A versatile module-based cognitive behavioral remedy for gaming dysfunction: research protocol of a randomized managed trial | Trials

Plans for evaluation and assortment of outcomes {18a}

Several self-report questionnaires and semi-structured diagnostic devices might be used on this trial.

Data might be collected digitally at a number of time-points earlier than, throughout and after the intervention (see Table 2 Timeline). For sufferers who should not capable of entry the digital questionnaire service, it is going to be doable to fill out the questionnaires on paper.

The first evaluation might be accomplished earlier than the preliminary go to to the clinic (T0). The second will happen proper earlier than the beginning of therapy (T1). Measurements will proceed by means of the therapy interval with questionnaires distributed at session 4 (T2) and 9 (finish of therapy) (T3). If the therapy takes longer than anticipated an additional measurement will happen in the course of the therapy interval.

The members might be adopted up by phone three months after the top of therapy. In a subsequent research, the members may even be adopted up after 6, 12, 18 and 24 months, with the identical questionnaires as within the research described on this protocol.

The main consequence measure is:

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

When measuring GD, this is likely one of the most steadily used questionnaires internationally [28]. It relies on the 9 standards for IGD within the DSM-5. There is one query for each criterion, answered on a five-point Likert scale representing “never”, “rarely”, “sometimes”, “often” and “very often”. The rating ranges from 9 to 45 (increased scores mirror extra issues associated to gaming), with a advised medical cut-off at or above 32 [41]. At least 5 of the questions answered with “very often” signifies that the factors for a analysis of IGD have been met [28]. The scale is just not a diagnostic device, however an instrument to evaluate severity of GD. IGDS9-SF has been validated in opposition to weekly gameplay and the IGD-20-test [42] exhibiting good validity and a Cronbach´s alpha of 0.87. In this research, the whole rating is used as a measure of severity of IGD and might be included in any respect time factors from the primary go to (T0) to the follow-up after 3 months (T4). A decrease rating post-treatment in comparison with pre-treatment is seen as a optimistic consequence. For this research, an tailored model might be used, measuring signs over the last 4 weeks.

The secondary outcomes are:

Gaming Disorder Test (GDT)

This four-item questionnaire has been developed from the ICD-11 diagnostic standards of GD [32]. Answers to the questions are given on a 5-point Likert scale starting from 1 to five, representing “never”, “rarely”, “sometimes”, “often” and “very often”. The rating ranges from 4 to twenty, with increased scores indicating the next diploma of gaming issues. To rating “4” or “5” on a query signifies that the criterion is met. As with IGDS9-SF, GDT is just not a diagnostic device, however an instrument to evaluate severity of GD. The Gaming Disorder Test has been validated in opposition to IGDS9-SF (r = 0.82) and has a Cronbach´s alpha of 0.84. For this research an tailored model might be used, measuring signs over the last 4 weeks.

Gaming Disorder Timeline Follow-Back (GD-TLFB)

This gaming-related diary is the third primary consequence measure. It was initially developed to trace alcohol-consumption and has been tailored to measure gaming habits [43]. The tailored model collects measurements on a weekly foundation: variety of days gaming, whole hours of gaming and leisure time with out display (e.g., studying a e-book, assembly buddies, or exercising). The diary might be crammed out weekly throughout therapy to guage the method. It may even be used as a visible device for the members to realize an summary of their gaming habits. The management group may even fill out the gaming diary in the course of the management interval.

Exploratory outcomes are:

Patient Health Questionnaire-9 (PHQ-9)

This questionnaire consists of 9 objects screening for signs of despair over the last two weeks [33]. The 4 response alternate options are “not at all”, “several days”, “more than half of the days” and “nearly every day” with a doable whole rating starting from 0 to 27. The PHQ-9 has been developed in keeping with diagnostic standards within the DSM-4, and the rating can be utilized to evaluate the severity of depressive signs. The inner reliability of PHQ-9 has been proven to be good, with a Cronbach´s alpha of 0.89. Validity was examined in opposition to the Medical Outcomes Study Short-Form General Health Survey (SF-20), and the outcomes confirmed excessive validity. Based on the whole rating the extent of severity is classed as none (0–4), delicate (5–9), average (10–14), reasonably extreme (15–19) or extreme (20–27). PHQ-9 has been proven to have excessive validity in detecting the severity of despair. The whole rating might be used within the analyses to trace variations all through the research. Assessments might be made at each time level (T0-T4).

General Anxiety Disorder 7-Item Scale (GAD-7)

The General Anxiety Disorder-7-Item Scale was developed as an instrument to measure the presence and severity of signs of tension [34]. It is a seven-item questionnaire screening for signs over the last two weeks. The whole rating is 21, with cut-off factors at 5, 10 and 15, indicating minimal (0–4), delicate (5–9), average (10–14) and extreme (15–21) ranges of tension. The response classes for every query are “not at all”, “several days”, “more than half the days” and “nearly every day”. Both inner validity (Cronbach´s alpha 0.92) and take a look at–retest reliability (0.83) have been proven to be good. The whole rating might be assessed at time factors 0 to 4.

National Opinion Research Center DSM-IV Screen for Gambling (NODS-PERC)

This is a brief model of the unique 17-item scale NODS. It was developed primarily based on 4 of the DSM-4 standards for playing dysfunction: preoccupation, escape, chasing losses and social penalties. It is used as a screening device for playing issues and incorporates 4 questions concerning difficulties associated to playing. The questions are answered with “yes” or “no”. If at the very least one query is answered as “yes”, playing issues could also be current [44].

Difficulties in Emotion Regulation Scale (DERS-16)

This is a self-rating scale developed to measure the extent of difficulties in emotion regulation. Answers are given on a five-point Likert scale starting from 1) virtually by no means to five) virtually all the time. The whole rating ranges from 16–80, the place increased scores point out increased ranges of difficulties in emotion regulation. It is constructed on 5 subscales: readability, targets, impulse, methods and non-acceptance. Test–retest reliability is 0.85, and Cronbach´s alpha is between 0.92 and 0.95 [45, 46].

Brunnsviken Brief Quality of Life Scale (BBQ)

The Brunnsviken Brief Quality of Life Scale was developed in Sweden to measure a person´s subjective high quality of life in a medical setting [35]. The questionnaire is split into six completely different life areas equivalent to “view on life”, “creativity” and “friends and friendship”. Each life space is represented by two statements: the primary applies to “satisfaction” and the second applies to “importance”. Both statements are answered on a five-step Likert scale, scored visually from 0–4, with 0 representing “do not agree at all” and 4 “agree completely”. The rating on the “satisfaction” assertion is multiplied with the “importance” assertion. Thus, the whole doable rating is 96, with increased scores indicating increased perceived high quality of life, and with a advised medical cut-off rating at 52.5. The Cronbach´s alpha was 0.76, and the interior validity was proven to be 0.82. The BBQ might be included within the preliminary measurements (T0), post-treatment (T3) and on the 3-month follow-up (T4).

Motives for on-line gaming questionnaire (MOGQ-14)

The Motives for Online Gaming Questionnaire is a self-report instrument measuring motives for gaming [47]. It covers seven completely different motivational elements: social, escape, competitors, coping, talent improvement, fantasy and recreation. The questions are answered on a five-point Likert scale starting from 1 (virtually by no means) to five (more often than not). The questionnaire can be utilized for numerous varieties of video games and has been validated in a Swedish context [48].

Alcohol Use Disorders Identification Test (AUDIT)

The Alcohol Use Disorders Identification Test is a screening device for alcohol associated issues and identifies people with dangerous use of alcohol [49]. It consists of ten objects divided into three areas: alcohol consumption (merchandise 1–3), signs of dependence (merchandise 4–6) and unfavourable penalties of alcohol consumption (merchandise 7–10). Items 1–8 have 5 response alternate options, scored 0 to 4, whereas objects 9 and 10 has three alternate options, scored 0, 2 and 4. The most rating is 40, with a cut-off rating of 6 for girls and eight for males, indicating hazardous or dangerous consuming. The Cronbach´s alpha was 0.82, and take a look at–retest reliability was 0.93. This questionnaire might be administered on the preliminary go to (T0), post-treatment (T3) and at follow-up (T4).

Drug Use Disorders Identification Test (DUDIT)

The Drug Use Disorers Identification Test is a screening device for using medicine and occasions of drug-related penalties [50]. It is an 11-item instrument categorized within the three areas drug use, dependence signs and unfavourable penalties of drug use [50]. Items 1 to 9 have 5 response alternate options scored 0 to 4, and objects 10 and 11 has three alternate options scored 0, 2 and 4. It has a complete doable rating of 44. Clinical cut-offs for problematic use are 1 for girls and three for males, and the Cronbach´s alpha was 0.80. This questionnaire might be distributed on the preliminary go to (T0), post-treatment (T3) and follow-up (T4).

Physical exercise and sedentary behaviour

The stage of bodily exercise and sedentary habits might be evaluated utilizing three questions developed by the Research Group for Physical exercise and Health on the Swedish School of Sport and Health Sciences. These questions are validated in opposition to accelerometer, goal assessments (submaximal oxygen uptake take a look at, steadiness take a look at and vertical leap take a look at) and cardiovascular threat elements. One query measures time spent in train coaching (six response alternate options starting from 0 to greater than 120 min per week), whereas one other query measures time spent in on a regular basis bodily exercise (seven response alternate options starting from 0 to greater than 300 min per week). The final query measures time spent sitting throughout a day (seven response alternate options starting from “almost all day” to “never”) [51]. These questions are advisable by the Swedish National Board of Health and Welfare.

Demographics and gaming-related questions

Information about training, residing scenario, occupation, remedy, gaming-related somatic signs, size and top is obtained, in addition to details about gaming habits. The members are, for instance, requested about most well-liked recreation genres, primary sort of platform used for gaming and therapy targets for gaming.

Scales used solely at baseline (T0):

Adult ADHD Self-Report Scale (ASRS V1.1) Screener

The Adult Self-Report Scale V1.1 Screener is a shorter model of the ASRS V1.1 Symptoms Checklist and is used to establish grownup people with signs of ADHD [52]. It is a six-item instrument, which asks questions on signs of ADHD over the last six months primarily based on signs described within the DSM-4. The instrument makes use of a five-point response scale (0–4) representing “never”, “rarely”, “sometimes”, “often” and “very often” with a complete rating starting from 0 to 24. A cut-off of 14 or above is usually recommended as optimistic for ADHD (0—9: low unfavourable; 10—13: excessive unfavourable; 14—17: low optimistic; 18—24: excessive optimistic). In a research by Kim et al. (2013) the Cronbach´s alpha was proven to be 0.89 and the take a look at–retest reliability was 0.88 [53]. Although it was developed for an grownup inhabitants, the ASRS screener has additionally proven good reliability to be used in adolescents [54].

Ritvo Autism and Asberger Diagnostic Scale (RAADS-14 Screen)

The Ritvo Autism and Asberger Diagnostic Scale is a self-assessment kind screening for autism spectrum syndromes in adults [55]. The scale has three domains: mentalizing deficits, sensory reactivity, and social anxiousness. The response alternate options are: 1) true now and once I was younger, 2) true solely now, 3) true solely once I was younger, and 4) by no means true. The most rating is 42, with a cut-off of 14 indicating signs of autism spectrum dysfunction. The Cronbach´s alpha was above 0.8.

Scale used solely throughout therapy (T2):

Negative Effects Questionnaire (NEQ)

The function of the NEQ is to measure unfavourable or opposed results of psychological therapy, as skilled by the affected person [56]. It incorporates 20 statements linked to experiences from the therapy, for instance, “I felt more worried” and “Unpleasant memories resurfaced”. The statements are answered by “yes” or “no”. If the reply is sure, the assertion is graded on a five-point Likert scale with the response alternate options 0) “not at all”, 1) “slightly”, 2) “moderately”, 3) “very” or 4) “extremely”. The respondent then experiences whether or not the expertise was a results of the therapy or different circumstances. The whole rating ranges from 0 to 80, and may be divided into 5 elements: signs, high quality, stigma, dependency and hopelessness. The reliability has been proven to be good, with a Cronbach´s alpha of 0.95 [57].

Clinical interviews used at screening:

Semi-structured diagnostic interview for gaming dysfunction

This medical interview might be used as a assist for diagnosing GD. It relies on the 9 standards for IGD offered within the DSM-V and is a modified model of a semi-structured interview developed by Vadlin et al. [58]. The proposed cut-off for analysis is fulfilment of 5 or extra standards.

The Mini- International Neuropsychiatric Interview (MINI-7.0.1)

The Mini International Neuropsychiatric Interview is a structured screening interview for widespread psychiatric issues. It has been up to date to mirror the modifications within the DSM-5 [27, 30]. It consists of questions assessing a variety of psychiatric issues together with temper and anxiousness issues, suicide threat, and use of psychoactive substances. It additionally consists of objects assessing ADHD. The Swedish model of this structured medical interview might be used to evaluate psychiatric comorbidity within the evaluation of exclusion standards [59]. It has proven wonderful inter-rater reliability (all kappa values over 0.75) and good take a look at–retest reliability (61% of kappa values over 0.75) [27].

Plans to advertise participant retention and full follow-up {18b}

To encourage the members to finish the follow-ups, they are going to be rewarded with a present card after the post-treatment evaluation (T4). Reminders might be despatched out by SMS earlier than every follow-up. If the participant discontinues participation earlier than finish of research for any motive, they are going to be contacted by phone. Standardized questions might be requested with the intention to full questionnaires equal to these in T3 (see Table 2) in addition to the explanations for discontinuation (non-obligatory).

Data administration {19}

New members might be registered and coded each week. The collected knowledge might be repeatedly entered in IBM SPSS (as soon as a month). All digital knowledge might be saved on a protected server solely accessible by the concerned researchers by means of private identification. Data on paper might be saved for at the very least 25 years. Data high quality might be promoted by means of the automated scoring of questionnaires. Range checks for knowledge values may even be carried out.

Confidentiality {27}

All info collected on paper might be saved in a protected positioned in a locked room, with the important thing saved in a locker that may solely be accessed with a code. The digital questionnaires might be downloaded to a safe server that may solely be accessed by personnel concerned within the trial. Personal knowledge within the dataset might be coded and it’ll not be doable to establish people. The key code might be saved individually in a password protected digital folder. All knowledge might be anonymized.

Plans for assortment, laboratory analysis and storage of organic specimens for genetic or molecular evaluation on this trial/future use {33}

Not relevant. No organic specimens might be used on this research.