Internet Gaming DisorderNCT05328596
CBT Treatment for Internet Gaming Disorder
A study testing CBT-treatment in people with Internet Gaming Disorder and Gaming Disorder, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Internet Gaming Disorder, Gaming Disorder
- What is being tested?
- CBT-treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fulfilling 5 out of 9 criteria for IGD according to DSM V
- ≥ 16 years of age
- Can read and speak Swedish fluidly.
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)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Clinic for gambling addiction and screen health
Gothenburg
Elin Arvidson, PhD, +46 730 96 57 09, elin.arvidson@vgregion.se
About this study
Official title: Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
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.
Read the 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.
- Conditions
- Internet Gaming Disorder, Gaming Disorder
- Being tested
- CBT-treatment, Wait list control
- Keywords
- Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour
- Medical subject headings
- Internet Addiction Disorder, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-treatmentBehavioural
Cognitive Behavioral Treatment for Gaming Disorder.
Wait list controlBehavioural
No intervention
| Study group | Role | What they receive |
|---|---|---|
| CBT treatment | Experimental | The CBT-arm includes treatment according to a manual developed to treat GD. The manual is based on nine main and three optional modules. Each module covers different topics identified as problematic for individuals with GD, for example "thoughts" and "feelings". It is possible to adjust the number of modules, in line with the individual plan for every participant.
During the treatment period, the participants report their weekly time spent on gaming, non-gaming screen-time and on other activities. Receives: Behavioral: CBT-treatment |
| Wait list control | Other | Participants randomised to the control-arm is put on a twelve-week wait-list. During this time, the participants will report their weekly time spent on gaming, non-gaming screen-time and on other activities. Receives: Behavioral: Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internet Gaming Disorder Scale- Short Form (IGDS9-SF)
Change in number of diagnostic criteria of Internet Gaming Disorder according to DSM-5. The score ranges from 9 to 45. A higher score indicates more problems related to gaming.
Measured: Up to 24 weeks.
Secondary outcomes (2)
Timeline follow back for gaming (TLFB-GD)
Registration of time spent on gaming and other activities during the twelve weeks of treatment.
Measured: Up to 12 weeks.
Gaming Disorder Test (GDT)
Measures symptoms of GD according to ICD-10. A higher score indiciate a higher risk of GD.
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Internet 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Gordh, Sahlgrenska University Hospital
- Investigators
- Anna Gordh, Ass. Prof, Principal investigator, Mottagning för spelberoende och skärmhälsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328596
- Sponsor's protocol ID
- MSS 2022-IGD RCT
- Status last verified
- May 2025
- First submitted
- 9 Mar 2022
- Last updated
- 16 May 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
Arvidson E, Hofstedt A, Soderpalm Gordh A. A flexible module-based cognitive behavioral therapy for gaming disorder: study protocol of a randomized controlled trial. Trials. 2025 Oct 2;26(1):386. doi: 10.1186/s13063-025-09147-4.
PubMed 41039577Hofstedt A, Mide M, Arvidson E, Ljung S, Mattiasson J, Lindskog A, Soderpalm-Gordh A. Pilot data findings from the Gothenburg treatment for gaming disorder: a cognitive behavioral treatment manual. Front Psychiatry. 2023 Jun 6;14:1162492. doi: 10.3389/fpsyt.2023.1162492. eCollection 2023.
PubMed 37346899
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05328596
- Acronym / sponsor ID
- MSS 2022-IGD RCT
- Conditions
- Internet Gaming Disorder, Gaming Disorder
- Keywords
- Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT treatment | Experimental | Behavioral: CBT-treatmentThe CBT-arm includes treatment according to a manual developed to treat GD. The manual is based on nine main and three optional modules. Each module covers different topics identified as problematic for individuals with GD, for example "thoughts" and "feelings". It is possible to adjust the number of modules, in line with the individual plan for every participant. During the treatment period, the participants report their weekly time spent on gaming, non-gaming screen-time and on other activities. |
| Wait list control | Other | Behavioral: Wait list controlParticipants randomised to the control-arm is put on a twelve-week wait-list. During this time, the participants will report their weekly time spent on gaming, non-gaming screen-time and on other activities. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfilling 5 out of 9 criteria for IGD according to DSM V
- ≥ 16 years of age
- Can read and speak Swedish fluidly.
Key exclusion criteria (4 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)
- 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.
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 |
|---|---|---|
| CBT-treatmentCognitive Behavioral Treatment for Gaming Disorder. | Behavioural | CBT treatment |
| Wait list controlNo intervention | Behavioural | Wait list control |
Primary outcome
Internet Gaming Disorder Scale- Short Form (IGDS9-SF)
Time frame: Up to 24 weeks.
Change in number of diagnostic criteria of Internet Gaming Disorder according to DSM-5. The score ranges from 9 to 45. A higher score indicates more problems related to gaming.
2 secondary outcomes
Timeline follow back for gaming (TLFB-GD)
Time frame: Up to 12 weeks.
Gaming Disorder Test (GDT)
Time frame: Up to 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41039577Arvidson E, Hofstedt A, Soderpalm Gordh A. A flexible module-based cognitive behavioral therapy for gaming disorder: study protocol of a randomized controlled trial. Trials. 2025 Oct 2;26(1):386. doi: 10.1186/s13063-025-09147-4.
- Derived from this study: PubMed 37346899Hofstedt A, Mide M, Arvidson E, Ljung S, Mattiasson J, Lindskog A, Soderpalm-Gordh A. Pilot data findings from the Gothenburg treatment for gaming disorder: a cognitive behavioral treatment manual. Front Psychiatry. 2023 Jun 6;14:1162492. doi: 10.3389/fpsyt.2023.1162492. eCollection 2023.
- 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.
Anna Gordh, Ass. Prof principal investigator
Mottagning för spelberoende och skärmhälsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-treatment in people with Internet Gaming Disorder and Gaming Disorder, run by Sahlgrenska University Hospital 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 4 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: opening soon, as of the sponsor's last update on 16 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Gordh, Ass. Prof (+46 73 402 02 37, anna.gordh@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internet Gaming Disorder Scale- Short Form (IGDS9-SF) (time frame: Up to 24 weeks.). 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 NCT05328596, which also lists 2 linked publications.
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 16 May 2025.