History
# Registration date Revision Id
3 2024-11-20, 1403/08/30 321688
2 2023-09-20, 1402/06/29 279720
1 2023-08-19, 1402/05/28 275812
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  • General information

    empty
    Changing the person responsible for answering questions and the person responsible for scientific research
    empty
    تغییر مسئول پاسخگویی به سوالات و مسئول تحقیقات علمی
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: AZAD university
    Name of organization / entity - Persian: دانشگاه آزاد
    Full name of responsible person - English: masume bakhtiari
    Full name of responsible person - Persian: معصومه بختیاری
    Position - English: student
    Position - Persian: دانشجوی دکترا
    Latest degree: a_level
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Babaei highway (west to east), Hakimiya exit, Shahid Sadoughi street, Fafadar Boulevard
    Street address - Persian: بزرگراه شهید بابایی(غرب به شرق)، خروجی حکیمیه،خیابان شهید صدوقی، بلوار وفادار
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1651153511
    Phone: +98 21 7700 9801
    Mobile: 9058348198 0098
    Fax:
    Email: bakhtiarimasume@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mojtaba Habibi asgarabad
    Full name of responsible person - Persian: مجتبی حبیبی عسگرآباد
    Position - English: professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Iran University of Medical Sciences, Hemat Highway, next to Milad Tower
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Mobile: 9122387577 0098
    Fax:
    Email: Habibi.m@iums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad university
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: masume bakhtiari
    Full name of responsible person - Persian: معصومه بختیاری
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Babaei highway (west to east), Hakimiya exit, Shahid Sadoughi street, Fafadar Boulevard
    Street address - Persian: بزرگراه شهید بابایی(غرب به شرق)، خروجی حکیمیه،خیابان شهید صدوقی، بلوار وفادار
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1651153511
    Phone: +98 21 7700 9801
    Mobile: 9058348198 0098
    Fax:
    Email: bakhtiarimasume@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mojtaba Habibi asgarabad
    Full name of responsible person - Persian: معصومه بختیاریمجتبی حبیبی عسگرآباد
    Position - English: professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Iran University of Medical Sciences, Hemat Highway, next to Milad Tower
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Mobile: 9122387577 0098
    Fax:
    Email: Habibi.m@iums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining and comparing the effectiveness of cognitive therapy based on mindfulness and therapy based on reducing anxiety, depression and Internet addiction in adolescents with Internet addiction.
Design
parallel- randomized blined
Settings and conduct
The place is in Tuysarkan city. Educational classes in one of the schools of this city. and conducted by a trained instructor with the permission of the school principal. Some sessions are held in the summer and some in the fall. The students who participate in the research do not know about the effect of the interventions on the desired variables.
Participants/Inclusion and exclusion criteria
Be a first or second high school student. Young's internet addiction test score is 50 or higher and they meet the diagnostic criteria in the clinical interview. Their state anxiety test score should be 43 or above and their trait anxiety score should be above 46. Their depression scale score is above 77. Do not use other psychotherapy services at the same time as participating in the research. They are interested in participating in the research and declare it with a written consent.
Intervention groups
mindfulness-based cognitive therapy group and acceptance and commitment therapy
Main outcome variables
anxiety- depression-internet addiction

General information

Reason for update
Changing the person responsible for answering questions and the person responsible for scientific research
Acronym
IRCT registration information
IRCT registration number: IRCT20230102057027N1
Registration date: 2023-08-19, 1402/05/28
Registration timing: registered_while_recruiting

Last update: 2023-09-23, 1402/07/01
Update count: 2
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Masume Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3494 8425
Email address
bakhtiarimasume@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-29, 1402/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT) on reducing of anxiety and depression in adolescents with Internet addiction
Public title
comparison of the mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT) on reducing of anxiety and depression in adolescents with Internet addiction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be a first or second high school student.Young's internet addiction test score is 50 or higher and they meet the diagnostic criteria in the clinical interview.Their state anxiety test score should be 43 or above and their trait anxiety score should be above 46.Their depression scale score is above 77.Do not use other psychotherapy services at the same time as participating in the research.They are interested in participating in the research and declare it with a written consent.
Exclusion criteria:
After starting the research, they should undergo drug therapy or other psychotherapy.Absence for more than four sessions.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 111
Randomization (investigator's opinion)
Randomized
Randomization description
First, it was announced to all the first and second secondary schools of the city to register students who spend a lot of time on the Internet and are interested in participating in research. 350 students announced their cooperation and were registered. These people, 198 of whom were boys and 152 of whom were girls, responded to Young's Internet Addiction Questionnaire and were subjected to a clinical interview. 328 of them, including 181 boys and 147 girls, who were eligible, were evaluated in the next stage by Spielberger's Trait and State Anxiety Questionnaire and Reynolds' Adolescent Depression Questionnaire. 232 people with anxiety, including 119 boys and 113 girls, and 145 people with depression, including 87 boys and 58 girls, were diagnosed. Then the obtained scores were checked and 111 people including 66 boys and 45 girls who had anxiety and depression at the same time were selected for the sample group and randomly divided into two intervention groups of 37 people including 22 boys and 15 girls in each group and one group A control group of 37 people including 22 boys and 15 girls were assigned.
Blinding (investigator's opinion)
Single blinded
Blinding description
The students participating in the research do not know the effect of the intervention on the research variables.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University - North Tehran branch
Street address
Shahid Babaei Highway - Sadougi St. - Faithful Blvd
City
tehran
Province
Tehran
Postal code
1651153511
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.IAU.TNB.REC.1402.040

Health conditions studied

1

Description of health condition studied
Internet addicted with mild depression and anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
anxiety
Timepoint
pre intervention- a week after intervention- 3 months after intervention
Method of measurement
inventory

2

Description
depression
Timepoint
pre intervention- a week after intervention- 3 months after intervention
Method of measurement
inventory

3

Description
Internet addiction
Timepoint
pre intervention- a week after intervention- 3 months after intervention
Method of measurement
inventory

Secondary outcomes

empty

Intervention groups

1

Description
mindfulness- based cognitive therapy
Category
Rehabilitation

2

Description
acceptance and commtment therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
AZAHRA middle school and high school
Full name of responsible person
masume suri
Street address
serkan- Janbazan square- Shahid Beheshti boulevard
City
tuyserkan
Province
Hamadan
Postal code
6584134194
Phone
+98 81 3493 9334
Email
azahraserkan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad university
Full name of responsible person
dr samane yazdani
Street address
Shahid Babaei highway (west to east), Hakimiya exit, Shahid Sadoughi street, Fafadar Boulevard
City
tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9801
Email
ravabet-omomi@iau-tnb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad university
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
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Habibi asgarabad
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
Habibi.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Habibi asgarabad
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
Habibi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad university
Full name of responsible person
masume bakhtiari
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Psychology
Street address
Shahid Babaei highway (west to east), Hakimiya exit, Shahid Sadoughi street, Fafadar Boulevard
City
tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9801
Email
bakhtiarimasume@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
No - There is not 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
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