It is a double blind controlled study to test the hypothesis that it's possible to predict the response to naltrexone in Videogame Disorder with the use of Eye Tracking device, during a period of 12 weeks
This will be a double blind controlled study in which the investigators will select a specific sample of individuals diagnosed with a video game disorder representing a picture of genuine dependence on this technology. The sample will be submitted to the use of naltrexone over a period of 12 weeks and it wiil be assessed whether there was a response to this intervention and whether that response can be predicted through attentional bias analysis using the Eye Tracking device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
The patient undergoes an initial admission assessment, including an eye-tracking pattern analysis. During weeks 1 and 2, the patient starts naltrexone 50 mg orally once daily, with a new eye-tracking assessment 1 hour after the first dose. During weeks 3 and 4, an eye-tracking assessment is performed, the medication is switched to oral placebo once daily in the morning, and the assessment is repeated 1 hour after the first dose. During weeks 5 and 6 (washout), a new eye-tracking assessment is conducted and the placebo is maintained once daily. Finally, during weeks 7 to 12 (maintenance), the placebo is replaced by naltrexone 50 mg orally once daily in the morning for 6 weeks, with eye-tracking assessments performed every two weeks.
The patient undergoes an initial admission assessment, including an eye-tracking pattern analysis. During weeks 1 and 2, the patient starts placebo orally once daily, with a new eye-tracking assessment 1 hour after the first dose. During weeks 3 and 4, an eye-tracking assessment is performed, the medication is switched to naltrexone 50 mg orally once daily in the morning, and the assessment is repeated 1 hour after the first dose. During weeks 5 and 6 (washout), a new eye-tracking assessment is conducted and the medication is switched back to placebo once daily in the morning. Finally, during weeks 7 to 12 (maintenance), the placebo is replaced by naltrexone 50 mg orally once daily in the morning for 6 weeks, with eye-tracking assessments performed every two weeks.
Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
RECRUITINGAdpated Internet Gaming Disorder Scale-Short Form (IGDS9-SF)
IGDS9-SF is 9 items scale in which the patient must answer how often he performs a certain behavior in the last 12 months, the score ranges from 9 to 45, patients with 21 points or more are diagnosed with Video Game Disorder according to the Brazilian validation carried out in 2020. As the IGDS9-SF is a diagnostic scale, the adaptations described below were necessary to use it to assess the response to the intervention: * Reduction of the time interval to which the scale questions refer, from 12 months to the last 12 weeks. * Adaptation of the text of each item in order to reflect the interaction with the video game and its repercussions in the last 12 weeks. To validate these changes, the investigators will perform a cross-validation with the Gambling Follow-up Scale adapted for video games described in the next item. The application of the adapted IGDS9-SF will occur at the beginning of the follow-up, before the intervention, and at the end of the intervention.
Time frame: 12 Weeks.
Gambling Follow-Up Scale adapted to Videogames (Gaming Follow-up Scale)
The Gambling Follow-up Scale (GFS) is a self-administered scale of ten items for assessing pathological gamblers throughout treatment. For the use of GFS in this study, the third and fifth questions were excluded, which assessed the financial impact due to gambling, a rare situation in patients with Video Game Disorder (VGD). The eighth question were adapted in order to assess whether the patient had time to dedicate himself to his basic needs, a question that is more congruent to the psychopathology of VGD. And finally, the text of all the questions were adapted by exchanging the word gambling for video games. This adapted scale will be applied at the beginning of patient follow-up, before the intervention, being reapplied in 4 weeks and at the end of the intervention in the 12th week. To validate this adaptation, the investigators will do a cross-validation with the adapted IGDS9-SF scale described in the previous item.
Time frame: 12 Weeks
Gaming Timeline Follow-Back Method (TFB)
TFB is a retrospective interview technique designed to assess alcohol consumption. It has been used in a similar way to address other impulsive behaviors, for example, gambling. In this study it will be used to assess the patient's dedication to the video game. With this technique, the interviewer obtains information about the days and the amount of resources and time invested in the behavior. Initially, the interviewer identifies relevant dates for the patient in this period and uses them as markers that facilitate the recall of information. It helps and encourages the patient to recall, retrospectively, information about episodes of excessive gaming and write them down on a calendar sheet. Thus, a diary of the activity is obtained in the desired period.
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Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8
The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study: * Before taking the first dose of naltrexone or placebo. * One hour after taking the first dose of naltrexone or placebo. * One week after continuous and daily use of naltrexone or placebo. * At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.
Time frame: 12 weeks
Short Impulsive Behavior Scale (UPPS-P)
The Short UPPS-P, like the original UPPS-P, is a Likert scale with 4 possible answers for each item (from Strongly Agree to Strongly Disagree). This scale takes the form of self-report and has 20 items, which then produce scores for the five factors of impulsivity. Each factor ranges from 4 to 16, being the lower values indicative of dysfunctionality. This brief version was successfully validated in English, successfully replicating the internal consistency and the correlations between the factors of the original scale with the benefit of saving about 66% of the time required for application.
Time frame: 12 weeks
Social Adjustment Scale self-report version (SAS)
SAS is considered the most carefully developed social adjustment scale, showing the highest levels of reliability and validity. It is widely used and cited in the scientific literature, being useful to assess social adjustment in a wide variety of populations, both clinical and non-clinical. SAS allows an assessment of social adjustment in seven areas: work outside the home, work at home, studies, social life and leisure, relationship with family, spouse, children, home life and financial situation. It consists of 54 questions with 5 possible answers, with higher scores indicating greater impairment. In this study, it will be used to verify the effect of experimental treatment on social adjustment as a secondary outcome.
Time frame: 12 weeks
Global Clinical Scale
The Global Clinical Scale will be used to assess global severity, considering the frequency and intensity of symptoms. It is applied by a trained person. Its score varies between 1 (normal, not sick) and 7 (extremely sick). The criterion used for improvement (positive response to treatment) is 1 = improved and 2 = greatly improved.
Time frame: 12 weeks
Rotter's Locus of Control Scale
The prediction analysis in this study will be based on individual variation characteristics, more specifically on the internal-external control locus trait, for this the Rotter scale translated and adapted to Brazilian Portuguese will be used. It consists of 29 questions with 2 possible answers, with higher scores indicating External Locus of Control and lower scores indicating Internal Locus of Control
Time frame: 12 weeks
Eye tracking
The purpose of this intervention is to carry out assessments of the visual tracking patterns and verify their correlation with the clinical response of the individuals who underwent the intervention. The slide shows projected in the test will consist of neutral and video game related images. Each attempt will contain two images (video games and neutrals) and will last for 8 seconds, with 25 attempts in total. Each of the four eye tracking sessions will contain an exclusive slide show (that is, new images each time) and the order of presentation will be random. The dependent variables that will be measured will include: total number of fixations, average length of stay and duration of the first fixation in a video game figure.
Time frame: 12 weeks
Mini International Neuropsychiatric Interview (MINI)
Compared with several reference criteria, in different contexts (psychiatric units and primary care centers), this structured diagnostic interview showed psychometric qualities similar to more complex standardized diagnostic interviews and allows a reduction of at least 50% in the evaluation time, with duration 15 to 30 minutes. It will be used in this study to describe and control DSM-IV Axis 1 psychiatric disorders. MINI has a translated and adapted version for Brazil and will be used in this study to control psychiatric comorbidities.
Time frame: 12 weeks
PHQ-9 Patient Health Questionnaire
PHQ-9 is one of the most studied psychometric assessment tools for assessing depression in medicine. It is part of a more comprehensive and entirely self-administered test, the PHQ, developed with the aim of screening for frequent mental disorders in the context of primary care such as depression, alcohol use anxiety, somatoform disorders and eating disorders. PHQ-9 consists of nine questions, which correspond to the DSM-5's nine diagnostic criteria for depression. Each item receives a score from 0 to 3, indicating the frequency of the presence of symptoms in the last two weeks. The total score ranges from 0 to 27 and represents the sum of the responses of the nine items.
Time frame: 12 weeks
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a self-administered scale composed of 21 questions that measure the intensity of anxiety symptoms in the last week (0 = absent to 3 = severe) through descriptive statements and does not aim at diagnostic aspects. The proposed cut-off note for the Portuguese version, in samples from psychiatric patients, suggests: \<10 = minimum; 10-19 = light 20-30 = moderate; 31-63 = severe. This scale will be used in this study to control the associated anxious symptoms.
Time frame: 12 weeks
Ugvalg for Kliniske Undersgelser (UKU) scale of side effects
The UKU is a detailed scale for assessing drug side effects comprising the following 4 groups of psychic, neurological, autonomic and other side effects. Each item is evaluated on a scale from zero (absent) to 3 (severe). For each item, the causal relationship with the medication in use (unlikely, possible and probable) is marked. There is also an item of global assessment of the interference of side effects on the patient's daily performance (0 = no side effects, 3 = side effects markedly interfering with performance). There is also another item that assesses the consequence of interference: from 0 = no action to 3 = discontinuation of medication.
Time frame: 12 weeks