xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018922</url>
    </required_header>
    <id_info>
      <org_study_id>2021-06666-01</org_study_id>
      <secondary_id>2021-06666-01</secondary_id>
      <nct_id>NCT06018922</nct_id>
    </id_info>
    <brief_title>Psychological Therapy for Gaming Disorder</brief_title>
    <official_title>To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Skane</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Lund University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Skane</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Gaming is a common leisure activity, both for children and adult, and while it is generally a&#xD;
        positive experience for most, it can lead to problems for some individuals. There is&#xD;
        currently a lack of knowledge of when video gaming becomes a problem and why, and there is a&#xD;
        lack of evidence-based interventions for treating Gaming disorder. This pilot study aims to&#xD;
        evaluate a new treatment manual for Gaming Disorder, which consists of modules based on&#xD;
        cognitive behavioral therapy and family therapy. The therapy can be provided as individual&#xD;
        therapy to the patient, to relatives, or as family therapy involving both the patient and&#xD;
        their relatives. This study is an effectiveness trials and will follow all-patients at the&#xD;
        clinic who will be offered the treatment.&#xD;
  &#xD;
        The hypothesis is that the manual-based psychotherapy for Gaming Disorder will result in a&#xD;
        reduction of Gaming Disorder symptoms and psychological distress, as well as an improvement&#xD;
        in daily functioning.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a part of the clinical work at Gamingprojektet Maria Malmö, which is an&#xD;
        outpatient clinic for patients with problematic gaming or Gaming Disorder. The clinic is&#xD;
        focused on young people over 13 years of age and adults with problematic gaming or who meet&#xD;
        the diagnosis of Gaming Disorder.&#xD;
  &#xD;
        The study will aim to evaluate a new treatment that has been developed and are offered at&#xD;
        Gamingprojektet Maria Malmö for patients with a problematic gaming behavior or Gaming&#xD;
        Disorder. Before starting the treatment, they will undergo a semi-structured interview about&#xD;
        their gaming habits, motivation for playing, demographic information, gambling, social&#xD;
        habits, family climate, physical health, and psychiatric comorbidity. This is combined with&#xD;
        self-assessment questionnaires on mental health, social media habits, alcohol use, drug use,&#xD;
        gambling, emotion regulation, and everyday functioning. They will be offered a psychological&#xD;
        treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT). At each&#xD;
        session, they will answer short questions about their well-being, how much they have played&#xD;
        in the past week, and how much their well-being is related to their gaming. After completing&#xD;
        the treatment, the patients will undergo the same semi-structured interview and&#xD;
        questionnaires as pre-treatment. Three months after the treatment has ended, they will be&#xD;
        called for a follow-up, where they will complete questioners about symptoms of Gaming&#xD;
        disorder and psychological wellbeing. The study is conducted fully integrated into regular&#xD;
        clinical practice, which allows for the feasibility and possibilities for implementation to&#xD;
        be studied directly in connection with the study and in relation to treatment outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 20, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Gaming Disorder Test (GDT)</measure>
      <time_frame>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_frame>
      <description>Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)</measure>
      <time_frame>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_frame>
      <description>Change in symptoms of Internet Gaming Disorder. Min: 9 Max: 45 A higher outcome means worse gaming problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time spent on gaming in the last week</measure>
      <time_frame>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_frame>
      <description>Change in time spent on gaming per week</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time spent on gaming in the last week during the treatment</measure>
      <time_frame>Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks</time_frame>
      <description>Change in time spent on gaming per week during the treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)</measure>
      <time_frame>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_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Revised Child Anxiety and Depression Scale (RCADS) Youth</measure>
      <time_frame>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_frame>
      <description>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.&#xD;
  Min: 0 Max: 141 A higher outcome means higher psychological distress</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Revised Child Anxiety and Depression Scale (RCADS) Parent</measure>
      <time_frame>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_frame>
      <description>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.&#xD;
  Min: 0 Max: 141 A higher outcome means higher psychological distress</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Gaming Addiction Identification Test (GAIT)</measure>
      <time_frame>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_frame>
      <description>Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mini International Neuropsychiatric Interview (MINI)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in if the patients meet criteria for common psychiatric diagnoses. The instrument is a brief structured diagnostic interview for the major psychiatric disorders in DSM-5. The children will be administered MINI-KID</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Global Assessment of Functioning (GAF)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in functioning. The instrument is a numeric scale used by clinicians to rate subjectively the functioning of an patient Min: 0 Max: 100 A higher outcome means higher functioning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory 12 (WAI)</measure>
      <time_frame>Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>self-report questionnaire for measuring the quality of the working alliance after the treatment Min: 12 Max: 84 A higher outcome means higher working alliance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale - 16 item (Ders-16)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in difficulties in emotion regulation Min: 16 Max: 80 A higher outcome means more problems with emotion regulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bergen Social Media Addiction Scale</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motives for Online Gaming Questionnaire (MOGQ)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in motives for gaming. The motives are: Escape, Coping, Fantasy, Skill Development, Recreation, Competition, and Social Min: 27 Max: 135. A higher outcome indicate that the patient recognizes himself/herself to a greater extent in the various motives.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in symptoms of gambling disorder Min: 0 Max: 4 A higher outcome means worse gambling problems</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Alcohol Use Disorders Identification Test (Audit)</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug Use identification list</measure>
      <time_frame>At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);</time_frame>
      <description>Change in drug use. By a list to identify use of common substances and frequency of use.&#xD;
  Min: 0 Max: 45. A higher outcome means more problems with drug use</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Gaming Disorder</condition>
    <condition>Internet Gaming Disorder</condition>
    <arm_group>
      <arm_group_label>Psychological therapy for Gaming Disorder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychological treatment</intervention_name>
      <description>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.</description>
      <arm_group_label>Psychological therapy for Gaming Disorder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Can read and speak Swedish fluidly.&#xD;
  &#xD;
            -  ≥ 13 years of age&#xD;
  &#xD;
            -  Are treatment seeking for problematic gaming or Gaming disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Somatic or psychiatric disease that is contraindicating or severely complicates the&#xD;
          implementation of the intervention (e.g., ongoing psychotic, manic or hypomanic episode or&#xD;
          neuropsychiatric condition with severe disability)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emma Claesdotter-Knutsson, MD; PHD</last_name>
      <role>Study Chair</role>
      <affiliation>Region Skåne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Per Bore, Masters</last_name>
      <phone>00460724638625</phone>
      <email>per.bore@skane.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>Region Skåne</name>
        <address>
          <city>Malmö</city>
          <state>Skane</state>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Per Bore, Masters</last_name>
        <phone>0046724638625</phone>
        <email>per.bore@skane.se</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gaming</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Internet Addiction Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After publication of data the IPD will be available at request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>After publication of data</ipd_time_frame>
      <ipd_access_criteria>Not decided yet</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018922
  org study id: 2021-06666-01
  secondary id: 2021-06666-01
  nct id: NCT06018922
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  This study is a part of the clinical work at Gamingprojektet Maria Malmö, which is an
        outpatient clinic for patients with problematic gaming or Gaming Disorder. The clinic is
        focused on young people over 13 years of age and adults with problematic gaming or who meet
        the diagnosis of Gaming Disorder.
  
        The study will aim to evaluate a new treatment that has been developed and are offered at
        Gamingprojektet Maria Malmö for patients with a problematic gaming behavior or Gaming
        Disorder. Before starting the treatment, they will undergo a semi-structured interview about
        their gaming habits, motivation for playing, demographic information, gambling, social
        habits, family climate, physical health, and psychiatric comorbidity. This is combined with
        self-assessment questionnaires on mental health, social media habits, alcohol use, drug use,
        gambling, emotion regulation, and everyday functioning. They will be offered a psychological
        treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT). At each
        session, they will answer short questions about their well-being, how much they have played
        in the past week, and how much their well-being is related to their gaming. After completing
        the treatment, the patients will undergo the same semi-structured interview and
        questionnaires as pre-treatment. Three months after the treatment has ended, they will be
        called for a follow-up, where they will complete questioners about symptoms of Gaming
        disorder and psychological wellbeing. The study is conducted fully integrated into regular
        clinical practice, which allows for the feasibility and possibilities for implementation to
        be studied directly in connection with the study and in relation to treatment outcomes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The Gaming Disorder Test (GDT)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
  description: Change in symptoms of Gaming Disorder Min: 4 Max: 20 A higher outcome means worse gaming problems
  measure: Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
  description: Change in symptoms of Internet Gaming Disorder. Min: 9 Max: 45 A higher outcome means worse gaming problems
  measure: Time spent on gaming in the last week
  time frame: 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)
  description: Change in time spent on gaming per week
  measure: Time spent on gaming in the last week during the treatment
  time frame: Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks
  description: Change in time spent on gaming per week during the treatment
  measure: Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)
  time frame: 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)
  description: 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
  measure: The Revised Child Anxiety and Depression Scale (RCADS) Youth
  time frame: 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)
  description: 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
  measure: The Revised Child Anxiety and Depression Scale (RCADS) Parent
  time frame: 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)
  description: 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
  measure: The Gaming Addiction Identification Test (GAIT)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)
  description: Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems
  measure: Mini International Neuropsychiatric Interview (MINI)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in if the patients meet criteria for common psychiatric diagnoses. The instrument is a brief structured diagnostic interview for the major psychiatric disorders in DSM-5. The children will be administered MINI-KID
  measure: The Global Assessment of Functioning (GAF)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in functioning. The instrument is a numeric scale used by clinicians to rate subjectively the functioning of an patient Min: 0 Max: 100 A higher outcome means higher functioning
  measure: Working Alliance Inventory 12 (WAI)
  time frame: Post treatment: an average of 9 months from baseline (T2);
  description: self-report questionnaire for measuring the quality of the working alliance after the treatment Min: 12 Max: 84 A higher outcome means higher working alliance
  measure: Difficulties in Emotion Regulation Scale - 16 item (Ders-16)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in difficulties in emotion regulation Min: 16 Max: 80 A higher outcome means more problems with emotion regulation
  measure: Bergen Social Media Addiction Scale
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in symptom of social media disorder, Min: 6 Max: 30 A higher outcome means worse social media problems
  measure: Motives for Online Gaming Questionnaire (MOGQ)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in motives for gaming. The motives are: Escape, Coping, Fantasy, Skill Development, Recreation, Competition, and Social Min: 27 Max: 135. A higher outcome indicate that the patient recognizes himself/herself to a greater extent in the various motives.
  measure: National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in symptoms of gambling disorder Min: 0 Max: 4 A higher outcome means worse gambling problems
  measure: The Alcohol Use Disorders Identification Test (Audit)
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in alcohol use Min: 0 Max: 12 A higher outcome means more problems with alcohol use
  measure: Drug Use identification list
  time frame: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);
  description: Change in drug use. By a list to identify use of common substances and frequency of use.
  Min: 0 Max: 45. A higher outcome means more problems with drug use
  arm group label: Psychological therapy for Gaming Disorder
  arm group type: Experimental
  description: They will be offered a module-based psychological treatment that combines Cognitive behavioral therapy (CBT) and Family therapy (FT).
  intervention type: Behavioral
  intervention name: Psychological treatment
  description: 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.
  arm group label: Psychological therapy for Gaming Disorder
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emma Claesdotter-Knutsson, MD; PHD
  role: Study Chair
  affiliation: Region Skåne
  last name: Per Bore, Masters
  phone: 00460724638625
  email: per.bore@skane.se
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Internet Addiction Disorder
  sharing ipd: Yes
  ipd description: After publication of data the IPD will be available at request.
  ipd info type: Study Protocol
  ipd time frame: After publication of data
  ipd access criteria: Not decided yet