Evaluation the impact of psycho education on anxiety, depression and mania in bipolar disorder patients based on mobile application
Design
This study was two arms randomized clinical trial. The study population consisted of 60 patients aged 18-60 years who were discharged from Ibn Sina psychiatric hospital in Mashhad. They were randomly divided into two groups of intervention and control based on random number table. Then the software was installed on the cellphone of the intervention group and they were asked to use it for three months.
Settings and conduct
The study site is Ibn Sina Psychiatric Hospital in Mashhad
Participants/Inclusion and exclusion criteria
Diagnosis of bipolar I or bipolar II disorder
Having a compatible smartphone
Absence of obvious psychiatric symptoms
No alcohol or drug abuse
No physical illness at the same time
Be literate
Adults aged 18 to 60 years
Intervention groups
"Intervention group": Educational content of the application was extracted and summarized from a psychiatric book entitled "Bipolar Disorder and Continuing Life"and Medscape site. 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. 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 young Mania Rating Scale. After discharge from hospital, the application "Bipolar Disorder and Continuing Life" was installed on the intervention group' mobile phones. They were asked to use the application for three months.
Main outcome variables
Anxiety, Depression, Mania
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190520043645N1
Registration date:2020-01-01, 1398/10/11
Registration timing:retrospective
Last update:2020-01-01, 1398/10/11
Update count:0
Registration date
2020-01-01, 1398/10/11
Registrant information
Name
Bibi Zohreh Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5700
Email address
hashemiz2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-19, 1397/09/28
Expected recruitment end date
2019-01-18, 1397/10/28
Actual recruitment start date
2018-12-19, 1397/09/28
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-05-19, 1398/02/29
Scientific title
Evaluation the impact of psycho education on anxiety, depression and mania in bipolar disorder patients based on mobile application
Public title
Evaluation the impact of psycho education on anxiety, depression and mania in bipolar disorder patients based on mobile application
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Need for inpatient treatment at the time of recruitment, ,
Suicidality
Diagnosis of psychosis ، schizophrenia or an intellectual disability
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
The first center of Seven Alavi Gardens, Campus of Medical Sciences ,Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.KMU.REC.1397.241
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Depression Score in Beck Questionnaire
Timepoint
Three months
Method of measurement
Beck Depression Inventory
2
Description
Anxiety Score in Beck's Inventory
Timepoint
Three months
Method of measurement
Beck Anxiety Inventory
3
Description
Mania score in Young Mania Rating Scale
Timepoint
Three months
Method of measurement
Young Mania Rating Scale
Secondary outcomes
1
Description
1
Timepoint
1
Method of measurement
1
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn sina hospital
Full name of responsible person
Zohreh Hashemi
Street address
The first center of seven Alavi Gardens, Campus of Medical Science, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
hzohreh62@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Deputy Director of Research and Technology
Street address
The first center of Seven Alavi Gardens, Campus of Medical Sciences, Kerman
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
hzohreh62@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Hashemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Haramali Street, next to Astan Quds Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
hzohreh62@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Hashemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Horamali Street, next to Astan Quds Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
7616913555
Phone
+98 34 3132 5700
Email
hzohreh62@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Hashemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Ibn sina Hospital, Haramali Street, next to Astan Quds Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3700 2343
Email
hzohreh62@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available