Clinical trial NCT06018922: 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
Overall status: RECRUITING
Phase: NA
Conditions: Gaming Disorder
Internet Gaming Disorder
Keywords: Gaming
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: The Gaming Disorder Test (GDT)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
measure: Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
measure: Time spent on gaming in the last week
timeFrame: 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)
measure: Time spent on gaming in the last week during the treatment
timeFrame: Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
measure: Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)
timeFrame: 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)
measure: The Revised Child Anxiety and Depression Scale (RCADS) Youth
timeFrame: 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)
measure: The Revised Child Anxiety and Depression Scale (RCADS) Parent
timeFrame: 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)
measure: The Gaming Addiction Identification Test (GAIT)
timeFrame: 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 outcomes:
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: The Global Assessment of Functioning (GAF)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: Working Alliance Inventory 12 (WAI)
timeFrame: Post treatment: an average of 9 months from baseline (T2);
measure: Difficulties in Emotion Regulation Scale - 16 item (Ders-16)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: Bergen Social Media Addiction Scale
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: Motives for Online Gaming Questionnaire (MOGQ)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: The Alcohol Use Disorders Identification Test (Audit)
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
measure: Drug Use identification list
timeFrame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Region Skåne
state: Skane
Study officials:
affiliation: Region Skåne
name: Emma Claesdotter-Knutsson, MD; PHD
role: STUDY_CHAIR
References: