Protocol summary
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Study aim
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To assess the effectiveness of Mindfulness-Based Stress Reduction (MBSR) on anxiety sensitivity, perceived stress, emotion dysregulation and plasma oxidative and antioxidative biomarkers
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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chainging the sampling location
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Acronym
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MBSR
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IRCT registration information
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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
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Registration date
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2025-07-21, 1404/04/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-09-06, 1404/06/15
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Expected recruitment end date
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2025-09-23, 1404/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The Effect of Mindfulness-Based Stress Reduction (MBSR) on Anxiety Sensitivity, Perceived Stress, Emotion Dysregulation, and Blood Oxidative and Antioxidative Markers
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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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
Ethics committees
1
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Ethics committee
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Approval date
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2025-07-03, 1404/04/12
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Ethics committee reference number
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1404054
Health conditions studied
1
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Description of health condition studied
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chronic obstructive pulmonary disease
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ICD-10 code
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J44.9
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ICD-10 code description
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Chronic obstructive pulmonary disease, unspecified
Primary outcomes
1
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Description
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THE perceived stress score in the Cohen perceived stress scale
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (after the intervention)
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Method of measurement
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Cohen perceived stress scale
2
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Description
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The anxiety sesitivity score in the Floyd anxiety sensitivity scale
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (after the intervention)
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Method of measurement
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Floyd anxiety sensitivity inventory
3
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Description
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The emotion dysregulation score in the 16-item Difficulties in Emotion Regulation Scale
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (after the intervention)
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Method of measurement
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The 16-item Difficulties in Emotion Regulation Scale (DERS-16) by Bjureberg
4
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Description
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Levels of oxidative and antioxidant blood factors (MDA, TOS, TAC, Thiol groups) measured using diagnostic assy kits
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (after the intervention)
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Method of measurement
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Assy kits for TAC, MDA, TOS, Thiol groups
Intervention groups
1
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Description
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Intervention group: 8-week mindfulness-based stress reduction (MBSR)
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Category
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Treatment - Other
2
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Description
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Control group: The control group does not receive any intervention or treatment
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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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.
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To whom data/document is available
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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.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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