفهان، شهر کاشان، بولوار قطب راوندی، خیابان حکمت 5556، بولوار شهید هلی دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715981151 Phone: +98 71 3736 9497 Fax: Email: habibisara422@gmail.com Web page address:
Protocol summary
Study aim
To assess the effectiveness of Mindfulness-Based Stress Reduction (MBSR) on anxiety sensitivity, perceived stress, emotion dysregulation and plasma oxidative and antioxidative biomarkers
Design
The sample includes 30 eligible participants, non-randomly assigned to intervention and control groups based on smoking status, then matched for age, gender, and other variables.
Settings and conduct
Participants are recruited using convenience sampling. Assignment to groups is based on smoking status. Both groups are assessed,Then the intervention group receives 8 weekly MBSR sessions; while the control group does not. After treatment both groups are assessed and compared againe.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. confirmed diagnosis of COPD by a pulmonologist.
2. Age between 18 to 60 years. 3.Providing written informed consent .
4. No current major depressive or anxiety disorders. 5. No history of psychological treatment within the past year. 6. No history of arthritis in the medical history.
7. No history of metabolic disorders 8. Not using supplements that affect oxidative and antioxidative fbiomaekers.
Exclusion Criteria: 1. Missing more than two MBSR session.
2. Incomplete questionnaires. 3. Use of psychiatric medications. 4. Changes in medication or treatment during the study. 5 Occurrence of acute or emergency medical conditions during the the study, especially during MBSR sessions.
Intervention groups
Participants in the intervention group will attend 8 weekly 90-minute srssions of MBSR coductted by a licensed psychologist. And participants in the control group will not receive any psychological intervention.
Main outcome variables
reduction in anxiety sensitivity, perceived stress, emotion regulation, oxidative/antioxidative biomarkers and to determine the overral effectiveness of MBSR as a therapeutic approach
General information
Reason for update
chainging the sampling location
Acronym
MBSR
IRCT registration information
IRCT registration number:IRCT20250713066470N1
Registration date:2025-07-21, 1404/04/30
Registration timing:prospective
Last update:2025-12-25, 1404/10/04
Update count:1
Registration date
2025-07-21, 1404/04/30
Registrant information
Name
Sara Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3637 9497
Email address
habibisara422@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
The Effect of Mindfulness-Based Stress Reduction (MBSR) on Anxiety Sensitivity, Perceived Stress, Emotion Dysregulation, and Blood Oxidative and Antioxidative Markers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of medical sciences Ethnics Committee
Street address
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
Control group: The control group does not receive any intervention or treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic in Shiraz
Full name of responsible person
Sara Habibi
Street address
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 71 3736 9497
Email
habibisara422@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Kashan University of Medical Sciences, Shahid Helli Boulevard, Hekmat 55 Street, Ghotb-e Ravandi, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 71 3736 9497
Email
habibisara422@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara Habibi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 71 3736 9497
Email
habibisara422@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 71 3736 9497
Email
habibisara422@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara Habibi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Hekmat 56 Street, Qotb Ravandi Boulevard, Kashan, Isfahan Province, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 71 3736 9497
Email
habibisara422@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 become available and for how long
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 data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.