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IRCT20240110060672N1 IRCT 2024-02-17 Iran University of Medical Sciences Comparing the effectiveness of Cognitive Rehabilitation and Cognitive Behavioral Therapy (CBT) on reducing depressive symptoms and improving the quality of life in the elderly with Major Depressive Disorder (MDD) Comparing the effectiveness of Cognitive Rehabilitation and Cognitive Behavioral Therapy (CBT) on reducing depressive symptoms and improving the quality of life in the elderly with Major Depressive Disorder (MDD) 2023-10-23 anticipated 34 Complete https://irct.ir/trial/74937 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: This study is conducted as a double-blind study. The person responsible for assessing the elderly individuals based on the inclusion criteria and referring them to the main researcher will be unaware of the treatment assigned to each patient. Similarly, the trained person evaluating the effectiveness of the treatment will also be unaware of the type of treatment provided to the elderly. This process will be further explained in order to ensure double-blinding. To achieve double-blinding, cards with codes written on them are used. These codes are based on a randomization table with balanced blocks that were designed in advance. The coordinator will have access to these cards and will distribute them to individuals who meet the entry criteria and have completed the informed consent. The cards will then be provided to the main researcher for future reference. The main researcher or therapist will observe the letter written in front of each patient's code on the randomization table. If the letter A is written, cognitive rehabilitation intervention will be performed. If the letter B is written, cognitive behavioral therapy will be administered. Before the intervention begins, the effectiveness of the treatment will be evaluated by a trained person who is unaware of the treatment assigned to each patient. This person will enter the results of each test, along with the corresponding number and name of each elderly individual, into Excel, Blinding description: This study is conducted as a double-blind study. The person responsible for assessing the elderly individuals based on the inclusion criteria and referring them to the main researcher will be unaware of the treatment assigned to each patient. Similarly, the trained person evaluating the effectiveness of the treatment will also be unaware of the type of treatment provided to the elderly. This process will be further explained in order to ensure double-blinding. N/A Major Depressive Disorder (MDD). Intervention 1: Intervention group 1: Cognitive rehabilitation. Intervention 2: Intervention group 2: Cognitive Behavioral Therapy (CBT). No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Nafee Rasouli
Motahari street, Hosseini rad
Tehran Iran (Islamic Republic of) 1599953511 +98 21 8891 2928 nafeerasouli@gmail.com Iran University of Medical Sciences scientific Nafee Rasouli
Motahari street, Hosseinirad
Tehran Iran (Islamic Republic of) 1599953511 +98 21 8891 2928 nafeerasouli@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of major depression by semi-structured SCID interview A score higher than 6 in the Geriatric Depression Scale (GDS) Receiving antidepressants (SSRI) At least 3 weeks have passed since the start of drug treatment At least 55 years old Education above seventh grade 55 years no limit Both Major and minor cognitive impairment based on DSM-5 A score lower than 26 in the MoCA Having psychotic disorders or brain damage Rehabilitation Treatment - Other Intervention group 1: Cognitive rehabilitation Intervention group 2: Cognitive Behavioral Therapy (CBT) Depression symptoms. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Depression criteria of DSM-5 (SCID), Geriatric Depression Scale (GDS). Quality of life. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: The World Health Organization Quality of Life Persian questioner. Executive function. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Trial making test, Verbal fluency. Attention and consentration. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Digit span (DS). Information processing speed. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Symbol Digit Modality Test (SDMT). Verbal memory. Timepoint: In three stages including: the beginning of the study (before the start of the intervention), immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Logical Memory (LM). grant Approved 2023-07-23 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)