Clinical trial NCT05328596: CBT Treatment for Internet Gaming Disorder
Official title: Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet Gaming Disorder
Gaming Disorder
Keywords: Psychiatry
Psychology
Cognitive Behavioural Therapy
Randomized Controlled Trial
Addictive behaviour
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Gaming Disorder (GD). This study will evaluate a new manual for treatment of GD, divided into a number of modules and based on cognitive behavioural therapy (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 twelve weeks of individual CBT-treatment while participants allocated to the control group will be put on a twelve-week wait-list.

The hypothesis is that the manual based CBT treatment will result in a greater reduction in symptoms of criteria for GD.

Detailed description: The study is designed as a two-armed randomized controlled trial. After inclusion, every participant will be offered an overview of the participant´s psychosocial circumstances. Thereafter, the participants will be randomized to one of the two arms.

The main arm includes individual CBT treatment following a module-based manual. The manual includes nine main modules and three optional modules addressing different dimensions of gaming disorder, for example thoughts, emotions, and procrastination. Between every session the participants are working with home assignments, 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.The wait-list control has the same duration as the CBT-arm. After the control-period, participants in the control arm will be offered the same treatment as participants in the intervention arm.

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.

Primary outcomes:
measure: Internet Gaming Disorder Scale- Short Form (IGDS9-SF)
timeFrame: Up to 24 weeks.
Secondary outcomes:
measure: Timeline follow back for gaming (TLFB-GD)
timeFrame: Up to 12 weeks.
measure: Gaming Disorder Test (GDT)
timeFrame: Up to 24 weeks.
Other outcomes:
measure: Patient health´s questionnaire (PHQ-9)
timeFrame: Up to 24 weeks.
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Up to 24 weeks.
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Up to 24 weeks.
measure: Physical activity
timeFrame: Up to 24 weeks.
measure: Motives for Online Gaming Questionnaire (MOGQ)
timeFrame: Up to 24 weeks.
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Up to 24 weeks.
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Up to 24 weeks.
measure: Family APGAR
timeFrame: Up to 12 weeks.
measure: Negative Effects Questionnaire (NEQ)
timeFrame: After treatment completion (up to 12 weeks).
Locations:
city: Gothenburg
country: Sweden
facility: Clinic for gambling addiction and screen health
Study officials:
affiliation: Mottagning för spelberoende och skärmhälsa
name: Anna Gordh, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References: