CBT Treatment of Internet Gaming Disorder

Study Overview
=================
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.

Official Title
-----------------
Internet Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting

Conditions
-----------------
Internet Gaming Disorder

Intervention / Treatment
-----------------
* Behavioral: CBT treatment
* Behavioral: Wait list control


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT treatment<br>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. | Behavioral: CBT treatment<br>* CBT-treatment<br>|
| Active Comparator: Wait list control<br>The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation. | Behavioral: Wait list control<br>* No intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGDS-SF9 | Change in diagnostic criteria of Internet Gaming Disorder | 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) | 
| Timeline follow back for gaming | Change in time spent on gaming and other activities during the ten week of treatment | Once a week during the treatment period (week 0-10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient health´s questionnaire (PHQ-9) | Change in symptoms of depression | 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) | 
| Generalized Anxiety Disorder (GAD-7) | Change in symptoms of anxiety | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour