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IRCT20251024067740N1 IRCT 2025-11-04 Islamic Azad University Comparing the Effectiveness of Cognitive-Behavioral Therapy and Mindfulness-Based Stress Reduction in people with Mild Cognitive Impairments Comparing the Effectiveness of Cognitive-Behavioral Therapy and Mindfulness-Based Stress Reduction on Quality of Life, Perceived Stress, Attention and Working Memory in Individuals with Mild Cognitive Impairments. 2025-11-08 anticipated 45 Complete https://irct.ir/trial/87115 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients diagnosed with Mild Cognitive Impairment (MCI) will be randomly assigned to the intervention and control groups using a lot-drawing randomization method. Each participant was assigned a unique number, and the sample numbers were then randomly selected using the Excel software to determine group allocation, Blinding description: participants are unaware of the intervention identity. Allocation uses neutral codes (A/B). N/A Mild Cognitive Impairment. Intervention 1: Intervention group:Cognitive-Behavioral Therapy, Cognitive Behavioral Therapy (CBT), based on the classical cognitive-behavioral approach, will be conducted with the aim of improving the cognitive, behavioral, and emotional states of participants in the experimental group through nine group therapy sessions, held once a week, each lasting 90 minutes. Intervention 2: Intervention group:Mindfulness-Based Stress Reduction, The Mindfulness-Based Stress Reduction (MBSR) program will be conducted in eight weekly sessions. Each session will typically last for two and a half hours and will follow a structured program. Intervention 3: Control group:No intervention، They were included in the study for comparison with the intervention groups and did not receive any medication, placebo, or treatment. 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 is available.
public Anahita Tarki
No. 12, Pirooz Street., Shariati Ave., Tehran Town,. Iran
Tehran Iran (Islamic Republic of) 1661743539 +98 21 2670 0944 anahitatarki2013@gmail.com Islamic Azad University scientific Anahita Tarki
No. 12, Pirooz Street., Shariati Ave., Tehran Town
Tehran Iran (Islamic Republic of) 1661743539 +98 21 2670 0944 anahita.tarki@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) Receiving a confirmed diagnosis of Mild Cognitive Impairment (MCI) by a neurology specialist. Being between 60 and 80 years of age. Fluency in Persian language and having at least 8 years of formal education. The participant’s ability to attend treatment sessions as scheduled according to the therapeutic protocols and to regularly perform the exercises related to each intervention. The ability to write and fully complete the questions of self-report instruments and computer-based tools across the three stages of implementation. 60 years 80 years Both A confirmed diagnosis of any type of progressive dementia. Having progressive neurological disorders, or a diagnosed cognitive impairment resulting from conditions such as COVID-19 infection, brain injury, stroke, multiple sclerosis (MS), Parkinson’s disease, or other similar causes. Absence from more than four sessions in any of the intervention programs. Exacerbation of symptoms, hospitalization, or undergoing anesthesia and surgery during the implementation of the protocols. Presence of severe visual or hearing impairments, history of stroke, transient ischemic attack (TIA), or head injury with a history of loss of consciousness. History of internal medical conditions such as uncontrolled diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, obstructive sleep apnea, or a history of HIV infection. Presence of major neurological or psychiatric disorders, including stroke, epilepsy, seizures, Parkinson’s disease, multiple sclerosis (MS), brain injuries, diagnosed schizophrenia, adult attention-deficit/hyperactivity disorder (ADHD), or any condition requiring frequent hospital visits or hospitalizations. Dependence on or abuse of substances or specific medications. G31.84 Mild cognitive impairment, so stated Treatment - Other Treatment - Other Treatment - Other Intervention group:Cognitive-Behavioral Therapy, Cognitive Behavioral Therapy (CBT), based on the classical cognitive-behavioral approach, will be conducted with the aim of improving the cognitive, behavioral, and emotional states of participants in the experimental group through nine group therapy sessions, held once a week, each lasting 90 minutes. Intervention group:Mindfulness-Based Stress Reduction, The Mindfulness-Based Stress Reduction (MBSR) program will be conducted in eight weekly sessions. Each session will typically last for two and a half hours and will follow a structured program. Control group:No intervention، They were included in the study for comparison with the intervention groups and did not receive any medication, placebo, or treatment. Quality of Life. Timepoint: Before the intervention – Immediately after the intervention – Three-month follow-up after the intervention. Method of measurement: world health organization- quality of life questionnaire (WHOQOL-100). Perceived Stress. Timepoint: Before the intervention – Immediately after the intervention – Three-month follow-up after the intervention. Method of measurement: percieved stress scale-14 (PSS-14). Attention. Timepoint: Before the intervention – Immediately after the intervention – Three-month follow-up after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used in the subtests of Rapid Visual Information Processing (RVP) and Match to Sample Visual Search (MTS). Working Memory. Timepoint: Before the intervention – Immediately after the intervention – Three-month follow-up after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB) in the Spatial Working Memory (SWM) subtest. Islamic Azad University, Karaj Branch Approved 2024-04-23 Research Ethics Committees of Islamic azad University - Karaj Branch Islamic Azad University, Karaj Branch, Shahid Chamran Boulevard, Karaj, Alborz Province, Iran karaj Alborz Iran (Islamic Republic of)