CBT Treatment of Internet Gaming Disorder (IGD RCT)
Primary Purpose
Internet Gaming Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT treatment
Wait list control
Sponsored by
About this trial
This is an interventional treatment trial for Internet Gaming Disorder focused on measuring Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour
Eligibility Criteria
Inclusion Criteria:
- Fulfilling 5 out of 9 criteria for IGD according to DSM V
- ≥ 16 years of age
- Can read and speak Swedish fluidly.
Exclusion Criteria:
- Somatic or psychiatric disease that is contraindicating or severely complicates the implementation of the intervention (e.g., ongoing psychotic, manic or hypomanic episode or neuropsychiatric condition with severe disability)
- Ongoing increased suicide risk that is considered to make it inappropriate for the patient to participate in the study (based on evaluation at the structured clinical interview)
- have another ongoing psychological treatment with a content similar to that in the current study
- plan to start such treatment during the XX weeks that the study is ongoing or has during the last three weeks started or changed medication for any psychiatric problem.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT treatment
Wait list control
Arm Description
The CBT-treatment arm includes a review of the patient´s social conditions and overall health. It also includes manual based Cognitive Behavioural Treatment (CBT) in 10 individual sessions.
The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation.
Outcomes
Primary Outcome Measures
IGDS-SF9
Change in diagnostic criteria of Internet Gaming Disorder
Timeline follow back for gaming
Change in time spent on gaming and other activities during the ten week of treatment
Secondary Outcome Measures
Patient health´s questionnaire (PHQ-9)
Change in symptoms of depression
Generalized Anxiety Disorder (GAD-7)
Change in symptoms of anxiety
Full Information
NCT ID
NCT05328596
First Posted
March 9, 2022
Last Updated
April 6, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05328596
Brief Title
CBT Treatment of Internet Gaming Disorder
Acronym
IGD RCT
Official Title
Internet Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
For most people, gaming is perceived as a positive activity. In some cases, however, gaming may turn into an addiction with consequences for the individual health, quality of life and everyday life. Today, there is a lack of evidence-based interventions to treat this condition, called Internet Gaming Disorder (IGD). This study will evaluate a new manual for treatment of IGD, divided into a number of modules and based on cognitive behavioural treatment (CBT). The study is designed as a randomized controlled trial (RCT) and will be conducted at a clinic specialized in the treatment of gambling and gaming addiction.
Participants included in the study will be randomized to one of to groups. The intervention group will receive ten weeks of individual CBT-treatment while participants allocated to the control group will be offered a number of short weekly interactive psycho educative sessions.
The hypothesis is that the manual based CBT treatment will result in a greater reduction in number of hours spent on gaming and number of criteria for IGD.
Detailed Description
The study is designed as a two-armed randomized controlled trial. After inclusion, every participant will be offered social mapping (overview of the participant´s social circumstances) and a review of the participant´s general health (e.g., other addictions, physical activity and dietary habits). Thereafter, the participants will be randomized to one of the two arms.
The main arm includes individual CBT treatment following a new, module-based manual. The manual includes ten weekly sessions addressing different dimensions of gaming disorder, for example thoughts, emotions, and procrastination. Between every session the participants have home assignments to work with, in order to strengthen helpful behaviours. The participants also report amount of time spent on gaming and other activities every week.
Participants randomized to the control arm also report their time spent on gaming and other activities every week. In connection to the registration of gaming time, they also receive short, interactive psycho educative messengers. The control treatment has the same duration as the main arm. Participants in this group will then be offered the same treatment as participants in the main arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Gaming Disorder
Keywords
Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT treatment
Arm Type
Experimental
Arm Description
The CBT-treatment arm includes a review of the patient´s social conditions and overall health. It also includes manual based Cognitive Behavioural Treatment (CBT) in 10 individual sessions.
Arm Title
Wait list control
Arm Type
Active Comparator
Arm Description
The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation.
Intervention Type
Behavioral
Intervention Name(s)
CBT treatment
Intervention Description
CBT-treatment
Intervention Type
Behavioral
Intervention Name(s)
Wait list control
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
IGDS-SF9
Description
Change in diagnostic criteria of Internet Gaming Disorder
Time Frame
At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)
Title
Timeline follow back for gaming
Description
Change in time spent on gaming and other activities during the ten week of treatment
Time Frame
Once a week during the treatment period (week 0-10)
Secondary Outcome Measure Information:
Title
Patient health´s questionnaire (PHQ-9)
Description
Change in symptoms of depression
Time Frame
At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)
Title
Generalized Anxiety Disorder (GAD-7)
Description
Change in symptoms of anxiety
Time Frame
At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)
Other Pre-specified Outcome Measures:
Title
Brunnsviken Brief Quality of life scale (BBQ)
Description
Change in questionnaire for quality of life
Time Frame
At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)
Title
Gaming Addiction Identification Test (GAIT)
Description
Change in presence of Internet Gaming Addiction
Time Frame
At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfilling 5 out of 9 criteria for IGD according to DSM V
≥ 16 years of age
Can read and speak Swedish fluidly.
Exclusion Criteria:
Somatic or psychiatric disease that is contraindicating or severely complicates the implementation of the intervention (e.g., ongoing psychotic, manic or hypomanic episode or neuropsychiatric condition with severe disability)
Ongoing increased suicide risk that is considered to make it inappropriate for the patient to participate in the study (based on evaluation at the structured clinical interview)
have another ongoing psychological treatment with a content similar to that in the current study
plan to start such treatment during the XX weeks that the study is ongoing or has during the last three weeks started or changed medication for any psychiatric problem.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Gordh, Ass. Prof
Phone
+46 73 402 02 37
Email
anna.gordh@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Elin Arvidson, PhD
Phone
+46730965709
Email
elin.arvidson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Gordh, Ass. Prof
Organizational Affiliation
Mottagning för spelberoende och skärmhälsa
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of data the IPD will be available at request.
IPD Sharing Time Frame
After publication of data.
IPD Sharing Access Criteria
Not decided yet.
Learn more about this trial
CBT Treatment of Internet Gaming Disorder
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