Protocol summary

Study aim
To screen out the psychosocial issues due to social media addiction. To compare the level of psychosocial issues among male and female students. To screen out the severity level of social media addiction.
Design
This research study will be conducted in two phases: phase-I (screening and identification of psychosocial issues due to social media addiction), and phase-II (management of psychosocial issues due to social media addiction by using CBT). In this study 30, 30 students will be recruited for both groups with psychosocial issues. In phase-II, there will be two groups, experimental group (receive the treatment) and control group (will not receive the treatment) age between 18-25 years. For pre-test and post-test, researcher will use cross sectional research design for baseline assessment and evaluation, and at the time of management of psychosocial issues, there will be experimental research design.
Settings and conduct
Following settings and conduct will be follow in this study: It is not blinded study, Informed consent, Privacy/ confidentiality, Voluntary participation, Right to withdraw, Potential to harm, Anonymity, and Results communication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: University students aged 18-25 (Years) Male, Female students Provide informed consent Exclusion criteria: More than 25 years age and less than 18 years age Do not provide informed consent Students with severe mental health disorder Student who are currently receiving psychological treatment
Intervention groups
There will two intervention groups, experimental group (receive the treatment) and control group (will not receive the treatment) with psychosocial issues.
Main outcome variables
Main outcome variables are: Reduction of Psychosocial issues like Depression, anxiety, stress, cyberbullying, loneliness, social comparison.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241030063547N1
Registration date: 2025-03-09, 1403/12/19
Registration timing: registered_while_recruiting

Last update: 2025-03-09, 1403/12/19
Update count: 0
Registration date
2025-03-09, 1403/12/19
Registrant information
Name
Aamir Iqbal
Name of organization / entity
Islamia University Bahawalpur
Country
Pakistan
Phone
+92 334 7722602
Email address
s22bapsy4m01010@iub.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-06, 1403/11/18
Expected recruitment end date
2025-04-30, 1404/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Screening and Management of Psychosocial Issues Due to Social Media Addiction Among University Students by Using Cognitive Behavior Therapy
Public title
CBT intervention for social media addicts
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
University students Age-18-25 (Years) Male, Female students Who meet the criteria for social media addiction Who experience psychosocial issues Provide informed consent
Exclusion criteria:
More than 25 years age Less than 18 years age Less than substantial level of scoring Do not provide informed consent Students with severe mental health disorder Student who are currently receiving psychological treatment Who do not meet the criteria for social media addiction Who do not experience psychosocial issues
Age
From 18 years old to 25 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
This study will utilize a randomized controlled trial (RCT) design to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) in managing psychosocial issues due to social media addiction among university students. Participants who meet the inclusion criteria will be randomly assigned to either the Intervention Group (CBT therapy) or the Control Group (no intervention) by sealed envelops technique. Randomization will follow a 1:1 allocation ratio to ensure equal distribution of participants across groups. This randomization strategy ensures the study minimizes bias, and allows for valid comparisons between the intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bioethical research committee
Street address
IUB, Bahawalpur, Punjab, Pakistan
City
Bahawalpur
Postal code
63100
Approval date
2024-04-12, 1403/01/24
Ethics committee reference number
1421

Health conditions studied

1

Description of health condition studied
Psychosocial issues due to social media addiction
ICD-10 code
Z56.6
ICD-10 code description
Uncongenial work (Z56.6) Other Physical and Mental Strain Related to Work

Primary outcomes

1

Description
Reduction in severity of psychosocial issues, effectiveness of screening tools, Intervention efficacy, Efficacy of management plan
Timepoint
Before intervention, than after 4 weeks and than at the end of intervention
Method of measurement
Through screening tools of measurement

Secondary outcomes

1

Description
Prevalence of psychosocial issues due to social media addiction
Timepoint
Before and after the intervention
Method of measurement
Through screening tools of measurement

Intervention groups

1

Description
Intervention group: CBT intervention
Category
Prevention

2

Description
Control group: No treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamia University Bahawalpur
Full name of responsible person
Aqeel Ahmad Khan
Street address
Department of applied psychology, Islamia University Bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 300 6846464
Email
aqeelahmad@iub.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamia University Bahawalpur
Full name of responsible person
Aqeel Ahmad Khan
Street address
Islamia University Bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 300 6846464
Email
aqeel.ahmad@iub.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamia University Bahawalpur
Proportion provided by this source
50
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
Islamia University Bahawalpur
Full name of responsible person
Aamir Iqbal
Position
PhD scholar
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
IUB
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 301 7722602
Email
s22bapsy4m01010@iub.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamia University Bahawalpur
Full name of responsible person
Aqeel Ahmad Khan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
IUB
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 300 6846464
Email
aqeel.ahmad@iub.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
IUB
Full name of responsible person
Aamir Iqbal
Position
PhD Scolar
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
IUB
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 301 7722602
Email
s22bapsy4m01010@iub.edu.pk

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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Measuring tools
When the data will become available and for how long
After completion the intervention
To whom data/document is available
Both for academic and business purpose
Under which criteria data/document could be used
Related to the this research
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Simple by using email address
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