Gaming DisorderNCT06018922
Psychological Therapy for Gaming Disorder
A study testing Psychological treatment in people with Gaming Disorder and Internet Gaming Disorder, run by Region Skane at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Gaming Disorder, Internet Gaming Disorder
- What is being tested?
- Psychological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- 20 Dec 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Can read and speak Swedish fluidly.
- ≥ 13 years of age
- Are treatment seeking for problematic gaming or Gaming disorder
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.
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.
Read the 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.
- Conditions
- Gaming Disorder, Internet Gaming Disorder
- Being tested
- Psychological treatment
- Keywords
- Gaming
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychological therapy for Gaming Disorder | Experimental | They will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT). Receives: Behavioral: Psychological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gaming Disorder Test (GDT)
Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
Time spent on gaming in the last week
Change in time spent on gaming per week
Measured: 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)
Time spent on gaming in the last week during the treatment
Change in time spent on gaming per week during the treatment
Measured: Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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 (9)
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
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
Measured: Post treatment: an average of 9 months from baseline (T2);
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Bergen Social Media Addiction Scale
Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
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.
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
The Alcohol Use Disorders Identification Test (Audit)
Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
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
Measured: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start20 Dec 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Emma Claesdotter-Knutsson, MD; PHD, Study chair, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018922
- Sponsor's protocol ID
- 2021-06666-01
- Other IDs
- 2021-06666-01
- Status last verified
- Aug 2025
- First submitted
- 14 Jun 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of data the IPD will be available at request.
Publications
Bore P, Nilsson S, Andersson M, Oehm K, Attvall J, Hakansson A, Claesdotter-Knutsson E. Effectiveness and Acceptability of Cognitive Behavioral Therapy and Family Therapy for Gaming Disorder: Protocol for a Nonrandomized Intervention Study of a Novel Psychological Treatment. JMIR Res Protoc. 2024 Aug 16;13:e56315. doi: 10.2196/56315.
PubMed 39151165
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.
- ClinicalTrials.gov ID
- NCT06018922
- Acronym / sponsor ID
- 2021-06666-01
- Conditions
- Gaming Disorder, Internet Gaming Disorder
- Keywords
- Gaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological therapy for Gaming Disorder | Experimental | Behavioral: Psychological treatmentThey will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT). |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and speak Swedish fluidly.
- ≥ 13 years of age
- Are treatment seeking for problematic gaming or Gaming disorder
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological treatmentThe 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. | Behavioural | Psychological therapy for Gaming Disorder |
Primary outcome
The Gaming Disorder Test (GDT)
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)
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)
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)
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
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)
Change in time spent on gaming per week
Time spent on gaming in the last week during the treatment
Time frame: Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
Change in time spent on gaming per week during the treatment
Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)
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)
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
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)
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
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)
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)
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)
Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems
9 secondary outcomes
Mini International Neuropsychiatric Interview (MINI)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
The Global Assessment of Functioning (GAF)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Working Alliance Inventory 12 (WAI)
Time frame: Post treatment: an average of 9 months from baseline (T2);
Difficulties in Emotion Regulation Scale - 16 item (Ders-16)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Bergen Social Media Addiction Scale
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Motives for Online Gaming Questionnaire (MOGQ)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
The Alcohol Use Disorders Identification Test (Audit)
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Drug Use identification list
Time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 39151165Bore P, Nilsson S, Andersson M, Oehm K, Attvall J, Hakansson A, Claesdotter-Knutsson E. Effectiveness and Acceptability of Cognitive Behavioral Therapy and Family Therapy for Gaming Disorder: Protocol for a Nonrandomized Intervention Study of a Novel Psychological Treatment. JMIR Res Protoc. 2024 Aug 16;13:e56315. doi: 10.2196/56315.
- Individual participant dataSharing planned: Yes. After publication of data the IPD will be available at request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Claesdotter-Knutsson, MD; PHD study chair
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological treatment in people with Gaming Disorder and Internet Gaming Disorder, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gaming Disorder Test (GDT) (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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.