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IRCT20230408057849N1 IRCT 2023-05-04 Islamic Azad University of Marvdasht Investigating the effect of fluoxetine and online compassion-focused therapy in the treatment of post-chronic patients with post-traumatic stress disorder The Comparison of the Effectiveness of Pharmacotherapy and online Compassion-Based Therapy in Reducing the Severity of Post Traumatic Symptoms, Increasing Post-Traumatic Growth, Improving Quality of life, and Studying Changes in Hippocampal and Amygdala Volume in Improved Patients with Coronavirus 2021-08-22 anticipated 70 Complete https://irct.ir/trial/69474 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic. 1-2 Post Traumatic Stress Disorder. Intervention 1: The first intervention group: Pharmacotherapy: Prozac brand name، fluoxetine drug from the serotonin reuptake inhibitors (SSRIs) category at a dose of 20 mg, 2 times a day, morning and evening, in a period of 6 to 8 weeks, Exir pharmaceutical factory. Intervention 2: The intervention group: Compassion-focused therapy, online, in eight ninety-minute sessions, once a week and in a group setting. description of meetings; The first session: getting to know the group members with each other, explaining the group rules, explaining the symptoms of post-traumatic stress, talking about their problems, explaining how the mind works and how and why it malfunctions. The second session: explanation and description of compassion: what compassion is and how to overcome problems through it. The third session: thinking about compassion towards others, paying attention and focusing on compassion, thinking about compassionate compassion, compassionate behavior, portraying compassion The fourth session: increasing warmth and energy, mindfulness, acceptance, wisdom and strength, warmth and non-judgment. Sixth session: practice the color of compassion, sound and image of compassion, and letter writing based on compassion .Seventh session: writing letters of compassion, practicing anger and compassion, practicing fear of compassion, preparing for the end of the group. Eighth session: reviewing, summarizing, ending the group's work, and doing the post-test. Intervention 3: Control group: They did not receive any intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts one year after the results are published To whom: The data of this study will be available only to researchers working in academic and scientific institutions Conditions: The data of this study will be used in other similar researches for resources Where to obtain: Future researchers should contact the responsible author via email to use the data of this study. fatemehmodaresifard@gmail.com How to obtain: After sending the request email, the responsible author will send the data within a period of 7 days Comments:
public Fatemeh Modaresifard
No. 7, Vafaie Blvd. 21Ave., Shiraz
Shiraz Iran (Islamic Republic of) 7147885359 +98 71 3734 5881 fatemehmodaresifard@gmail.com American Psychological Association scientific Seyed Mohsen Zamir
North Nawab St., Shahid Salmani Alley. Qazvin University of Medical Sciences
Ghazvin Iran (Islamic Republic of) 3419759811 009822833336001-5 omidzamir@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 1- Being a resident of Shiraz city 2- having a positive PCR in Delta variant Corona virus 3- having a history of hospitalization and discharge. no limit no limit Both Older participant Not living in Shiraz city Not having a history of hospitalization in the corona ward F43.1 Post-traumatic stress disorder (PTSD) Treatment - Drugs Lifestyle Other The first intervention group: Pharmacotherapy: Prozac brand name، fluoxetine drug from the serotonin reuptake inhibitors (SSRIs) category at a dose of 20 mg, 2 times a day, morning and evening, in a period of 6 to 8 weeks, Exir pharmaceutical factory The intervention group: Compassion-focused therapy, online, in eight ninety-minute sessions, once a week and in a group setting. description of meetings; The first session: getting to know the group members with each other, explaining the group rules, explaining the symptoms of post-traumatic stress, talking about their problems, explaining how the mind works and how and why it malfunctions. The second session: explanation and description of compassion: what compassion is and how to overcome problems through it. The third session: thinking about compassion towards others, paying attention and focusing on compassion, thinking about compassionate compassion, compassionate behavior, portraying compassion The fourth session: increasing warmth and energy, mindfulness, acceptance, wisdom and strength, warmth and non-judgment. Sixth session: practice the color of compassion, sound and image of compassion, and letter writing based on compassion .Seventh session: writing letters of compassion, practicing anger and compassion, practicing fear of compassion, preparing for the end of the group. Eighth session: reviewing, summarizing, ending the group's work, and doing the post-test Control group: They did not receive any intervention The percentage of people whose questionnaire score was reported to be low. Timepoint: Measuring the severity of post-traumatic stress symptoms, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention. Method of measurement: Post-traumatic growth and development questionnaire, post-traumatic stress disorder questionnaire (PCL-5), World Health Organization quality of life questionnaire - short form, brain imaging to measure the Hippocampus and Amygdala. The percentage of people whose questionnaire scores are high. Timepoint: Measurement of growth and development after the accident, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention. Method of measurement: Post-traumatic growth and development questionnaire. The percentage of people whose questionnaire scores are reported to be high. Timepoint: Measuring the quality of life, one week before the start of the intervention (pre-test) and 2 weeks after the intervention (post-test) and for the follow-up stage 3 months after the intervention. Method of measurement: World Health Organization quality of life questionnaire - short form. Changes in the size of the Hippocampus and Amygdala. Timepoint: At the beginning of the study (before the interventions) and one year after the interventions. Method of measurement: Brain imaging to measure the hippocampus and amygdala. The financial sponsor of this thesis is the PhD student, Mrs. Fateme Modaresi Fard Approved 2022-08-20 سامانه ملی اخلاق در پژوهش های زیست پزشکی Floor.13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran Tehran Tehran Iran (Islamic Republic of)