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IRCT20250223064822N1 IRCT 2025-04-06 Islamic Azad University, Semnan branch The effect of mindfulness-based stress reduction therapy on mental vitality and self-compassion The effectiveness of mindfulness-based stress reduction (MBSR) therapy on subjective vitality and self-compassion in people with panic attacks 2025-04-21 anticipated 30 Complete https://irct.ir/trial/82254 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 30 participants are randomly assigned to two intervention and control groups. The randomization unit in this study is the individual. Randomization is performed using the random block method with variable block sizes of 4 and 6 and an allocation ratio of 1:1. First, each participant is assigned a unique number from 1 to 30. Then, using Random Allocation Software (RAS) version 4.9, the sequence of allocation to the intervention and control groups is generated based on the random blocks. The randomization process is performed by an independent person who has no role in conducting the study. This person places the allocation list in numbered, sealed, and opaque envelopes. When each participant enters, the corresponding envelope is opened and the group allocation is determined. This method ensures that the allocation of individuals to groups is completely random, in compliance with the principle of allocation concealment, and without bias. N/A Panic disorder. Intervention 1: Intervention group: The experimental group will undergo Mindfulness-Based Stress Reduction (MBSR) therapy intervention, which will be held in 8 weekly 90-minute sessions. This intervention is designed to reduce stress, increase mental vitality, and improve self-compassion in people with panic attacks. Initially, participants will be introduced to the basic concepts of mindfulness, focusing on the present moment, and nonjudgmental acceptance. Then, exercises including body scanning, mindfulness meditation, conscious breathing, and gentle yoga will be provided to increase awareness of internal experiences and reduce automatic reactions to stress. In the following stages, participants will practice techniques such as accepting thoughts and feelings, changing their relationship with rumination, regulating emotions, and developing self-compassion. Finally, the learned skills for consciously facing anxiety, preventing the recurrence of panic attacks, and improving the quality of life in everyday situations will be reviewed and consolidated. Intervention 2: Control group: This group does not receive any intervention and serves only as a comparison. People in this group continue to receive their usual, standard care and do not receive any mindfulness-based stress reduction (MBSR)-related treatment or intervention during the study. The aim is to keep the control group conditions unchanged so that their results can be compared with those of the MBSR group. This method allows for a precise assessment of the effects of the treatment intervention on the subjective vitality and self-compassion of people with panic attacks. Yes - There is a plan to make this available What will be shared: In this study, data and research-related documentation will be shared in accordance with ethical principles and confidentiality considerations. Individual data of participants will only be published after removing identifying information and in an anonymous form. Primary data, including results related to research variables (such as primary and secondary outcome variables), will be made available to eligible researchers in the form of structured datasets without personal information. In addition to quantitative data, methodological documentation of the research, including the study protocol, data collection methods, intervention implementation instructions, and tools used, will also be shared. When: Access to the data and documentation of this study will be possible six months after the publication of the final results. This time frame is intended to ensure complete data analysis and adherence to ethical principles in sharing information. To whom: The data and documentation of this research will be available only to researchers and experts in the relevant scientific field who work in academic institutions, research centers, and reputable scientific organizations. Access requests from independent researchers will also be considered if they submit a relevant research plan and receive approval from the research ethics committee. Access to data for people working in industry will only be possible if they cooperate with academic or research centers and comply with research ethics principles. Conditions: The data and documentation of this study can only be used for scientific and research purposes related to the subject of the study and any commercial or promotional use is prohibited. Statistical analyses and meta-analyses are permitted in compliance with scientific and ethical principles. The use of data must be in such a way that the identity of the participants cannot be identified. Applicant researchers must submit a formal application, sign an ethical commitment letter, and receive approval from the research ethics committee. Reference to the original source is mandatory and sharing of data with third parties without official permission is prohibited. This framework ensures that the data are used responsibly to advance scientific knowledge. Where to obtain: If you need data, please contact mohammadrajbi4545@gmail.com. How to obtain: Applicants must submit a written application including the research objective and methodology. After an initial review, if approved, the necessary forms will be completed and an ethics commitment will be signed. Applications will be assessed within 2-4 weeks and, if approved, de-identified data will be made available to the applicant via a secure platform. The applicant will be committed to ethical principles and appropriate citation in the publication of the results. The entire process usually takes 4-6 weeks. Comments:
public Shahab Moradi
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 shahabmoradi66@gmail.com Islamic Azad University, Semnan branch scientific Maryam Salehyan
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 maryam.salehyan@gmail.com Islamic Azad University, Semnan branch Iran (Islamic Republic of) Definitive diagnosis of panic attack disorder based on DSM-5 criteria and confirmation by a psychiatrist or clinical psychologist. Age range 20 to 50 years. Participants must have a minimum of 3 months and a maximum of 12 months of history of taking psychiatric medications related to panic disorder. Willingness to participate regularly in Mindfulness-Based Stress Reduction (MBSR) therapy sessions for 8 weeks. Not using similar treatments at the same time, such as cognitive therapy or other mindfulness-based interventions. Ability to understand treatment concepts and perform mindfulness exercises. Absence of severe physical illnesses that would prevent participation in therapy sessions or mindfulness exercises. 20 years 50 years Both Having a severe psychiatric disorder or experiencing a recent acute psychological crisis, such as a suicide attempt. Use of unregulated psychiatric medications, changes in medication dosage in the past three months, or use of drugs and alcohol in the past six months. F41.0 Panic disorder [episodic paroxysmal anxiety] without agoraphobia Treatment - Other Treatment - Other Intervention group: The experimental group will undergo Mindfulness-Based Stress Reduction (MBSR) therapy intervention, which will be held in 8 weekly 90-minute sessions. This intervention is designed to reduce stress, increase mental vitality, and improve self-compassion in people with panic attacks. Initially, participants will be introduced to the basic concepts of mindfulness, focusing on the present moment, and nonjudgmental acceptance. Then, exercises including body scanning, mindfulness meditation, conscious breathing, and gentle yoga will be provided to increase awareness of internal experiences and reduce automatic reactions to stress. In the following stages, participants will practice techniques such as accepting thoughts and feelings, changing their relationship with rumination, regulating emotions, and developing self-compassion. Finally, the learned skills for consciously facing anxiety, preventing the recurrence of panic attacks, and improving the quality of life in everyday situations will be reviewed and consolidated. Control group: This group does not receive any intervention and serves only as a comparison. People in this group continue to receive their usual, standard care and do not receive any mindfulness-based stress reduction (MBSR)-related treatment or intervention during the study. The aim is to keep the control group conditions unchanged so that their results can be compared with those of the MBSR group. This method allows for a precise assessment of the effects of the treatment intervention on the subjective vitality and self-compassion of people with panic attacks. Subjective vitality. Timepoint: Before the start of the intervention and after completing 8 intervention sessions. Method of measurement: Ryan and Frederick Subjective Vitality Questionnaire (1997). Self-Compassion. Timepoint: Before the start of the intervention and after completing 8 intervention sessions. Method of measurement: Neff et al.'s Self-Compassion Questionnaire (2003). Islamic Azad University, Semnan branch Approved 2024-12-30 Ethics Committee of Semnan Azad University Islamic Azad University, University Town, Semnan Semnan Semnan Iran (Islamic Republic of)