Effectiveness of Mindfulness-Based Stress Reduction on Anxiety Sensitivity and Problem-Solving Ability of Students

This study aims to evaluate the effectiveness of mindfulness-based stress reduction (MBSR) on anxiety sensitivity and problem-solving ability in university students.

This is a randomized, double-blind, parallel-group clinical trial with pre- and post-test design.

The study will be conducted at Mashhad University of Medical Sciences, involving volunteer students recruited via announcements. The intervention will be administered by a trained clinical psychologist.

Participants are university students aged 18–35. Inclusion criteria: willingness to participate, moderate to high anxiety sensitivity, and availability. Exclusion criteria: psychiatric medication, psychotherapy, or major psychological disorders.

Intervention group will receive 8 weekly MBSR sessions (90 minutes each). Control group will receive no intervention during the study but will be offered training afterward.

Primary outcomes include anxiety sensitivity (measured by ASI) and problem-solving ability (measured by SPSI-R) assessed at baseline and post-intervention.

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.

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.

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.

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.

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.

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).

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

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.