The effectiveness of mindfulness-based stress reduction (MBSR) therapy on subjective vitality and self-compassion in people with panic attacks

Determining the effectiveness of mindfulness-based stress reduction (MBSR) therapy on subjective vitality and self-compassion in people with panic attacks

A randomized, controlled, parallel-group clinical trial on 30 people with panic attacks used a randomized block method to randomize participants.

The study is being conducted at the Empathy Psychology Clinic in Semnan and involves people with panic attacks. Participants will be randomly divided into two groups: an experimental group that receives mindfulness-based stress reduction (MBSR) therapy, and a control group that only follows the center's routine programs.

Inclusion criteria: Participants must be between 20 and 50 years old, have received a diagnosis of panic disorder according to DSM-5, and have a history of taking related medications for between 3 and 12 months. Also, be willing to participate in mindfulness-based stress reduction therapy for 8 weeks and not use similar treatments. Exclusion criteria: Participants must not have severe psychiatric disorders, medication dose changes, and drug and alcohol use.

In this study, the experimental group will participate in 8 weekly 90-minute sessions designed based on mindfulness-based stress reduction (MBSR) therapy. The content of these sessions includes mindfulness exercises, stress management, and increased awareness of mental states. The control group will receive only usual care and no specific therapeutic intervention will be provided to them.

Subjective vitality, self-compassion

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.

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.

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.

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.

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.

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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.