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IRCT20250523065853N3 IRCT 2025-06-28 Mashhad University of Medical Sciences The Impact of Mindfulness-Based Stress Reduction on Anxiety and Problem-Solving in Students Effectiveness of Mindfulness-Based Stress Reduction on Anxiety Sensitivity and Problem-Solving Ability of Students 2025-08-31 anticipated 60 Complete https://irct.ir/trial/84334 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: This study includes repeated measures with pre- and post-intervention assessments to evaluate changes over time. Random allocation is applied using block randomization to ensure group balance. The study also follows the intention-to-treat principle to maintain the integrity of statistical analysis, Randomization description: Participants will be randomly assigned to the intervention or control group using a computer-generated random sequence created by block randomization with a 1:1 allocation ratio. Block sizes will be fixed and generated in advance to ensure balanced group sizes throughout recruitment. Allocation concealment will be ensured using sealed, opaque, and sequentially numbered envelopes. The randomization list will be prepared and maintained by an independent researcher who is not involved in participant recruitment or assessment. This process aims to minimize selection bias and maintain allocation integrity, Blinding description: This study is double-blind. Participants are informed that the study involves two different educational programs and are not told which group is considered the intervention or the control. The sessions are presented as potentially beneficial stress management trainings. Outcome assessors, who administer pre- and post-intervention questionnaires, are not involved in delivering the sessions and are unaware of group assignments. Group codes are used during data collection and analysis to maintain blinding and minimize assessment bias. N/A This study focuses on anxiety sensitivity, a psychological trait characterized by the fear of anxiety-related sensations due to beliefs that these sensations have harmful consequences. It is commonly associated with anxiety disorders, especially panic disorder.. Intervention 1: Intervention group: Participants in this group will attend an eight-week Mindfulness-Based Stress Reduction (MBSR) program. The program includes weekly 90-minute group sessions. The content involves practical training in mindfulness practices such as body scan, breathing awareness, seated meditation, and mindful movement. Participants are instructed to perform daily home practice for 45 minutes. Audio files and written educational materials are provided. The sessions will be delivered by a trained and experienced instructor in mindfulness-based interventions. Intervention 2: Control group: Control group: Participants in this group will not receive any psychological intervention during the study period. They will be placed on a waiting list and offered the same MBSR training program after completing the post-intervention assessment. Yes - There is a plan to make this available What will be shared: All the deidentified individual participant data, along with the study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code, and data dictionary will be shared with qualified researchers upon reasonable request. Data will be available after publication of main results for a period of 3 years. Requests should be sent via email to the principal investigator at. Data will be provided via institutional secure file-sharing platforms under appropriate ethical and legal agreements. When: The deidentified individual participant data (IPD) and related documents will be made available 6 months after publication of the main study results. The data will be available for a period of 3 years after that. To whom: The data will be shared with qualified researchers working in academic institutions, governmental organizations, or non-profit research centers. Researchers affiliated with industry may also apply under specific conditions. Conditions: Data may be used only for scientific research purposes, such as secondary analysis, meta-analysis, and validation studies. Applicants must submit a research proposal, ethical approval, and sign a Data Use Agreement (DUA). All requests will be evaluated by a Data Access Committee (DAC). Where to obtain: Requests should be sent to the following contact: Dr. Zahra Saeedi Mashhad University of Medical Sciences School of Medicine, Department of Psychology Mashhad, Razavi Khorasan, Iran Phone: +98 916 604 6877 Email: darya2674@gmail.com How to obtain: Applicants must submit: A detailed research proposal Ethical committee approval A signed Data Use Agreement (DUA) Requests will be reviewed by the Data Access Committee (DAC) within 4–6 weeks. If approved, data will be shared via secure digital transfer. Comments:
public Zahra Saedi
Department of Psychology, School of Medicine, Pardis Daneshgah, Azadi Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 916 604 6877 darya2674@gmail.com Mashhad University of Medical Sciences scientific Zahra Saedi
Department of Psychology, School of Medicine, Pardis Daneshgah, Azadi Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 916 604 6877 darya2674@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) University students aged between 18 and 35 years Willingness to participate in the study and provide informed consent Having moderate to high anxiety sensitivity based on the Anxiety Sensitivity Index (ASI) Availability to attend all mindfulness sessions Not currently participating in other psychological or psychiatric interventions Basic literacy and ability to complete self-report questionnaires 18 years 35 years Both Current diagnosis of severe psychiatric disorders (e.g., psychosis, bipolar disorder) Use of psychiatric medication during the intervention period Participation in other psychological treatment programs concurrently Absence from more than two mindfulness sessions Any physical condition that prevents regular attendance or participation Incomplete response to pre-test questionnaires F41.1 Generalized anxiety disorder Behavior N/A Intervention group: Participants in this group will attend an eight-week Mindfulness-Based Stress Reduction (MBSR) program. The program includes weekly 90-minute group sessions. The content involves practical training in mindfulness practices such as body scan, breathing awareness, seated meditation, and mindful movement. Participants are instructed to perform daily home practice for 45 minutes. Audio files and written educational materials are provided. The sessions will be delivered by a trained and experienced instructor in mindfulness-based interventions. Control group: Control group: Participants in this group will not receive any psychological intervention during the study period. They will be placed on a waiting list and offered the same MBSR training program after completing the post-intervention assessment. The primary outcome is the change in anxiety sensitivity levels among students after undergoing mindfulness-based stress reduction (MBSR) intervention. Anxiety sensitivity will be measured using a validated questionnaire. Timepoint: Anxiety sensitivity will be measured at baseline (before the intervention), immediately after the intervention, and at 3 months follow-up. Method of measurement: Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index (ASI), a validated self-report questionnaire. The secondary outcome is the change in problem-solving ability among students after mindfulness-based stress reduction intervention. Timepoint: Problem-solving ability will be measured at baseline, immediately after the intervention, and at 3 months follow-up. Method of measurement: Problem-solving ability will be assessed using a standardized and validated problem-solving inventory questionnaire. The secondary outcome is the change in problem-solving ability of students following the mindfulness-based stress reduction intervention. Timepoint: Measured at baseline, immediately after the intervention, and 3 months after the intervention. Method of measurement: Problem-solving ability will be assessed using a validated problem-solving inventory questionnaire. The secondary outcome is the change in perceived stress levels of students after mindfulness-based stress reduction intervention. Timepoint: Measured at baseline, immediately after the intervention, and at 3 months follow-up. Method of measurement: Perceived stress will be assessed using the Perceived Stress Scale (PSS), a validated self-report questionnaire. Mashhad University of Medical Sciences Approved 2025-05-26 Ethics Committee of the School of Medicine, Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)