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IRCT20210216050373N5 IRCT 2023-03-11 Tehran University of Medical Sciences Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV Comparison of the effectiveness of mindfulness-based cognitive therapy and Silva-based relaxation therapy on psychological capital, social anxiety and CD4 count in people with HIV 2023-04-03 anticipated 90 Complete https://irct.ir/trial/68797 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method will be used for randomization. According to the three study groups, blocks of fixed size will be used in this research, with six patients in each block. After generating the randomization sequence using the software (Random allocation software), the central randomization method will be used for allocation concealment. To implement allocation concealment using the central randomization method, the generated randomization sequence is provided to the research department of the Iranian Research Center for HIV/AIDS (IRCHA). After the patients' eligibility to enter the study and obtaining written informed consent from the patients, the researchers will call (phone) the relevant center (IRCHA) and ask about the allocation of the participants to the study groups. N/A HIV-1 infection. Intervention 1: Intervention group 1: Mindfulness-based cognitive therapy group training: Before the training, a pre-test will be conducted. In this way, the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, cognitive therapy sessions based on mindfulness will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test. Intervention 2: Intervention group 2: Silva-based relaxation therapy: Group relaxation training in the Silva method: Before the implementation of the training, a pre-test will be performed. In this way, the research questionnaires (Lutans psychological capital and Lajerka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, the Silva relaxation sessions will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test. Intervention 3: Control group: they don't see any training. The pre-test will be conducted in such a way that the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml of blood sampling will be done for the CD4 count. After the pre-test and after cognitive therapy training sessions based on mindfulness and Silva-based relaxation therapy were implemented for the intervention groups, after two weeks From the implementation of the trainings, the "post-test" will be implemented like the pre-test for the control group. Yes - There is a plan to make this available What will be shared: The research results will be presented and published only in the form of reports and articles. When: The access period starts 6 months after the results are published. To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Researchers for use in articles and reports, especially systematic review articles. Where to obtain: To receive the required documents or data, refer to the project manager, Dr. Seyed Ahmad Seyed Alinghi, at the Iranian Research Center for HIV/AIDS. Phone number: 00982166581583 Email: s.a.alinaghi@gmail.com Address: Iranian Research Center for HIV/AIDS, behind the Infectious Diseases Building, Imam Khomeini Hospital Complex, end of Keshavarz Boulevard, Tehran. How to obtain: After making the call(Phone, meet, Email) and providing the necessary documents(Written request), the documents or data files will reach the applicant. Comments:
public Pegah Mirzapour
Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 919 436 5685 pegah.mirzapour@yahoo.com Tehran University of Medical Sciences scientific SeyedAhmad SeyedAlinaghi
Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 912 644 8153 s.a.alinaghi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) HIV infection Having full consent to cooperate Absence of acute disorders in the field of psychology and psychiatry Not using drugs; Psychiatric drugs Being literate in reading and writing no limit no limit Both Refusing to cooperate with the researcher Absence of more than two sessions in therapy training B20 Human immunodeficiency virus [HIV] disease Lifestyle Lifestyle Lifestyle Intervention group 1: Mindfulness-based cognitive therapy group training: Before the training, a pre-test will be conducted. In this way, the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, cognitive therapy sessions based on mindfulness will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test. Intervention group 2: Silva-based relaxation therapy: Group relaxation training in the Silva method: Before the implementation of the training, a pre-test will be performed. In this way, the research questionnaires (Lutans psychological capital and Lajerka social anxiety) will be completed. Also, 2 ml blood sampling will be done for the CD4 count. After the pre-test, the Silva relaxation sessions will be held twice a week for one month (each training session is 40 minutes). After two weeks of training, the "post-test" will be conducted like the pre-test. Control group: they don't see any training. The pre-test will be conducted in such a way that the research questionnaires (Lutans psychological capital and Lajarka social anxiety) will be completed. Also, 2 ml of blood sampling will be done for the CD4 count. After the pre-test and after cognitive therapy training sessions based on mindfulness and Silva-based relaxation therapy were implemented for the intervention groups, after two weeks From the implementation of the trainings, the "post-test" will be implemented like the pre-test for the control group. Conscious attention in the present with acceptance and non-judgment. Timepoint: 1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention. Method of measurement: Questionnaire. Awareness and alertness based on care and attention. Timepoint: 1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention. Method of measurement: Questionnaire. Increase mental strength and concentration. Timepoint: 1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention. Method of measurement: Questionnaire. CD4 count. Timepoint: 1- At the beginning of the study (before the start of the intervention) 2- 14 days after the last educational intervention. Method of measurement: Blood test. Vice-Chancellors of Research and Technology of Tehran University of Medical Sciences Approved 2023-02-14 Ethics committee of Imam khomeini Hospital Complex- Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)