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IRCT20211118053093N2 IRCT 2022-01-09 Shiraz University of Medical Sciences combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy in HIV patients with associated neurocognitive disorders. The effectiveness of combination therapy of cognitive rehabilitation and emotion regulation based on dialectical behavior therapy on cognitive functions, emotional problems and quality of life of HIV patients with associated neurocognitive disorders. 2021-12-20 anticipated 70 Complete https://irct.ir/trial/60173 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, it is assumed that if cognitive rehabilitation interventions and psychological interventions such as emotion regulation based on dialectical behavior therapy are used as a combination, applied and supportive therapeutic approach along with pharmacotherapy, due to the chronicity of this disease, the therapeutic effects will be long and profound and will lead to improvement of cognitive function and emotional problems and increasing the quality of life in these people, Blinding description: Patients in all three groups do not know what intervention will be made for them. Researcher and analyst also has no knowledge of which person is in which group. N/A HIV. Intervention 1: "Intervention group 1:" Cognitive rehabilitation 12 sessions one hour, twice a week Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education. Intervention 2: "Intervention group 2:" 1.emotion regulation based on dialectic behavioral therapy and 2.emotion regulation based on dialectic behavioral therapy eight two-hour sessions twice a week. Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education Session13 and14:They will learn to view and describe their emotional experiences without judgment and to validate their emotions. Session15:Self-assessment or observation of emotions Session16: Performing different mindfulness exercises Session17:Training discomfort tolerance skills Session18: Training emotional relief skills Session19:Training positive excitement skills Session20: Reassessment and planning for the application of education. Intervention 3: "Control group:" routine daily therapy without psychotherapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Leila Razeghian Jahromi
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
Shiraz Iran (Islamic Republic of) 71441-13331 +98 71 3260 5701 leilarazeghian1366@gmail.com Shiraz University of Medical Sciences scientific Leila Razeghian Jahromi
Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway
Shiraz Iran (Islamic Republic of) 71441-13331 +98 71 3260 5701 leilarazeghian1366@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Receiving antiretroviral therapy for at least 6 months Plasma HIV- RNA lesser or equal to 50 cells in one mililiter for at least 6 months Number of lymphocytes +T CD4 less than 350 cells in 1 microliter for at least six months Proficiency in Persian Informed consent no limit no limit Both neurodegenerative diseases severe psychiatric disorder metabolic encephalopathy use of psychotropic drugs head trauma B20 Human immunodeficiency virus [HIV] disease Treatment - Other Treatment - Other Treatment - Other "Intervention group 1:" Cognitive rehabilitation 12 sessions one hour, twice a week Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education "Intervention group 2:" 1.emotion regulation based on dialectic behavioral therapy and 2.emotion regulation based on dialectic behavioral therapy eight two-hour sessions twice a week. Session1:Familiarity of members with each other Session2and 3: Members will learn to describe their emotional experiences without judgment and validate their emotions. Session4 and 5: Self assessment or observation of emotions Session6 and7: The role of awareness and being in the present in mental health Session 8and9: Members discuss how to do mindfulness exercises Session10: Training emotional relief skills Session11: Members will discuss how to apply relief skills Session12:Reassessment and planning for the application of education Session13 and14:They will learn to view and describe their emotional experiences without judgment and to validate their emotions. Session15:Self-assessment or observation of emotions Session16: Performing different mindfulness exercises Session17:Training discomfort tolerance skills Session18: Training emotional relief skills Session19:Training positive excitement skills Session20: Reassessment and planning for the application of education "Control group:" routine daily therapy without psychotherapy Quality of life of HIV patients with associated neurocognitive disorders. Timepoint: Before treatment End of treatment Four months after treatment. Method of measurement: Quality of Life Questionnaire. Cognitive Function. Timepoint: Before treatment End of treatment Four months after treatment. Method of measurement: Cognitive Function Questionnaire. Emotional problems. Timepoint: Before treatment End of treatment Four months after treatment. Method of measurement: Emotional Problems Questionnaire. Shiraz University of Medical Sciences Approved 2021-12-12 Ethic committee of Shiraz University of Medical Sciences Ostad Mohrrari Hospital, 13th Km Shiraz-Isfahan Highway Shiraz Fars Iran (Islamic Republic of)