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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05328596
Other study ID # MSS 2022-IGD RCT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date October 2025

Study information

Verified date April 2022
Source Sahlgrenska University Hospital, Sweden
Contact Anna Gordh, Ass. Prof
Phone +46 73 402 02 37
Email anna.gordh@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT treatment
CBT-treatment
Wait list control
No intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Outcome

Type Measure Description Time frame Safety issue
Other Brunnsviken Brief Quality of life scale (BBQ) Change in questionnaire for quality of life 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)
Other Gaming Addiction Identification Test (GAIT) Change in presence of Internet Gaming Addiction 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)
Primary 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)
Primary 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 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)
Secondary 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)
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