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临床试验/NCT06018922
NCT06018922已完成不适用

To Evaluate the Effect of a Psychological Treatment for Patients With Gaming Disorder or Hazardous Gaming.

Region Skane1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
68
试验地点
1
主要终点
Time spent on gaming in the last week

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • - 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)

结局指标

主要结局

Time spent on gaming in the last week

时间窗: 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)

Change in time spent on gaming per week

Time spent on gaming in the last week during the treatment

时间窗: Once a week during the treatment period: (Post-assessment to Post-treatment) an average of 25 weeks

Change in time spent on gaming per week during the treatment

Clinical Outcomes in Routine Evaluation - Outcome Measure 34 (Core-OM 34)

时间窗: 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)

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

The Gaming Disorder Test (GDT)

时间窗: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)

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

Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)

时间窗: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)

Change in symptoms of Internet Gaming Disorder. Min: 9 Max: 45 A higher outcome means worse gaming problems

The Revised Child Anxiety and Depression Scale (RCADS) Youth

时间窗: 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)

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

The Revised Child Anxiety and Depression Scale (RCADS) Parent

时间窗: 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)

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

The Gaming Addiction Identification Test (GAIT)

时间窗: At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2); At follow up: 3 months after post treatment (T3)

Change in a parent report measure of problematic gaming in adolescents (For children) Min: 0 Max: 35 A higher outcome means worse gaming problems

次要结局

  • Bergen Social Media Addiction Scale(At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);)
  • Motives for Online Gaming Questionnaire (MOGQ)(At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);)
  • National Opinion Research Center DSM-IV Screen for Gambling: Preoccupation + Escape + Risked Relationships + Chasing (NODS-PERC)(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);)
  • Mini International Neuropsychiatric Interview (MINI)(At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);)
  • The Alcohol Use Disorders Identification Test (Audit)(At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);)
  • Drug Use identification list(At baseline (Timepoint (T) 0); Post treatment: an average of 9 months from baseline (T2);)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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