Investigating the effect of body psychotherapy on Perception of time, decision making ,boredom and Internet addiction, with the mediating role of:executive functions and emotional regulation
Investigating the effect of body psychotherapy on Perception of time, decision making ,boredom and Internet addiction, with the mediating role of :executive functions and emotional regulation
Design
Clinical trial with a control group and a sample size of 60 participants, with parallel groups, single blind, randomized with Trek software
Settings and conduct
This study is an experimental method (pre-test and post-test) and single blind intervention which is done in students of Kashan University of Medical Sciences .The sample size is 60 participant that divided into two groups of 30 participant. In the experimental group for a period of 60 days, participants are participate in body psychotherapy sessions during 60 days. In the control group, general psychological training, such as the history of psychologists
Participants/Inclusion and exclusion criteria
Inclusion criteria: vulnerable of the participants to the experiment ؛ Age between of 18-30 years old ؛ participant scored above 64 in the internet addiction test and had only internet addiction in the clinical interview؛ No drug use or smoking ؛ Not under any type of psychotherapy or not used before ؛No mental disorder and not use of psychiatric medication.
Exclusion criteria: leave from the experiment or not assisting enough ؛ use any kind of drugs during the research ؛ novel diagnosed chronic physical disease or mental disorders that interferes with the test results
Intervention groups
Intervention group: includes 30 participants. body awareness psychotherapy for 60 days. Control group: includes 30 participants. The use of general psychological education (history of psychologists)
Main outcome variables
Primary outcomes in perception of time, decision making, boredom and level of addiction of people addicted to the Internet, secondary outcomes of executive functions and emotion regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061584N1
Registration date:2024-05-07, 1403/02/18
Registration timing:prospective
Last update:2024-05-07, 1403/02/18
Update count:0
Registration date
2024-05-07, 1403/02/18
Registrant information
Name
Maliheh Fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 314 6775
Email address
fallah-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of body psychotherapy on Perception of time, decision making ,boredom and Internet addiction, with the mediating role of:executive functions and emotional regulation
Public title
Investigating the effect of body psychotherapy on Perception of time, decision making ,boredom and Internet addiction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteering participants to the experiment
Age between18-30 years old
All participant who have scored above 64 in the chen internet addiction test and have an interview with internet addiction.
Not using drugs and not smoking ciggerate or any type of this
Any type of psychotherapy or has not used it before
Absence of psychosis and non-use of psychiatric drugs
Exclusion criteria:
Put off from the research or not assisting enough
Starting to use any kind of drugs during in the research
Novel diagnosed chronic physical disease that interferes with the test results, including chronic mental disorder or diabetes, hypertension or heart disease and hepatitis, etc.
Novel diagnosed mental disorders or start using psychiatric drugs.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This test is conducted in the age range of 18-30, the sample size is 60 participant, and randomly divided into two groups of 30 people, test and control. For single blind, blinding is coded 1, 2, and also randomization is done using Stat Trek software and based on the random number table method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the participant, codes 1 and 2 are placed
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Rawandi St
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.011
Health conditions studied
1
Description of health condition studied
Internet addiction
ICD-10 code
F63.8
ICD-10 code description
Other impulse disorders
Primary outcomes
1
Description
Chen et al internet addiction score
Timepoint
Completing the questionnaire before and after 60 days of psychotherapy intervention
Method of measurement
Chen et al internet addiction scale
2
Description
Body awareness psychotherapy
Timepoint
60 days body psychotherapy
Method of measurement
Body awareness questionnaire
3
Description
Perception of time
Timepoint
Before and after a 60-day body awareness psychotherapy intervention
Method of measurement
Computer task Perception of time Broadway and Engle
4
Description
Decision making
Timepoint
Before and after a 60-day body awareness psychotherapy intervention
Method of measurement
Iowa Gambling Task
5
Description
Boredom
Timepoint
Before and after a 60-day body awareness psychotherapy intervention
Method of measurement
Multidimensional scale of boredom 2002
Secondary outcomes
1
Description
Emotion regulation
Timepoint
Before and after 60-day body awareness psychotherapy intervention
Method of measurement
Difficulty in Emotion Regulation Scale (DERS)
2
Description
Executive function
Timepoint
Before and after 60-day body awareness psychotherapy intervention
Method of measurement
Computer Stroop task
Intervention groups
1
Description
Intervention group: Before the intervention, the participants are evaluated about Internet addiction, and then body awareness psychotherapy is taught for 60 days, in 90-minute weekly sessions and then Internet addiction tests are examined again.
Category
Rehabilitation
2
Description
Control group: Before the intervention, the participants are evaluated about Internet addiction, and then general psychoeducation, such as the history of psychologists, is taught for 60 days ؛ once a week in 90-minute sessions, and then Internet addiction tests are examined again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
Maliheh fallah
Street address
Ravandi Street
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
fallah-m@kaums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Maliheh Fallah
Street address
Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
fallah-m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.gholamali hamidi
Street address
Vice President of Research and Technology, Kashan University of Medical Sciences, ravandi st
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
hamiidi@yahoo.com
Grant name
kashan university medical Sieneses
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Amir ghaderi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
addiction studies
Street address
Faculty of Medicine, Kashan University of Medical Sciences, ravandi street
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
gaderiam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir ghaderi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D in addiction studies
Street address
Faculty of Medicine, Kashan University of Medical Sciences, Ravandi Street
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 937 314 6775
Email
gaderiam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maliheh fallah
Position
clinical psychologist
Latest degree
Master
Other areas of specialty/work
Ph.D. candidate addiction studies
Street address
Faculty of Medicine, Kashan University of Medical Sciences, Ravandi Street
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 937 314 6775
Email
fallah-m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of participant information
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