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IRCT20241117063755N1 IRCT 2024-12-16 Mashhad University of Medical Sciences Comparing the Effectiveness of Individual Cognitive Behavioural Therapy and Couple Cognitive Behavioural Therapy on Negative Emotional States, Fertility Problem and Pregnancy Rate in Infertile Women Comparing the Effectiveness of Cognitive Behavioural Therapy in Individual and Couple Settings on Negative Emotional States, Fertility Problem and Pregnancy Rate in Infertile Women 2025-01-18 anticipated 100 Complete https://irct.ir/trial/80251 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals who meet the criteria for entering the project and have filled out the informed consent form will be randomly placed into three groups (experimental group one (individual CBT), experimental group two (couple CBT), and control group). It should be noted that the web-based randomization method and the site http://www.Randomiszation.com are used to randomly assign individuals to groups, Blinding description: The researcher and clinical caregiver are not blinded to the experiment, but the person analyzing the data is blinded to the study. N/A Depression, stress, anxiety, infertility-related stress. Intervention 1: First intervention group: Individual cognitive behavioral therapy. This psychological therapy is provided in 10 sessions and its components include identifying and correcting cognitive biases and ineffective emotion regulation strategies. Intervention 2: Second intervention group: Cognitive behavioral couple therapy. This psychological therapy is provided in 10 sessions and its components include training in communication skills, problem solving, expressing emotions, cognitive restructuring, tolerance, and acceptance. Intervention 3: Control group: This group does not receive any intervention and is placed on a waiting list. 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 No more information available.
public Maryam Sedaghat
No. 29, 21/10 Hedayat St., Hedayat Blvd
Mashhad Iran (Islamic Republic of) 9194994416 +98 51 3753 7986 samse@uk.ac.ir Shahid Bahonar University of Kerman scientific Seyed Mohammad Hossein Mousavi-Nasab
Department of Psychology., Faculty of Literature and Humanities., Shahid Bahonar University., Pazhohesh Square., Imam Khomeini Highway., Kerman., Iran.
Kerman Iran (Islamic Republic of) 7616913439 +98 34 3132 2393 hossein.mousavi-nasab@uk.ac.ir Shahid Bahonar University of Kerman Iran (Islamic Republic of) Be under 40 years of age. Follicle-stimulating hormone is less than 10. Body mass index is less than 30. Must have at least a middle school education. Not taking psychiatric medications No history of suicide The patient does not have Uterine abnormalities or thrombophilia. The couple's karyotype should be normal. There is no strong male factor in infertility. Couples who are candidates for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). no limit 40 years Female Receiving other psychological treatment at the same time Not being physically or mentally fit to answer questionnaires or attend meetings F43.2 Adjustment disorders Behavior Behavior Behavior First intervention group: Individual cognitive behavioral therapy. This psychological therapy is provided in 10 sessions and its components include identifying and correcting cognitive biases and ineffective emotion regulation strategies. Second intervention group: Cognitive behavioral couple therapy. This psychological therapy is provided in 10 sessions and its components include training in communication skills, problem solving, expressing emotions, cognitive restructuring, tolerance, and acceptance. Control group: This group does not receive any intervention and is placed on a waiting list. Depression, anxiety, and stress scores in the Depression Anxiety Stress Scalls-21. Timepoint: Measurement of Negative Emotional States before the start of the intervention and 60 days later (immediately after the end of the intervention). Method of measurement: Depression Anxiety Stress Scalls-21. Infertility-related stress score on the Fertility Problem Questionnaire. Timepoint: Measurement of infertility-related stress before the intervention began and 60 days later (immediately after the intervention ended). Method of measurement: Fertility Problem Questionnaire. Chemical Pregnancy. Timepoint: Two weeks after assisted reproductive treatment or one month after completing cognitive behavioral therapy. Method of measurement: Gonadotropin hormone measurement through blood test. Shahid Bahonar University of Kerman Mashhad University of Medical Sciences Shahid Bahonar University of Kerman Approved 2024-11-26 Ethics committee of Kerman University of Medical Sciences No: Ebn Sina Ave., Jahad Blvd., Kerman., Iran Kerman Kerman Iran (Islamic Republic of)