Evaluation of the effect of minor depression self-care software on the severity of depression among students of Mazandaran University of Medical Sciences
The effect of mobile self-care software, on the severity of minor depression in students of Mazandaran University of Medical Sciences (2021)
Design
A concealed, randomized clinical trial with an intervention group and a control group, in which 56 students are grouped by random numbers using the SAS software.
Settings and conduct
Research environment: Mazandaran University of Medical Sciences Patients will be randomly assigned to one of the two groups of mobile therapy and the control group based on random numbers. In the mobile-based treatment group, software containing treatment assignments will be provided to patients. No assignments are given in the control group. Participants will not be given information about the group they are in.
Participants/Inclusion and exclusion criteria
Students that studying at Mazandaran University of Medical Sciences; Students with access to smartphones; Students with minor depression (based on PHQ-9). Exclusion criteria: Students who have suicidal thoughts.
Intervention groups
The intervention group includes students with minor depression who install a designed mobile system and use it for their treatment. The severity of depression in these people will be measured by this app on a weekly basis. The control group includes students who have minor depression and will not receive any intervention. Like the intervention group, the severity of their depression will be measured weekly.
Main outcome variables
Degree of depression severity measured using PHQ-9 tool.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201031049206N1
Registration date:2021-01-13, 1399/10/24
Registration timing:prospective
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Saeed Barzegari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 3037
Email address
barz_saeed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of minor depression self-care software on the severity of depression among students of Mazandaran University of Medical Sciences
Public title
Design, implementation and evaluation of screening and self-care software for minor depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
En Be a student of Mazandaran University of Medical Sciences.
According to PHQ-9 tool have minor depression.
Exclusion criteria:
Taking sedatives
Dissatisfaction
Underlying diseases such as hypothyroidism and ...
History of self-harm
History of suicide
Age
From 18 years old to 26 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
A simple individual randomization method with flipping coins will be used.
Randomization tool: SAS statistical software.
We will use the website to create a random sequence.
We will use the central randomization method (email) for allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Health and Paramedical Sciences - Tehran University of Medical Science
Before the intervention, 7, 14, and 21 days after the start of the intervention
Method of measurement
PHQ-9 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Students install the software on their smartphone and complete the PHQ-9 questionnaire. If they have a mild depression, they are invited to use the software. Participants will follow the assignments provided in the software for 4 weeks (4 sessions, each session is two weeks). The proposed intervention includes a combination of basic cognitive-behavioral therapy and self-regulatory therapy. The tasks are the worksheets and concepts of these two treatments.In the first session, the user will be given tasks to improve self-awareness and tools for daily planning.Our goal in the second session is behavioral activation,Identify lost activities, and prevent idealism.In the third session, we increase the areas of activity and the number of activities of the behavioral activation worksheet and lead the user to choose promotion activities, we will identify users areas of life that have promotion or deterrence goals, we will identify the person's negative thoughts.In the final session, we will extend behavioral activation to various areas of the user's life, we will replace negative thoughts with logical ones, and by determining the costs and benefits of perfectionist thoughts, we will prepare the user to reconsider and determine realistic thoughts, we will also determine the cost-effectiveness of this changes for each of their goals.At the end of each session, the severity of their depression will be measured by the PHQ-9 questionnaire.
Category
Behavior
2
Description
Control group: The rest of the students whose mild depression was confirmed by the questionnaire will be grouped in the control group.These students will not be subject to any intervention and we will receive their depression severity at the end of each week (4 weeks) via email.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Dean of Amol School of Nursing, Midwifery and Paramedical Sciences
Street address
Talib Amoli St., Fayyaz Bakhsh Alley
City
Amol
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 4422 1919
Email
ict@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
No. 17, Fardanesh Alley, Ghods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
44361-14177
Phone
+98 21 8898 2905
Email
alliedmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saeed Barzegari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Information Management
Street address
No. 27, Ostad Shahriyar Alley, First 12 Meter Alley
City
Ahar
Province
East Azarbaijan
Postal code
5451773979
Phone
+98 41 4423 7355
Email
barz_saeed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Barzegari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Information Management
Street address
No. 27, Ostad Shahriyar Alley, First 12 Meter Alley
City
Ahar
Province
East Azarbaijan
Postal code
5451773979
Phone
+98 41 4423 7355
Email
barz_saeed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Barzegari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Information Management
Street address
No. 27, Ostad Shahriyar St., the first 12-meter alley
City
Ahar
Province
East Azarbaijan
Postal code
5451773979
Phone
+98 41 4423 7355
Email
barz_saeed@yahoo.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
No - There is not 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