Evaluation of the effectiveness of ACT psychological therapy on the severity of symptoms of IGD comorbid with ADHD
Design
In this randomized clinical trial with parallel groups, 40 patients were randomly divided into two groups of 20 (case and control). After obtaining informed consent, a demographic questionnaire will be completed for each patient.after reaching the patients to number of 16 (equivalent to 2 groups of 8 individuals), each individual is assigned a specific code by permuted block randomization method and thus individuals are assigned to the intervention and control groups.
Settings and conduct
Adolescents between 13-18 years old with ADHD (under treatment of Ritalin from at least 3 months ago) and IGD are included in the study. for each person, the IGD questionnaire is filled by a psychiatrist before and after the treatment. The score of this questionnaire is considered as an indicator of severity of IGD and is compared for each individual before and after treatment. ACT psychotherapy sessions are held at Kargarnejad Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Entry requirements:
Adolescents with IGD aged 13-18 years who are comorbid with ADHD
Exclusion criteria:
Receive other psychological treatment in the last year and time of research
Other psychiatric disorders other than ADHD
Psychosis
Mental disability
Thoughts and attempted suicide and homicide
Intervention groups
Patients in the intervention group will receive ACT psychotherapy as part of their weekly group sessions (8 person per group) for 8 weeks as they receive ADHD medication. Patients in the control group are treated with ADHD medication and for IGD, psychoeducation is performed on the patient and his family.
Main outcome variables
Severity of Internet Games Disorder Using IGDS-SF9 Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046168N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Fahimeh Moghaddas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 2655
Email address
moghaddas-f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-08, 1398/10/18
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Acceptance and Commitment Therapy (ACT) on severity of Internet Gaming Disorder in 13-18 years old adolescents comorbid with ADHD
Public title
efficacy of ACT treatment on severity of internet gaming disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents between 13-18 years old
Internet gaming disorder
ADHD
Exclusion criteria:
Receive other psychological treatment interventions in the last year and time of research
Psychiatric comorbidities other than ADHD
Psychosis
Mental disability
Thoughts and attempted suicide and homicide
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After diagnosis of psychiatric disorders and evaluation of inclusion and exclusion criteria, and after reaching 16 persons, each individual is assigned a unique code by permuted block randomization method and thus individuals are assigned to intervention and control groups
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 Kashan University of Medical Sciences
Street address
kargarnejad hospital, end of Parastar Blvd, Ghotb ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.121
Health conditions studied
1
Description of health condition studied
Internet Gaming Disorder
ICD-10 code
6C51.0
ICD-10 code description
Gaming Disorder, predominantly online
Primary outcomes
1
Description
IGDS-SF9 questionnaire severity score for internet gaming disorder
Timepoint
Measurement of severity of internet gaming disorder before intervention, at the end of intervention and one month after intervention
Method of measurement
Internet Gaming Disorder Scale–Short-Form 9 questionnaire (IGDS-SF9)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients will receive ACT psychotherapy as part of weekly group sessions for 8 weeks while receiving ritalin medication (at a dose that has been stable for at least three months) and psychoeducation for IGD. These ACT sessions are run by a child and adolescent clinical psychologist trained in the field.
Category
Treatment - Other
2
Description
Control group: these patients undergo psychoeducation for IGD while receiving Ritalin (at a dose that has been stable for at least three months).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
Fahimeh Moghaddas
Street address
Kargarnejad Hospital, end of Parastar Blvd, Ghotb ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 9111
Email
fah_mds@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
research@kaums.ac.ir
Grant name
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
Fahimeh Moghaddas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital, end of parastar Blvd, kilometer 5 qotb ravandi Blvd, kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 2655
Fax
Email
moghaddas-f@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Moghaddas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital, end of parastar Blvd, kilometer 5 qotb ravandi Blvd, kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 2655
Fax
Email
moghaddas-f@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Moghaddas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad hospital, end of parastar Blvd, kilometer 5 qotb ravandi Blvd, kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 2655
Fax
Email
moghaddas-f@kaums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available