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Article History

Received: 20 September 2024

Accepted: 24 May 2025

First Online: 11 August 2025

Declarations

:

: The study protocol and all measures and forms, including the consent form, have been reviewed and confirmed by the MUI Research Ethics Committees of the Schools of Pharmacy and Nutrition (certificate number: IR.MUI.PHANUT.REC.1402.055).

: Any change in the study protocol and conduction will need to be first approved by the MUI review board and ethics committee. This includes, but is not limited to, any change in the study population, interventions, measurement tools, site of the study, and data usage.

: All participants must give consent prior to randomization and inclusion in the study. A researcher will give participants detailed information on the nature of the study and its possible benefits/harms. A copy of the form will be held by the study conductors, and a copy will be given to the participants. We will use the standard consent form format from the MUI. This standard format provides the name of the study, the name of the primary conductor, the name of the research center conducting the study, a brief introduction of the study, the nature of interventions, what will be expected from the patients, how to contact the ethics committee in the face of problems, possible benefits, possible harms, how they will be compensated, possible alternative treatments, confidentiality, and contact details of the study conductors. The form is freely available at:

: All data will be held by one researcher. These data will only be available to others with an official order from eligible authorities. If it is decided to make the data public, no names and contact information will be contained, and only the code assigned to each participant will be provided.

: In case of any adverse events, the study conductors take full responsibility for providing access to proper medical care and compensating for related costs. For example, in case of worsening anxiety/depression, study conductors will arrange a consult time with a psychologist and pay for visit charges and medications until recovery to baseline conditions.After the end of the study, if the ME intervention proves to be of significant benefit, those allocated to the SDT group will also gain access to training sessions, and the study conductors will be available to them in the face of any problems using the training material.

: We plan to publish the results of our study irrespective of the results. As soon as the final report is ready, we will submit the results to an appropriate journal. There are no restrictions forced upon authors not to do so. The funder of the study (MUI) will not affect the decision whether to publish the results or not. All participants in the study will also be informed of the results in a way understandable to them irrespective of cooperation till the study’s completion.

: We will follow the authorship guidelines determined by MUI. As such, all authors must have substantive contributions to the design, conduct, interpretation, and reporting of the results. As such, all authors have contributed to the design of the study; SA and ZM will contribute to the conduction of the study, GA will get the funds from MUI and will be responsible for the supervision of the study, data interpretation, and analysis of the results. All authors will contribute to the writing and must confirm the final report.

: All authors declare to have no competing interests.