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IRCT20250704066367N1 IRCT 2025-09-14 Islamic Azad University The impact of cognitive-behavioral approach on anxiety, depression, and feelings of shame and guilt. The effectiveness of cognitive-behavioral counseling based on the "interactive cognitive subsystems" approach on anxiety, depression, and feelings of shame and guilt 2025-10-01 anticipated 30 Complete https://irct.ir/trial/85231 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method used in this study is block randomization with a block size of 4. The allocation sequence will be generated using Random Allocation Software and placed in consecutive sealed envelopes. After final confirmation of each participant's entry conditions, the researcher will open the envelopes in order to allocate individuals to the intervention or control group, Blinding description: The present study will be designed as a single-blind study. In this design, only the outcome assessors and data analysts will be kept unaware of the allocation of couples to the intervention and control groups. This will ensure that data collection and analysis of the results are free from any bias. Participating couples will be fully aware of the nature of the study and their treatment group, as this information will be provided transparently during the informed consent process. The principal investigator and treatment personnel will also be informed of the details of group allocation to enable safe and effective delivery of the interventions. This approach will ensure that data integrity and impartiality in the assessment of the results are maintained. N/A Feelings of shame and guilt. Intervention 1: Intervention group: Intervention group (infertile couples): This group will receive a cognitive-behavioral counseling protocol based on the interacting cognitive subsystems approach. The intervention will consist of 12 structured 90-minute sessions conducted weekly. Session content will include identifying and modifying maladaptive thought patterns, managing negative emotions, and improving marital communication related to infertility. Intervention 2: Control group: Control group (infertile couples): This group will receive no psychological intervention and will only be placed on a waiting list. Pre- and post-test assessments using standardized questionnaires will be conducted for this group. 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 further information available.
public Siyed Kazam Mousavi
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
Ahvaz Iran (Islamic Republic of) 3733361349 +98 61 3334 8420 info@iauahvaz.ac.ir Islamic Azad University scientific Siyed Kazam Mousavi
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
Ahvaz Iran (Islamic Republic of) 3733361349 +98 61 3334 8420 info@iauahvaz.ac.ir Islamic Azad University Iran (Islamic Republic of) Age criterion of 25-45 years for both spouses. Diagnosis of infertility by a gynecologist. Presence of measurable anxiety or depression. Informed consent and willingness of both spouses. 25 years 45 years Both History of severe psychiatric disorder. Current use of psychiatric medications. Concurrent receipt of psychotherapy. Unwillingness of one spouse to participate. N/A N/A Intervention group: Intervention group (infertile couples): This group will receive a cognitive-behavioral counseling protocol based on the interacting cognitive subsystems approach. The intervention will consist of 12 structured 90-minute sessions conducted weekly. Session content will include identifying and modifying maladaptive thought patterns, managing negative emotions, and improving marital communication related to infertility. Control group: Control group (infertile couples): This group will receive no psychological intervention and will only be placed on a waiting list. Pre- and post-test assessments using standardized questionnaires will be conducted for this group. Fertility-Related Quality of Life Index (FERIS). Timepoint: At the beginning of the study (before the intervention began) and two months later (when the intervention ended). Method of measurement: Fertility-Related Quality of Life Questionnaire (Ferticol، 2011). Depression. Timepoint: At the beginning of the study (before the intervention began) and two months later (when the intervention ended). Method of measurement: Beck Depression Inventory-II. Feelings of shame and guilt. Timepoint: At the beginning of the study (before the intervention began) and two months later (when the intervention ended). Method of measurement: Orth Shame and Guilt Scale Questionnaire. Anxiety,. Timepoint: At the beginning of the study (before the intervention began) and two months later (when the intervention ended). Method of measurement: Beck Anxiety Inventory (BAI). Islamic Azad University Approved 2025-08-30 Ethics Committee of Islamic Azad University, Ahvaz Branch Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)