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CBT Treatment of Internet Gaming Disorder (IGD RCT)

Primary Purpose

Internet Gaming Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT treatment
Wait list control
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internet Gaming Disorder focused on measuring Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CBT treatment

    Wait list control

    Arm Description

    The CBT-treatment arm includes a review of the patient´s social conditions and overall health. It also includes manual based Cognitive Behavioural Treatment (CBT) in 10 individual sessions.

    The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation.

    Outcomes

    Primary Outcome Measures

    IGDS-SF9
    Change in diagnostic criteria of Internet Gaming Disorder
    Timeline follow back for gaming
    Change in time spent on gaming and other activities during the ten week of treatment

    Secondary Outcome Measures

    Patient health´s questionnaire (PHQ-9)
    Change in symptoms of depression
    Generalized Anxiety Disorder (GAD-7)
    Change in symptoms of anxiety

    Full Information

    First Posted
    March 9, 2022
    Last Updated
    April 6, 2022
    Sponsor
    Sahlgrenska University Hospital, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05328596
    Brief Title
    CBT Treatment of Internet Gaming Disorder
    Acronym
    IGD RCT
    Official Title
    Internet Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sahlgrenska University Hospital, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Internet Gaming Disorder
    Keywords
    Psychiatry, Psychology, Cognitive Behavioural Therapy, Randomized Controlled Trial, Addictive behaviour

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT treatment
    Arm Type
    Experimental
    Arm Description
    The CBT-treatment arm includes a review of the patient´s social conditions and overall health. It also includes manual based Cognitive Behavioural Treatment (CBT) in 10 individual sessions.
    Arm Title
    Wait list control
    Arm Type
    Active Comparator
    Arm Description
    The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CBT treatment
    Intervention Description
    CBT-treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Wait list control
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    IGDS-SF9
    Description
    Change in diagnostic criteria of Internet Gaming Disorder
    Time Frame
    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)
    Title
    Timeline follow back for gaming
    Description
    Change in time spent on gaming and other activities during the ten week of treatment
    Time Frame
    Once a week during the treatment period (week 0-10)
    Secondary Outcome Measure Information:
    Title
    Patient health´s questionnaire (PHQ-9)
    Description
    Change in symptoms of depression
    Time Frame
    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)
    Title
    Generalized Anxiety Disorder (GAD-7)
    Description
    Change in symptoms of anxiety
    Time Frame
    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 Pre-specified Outcome Measures:
    Title
    Brunnsviken Brief Quality of life scale (BBQ)
    Description
    Change in questionnaire for quality of life
    Time Frame
    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)
    Title
    Gaming Addiction Identification Test (GAIT)
    Description
    Change in presence of Internet Gaming Addiction
    Time Frame
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Gordh, Ass. Prof
    Phone
    +46 73 402 02 37
    Email
    anna.gordh@vgregion.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elin Arvidson, PhD
    Phone
    +46730965709
    Email
    elin.arvidson@vgregion.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anna Gordh, Ass. Prof
    Organizational Affiliation
    Mottagning för spelberoende och skärmhälsa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After publication of data the IPD will be available at request.
    IPD Sharing Time Frame
    After publication of data.
    IPD Sharing Access Criteria
    Not decided yet.

    Learn more about this trial

    CBT Treatment of Internet Gaming Disorder

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