NCT05328596

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

March 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
3.3 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

March 9, 2022

Last Update Submit

May 13, 2025

Conditions

Keywords

PsychiatryPsychologyCognitive Behavioural TherapyRandomized Controlled TrialAddictive behaviour

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 24 weeks.

Secondary Outcomes (2)

  • Timeline follow back for gaming (TLFB-GD)

    Up to 12 weeks.

  • Gaming Disorder Test (GDT)

    Up to 24 weeks.

Other Outcomes (9)

  • Patient health´s questionnaire (PHQ-9)

    Up to 24 weeks.

  • Generalized Anxiety Disorder (GAD-7)

    Up to 24 weeks.

  • Brunnsviken Brief Quality of life scale (BBQ)

    Up to 24 weeks.

  • +6 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Wait list control

Interventions

CBT-treatmentBEHAVIORAL

Cognitive Behavioral Treatment for Gaming Disorder.

CBT treatment

No intervention

Wait list control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilling 5 out of 9 criteria for IGD according to DSM V
  • ≥ 16 years of age
  • Can read and speak Swedish fluidly.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for gambling addiction and screen health

Gothenburg, Sweden

Location

Related Publications (2)

  • 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.

  • Hofstedt 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.

MeSH Terms

Conditions

Internet Addiction DisorderBehavior, Addictive

Condition Hierarchy (Ancestors)

Technology AddictionCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Anna Gordh, Ass. Prof

    Mottagning för spelberoende och skärmhälsa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Gordh, Ass. Prof

CONTACT

Elin Arvidson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 14, 2022

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

After publication of data the IPD will be available at request.

Shared Documents
STUDY PROTOCOL
Time Frame
After publication of data.
Access Criteria
Not decided yet.

Locations