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IRCT20231004059614N1 IRCT 2023-10-12 Ahvaz University of Medical Sciences The effectiveness of mindfulness-based cognitive therapy on the happiness of women with HIV The effectiveness of mindfulness-based cognitive therapy on the happiness of women with HIV 2023-10-23 anticipated 92 Complete https://irct.ir/trial/73047 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The current research will be a clinical trial study that will be conducted with the aim of determining the effectiveness of cognitive therapy based on mindfulness on the happiness of women with HIV. After obtaining the code of ethics and registration in the clinical trial center, and obtaining the letter of recommendation, the researcher will visit the high-risk disease center in Ahvaz in person to collect the samples. Using targeted sampling, samples will be selected from women who are eligible and who meet the entry criteria and do not have the exit criteria. Due to the lack of presence of all women in the center at the same time, the researcher will conduct the sampling both in person and from the files registered in the center in such a way that he will extract the contact numbers of the people from the file and firstly about the objectives of the research and how The intervention will give the same explanation to each eligible person and ask for written consent from the eligible people. Completing the demographic, depression and happiness questionnaire will be done by the samples who meet the conditions for entering the study (the researcher will be present at the center and if the participants have any questions, he will answer their questions). One of the conditions for entering the study is to score less than 42 in the happiness questionnaire total number of participants in the study will be 92 people based on statistical calculations, and 46 people will enter the research in each group. After the initial selection of the samples, the method of assigning people to the control and test groups will be randomly and blocks of four (using the table of random permutations). After determining the size of the block, which is 4 in this study, a list of blocks (23 blocks of 4) will be prepared and numbers will be assigned to them, then random numbers between 1 and 6 will be selected (1) AABB, ( 2) ABAB, (3) ABBA, (4) BBAA, (5) BABA, (6) BAAB). Due to the nature of this study, it will not be possible to blind the researcher and the participant. Since the sample size of people in the mindfulness treatment group should not exceed 14 people, because the effectiveness of psychotherapy decreases with the increase in the number of groups, so the intervention group was divided into 4 groups (2 groups of 11 people and 2 groups of 12 people) ) will be divided, then the intervention will be implemented in the form of 8 counseling sessions and a follow-up phase (8 weeks after the end of the counseling sessions) so that all women in both groups (intervention and control) at the beginning and immediately after the intervention and 8 weeks (39) After the end of the intervention, they will complete the happiness questionnaire in the form of self-reporting. Counseling will be done by a trained researcher (the researcher will participate in a three-day mindfulness workshop and receive a certificate) under the supervision of the respected scientific advisor at the center. The women of the intervention group will undergo 8 group counseling sessions (one session per week) with a cognitive therapy approach based on mindfulness with the aim of improving happiness. The content of the sessions will be compiled using the book "Mindfulness-Based Interventions in the Context: Past, Present and Future" written by Kabat Zain and under the supervision of the scientific advisor of the research. Group meetings, one 90-minute meeting per week will be held between the counselor and the clients according to the schedule. Considering that the control group will not receive any intervention despite the low happiness, in order to comply with the ethical standards, after completing the study, they will be given a training booklet and a summary of the contents of the sessions. N/A Human immunodeficiency virus [HIV] disease. Intervention 1: Intervention group: Intervention group: Using targeted sampling, samples will be selected from women who are eligible and who meet the entry criteria and do not have the exit criteria. Due to the lack of presence of all women in the center at the same time, the researcher will conduct the sampling both in person and from the files registered in the center in such a way that he will extract the contact numbers of the people from the file and firstly about the objectives of the research and how The intervention will give the same explanation to each eligible person and ask for written consent from the eligible people. Completing the demographic, depression and happiness questionnaire will be done by the samples who meet the conditions for entering the study (the researcher will be present at the center and if the participants have any questions, he will answer their questions). One of the conditions for entering the study is to score less than 42 in the happiness questionnaire. The total number of participants in the study will be 92 people based on statistical calculations, and 46 people will enter the research in each group. After the initial selection of the samples, the method of assigning people to the control and test groups will be randomly and blocks of four (using the table of random permutations). After determining the size of the block, which is 4 in this study, a list of blocks (23 blocks of 4) will be prepared and numbers will be assigned to them, then random numbers between 1 and 6 will be selected (1) AABB, ( 2) ABAB, (3) ABBA, (4) BBAA, (5) BABA, (6) BAAB). Due to the nature of this study, it will not be possible to blind the researcher and the participants. Since the sample size of people in the group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with the increase in the number of groups, so the group The intervention will be divided into 4 groups (2 groups of 11 people and 2 groups of 12 people), then the intervention will be implemented in the form of 8 counseling sessions and a follow-up phase (8 weeks after the end of the counseling sessions) so that all the women of both groups ( intervention and control) at the beginning and immediately after the end of the intervention and 8 weeks (39) after the end of the intervention, they will complete the happiness questionnaire in the form of self-reporting. Counseling will be done by a trained researcher (the researcher will participate in a three-day mindfulness workshop and receive a certificate) under the supervision of the respected scientific advisor at the center. The women of the intervention group will undergo 8 group counseling sessions (one session per week) with a cognitive therapy approach based on mindfulness with the aim of improving happiness. The content of the sessions will be compiled using the book "Mindfulness-Based Interventions in the Context: Past, Present and Future" written by Kabat Zain and under the supervision of the scientific advisor of the research (46). Group meetings, one 90-minute meeting per week will be held between the counselor and the clients according to the schedule. Intervention 2: Control group: Considering that the control group will not receive any intervention despite the low happiness, in order to comply with the ethical standards, after completing the study, they will be given a training booklet and a summary of the contents of the sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nahid asadi
Faculty of Nursing and Midwifery, Jundishapur university of medical sciences, Esfand Ave.,Golestan Blv.
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3373 8538 nahid.asadi.mid@gmail.com Ahvaz University of Medical Sciences scientific Parvaneh Mousavi
Faculty of Nursing and Midwifery, Jundishapur university of medical sciences, Esfand Ave.,Golestan Blv.
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3373 8385 mousavi-p@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Consent and informed desire to participate in the research Ability to participate in meetings and cooperate in doing assignments Physical and psychological stability (not having obvious physical or psychological symptoms that interfere with participation in meetings, such as fatigue, muscle pain, etc.) Having at least reading and writing literacy Obtaining a score less than 42 from the happiness questionnaire Age range between 20 and 45 years Having a test (rapid test or ELISA) that shows that the person is HIV positive One year has passed since the person was infected with HIV 20 years 45 years Female The presence of acute and severe symptoms of the disease in a way that makes it difficult or almost impossible for the patient to participate in the present study Suffering from moderate or severe depression according to the Beck depression questionnaire (getting a score higher than 18 Taking antidepressants consumption of alcohol and psychoactive substances by the patient بهره مندی همزمان از مشاوره و خدمات آموزشي ديگر در جهت افزايش شادکامی و بهزیستی Major stressors in the last 3 months such as loss of loved ones and divorce Other Other Intervention group: Intervention group: Using targeted sampling, samples will be selected from women who are eligible and who meet the entry criteria and do not have the exit criteria. Due to the lack of presence of all women in the center at the same time, the researcher will conduct the sampling both in person and from the files registered in the center in such a way that he will extract the contact numbers of the people from the file and firstly about the objectives of the research and how The intervention will give the same explanation to each eligible person and ask for written consent from the eligible people. Completing the demographic, depression and happiness questionnaire will be done by the samples who meet the conditions for entering the study (the researcher will be present at the center and if the participants have any questions, he will answer their questions). One of the conditions for entering the study is to score less than 42 in the happiness questionnaire. The total number of participants in the study will be 92 people based on statistical calculations, and 46 people will enter the research in each group. After the initial selection of the samples, the method of assigning people to the control and test groups will be randomly and blocks of four (using the table of random permutations). After determining the size of the block, which is 4 in this study, a list of blocks (23 blocks of 4) will be prepared and numbers will be assigned to them, then random numbers between 1 and 6 will be selected (1) AABB, ( 2) ABAB, (3) ABBA, (4) BBAA, (5) BABA, (6) BAAB). Due to the nature of this study, it will not be possible to blind the researcher and the participants. Since the sample size of people in the group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with the increase in the number of groups, so the group The intervention will be divided into 4 groups (2 groups of 11 people and 2 groups of 12 people), then the intervention will be implemented in the form of 8 counseling sessions and a follow-up phase (8 weeks after the end of the counseling sessions) so that all the women of both groups ( intervention and control) at the beginning and immediately after the end of the intervention and 8 weeks (39) after the end of the intervention, they will complete the happiness questionnaire in the form of self-reporting. Counseling will be done by a trained researcher (the researcher will participate in a three-day mindfulness workshop and receive a certificate) under the supervision of the respected scientific advisor at the center. The women of the intervention group will undergo 8 group counseling sessions (one session per week) with a cognitive therapy approach based on mindfulness with the aim of improving happiness. The content of the sessions will be compiled using the book "Mindfulness-Based Interventions in the Context: Past, Present and Future" written by Kabat Zain and under the supervision of the scientific advisor of the research (46). Group meetings, one 90-minute meeting per week will be held between the counselor and the clients according to the schedule. Control group: Considering that the control group will not receive any intervention despite the low happiness, in order to comply with the ethical standards, after completing the study, they will be given a training booklet and a summary of the contents of the sessions. Happiness. Timepoint: At the beginning and immediately after the end of the intervention and 8 weeks after the end of the intervention. Method of measurement: Oxford Happiness Questionnaire. Ahvaz University of Medical Sciences Approved 2023-10-08 Ethics Committee of Jundishapur University of Medical Sciences Golestan Street, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)