Psychological Therapy for Gaming Disorder

Internet Gaming Disorder Clinical Trial

Official title:

To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018922
• Other study ID #: 2021-06666-01
• Secondary ID: 2021-06666-01
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Region Skane
• Contact: Per Bore, Masters
• Phone: 00460724638625
• Email: per.bore[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gaming Disorder
• Internet Gaming Disorder

Intervention

Behavioral:
• Psychological treatment
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.

Locations

Country	Name	City	State
Sweden	Region Skåne	Malmö	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Gaming Disorder Test (GDT)	Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Primary	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Primary	Time spent on gaming in the last week	Change in time spent on gaming per week	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)
Primary	Time spent on gaming in the last week during the treatment	Change in time spent on gaming per week during the treatment	Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
Primary	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	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)
Primary	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	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)
Primary	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	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)
Primary	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	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	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	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	Post treatment: an average of 9 months from baseline (T2);
Secondary	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	Bergen Social Media Addiction Scale	Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	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.	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	The Alcohol Use Disorders Identification Test (Audit)	Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Secondary	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	At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);