NCT06018922

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

June 14, 2023

Last Update Submit

September 2, 2025

Conditions

Keywords

Gaming

Outcome Measures

Primary Outcomes (8)

  • The Gaming Disorder Test (GDT)

    Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems

    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

    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

    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

    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

    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

    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

    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

    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)

    At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);

  • The Global Assessment of Functioning (GAF)

    At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);

  • Working Alliance Inventory 12 (WAI)

    Post treatment: an average of 9 months from baseline (T2);

  • Difficulties in Emotion Regulation Scale - 16 item (Ders-16)

    At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);

  • Bergen Social Media Addiction Scale

    At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);

  • +4 more secondary outcomes

Study Arms (1)

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).

Behavioral: Psychological treatment

Interventions

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.

Psychological therapy for Gaming Disorder

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Can read and speak Swedish fluidly.
  • ≥ 13 years of age
  • Are treatment seeking for problematic gaming or Gaming disorder

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skåne

Malmo, Skåne County, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Emma Claesdotter-Knutsson, MD; PHD

    Region Skåne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

August 31, 2023

Study Start

December 20, 2021

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

September 9, 2025

Record last verified: 2025-08

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