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IRCT20190520043645N1 IRCT 2020-01-01 Kerman University of Medical Sciences Evaluation the impact of psycho education on anxiety, depression and mania in bipolar disorder patients based on mobile application Evaluation the impact of psycho education on anxiety, depression and mania in bipolar disorder patients based on mobile application 2018-12-19 anticipated 60 Complete https://irct.ir/trial/39685 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: The current study is a two-group randomized trial with pre-test and post-test design. The method used to randomize the random number table was done by the project partner. As the colleague touches one of the numbers and moves in a predetermined direction, the numbers are recorded and assigned to different groups. Randomization was performed at the first measurement at the individual level. Researchers responsible for collecting data and participants were aware of the group's task after randomization. The researchers who analyzed the data were not aware of the group allocation of participants. N/A Bipolar affective disorder. Intervention 1: Intervention group: Educational content of the application was extracted from a psychiatric book entitled "Bipolar Disorder and Continuing Life". All extracted information were summarized and rewrite in simple language. The educational content was disused in an expert panel consisted of psychiatrists and medical bioinformatic. The 12 main topics of the educational content were pharmaceutical therapy, psychiatry therapy, adolescents, marriage, anxiety management, cognitive bias, irritability, communication skill, focusing on goals, health improvement, definitions of concepts and medications. The application with the name of "Bipolar Disorder and Continuing Life", was designed for the Android operating system in the Android Studio environment using Java language. The 12 main topics of educational content was embedded into the application. Each main menus is subdivided into sub-menus according to the volume and categorization of the contents.To evaluate the initial version of the application several psychiatrists and users were assessed the application. Finally, after troubleshooting, the final version of the application was prepared.The participants were evaluated in two stages. In the first step, when entering the study depression, anxiety, and mania of all participants were measured using Beck Anxiety Inventory, Beck Depression Inventory, and Yankee Mania Rating Scale. After discharge from hospital, the application "Bipolar Disorder and Continuing Life" was installed on the patients' mobile phones. Intervention 2: Control group:After randomization, per-test was conducted one day before starting the intervention. Participants were assessed depression, mania and anxiety as outcome variable. Also, post-test was performed one day after the end of intervention. The "Bipolar disorder and continuing life" application did not provided to the control group and they received routine education after discharge. 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 more information
public Zohreh Hashemi
Haramali Street, next to Astan Quds Razavi, Mashhad
Mashhad Iran (Islamic Republic of) 919583134 +98 51 3711 2701 hzohreh62@gmail.com Kerman University of Medical Sciences scientific Zohreh Hashemi
Horamali Street, next to Astan Quds Razavi, Mashhad
Mashhad Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 hzohreh62@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Diagnosis of bipolar I or bipolar II disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) Having a compatible smartphone for the 3-month study period Absence of obvious psychiatric symptoms (euthymic state) No alcohol or drug abuse up to 6 month prior to the study No physical illness at the same time Be literate Sufficient knowledge of the Persian languag Adults aged 18 to 60 years 18 years 60 years Both Need for inpatient treatment at the time of recruitment, , Suicidality Diagnosis of psychosis ، schizophrenia or an intellectual disability F31 Bipolar disorder Behavior N/A Intervention group: Educational content of the application was extracted from a psychiatric book entitled "Bipolar Disorder and Continuing Life". All extracted information were summarized and rewrite in simple language. The educational content was disused in an expert panel consisted of psychiatrists and medical bioinformatic. The 12 main topics of the educational content were pharmaceutical therapy, psychiatry therapy, adolescents, marriage, anxiety management, cognitive bias, irritability, communication skill, focusing on goals, health improvement, definitions of concepts and medications. The application with the name of "Bipolar Disorder and Continuing Life", was designed for the Android operating system in the Android Studio environment using Java language. The 12 main topics of educational content was embedded into the application. Each main menus is subdivided into sub-menus according to the volume and categorization of the contents.To evaluate the initial version of the application several psychiatrists and users were assessed the application. Finally, after troubleshooting, the final version of the application was prepared.The participants were evaluated in two stages. In the first step, when entering the study depression, anxiety, and mania of all participants were measured using Beck Anxiety Inventory, Beck Depression Inventory, and Yankee Mania Rating Scale. After discharge from hospital, the application "Bipolar Disorder and Continuing Life" was installed on the patients' mobile phones. Control group:After randomization, per-test was conducted one day before starting the intervention. Participants were assessed depression, mania and anxiety as outcome variable. Also, post-test was performed one day after the end of intervention. The "Bipolar disorder and continuing life" application did not provided to the control group and they received routine education after discharge. Depression Score in Beck Questionnaire. Timepoint: Three months. Method of measurement: Beck Depression Inventory. Anxiety Score in Beck's Inventory. Timepoint: Three months. Method of measurement: Beck Anxiety Inventory. Mania score in Young Mania Rating Scale. Timepoint: Three months. Method of measurement: Young Mania Rating Scale. 1. Timepoint: 1. Method of measurement: 1. Kerman University of Medical Sciences Approved 2018-07-21 Ethics Committee of Kerman University of Medical Sciences The first center of Seven Alavi Gardens, Campus of Medical Sciences ,Kerman Kerman Kerman Iran (Islamic Republic of)