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 behavioral therapy and cognitive rehabilitation intervention on reducing depressive symptoms and the quality of life in the elderly with major depressive disorder

The clinical trial consists of two treatment groups. A randomization table with balanced blocks will be used. To ensure blinding, the coordinator and evaluator will not be aware of the intervention given to each patient. Patients will be evaluated on three occasions. The sample size for each group is 17 individuals.

The research environment is the clinic of the Iran University of Medical Sciences. To ensure the double-blind process, cards with codes are given to eligible participants. The main researcher will receive the assigned card for each patient. A: cognitive rehabilitation intervention, B: cognitive behavioral therapy. A trained individual, who is unaware of the treatment type, will evaluate the effectiveness of the treatment.

Entry criteria: Obtaining a diagnosis of major depression, scoring higher than 6 on the Geriatric Depression Scale, Receiving antidepressants, age over 55 years, education above seventh grade. Non-entry criteria: Suffering from cognitive disorders, scoring higher than 26 on the Montreal Cognitive Assessment Test, Suffering from psychotic disorders or brain damage

In the cognitive-behavioral intervention group (gold standard treatment), we will be using the treatment protocol for elderly depression. This protocol consists of 7 main modules. We have specifically 4 modules in cognitive rehabilitation group. Both groups of patients will receive 16 intervention sessions, twice a week.

The main outcome: depression symptoms and quality of life. Secondary outcomes: executive function, attention and concentration, processing speed, and verbal memory.

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.

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.

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