]>
IRCT20230202057308N1 IRCT 2023-02-11 University of social welfare and rehabilitation sciences Prospective Memory Training for Inpatient Older adults with Severe Mental Illness Razi PM Study Effectiveness of prospective memory training program on prospective memory performance in hospitalized elderly patients suffering from severe psychiatric disorders 2023-04-03 anticipated 60 Complete https://irct.ir/trial/68421 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a single-blind clinical trial. In this sense, the CONSORT criteria will be fully observed. In order to comply with the mentioned criteria, some basic steps should be implemented in the study. The first step is blinding the study as follows: the experimenter/facilitator will be unaware of all the steps of randomization and allocation of intervention and control group members, and these tasks will be performed by other collaborators of the project (this study , one study is a blind examiner/facilitator). Another important step is randomization, which will be implemented as follows: First, all potential participants are screened (the participants, before entering the study, in terms of demographic information, level of symptoms, intelligence, entry and exit criteria and factors Affecting the homogeneity of the study groups, they are placed in random blocks (one person). Then, using a table of random numbers or random blocks (via the random block website, or online randomization), participants are randomized based on demographic information and entry criteria (for example, based on age equalization, gender, level of intelligence, etc.) are assigned to two intervention and control groups. The main examiner/facilitator will be unaware of the allocation of people in the study groups and this step will be done by other collaborators of the project who are not related to the examiner/facilitator, Blinding description: Single blinding of the study is as follows: the experimenter/facilitator will be unaware of all the steps of randomization and allocation of members to the intervention and control groups, and these tasks will be performed by other collaborators of the project (this study is a study , the examiner/facilitator is blind). N/A Condition 1: Severe psychiatric disorders including the spectrum of schizophrenia and bipolar disorder. Condition 2: Bipolar Disorder. Intervention group: To present the present multi-centered intervention, it is necessary to teach its components to the participants before starting the intervention. First, an introduction in very simple language about prospective memory, its function and its tasks is presented. Then, "carrying out the intentions" is taught in simple language and with a concrete example (for example, first a small ball is shown to the participants and it is said that "every position you hold this ball in your hand , this simple command in the "Execution of Intentions" formula is as follows: "If I catch the ball, then I must raise my hand." Similar oral assignments are considered and made for each week. will be implemented. This introduction and, in fact, the warm-up exercise for the patients, prepares them to enter the next part, i.e. doing the tasks related to the PM-Tasks program (the details related to this program are given in the tools section). After practicing with the PM-Tasks program, the participants are ready to play the virtual week game and can play a certain number of game days in each session (details about this program are in the tools section). Since the training and strengthening of prospective memory performance requires continuous but short-term sessions, a program to strengthen this memory has been designed in the form of 6 two-hour sessions (including rest time between sessions). After the intervention, the first and second follow-ups (3 and 6 months) will be done respectively. This point should also be taken into account that according to the ethical duty of the researchers of this study, after the full implementation of the intervention and the completion of the two follow-ups of this study, the intervention will be implemented for the control group so that this group will also benefit from the intervention.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Maintaining confidentiality and scientific use of data Where to obtain: To the person in charge of this study How to obtain: After confirming the identity and purpose of the requester, the data will be sent to him within 3 months while maintaining confidentiality. It should be noted that a written commitment to not misuse the data will also be obtained. Comments:
public Omid Rezaei
Kodakyar Ave., Daneshjo Blvd., Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0066 azinfarzings@gmail.com University of social welfare and rehabilitation sciences scientific Omid Rezaei
Kodakyar Ave., Daneshjo Blvd., Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0066 azinfarzings@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) A) the age of the participants is 55 years and older, B) Being of Iranian origin (mother tongue is Farsi), C) suffering from severe psychiatric disorders (according to the definition, and using DSM 5 criteria) (schizophrenia spectrum and bipolar disorder, D) have at least 5 years of history of the disorder, E) have the desire to participate in the study and give informed consent ,and F) do not have cognitive impairment (have obtained a score of at least 23 on the MMSE scale). 55 years no limit Both A) There are coexisting psychiatric disorders, including anxiety and mood disorders, B) There is a history of ECT treatment in the last 12 months. C) There is a history of alcohol and drug use in the last 12 months, D) Suffering from physical diseases that require treatment at the moment (including diabetes, heart disease, blood pressure) (these diseases)Due to their effect on cognitive functions, especially prospective memory function, they should be controlled and removed in the study. F20 F31 Schizophrenia Bipolar disorder Treatment - Other Intervention group: To present the present multi-centered intervention, it is necessary to teach its components to the participants before starting the intervention. First, an introduction in very simple language about prospective memory, its function and its tasks is presented. Then, "carrying out the intentions" is taught in simple language and with a concrete example (for example, first a small ball is shown to the participants and it is said that "every position you hold this ball in your hand , this simple command in the "Execution of Intentions" formula is as follows: "If I catch the ball, then I must raise my hand." Similar oral assignments are considered and made for each week. will be implemented. This introduction and, in fact, the warm-up exercise for the patients, prepares them to enter the next part, i.e. doing the tasks related to the PM-Tasks program (the details related to this program are given in the tools section). After practicing with the PM-Tasks program, the participants are ready to play the virtual week game and can play a certain number of game days in each session (details about this program are in the tools section). Since the training and strengthening of prospective memory performance requires continuous but short-term sessions, a program to strengthen this memory has been designed in the form of 6 two-hour sessions (including rest time between sessions). After the intervention, the first and second follow-ups (3 and 6 months) will be done respectively. This point should also be taken into account that according to the ethical duty of the researchers of this study, after the full implementation of the intervention and the completion of the two follow-ups of this study, the intervention will be implemented for the control group so that this group will also benefit from the intervention. Prospective memory performance: Prospective memory is the memory related to doing tasks in the future (for example, remembering to take medicine at the appointed time), which tasks are divided into two types of temporal and event tasks. Timepoint: One week before the intervention, 6, 18 and 30 weeks after the intervention. Method of measurement: Virtual Week Game: a computer-based tool designed to assess and enhance factors underlying prospective memory. The virtual week game simulates a number of PM tasks similar to real, everyday tasks associated with prospective memory tasks (for example, remembering to take an antibiotic pill at certain times of the day or returning a book to the library). The game paradigm has a general storyline for seven virtual days and several types of time- and event-dependent PM tasks for each day of the virtual week. Each virtual day includes a dedicated story with a number of PM assignments. The paradigm also allows the experimenter to record the participants' performance. Level of independence: A person's ability to perform several skills such as shopping, cooking, and managing finances, which are critical skills for older adults to be able to live independently, is influenced by prospective memory performance. Timepoint: 1 week before the intervention (pre-test), immediately after the end of the intervention (at the end of week 6), 18 and 30 weeks after the end of the intervention (study follow-ups). Method of measurement: Instrumental Daily Living Activities (IADL): A questionnaire to assess the level of individual independence that can be used as a self-report as well as an interview (in hospitalized conditions). The tool measures a person's ability in several skills, such as shopping, cooking and managing finances (which are critical skills for older adults to be able to live independently). This scale takes 10 to 15 minutes to complete and includes eight areas of daily functioning with scores of 0 to 8. This scale can be used as a written questionnaire or as an interview scale. Depression level: prospective memory performance in the elderly has a significant effect on factors related to mental health (anxiety and depression levels) of these people. Therefore, measuring the level of depression and anxiety in this study are considered as secondary variables. Timepoint: 1 week before the intervention (pre-test), immediately after the end of the intervention (at the end of week 6), 18 and 30 weeks after the end of the intervention (study follow-ups). Method of measurement: The Geriatric Depression Scale (GDS): A questionnaire to assess the symptoms of depression in the elderly, which can be used in both normal and clinical populations. The GDS consists of 30 questions in which participants have to answer yes or no questions based on their mood about the situations mentioned in the past week. The cutoff score for this scale is 11 and above. Therefore, higher scores on the GDS indicate worse performance. It can be executed within 5 to 7 minutes. This scale can be used for healthy and sick elderly people (even with mild to moderate cognitive impairment). In GDS scoring, each question is given a score of 0 or 1 based on the nature of the question, so for some questions, if the answer is positive, the score will be 1, and for some, if the answer is positive, the score will be 0. Anxiety level: prospective memory performance in the elderly has a significant effect on factors related to mental health (anxiety and depression levels) of these people. Therefore, measuring the level of depression and anxiety in this study are considered as secondary variables. Timepoint: 1 week before the intervention (pre-test), immediately after the end of the intervention (at the end of week 6), 18 and 30 weeks after the end of the intervention (study follow-ups). Method of measurement: The Geriatric Anxiety Inventory (GAI): (a questionnaire to assess anxiety symptoms in the elderly that can be used in both normal and clinical populations). This instrument has 30 items (the only scorable items are items 1 to 25. Items 26 to 30 can be used for clinical purposes to test individual domains of interest. They are used for a total score or none of the subscale scores are not calculated). This scale is used to assess anxiety symptoms among the elderly. People respond to the items on a four-point Likert scale from "not at all" (0) to "always" (3). This scale does not have a clear cut score reported. Higher scores on this scale indicate higher levels of anxiety. It takes about 10 minutes to complete this test. University of social welfare and rehabilitation sciences Approved 2023-01-29 Ethics Committee of the University of Rehabilitation Sciences and Social Health Kodakyar Ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)