Protocol summary

Study aim
The Effictiveness of mobile application Positive Psychological Intervention (PPI) on Improving Well‑Being Among Students of Hamadan Universities during Corona Virus Pandemic.
Design
A, controlled clinical trial with a parallel-group design of 252 students, who will be registered and studied and will be followed for three months.
Settings and conduct
This study will be conducted in the universities of medical sciences, Islamic Azad in Hamadan City. The sample number is 252 students who will be assigned to intervention groups (intervention and control) by cluster method. The intervention includes fourteen application-based education sessions. The intervention is performed at the universities of the experimental group and three months after the intervention, the questionnaires are completed again and the data obtained from the two groups are analyzed and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria also include student enrollment in hamadan universities; Desire to participate in the study (completing the consent form, completing the questionnaire), and having completed at least one semester of the student's education at the mentioned university. Exclusion criteria include students who are unable to respond and participate in the study and have a mental illness under psychological counseling elsewhere, suffering from mental illness; Depression and the use of anti-stress and anxiety medications are noted.
Intervention groups
Students of universities in Hamadan will include students of the University of Medical Sciences, Islamic Azad University of Hamadan .
Main outcome variables
Changes in flourishing scores, measuring depressive symptoms, and fear of covid19 scores

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200914048719N2
Registration date: 2021-05-03, 1400/02/13
Registration timing: retrospective

Last update: 2021-05-03, 1400/02/13
Update count: 0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Hanieh Jormand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0090
Email address
jormand69h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of mobile application Positive Psychological Intervention (PPI) on Improving Well‑Being Among Students of Hamadan Universities during Corona Virus Pandemic
Public title
The Efficacy of Positive Psychological Intervention (PPI) on Improving Well‑Being Among Students of Hamadan Universities
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Access to the Internet Being a student in one of the universities in the city of Hamadan Being interested in participating in the study
Exclusion criteria:
Access to the Internet Being a student in one of the universities in the city of Hamadan Being interested in participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 252
Randomization (investigator's opinion)
N/A
Randomization description
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
Vice Chancellor for Technology Research, Hamadan University of Medical Sciences
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2021-04-09, 1400/01/20
Ethics committee reference number
IR.UMSHA.REC.1400.055

Health conditions studied

1

Description of health condition studied
Flourishing , depressive symptoms, and fear of covid-19
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Positive emotions
Timepoint
Before, one and three months after the intervention
Method of measurement
The Positive and Negative Affect Schedule Scale

2

Description
Basic Psychological Needs
Timepoint
Before, one and three months after the intervention
Method of measurement
Basic Psychological Needs Satisfaction and Frustration Scale

3

Description
Person-Activity Fit
Timepoint
Before, one and three months after the intervention
Method of measurement
Checklist

4

Description
Positive Though
Timepoint
Before, one and three months after the intervention
Method of measurement
Adult Hope Scale

Secondary outcomes

1

Description
Flourishing
Timepoint
Before one and three months after the intervention
Method of measurement
Flourishing scale

2

Description
depressive symptoms
Timepoint
Before one and three months after the intervention
Method of measurement
Depressive symptoms scale

3

Description
Fear of Covid-19
Timepoint
Before one and three months after the intervention
Method of measurement
Fear of Corona Virus Scale (FCV-19S )

Intervention groups

1

Description
In the intervention group: The educational intervention includes 14 application-based education sessions on positive training sessions, each of which includes 40-45 minutes of training with methods of sending exercises and assignments and using multimedia training materials. For example, the first education session aimed at identifying strengths, the second session with the goal of identifying capability, the third session achieving the goal and the fourth session introducing the annoying situation in the corona days and the fifth session to reduce the fear of coronary heart disease and ..... the fourteenth session will be held with the grace of time and non-procrastination with the mentioned methods and training materials based on the application.
Category
Lifestyle

2

Description
Control group: who did not receive any educational intervention, but in order to comply with research ethics , after receiving the results of three months follow up in the intervention group, all educational interventions will be provided to the control group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences and Islamic Azad University of Hamadan
Full name of responsible person
Hanieh Jormand
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences; Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517619657
Phone
+98 81 3838 0717
Email
Fanavari@umsha.ac.ir
Web page address
http://en.umsha.ac.ir/?p=289
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
Barati@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Jormand
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Public Health, Faculty of Health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Jormand
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
6 months after the publication of the article.
To whom data/document is available
All researchers who request data access to one of the authors of the article.
Under which criteria data/document could be used
For further studies.
From where data/document is obtainable
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
What processes are involved for a request to access data/document
Up to one month
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