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IRCT20240521061854N2 IRCT 2025-11-19 The University of Mohaghegh Ardabili Comparison of the effectiveness of computer-based cognitive rehabilitation and transcranial direct current stimulation on cognitive functions in patients with schizophrenia CCRT-tDCS Study Comparison of the Effectiveness of Computer-Based Cognitive Rehabilitation and Transcranial Direct Current Stimulation (tDCS) on Improving Cognitive Functions in Patients with Chronic Schizophrenia 2025-12-12 anticipated 54 Complete https://irct.ir/trial/86836 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization of participants was performed after assessing the inclusion criteria and obtaining informed consent. A block randomization method with a block size of six was used to ensure a balanced distribution of participants across the three study groups (computer-based cognitive rehabilitation, transcranial direct current stimulation, and control). The unit of randomization was the individual, and no cluster randomization was applied. To control for demographic variables such as age and gender, stratified randomization was implemented. The allocation sequence was generated by the study statistician using SPSS version 26 and a table of random numbers, and the final assignment was conducted through numbered, opaque, sealed envelopes to maintain allocation concealment and prevent potential bias in the assignment process, Blinding description: A single-blind design was implemented in this study. Participants were unaware of their allocation to one of the three groups (transcranial direct current stimulation, computer-based cognitive rehabilitation, or control group) to minimize potential bias due to expectancy effects. The researchers, intervention administrators, outcome assessors, and data analysts were aware of the group assignments, as full blinding was not feasible given the nature of the interventions. However, all participants were treated under similar environmental conditions, session schedules, and researcher interactions to minimize subjective bias across groups. N/A Schizophrenia spectrum disorder. Intervention 1: Intervention Group 1: Computer-based Cognitive Rehabilitation. Participants in this group will perform cognitive rehabilitation exercises using the Captain Log software to improve cognitive functions such as working memory, cognitive flexibility, and attention. Intervention 2: Intervention Group 2: Transcranial Direct Current Stimulation (tDCS)Participants will undergo transcranial direct current stimulation to enhance cognitive functions such as attention and impulse control. Intervention 3: Control group: Participants in this group will receive only standard pharmacological treatment and routine care without any additional intervention. Yes - There is a plan to make this available What will be shared: Raw data from neuropsychological test scores (including N-Back, Simple Stroop, and Continuous Performance Test) will be available in Excel format after de-identification of participants. Shared data will include only outcome-related variables (primary and secondary) and will not contain any personal or identifiable information of patients. When: Access to the data will begin six months after publication of the study results in a scientific journal and will remain available for five years thereafter. To whom: The data will be available to researchers and academic staff from universities and research centers who submit a written request and specify a clear research purpose. Conditions: The data may be used only for research and educational purposes. Any commercial use or redistribution without written permission from the study investigators is prohibited. Requests must include a research proposal, study objectives, and a confidentiality agreement. Where to obtain: Requests for access to study data or related documents should be directed to the corresponding researcher via email. How to obtain: Data access requests will be reviewed by the principal investigator upon receipt via email. The research purpose and eligibility of the applicant will be evaluated. Upon approval and signing of a confidentiality and data use agreement, anonymized data will be shared within 4 weeks. Comments:
public Mahdis Alaei Kalajahi
University of Mohaghegh Ardabili, End of Daneshgah Street, Ardabil, Iran
Ardabil Iran (Islamic Republic of) 5619911367 +9894134787055 mahdisalaeikl@gmail.com The University of Mohaghegh Ardabili scientific Mahdis Alaei Kalajahi
University of Mohaghegh Ardabili, End of Daneshgah Street, Ardabil, Iran
Ardabil Iran (Islamic Republic of) 5619911367 +98 41 3478 7055 mahdisalaeikl@gmail.com The University of Mohaghegh Ardabili Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 20 and 60 years basic literacy in reading and writing definite diagnosis of schizophrenia spectrum disorder based on DSM-5 criteria and confirmed by a psychiatrist at least one year since disease onset and hospitalization stable medication regimen and clinical stability during the past three months (no medication change and stable psychotic symptoms) no history of major neurological or cognitive disorders, epilepsy, brain injury, or intellectual disability ability to participate and cooperate in cognitive rehabilitation sessions and cognitive assessments providing informed consent by the patient or legal guardian and obtaining institutional approval for participation 20 years 60 years Both Presence of major neurological or cognitive disorders such as epilepsy, brain injury, or intellectual disability Current or recent (within the past six months) substance abuse or alcohol dependence Clinical instability or recent changes in antipsychotic medication during the past three months Presence of severe or disabling physical illness that prevents participation in therapeutic sessions or study assessments Inability to read, write, or understand test instructions and cognitive rehabilitation tasks Dominant psychiatric comorbidities other than schizophrenia spectrum disorders that may interfere with diagnosis Lack of informed consent or refusal to participate by the patient or legal guardian Pregnancy or breastfeeding (if female participants are included) F20 Schizophrenia Rehabilitation Treatment - Devices Other Intervention Group 1: Computer-based Cognitive Rehabilitation. Participants in this group will perform cognitive rehabilitation exercises using the Captain Log software to improve cognitive functions such as working memory, cognitive flexibility, and attention. Intervention Group 2: Transcranial Direct Current Stimulation (tDCS)Participants will undergo transcranial direct current stimulation to enhance cognitive functions such as attention and impulse control. Control group: Participants in this group will receive only standard pharmacological treatment and routine care without any additional intervention. The cognitive performance scores of patients with chronic schizophrenia, assessed using standard neuropsychological tests (including the N-Back, Simple Stroop, and Continuous Performance Test). Timepoint: Outcome measures will be assessed at three time points: pre-test (before the intervention), post-test (immediately after the intervention), and two-month follow-up (two months after the intervention). Method of measurement: Cognitive functions of participants will be assessed using standardized neuropsychological tests and their computerized versions. Response inhibition, selective attention, and cognitive flexibility will be measured by the Simple Stroop Test; working memory and processing speed by the N-Back Task; sustained attention and impulsivity control by the Continuous Performance Test; and social cognition by the Reading the Mind in the Eyes Test. All assessments will be administered by a trained evaluator in a controlled environment. Cognitive Flexibility: Changes in cognitive flexibility after the intervention will be assessed. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Simple Stroop Test. Selective Attention: The effect of the intervention on selective attention will be evaluated. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Simple Stroop Test. Response Inhibition: The study examines changes in response inhibition following the intervention. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Simple Stroop Test. Processing Speed: Processing speed will be measured as a secondary outcome. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Simple Stroop Test. Sustained Attention: Improvements in sustained attention after the intervention will be assessed. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Continuous Performance Test. Impulsivity Control: The effect of the intervention on impulsivity control will be evaluated. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Continuous Performance Test. Working Memory: Changes in working memory after the intervention will be measured. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: n-back Test. Social Cognition: The impact of the intervention on social cognition will be assessed. Timepoint: In this study, the secondary outcome variables will be measured at three time points: before the intervention (pre-test), immediately after the completion of the intervention (post-test), and two months after the intervention (follow-up). Method of measurement: Reading the Mind in the Eyes Test. The University of Mohaghegh Ardabili Approved 2025-09-24 Ethics committee of University of Mohaghegh Ardabili University of Mohaghegh Ardabili, End of Daneshgah Street, Ardabil, Iran Ardabil Ardabil Iran (Islamic Republic of)