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IRCT20230305057617N1 IRCT 2023-04-13 Qazvin University of Medical Sciences The effect of software monitoring on relapse of bipolar disease Evaluating the effect of mobile application-based monitoring in reducing disorder recurrence in bipolar patients 2023-04-21 anticipated 50 Complete https://irct.ir/trial/69066 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Making mobile phone software, Randomization description: The randomization method is simple. The unit of randomization is individual and its tool is a table of random numbers. Creating a random sequence using web randomization. Concealment is done by central randomization method. N/A Bipolar Disorder. Intervention 1: Intervention group: First, the monitoring software will be installed on the patients' phones and the patients will be taught how to use the software. Patients are prompted with an alarm in the system to perform their daily monitoring. The symptoms that patients should evaluate on a daily basis will include mood, activity level, sleep duration, and drug consumption. For the convenience of patients, this system will be designed in Persian language and will be available to patients. Intervention 2: Control group: In the control group, without installing the software, they are visited the same as the control group, and the symptoms of the disease are monitored by a questionnaire. 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 There is no further information
public Zahra Arabyazdi
22Bahman Hospital; Pastor Alley; Rahahan Street
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3355 5054 Za.yazdi@gmail.com Qazvin University of Medical Sciences scientific Zahra Arzbyazdi
22Bahman Hospital; Pastor Alley; Rahahan Street
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3355 5054 Za.yazdi@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Having a minimum level of literacy Having a smartphone Diagnosis of bipolar disorder according to DSM-V Discharge following an episode (depression, mania, or mixed episode) from a psychiatric hospital 18 years no limit Both pregnancy substance use Lack of Persian language skills Lack of consent to participate in the study F31 Bipolar disorder Rehabilitation Rehabilitation Intervention group: First, the monitoring software will be installed on the patients' phones and the patients will be taught how to use the software. Patients are prompted with an alarm in the system to perform their daily monitoring. The symptoms that patients should evaluate on a daily basis will include mood, activity level, sleep duration, and drug consumption. For the convenience of patients, this system will be designed in Persian language and will be available to patients. Control group: In the control group, without installing the software, they are visited the same as the control group, and the symptoms of the disease are monitored by a questionnaire. The rate of readmission. Timepoint: Patients are visited by a psychiatrist 2 weeks, 6 weeks, 2 months, and 6 months after discharge, and the use of the software is checked with available charts and the study objectives are checked with questionnaires. Method of measurement: Use of patients' electronic files. Duration of re-hospitalization. Timepoint: Patients are visited by a psychiatrist 2 weeks, 6 weeks, 2 months, and 6 months after discharge, and the use of the software is checked with available charts and the study objectives are checked with questionnaires. Method of measurement: Use of patients' hospitalization records. Recurrence of depressive symptoms. Timepoint: Patients are visited by a psychiatrist 2 weeks, 6 weeks, 2 months, and 6 months after discharge. Method of measurement: Hamilton Depression Rating Scale. Recurrence of mania symptoms. Timepoint: Patients are visited by a psychiatrist 2 weeks, 6 weeks, 2 months, and 6 months after discharge. Method of measurement: Young Mania Rating Scale. General health status. Timepoint: Patients are visited by a psychiatrist 2 weeks, 6 weeks, 2 months, and 6 months after discharge. Method of measurement: General Health Questionnaire. Qazvin University of Medical Sciences Approved 2022-07-20 Ethics Committee of Qazvin University of Medical Sciences 22bahman hospital; Pastor Alley; Rahahan Street Qazvin Qazvin Iran (Islamic Republic of)