search
Back to results

Psychological Therapy for Gaming Disorder

Primary Purpose

Gaming Disorder, Internet Gaming Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Psychological treatment
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gaming Disorder focused on measuring Gaming

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Can read and speak Swedish fluidly. ≥ 13 years of age Are treatment seeking for problematic gaming or Gaming disorder 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)

Sites / Locations

  • Region SkåneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychological therapy for Gaming Disorder

Arm Description

They will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT).

Outcomes

Primary Outcome Measures

The Gaming Disorder Test (GDT)
Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems
Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
Change in symptoms of Internet Gaming Disorder. Min: 9 Max: 45 A higher outcome means worse gaming problems
Time spent on gaming in the last week
Change in time spent on gaming per week
Time spent on gaming in the last week during the treatment
Change in time spent on gaming per week during the treatment
Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)
Change in self-report measure of psychological distress (for the the patients 16 years and older) Min: 0 Max: 136 A higher outcome means higher psychological distress
The Revised Child Anxiety and Depression Scale (RCADS) Youth
Change in self-report measure of psychological distress (For children) a 47-item self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood. Min: 0 Max: 141 A higher outcome means higher psychological distress
The Revised Child Anxiety and Depression Scale (RCADS) Parent
Change in self-report measure of psychological distress (For children) a parent 47-item questionnaire about their children with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood. Min: 0 Max: 141 A higher outcome means higher psychological distress
The Gaming Addiction Identification Test (GAIT)
Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems

Secondary Outcome Measures

Mini International Neuropsychiatric Interview (MINI)
Change in if the patients meet criteria for common psychiatric diagnoses. The instrument is a brief structured diagnostic interview for the major psychiatric disorders in DSM-5. The children will be administered MINI-KID
The Global Assessment of Functioning (GAF)
Change in functioning. The instrument is a numeric scale used by clinicians to rate subjectively the functioning of an patient Min: 0 Max: 100 A higher outcome means higher functioning
Working Alliance Inventory 12 (WAI)
self-report questionnaire for measuring the quality of the working alliance after the treatment Min: 12 Max: 84 A higher outcome means higher working alliance
Difficulties in Emotion Regulation Scale - 16 item (Ders-16)
Change in difficulties in emotion regulation Min: 16 Max: 80 A higher outcome means more problems with emotion regulation
Bergen Social Media Addiction Scale
Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems
Motives for Online Gaming Questionnaire (MOGQ)
Change in motives for gaming. The motives are: Escape, Coping, Fantasy, Skill Development, Recreation, Competition, and Social Min: 27 Max: 135. A higher outcome indicate that the patient recognizes himself/herself to a greater extent in the various motives.
National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)
Change in symptoms of gambling disorder Min: 0 Max: 4 A higher outcome means worse gambling problems
The Alcohol Use Disorders Identification Test (Audit)
Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use
Drug Use identification list
Change in drug use. By a list to identify use of common substances and frequency of use. Min: 0 Max: 45. A higher outcome means more problems with drug use

Full Information

First Posted
June 14, 2023
Last Updated
August 30, 2023
Sponsor
Region Skane
Collaborators
Lund University
search

1. Study Identification

Unique Protocol Identification Number
NCT06018922
Brief Title
Psychological Therapy for Gaming Disorder
Official Title
To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University

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
Gaming is a common leisure activity, both for children and adult, and while it is generally a positive experience for most, it can lead to problems for some individuals. There is currently a lack of knowledge of when video gaming becomes a problem and why, and there is a lack of evidence-based interventions for treating Gaming disorder. This pilot study aims to evaluate a new treatment manual for Gaming Disorder, which consists of modules based on cognitive behavioral therapy and family therapy. The therapy can be provided as individual therapy to the patient, to relatives, or as family therapy involving both the patient and their relatives. This study is an effectiveness trials and will follow all-patients at the clinic who will be offered the treatment. The hypothesis is that the manual-based psychotherapy for Gaming Disorder will result in a reduction of Gaming Disorder symptoms and psychological distress, as well as an improvement in daily functioning.
Detailed Description
This study is a part of the clinical work at Gamingprojektet Maria Malmö, which is an outpatient clinic for patients with problematic gaming or Gaming Disorder. The clinic is focused on young people over 13 years of age and adults with problematic gaming or who meet the diagnosis of Gaming Disorder. The study will aim to evaluate a new treatment that has been developed and are offered at Gamingprojektet Maria Malmö for patients with a problematic gaming behavior or Gaming Disorder. Before starting the treatment, they will undergo a semi-structured interview about their gaming habits, motivation for playing, demographic information, gambling, social habits, family climate, physical health, and psychiatric comorbidity. This is combined with self-assessment questionnaires on mental health, social media habits, alcohol use, drug use, gambling, emotion regulation, and everyday functioning. They will be offered a psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT). At each session, they will answer short questions about their well-being, how much they have played in the past week, and how much their well-being is related to their gaming. After completing the treatment, the patients will undergo the same semi-structured interview and questionnaires as pre-treatment. Three months after the treatment has ended, they will be called for a follow-up, where they will complete questioners about symptoms of Gaming disorder and psychological wellbeing. The study is conducted fully integrated into regular clinical practice, which allows for the feasibility and possibilities for implementation to be studied directly in connection with the study and in relation to treatment outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gaming Disorder, Internet Gaming Disorder
Keywords
Gaming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychological therapy for Gaming Disorder
Arm Type
Experimental
Arm Description
They will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT).
Intervention Type
Behavioral
Intervention Name(s)
Psychological treatment
Intervention Description
The treatment is module-based, and the clinician are supposed to choose a small number of modules to work with depending on the patients need. The individual CBT modules are: 1) Behavioral activation, 2) Accepting thought, 3) Emotion regulation, 4) Impulse control, 5) Procrastination, 6) Relationships, 7) Problem-solving skills, 8) Structuring everyday-life, 9) Diet-Exercise-Sleep, and 10) Social anxiety. The family therapy modules are: 1) Psychoeducation about gaming, 2) Encourage other activities, 3) Positive time together, 4) Expectations and the patients abilities, 5) Making agreements in the family, 6) Emotional validation, and 7) Conflict management.
Primary Outcome Measure Information:
Title
The Gaming Disorder Test (GDT)
Description
Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
Description
Change in symptoms of Internet Gaming Disorder. Min: 9 Max: 45 A higher outcome means worse gaming problems
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
Time spent on gaming in the last week
Description
Change in time spent on gaming per week
Time Frame
At baseline (Timepoint (T) 0); Post assessment: an average of 4 weeks from baseline (T1); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
Time spent on gaming in the last week during the treatment
Description
Change in time spent on gaming per week during the treatment
Time Frame
Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
Title
Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)
Description
Change in self-report measure of psychological distress (for the the patients 16 years and older) Min: 0 Max: 136 A higher outcome means higher psychological distress
Time Frame
At baseline (Timepoint (T) 0); Post assessment: an average of 4 weeks from baseline (T1); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
The Revised Child Anxiety and Depression Scale (RCADS) Youth
Description
Change in self-report measure of psychological distress (For children) a 47-item self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood. Min: 0 Max: 141 A higher outcome means higher psychological distress
Time Frame
At baseline (Timepoint (T) 0); Post assessment: an average of 4 weeks from baseline (T1); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
The Revised Child Anxiety and Depression Scale (RCADS) Parent
Description
Change in self-report measure of psychological distress (For children) a parent 47-item questionnaire about their children with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood. Min: 0 Max: 141 A higher outcome means higher psychological distress
Time Frame
At baseline (Timepoint (T) 0); Post assessment: an average of 4 weeks from baseline (T1); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Title
The Gaming Addiction Identification Test (GAIT)
Description
Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Secondary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview (MINI)
Description
Change in if the patients meet criteria for common psychiatric diagnoses. The instrument is a brief structured diagnostic interview for the major psychiatric disorders in DSM-5. The children will be administered MINI-KID
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
The Global Assessment of Functioning (GAF)
Description
Change in functioning. The instrument is a numeric scale used by clinicians to rate subjectively the functioning of an patient Min: 0 Max: 100 A higher outcome means higher functioning
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
Working Alliance Inventory 12 (WAI)
Description
self-report questionnaire for measuring the quality of the working alliance after the treatment Min: 12 Max: 84 A higher outcome means higher working alliance
Time Frame
Post treatment: an average of 9 months from baseline (T2);
Title
Difficulties in Emotion Regulation Scale - 16 item (Ders-16)
Description
Change in difficulties in emotion regulation Min: 16 Max: 80 A higher outcome means more problems with emotion regulation
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
Bergen Social Media Addiction Scale
Description
Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
Motives for Online Gaming Questionnaire (MOGQ)
Description
Change in motives for gaming. The motives are: Escape, Coping, Fantasy, Skill Development, Recreation, Competition, and Social Min: 27 Max: 135. A higher outcome indicate that the patient recognizes himself/herself to a greater extent in the various motives.
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)
Description
Change in symptoms of gambling disorder Min: 0 Max: 4 A higher outcome means worse gambling problems
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
The Alcohol Use Disorders Identification Test (Audit)
Description
Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Title
Drug Use identification list
Description
Change in drug use. By a list to identify use of common substances and frequency of use. Min: 0 Max: 45. A higher outcome means more problems with drug use
Time Frame
At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Can read and speak Swedish fluidly. ≥ 13 years of age Are treatment seeking for problematic gaming or Gaming disorder 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Bore, Masters
Phone
00460724638625
Email
per.bore@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Claesdotter-Knutsson, MD; PHD
Organizational Affiliation
Region Skåne
Official's Role
Study Chair
Facility Information:
Facility Name
Region Skåne
City
Malmö
State/Province
Skane
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Bore, Masters
Phone
0046724638625
Email
per.bore@skane.se

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

Psychological Therapy for Gaming Disorder

We'll reach out to this number within 24 hrs